The effect of behavioral activation play therapy in adolescents with depression: a study protocol for a randomized controlled trial

The effect of behavioral activation play therapy in adolescents with depression: a study protocol for a randomized controlled trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Study protocol The effect of behavioral activation play therapy in adolescents with depression: a study protocol for a randomized controlled trial Xiaolong Huang, Yuqi Chen, Jiacheng Luo, Wei Luo, Dongdong Wang, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3498407/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 20 Jun, 2024 Read the published version in PLOS ONE → Version 1 posted You are reading this latest preprint version Abstract Background Depression is a common psychological problem in adolescents worldwide. Although the World Health Organization recommends physical activity to reduce depressive symptoms in this population, compliance with this recommendation is often low. Furthermore, although behavioral activation therapy (BAT) is recommended as a treatment for adolescents with depression, the reported effect size is small. Compared with traditional exercises, gamified physical activities (GPA) can be particularly appealing to adolescents because they are considered to be enjoyable experiences. Thereby, they often have good uptake in adolescent populations. In this study, we integrated BAT and GPA to create behavioral activation play therapy (BAPT). We designed a clinical trial to investigate the feasibility, acceptability, and effectiveness of this treatment in adolescents with depression. Methods The study is a randomized controlled trial (RCT) with a single-blind, two-arm design, conducted to validate the effectiveness and applicability of BAPT for adolescent depression. On the basis of conventional treatment and care, we will compare the outcomes of BAPT and BAT. The intervention group and control group will receive nine sessions of BAPT or BAT, respectively. The number of adolescents recruited will be 200, with a 1:1 distribution ratio. Discussion This is the first RCT to explore the effectiveness and adaptability of BAPT in adolescents with depression. This study will provide evidence that may help to decrease depressive symptoms in adolescents, and will demonstrate the treatment effectiveness in terms of increasing levels of physical activity, reducing the rate of non-suicidal self-injury behaviors, and improving sleep quality. We also hope to assess other possible clinical effects of BAPT. Trial registration: Chinese Clinical Trial Register Center, ChiCTR2300072671. Registered on 20 June 2023. Behavioral activation Gamified physical activity Adolescents Depression Randomized controlled trial Protocol Figures Figure 1 Figure 2 Background From 2012 to 2022, the incidence of depression in adolescents increased dramatically [ 1 ]. In 2020, 17.2% and 7.4% of adolescents in China were found to have mild and severe depressive symptoms, respectively, and the lifetime prevalence is expected to be 11–20% [ 2 ]. In 2022, the overall incidence of mental disorders in China was 17.5% [ 3 ]. This included major depressive disorder (MDD), which is one of the most common mental disorders. The high prevalence of depression in adolescents is a public health issue because it can interrupt the developmental process and have negative effects throughout life [ 4 , 5 ]. Adolescent MDD can lead to serious consequences such as dropping out of school, drug use, self-harm, and suicide, and it is the main cause of illness and disability among adolescents. Currently, clinical guidelines recommend psychotherapy and medication for adolescents with depression [6]. However, there exist potential problems with psychotherapy, such as the inaccessibility of cognitive behavioral therapy (CBT), high costs, and minimal effects. Several medications such as fluoxetine and venlafaxine, have the side effects of increasing suicidal thoughts and behaviors in adolescents. In short, some adolescents with depression do not benefit from medication and psychotherapies [7]. Accordingly, effective interventions are an important focus for mental health researchers around the world [8, 9]. In the early 2000s, the World Health Organization (WHO) recommended that children and adolescents engage in physical activity (PA) because of the benefits of improved physical fitness and reduced depressive symptoms [10]. In 2020, the guidelines specified that adolescents should get moderate to high intensity PA for at least 60 minutes per day [11]. Exercise therapy has attracted worldwide attention because of its simplicity and strong effects [12]. For instance, the effects of high and moderate intensity exercise have been shown to be comparable to antidepressant treatment [13]. As a result, physical activity is recommended as the standard treatment for depression by the WHO and the UK National Institute for Health and Care Excellence (NICE) [14]. In recent years, clinicians have held an increasingly positive attitude towards exercise in the treatment of adolescents with MDD [15]. Behavioral activation therapy (BAT), a therapeutic intervention that emphasizes identifying and changing patient behavior patterns to maintain low levels of everyday depressive symptoms, is clinically as effective as cognitive behavioral therapy (CBT) and costs up to 21% less [16]. BAT is safe and acceptable for adolescents, and was recommended as an effective psychotherapy for depression by the WHO. Some researchers have additionally suggested that BAT could be a first-line treatment for depression, given that it can be provided even by inexperienced primary mental health workers [17]. Different behavioral activation (BA) models are based on unique behavioral models of depression [18], and psychotherapists can customize BA according to the needs of individual patients. As a global psychological intervention, BA can reduce depressive symptoms as well as promote mental and physical health. It uses a systematic and hierarchical approach to help patients overcome negative reinforcement associated with avoidance and grasp sources of positive reinforcement existing in the environment. This can help them to reduce non-adaptive behaviors such as social avoidance and promote the return to normal life. Thus, the treatment can function as a short-term structured treatment for depression [19, 20]. BA, including the completion of PA to improve mood, has many benefits as a form of exercise enhancement. It is beneficial for patients with depression to increase their habitual amount of exercise [16]. Studies have shown that BA interventions combined with PA have a high completion rate, and that they can significantly reduce depressive symptoms of patients. BA and PA are highly consistent in terms of techniques and methods, such as self-monitoring, goal setting, and problem-solving techniques. Both interventions have been independently found to be effective strategies for behavioral change, and combining them can overcome the limitations of using each intervention alone, as well as reduce the recurrence rate of depression after treatment [21]. Recent studies have shown that group BA substantially benefited patients with major depression, and it is practical, simple, easy to manage, and cost-effective in the treatment of depression [22]. Although BAT is an effective treatment for adolescents with depression, it is difficult to conduct in the adolescent population and the outcome has been found to be insufficient [23]. Similarly, only 20% of children and adolescents aged 13–15 comply with the WHO's guidance regarding participating in moderate-to-vigorous exercise for at least 60 minutes per day [24]. Given that depression symptoms can decrease motivation for exercise [25], more effective treatment strategies are urgently needed. Studies have shown that interventions that focus on light activity (such as play) may be a practical way to reduce sedentary behavior and depression risk in adolescents [26]. In most adolescents, play is a vital element of PA interventions, and the integration of play-centered activities in the outdoors is likely to be an effective method for increasing the level of PA and improving social connections. Indeed, encouraging adolescents to participate in active, stimulating, and adventurous play could enable them to test their abilities independently, thus improving social resilience [27–29]. Therefore, it is crucial to increase the degree to which physical activities are perceived as pleasurable [30]. Using competition and rewards may help to promote physical activity, along with other more innovative approaches [31]. To date, no empirical studies have verified the effects of interventions that integrate GPA into BAT with the goal of improving depressive symptoms in adolescents with depression in clinical settings in China. As a result, there are no guidelines regarding the parameters of exercise necessary for anti-depressive effects. To address this, our research group integrated BAT and GPA into BAPT, and developed an RCT to evaluate the efficacy of BAPT for treating adolescents with depression. We plan to assess the effectiveness of BAPT in increasing levels of physical activity, reducing non-suicidal self-injury behavior, and ameliorating sleep quality. We also hope to discern the adaptability of this treatment in terms of clinical applications. We hypothesize that BAPT (intervention group) will be more effective than BAT (control group) in relieving depressive symptoms and enhancing treatment adherence in adolescents with depression. Methods and design Study design and setting This study is a two-arm single-blind RCT. The intervention group will receive nine sessions of BAPT and the control group will receive nine sessions of BAT. Because adolescents with depression who are hospitalized generally have a relatively short stay in the hospital, the participants in this study will complete the first four sessions during hospitalization and then will be asked to return to the department for the remaining five sessions after they are discharged. This study was approved by the ethics committee of the Affiliated Brain Hospital of Guangzhou Medical University on April 27, 2023 (Ethics number: 2023 [027]) and registered with the China Clinical Trials Center under the registration number ChiCTR2300072671. The study will be supervised by the Department of Child and Adolescent Psychiatry (DCAP) and the Academic Management Committee of the Affiliated Brain Hospital of Guangzhou Medical University. Recruitment Participants will be recruited at the Department of Child and Adolescent Psychiatry in the Affiliated Brain Hospital of Guangzhou Medical University. Prior to screening, researchers will offer an explanation of the study process to the participants and their legal guardians, along with the significance of the study, risks, and benefits. All participants and their legal guardians will to partake the study voluntarily, as indicated by signing an informed consent form, and will be able to withdraw at any time in the process of the study. The interventions provided in the study will be free of charge. Participants Listed in Table 1 are the inclusion and exclusion criteria for adolescents with depression. The investigator may decide to withdraw participants from the study if they have a medical emergency or their medical condition changes during the study period. Table 1 Inclusion and exclusion criteria Subject eligibility Inclusion criteria Exclusion criteria Met the criteria for a DSM-5 diagnosis of depression without psychotic features; MADRS scores ≥ 12; Age 12–17 years inpatients; Participants with intelligence level in the normal range, normal perception,self-expression ability, can complete the baseline scale assessment; Informed consent is signed by the participants and their legal guardians. Participants with a DSM-5 diagnosis of other mental disorders, including addictive disorders, developmental disorders, bipolar disorder, substance-related disorders and schizophrenia (except anxiety disorders); Participants with severely disruptive or aggressive behaviors, or positive suicidal ideation (suicide item scores of the MADRS > 4); Participants with severe psychotic symptoms (presence of painfulness or common hallucinations and/or delusions); Participants with clinically significant and uncontrolled pulmonary, endocrine, immunological, cardiovascular diseases (judgement based on ancillary examination, physical examination, medical history); According to the research group, participants who could not cooperate with the cognitive function tests or will not be suitable for this study. Abbreviations : DSM-5 : Diagnostic and Statistical Manual of Mental Disorders; MADRS : Montgomery-Asberg Depression Rating Scale. Randomization Random sequences will be generated by a specially recruited staff member, who will use the SPSS Rv.Uniform function to generate a random number table. The random seed parameters and groupings will be sealed as confidential data in an opaque envelope. The random sequence and grouping data will be kept by one designated person, who will open the envelope after the subjects meeting the criteria are selected to enter the study and have signed the informed consent form. The investigator will be informed regarding the participants’ treatment allocation, and the participants will be randomized according to a pre-defined randomization protocol. Blinding This study will use a single-blind approach because in this intervention, the participants and health care professionals cannot be blinded to the study conditions. Therefore, to minimize the impact of information bias, the researcher administering the outcome measurement will be unaware of the group assignment. To maintain researcher blindness regarding group assignment, the same researcher will not conduct follow-up measurements on the same pair of elements. Intervention All interventions will be conducted in a group format and delivered by a psychotherapist. The course of BAPT will include a combination of BAT and GPA. The participants will complete an educational course in which they receive an explanation of the theory of the BAT. BAT interventions were adapted from the protocol of Kellett et al. [32] and Lejuez et al. [33], as well as appropriate modifications according to the actual situation. In the course, participants will receive information about the core principles of BA, which can be summarized as nine topics as follows. (1) Initiation of BA: the sense of values and connection; (2) the BA model and emotional monitoring; (3) getting motivated: goal-oriented behavior; (4) getting activated: situation-action-emotion; (5) problem solving skills; (6) goal setting and adjustment; (7) identifying obstacles and overcoming avoidance; (8) thinking: worrying, ruminating; (9) prevention of recurrence. Each session contains one topic, and there are nine sessions in total. The specific GPA that is related to each topic will be scheduled to take place after the theory session. The BAPT scheme is shown in Table 2. All GPAs are competitive, adventurous, interactive, and follow certain rules that are in line with the physical and mental development characteristics of adolescents [34]. The GPA sessions will be conducted by experienced psychotherapists. For example, “Cat catches mouse” is a type of exciting chase game in which participants are asked to choose one of three roles: one pair of participants are the cat and mouse, while the others are fences. All of the fences form a circle such that the participants are standing about 1 meter apart. The mouse is inside the circle and the cat is outside, and when the game starts, the cat attempts to enter the circle to catch the mouse. To avoid being captured, the mouse can choose a fence by touching that participant. Then, the original fence becomes the cat, the original cat becomes a mouse, and the cycle continues until the cat catches the mouse. The game is interesting and challenging because of the constantly changing roles of the participants in the game. The researchers selected this and the other GPAs after experiencing the activities and rating them as moderately to highly intensely physical via electronic exercise wristbands. Meanwhile, the team prepared a complete risk plan, which passed the review of the ethics committee of the Affiliated Brain Hospital of Guangzhou Medical University. The goal of this plan was to protect the safety of the participants to the greatest extent. After each lesson, the participants will receive homework, and they will be encouraged to schedule activities that are enjoyable, rewarding, and offer a sense of control during the following week. They will also be asked to monitor the impact of these activities on their personal mood. All participants in both the intervention and control groups will use electronic exercise wristbands (Beijing Xiaomi Technology Co., LTD. Product number: Xiaomi Band 7pro, M2140B1) to record the daily intensity of their physical activities, and the researchers will collect this information once per week. The electronic exercise wristbands utilize photocapacitance pulse wave tracing (PPG) and acceleration sensors to measure the intensity of physical activity in adolescents [35-38]. Participants who complete the homework and exercise at a moderate intensity for 150 minutes or above per week will be rewarded with small gifts for activation and positive reinforcement. The electronic exercise wristbands will be purchased by the project team to ensure the consistency of monitoring. During the study period, the participants will only receive conventional clinical medication and care, and will not be involved in any other psychological therapy programs. Table 2 The Scheme of BAPT Time Session Content theoretical courses Gamily physical activities Weeks 1 - 2 (During hospitalization) 1 Initiate BA: the sense of values and connection Strong Winds Blow 2 The model of BA and emotional monitoring Balloon Missile 3 Get motivated: goal-oriented behavior Giant's Hat 4 Get activated: situation-action-emotion Overcome The Obstacle Weeks 3 - 4 (Returning to the department after discharge) 5 Problem solving skills Transmitting Things By Sole 6 Goal’s setting and adjustment Blindfolded Communication 7 Identify obstacles and overcome avoidance Cat Catches Mouse 8 Thinking: worrying, ruminating Knee Pat 9 Prevention of recurrence Queen Ant Game Abbreviations: Weeks 1 - 2: completed the sessions 1 - 4; Weeks 3 - 4: completed the sessions 5 - 9. Intervention Fidelity The BAT or BAPT interventions will be delivered by psychotherapists recruited from the clinical staff of the Affiliated Brain Hospital of Guangzhou Medical University. All psychotherapists will complete a two-week consistency training program, followed by weekly sessions. Group supervision will be conducted by an experienced senior clinical psychologist throughout the study, and all sessions will be recorded so that the treatment adherence can be assessed. Fig.1 represents the research procedure schematically. Control group: BAT The control group will receive nine BAT sessions, twice a week, for 60 minutes each time. This intervention will consists of two parts: (1) the BAT sessions that are 1 hour long; (2) homework, in which the adolescents will be encouraged to schedule activities that are enjoyable, rewarding, and offer a sense of control during the following week. The participants will be asked to monitor the impact of these activities on their personal mood. Intervention group: BAPT The intervention group will receive nine BAPT sessions, twice a week, for 60 minutes each time. This intervention will consist of three parts: (1) the BAT sessions that are 30 minutes long; (2) the GPA sessions immediately after each meeting, for 30 minutes long; and (3) homework, in which the adolescents will be encouraged to schedule activities (social exercise games, etc.) which feel enjoyable, rewarding, and offer a sense of control over the following week, and to monitor the impact of these activities on their personal mood. Safety and monitoring Before each intervention session, the subjects will complete the 10th item of the clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) for suicidal risk. If the scores are > 4, the subjects will be temporarily withdrawn from the study. During the intervention, if the subjects show severe self-injury or suicidal behavior, they also will be temporarily withdrawn from the study. Subsequently, the doctors on the project team will conduct suicide crisis interventions and follow-up visits, organize expert discussions regarding the incident, and make modifications to the intervention for that participant according to the situation to avoid recurrence of similar incidents. Efficacy evaluations From week 0 to week 16, researchers will utilize MADRS scores as a primary outcome to assess changes in depressive symptoms. A total score of 0–60 is obtained by completing 10 items with scores ranging from 0 to 6 [39]. The depressive symptoms will be grouped as extreme, major, moderate, or mild according to the following scores: MADRS > 35, 30 ≤ MADRS < 35, 22 ≤ MADRS < 30, 12 ≤ MADRS < 22, respectively, and MADRS < 12 indicates no depressive symptoms. Compared with the baseline, a MADRS total score reduction of 50% will be defined as a significant antidepressant response, while a reduction of 20% will be defined as an improvement. Secondary outcome measures include: (1) Self-rated depressive symptoms on the Baker Depression Scale, second Chinese version (BDI-II-C): This scale has high internal consistency, and reflects the severity of depression in the past two weeks. It contains 21 items, each rated on a 0–3 scale, with an overall score of 0–63 points. The levels of depression will be grouped as severe, moderate, or mild according to the following ranges of scores: 29–63, 20–28, and 14–19, respectively, and a score of 0–13 will be classified as no depression [40]. (2) Behavioral Activation for Depression Scale Short Form (BADS-SF): This scale consists of nine items that measure changes in behavioral activation during the past week, including the measurement day. The activation (AC) subscale includes questions 1, 2, 3, 4, 5, and 9, while the avoidance (AV) subscale includes questions 6, 7, and 8. The scale uses a 7-level scoring method, which ranges from 0 (not at all) to 6 (completely). A higher score for an item represents an answer that is closer to the item statement. The scale has been demonstrated to have robust reliability and validity [41] (3) Adolescent Non-suicidal Self-injury Assessment Questionnaire (ANSAQ): This questionnaire is divided into two parts: a behavioral questionnaire (12 items) and a functional questionnaire (19 items) to evaluate self-injury behavior [42]. It uses the Likert 5-point scale, where “1 to 5” corresponds with “no, occasionally, sometimes, often, always”, respectively. A higher score represents a more serious degree of self-injury. The questionnaire has high internal consistency, while that of the functional questionnaire was 0.905. In this study, we will only use the behavioral dimension of the questionnaire (12 questions in total) to assess whether the depressed adolescents engage in self-injury behavior. (4) Insomnia Severity Index (ISI): this is used to evaluate the severity of insomnia in patients. Total scores of 0–28 are obtained according to responses to 7 items with scores ranging from 0 to 4 [43]. According to the scoring guide, scores for mild, moderate, and severe clinical insomnia range from 8–14, 15–21, and 22–28, respectively, while scores less than 7 are considered to represent non-clinical insomnia. (5) International Physical Activity Questionnaire-Short Forms (IPAQ-SF): This short form records activity for four intensity levels: 1) vigorous-intensity activity such as aerobics, 2) moderate-intensity activity such as leisure cycling, 3) walking, and 4) sitting [44]. These four intensity levels (except sitting) can be determined and reported as MET-minutes per week. The IPAQ-SF has good internal consistency. (6) Custom 5-point Likert score acceptance questionnaire: to assess the acceptance of the intervention by patients and their families. At the baseline, week 2 (the end of the basic intervention), week 4 (the end of all the high-order intervention), week 8, and week 16, participants from the two groups will be evaluated with the corresponding scales to assess the degree of depression, behavioral activation level, non-suicidal self-injury behavior, and sleep quality scores. We will also calculate the improvement of symptoms for each dimension in each group at each time point, and then compare the divergences between the two groups. Fig. 2 represents the measures and time points of the study. Demographic and clinical data Demographic data (age, sex, occupation, culture, residence, family structure, economic income, etc.), medical expenses, growth history, history of tobacco, alcohol and other psychoactive substance use, sleep status, psychiatric symptoms, length of hospital stay, and diagnosis will be collected during the screening stage. All participants and their families will volunteer to participate and sign informed consent. Auxiliary inspection: Electrocardiograms, routine blood analysis, and biochemical indexes of clinical treatment will be completed at the baseline assessment. BA data acquisition A homework assignment will be given at the end of each session to encourage the participants to take part in one or more behaviors associated with feeling less depressed and to monitor the effect on their individual mood. Homework will be collected by the researchers once per week. Physical activity intensity The Metabolic Equivalent (MET) can be used to express the relative energy metabolism level of physical activity. Depending on the intensity of the exercise, which can be divided into light, medium, or heavy grade, it can be represented by a score of 0–3, 3–6, and more than 6, respectively. The participants will use electronic exercise wristbands to record the daily intensity of their physical activities, and the researchers will collect information once per week. Data management The Case Report Form (CRF) will be utilized to document the demographic information and clinical symptoms of all participants, which will subsequently be stored in the database through a process of double data entry. The primary responsibility of the study leader will be to ensure the integrity, accuracy, and promptness of the data inputting process. In an effort not to disclose the privacy of participants, researchers will remove the names, phone numbers, and addresses that are not related to the study. Numbers will be used to identify the participants. In addition, the original CRF will be securely stored throughout the study and will be accessible to the project leader. A dedicated physician (Prof. Yanling Zhou) will monitor the wholeness, uniformity and plausibility of the data. We have mapped out a complete risk prevention scenario, and once an adverse event occurs, it will be recorded and reported to the ethics committee. The study leader will organize any necessary discussions. Statistical analysis Sample size calculation The depressive symptom scores of the study subjects will be used as the main outcome index, with a bilateral α = 0.05 and a 90% confidence interval. In a previous study on the effects of BA combined with traditional exercise therapy, the depression scores of the intervention group at the baseline and at the 16-week follow-up period were 27.3 ± 8.0 and 16.0 ± 9.5, respectively [45]. Therefore, we expect that the depression score of the experimental group in the present study could be decreased by 11.3 points compared with the baseline and 4.8 points compared with the control group. We used PASS 15 software to calculate the sample size of the experimental group: N1 = N2 = 84. Considering the expectation that 10%­–20% of the cases will be lost during the period following the study, the number of participants needed in the intervention group and control group will be about 100, respectively, with a total of 200 participants. Data analysis The study is based on the intention-to-treat principle. SPSS 28.0 will be used for data analysis. First, to ensure comparability after randomization, we will compare the differences between the groups at the baseline. The continuous variables will be analyzed by a t-test when the data have a normal distribution, and non-normally distributed data will be analyzed using the Mann-Whitney U test. Baseline differences between groups in terms of sociodemographic and clinical variables will be assessed using Chi-square tests for categorical variables and an analysis of variance (ANOVA) for continuous data. To compare intervention effects, a mixed-effect regression model will be used. Group (BAPT or BAT) will be used as an inter-subject factor, and time (baseline, post-treatment, and follow-up) as an intra-subject factor. We will utilize Cohen's d to achieve both the intra- and intergroup analyses. P < 0.05 was set as statistically significant. Discussion A close relationship between physical activities and depression has been repeatedly confirmed by numerous studies. Kandola et al. used objective measures to find that declining levels of light activity and increasing periods of sedentary behavior between the ages of 12 and 16 years were related to greater depressive symptoms at age 18 years. Compared with those with consistently low levels of sedentary behavior, depression scores were 24.9%–28.2% higher in those with consistently high levels of sedentary behavior. Increasing light activity by one hour every day has previously been found to decrease depression scores by 8–11%, and sustained heavy physical activity was also related to lower depression scores [46]. Furthermore, PA, whether low, moderate, or high intensity, was found to be effective in treating mild to moderate depression [18]. Although physical activity can boost mental health, a pooled analysis of 16 million adolescents in more than 140 countries showed low rates of participation in physical activity among adolescents [47], such that nearly 85% of young people in China lacked adequate physical activity. Only approximately 20% of students tested met the standard of one hour of PA per day. In addition, PA levels in adolescents tend to decline with age because of excessive academic pressure, a lack of interest in sports and self-exercise habits, inadequate guidance, changes in leisure and entertainment methods, and insufficient sports venues and equipment [48]. Particularly, adolescents with depression on account of persistent low mood, loss of interest, and other disease symptoms had lower adherence to physical activity guidelines [25]. Many guidelines recommend psychotherapy as an evidence-based treatment for adolescent with depression [49]. Psychotherapy in this group has been found to have a significant effect compared with a control group, but the effect sizes tend to be relatively small [50]. Specifically, the overall response rates for psychotherapy at 2 (±1) months after baseline were only 39% (95% CI: 34–45) and 24% (95% CI: 0.19–28), and over 60% of adolescents who had received relevant psychological treatment did not respond to it [23]. Some researchers analyzed the effects of psychological treatment in individuals with depression across all ages, and found that the effect size was small in adolescents, especially those younger than 13 years, compared with adults [51]. However, it is difficult to estimate the long-term efficacy of psychotherapy. Despite the best efforts of researchers, the current interventions do not adequately satisfy the needs of adolescents with depression [52]. This may be the reason for the small therapeutic effect. Adolescents habitually use some behavioral strategies (rather than cognitive ones) to alleviate depression [53]. A meta-analysis using data from 23 RCTs [53] showed that the pooled standardized mean difference (SMD) for a BA intervention was 0.7, (95% CI -1.20, -0.20), with high heterogeneity (I 2 = 0.79) [53, 54]. These findings indicate that to further reduce the burden of adolescents with depression, effective and innovative treatments are essential. Although studies have demonstrated that BA combined with PA is feasible and acceptable for improving depressive symptoms in adults, no studies have been conducted in adolescents until now. People of different ages may choose different forms of PA. In contrast to traditional forms of PA, adolescents are more inclined to select game forms of PA [34]. BAPT, as an innovative intervention therapy, includes both psychological intervention techniques and GPA, and thus may be more suitable for adolescents. We anticipate that our BAPT intervention study will determine its feasibility and acceptability for adolescents with depression. Furthermore, we will compare the benefits of BAPT with those of BA in terms of improving depressive symptoms, behavioral activation level, and sleep quality, as well as decreasing non-suicidal self-injury in adolescents, and further explore whether BAPT has clinical value. Advantages and limitations This is a preliminary investigation of the effects of a new innovative intervention for depression known as BAPT. This study is the first to compare the intervention effects of BAPT and BAT in adolescents with depression. There are some limitations to this study. First, because of the short hospitalization period, participants are unlikely to complete all the intervention sessions in the hospital. Thus, we will ask them to return to the hospital for the remaining five sessions after they have been discharged. This carries a risk of an increased participant drop-out rate. Second, we will only compare BAPT with BA, but not with traditional exercise. Follow-up studies may compare BAPT with traditional exercise, along with changes in biochemical indicators and imaging data to explore the mechanisms of the BAPT intervention. Conclusion This study is a pragmatic RCT focused on examining the utility of BAPT in improving depression symptoms as an effective adjuvant therapy. We hope to provide evidence for the clinical implementation of a new mental health treatment for adolescents with depression. Future studies should employ larger sample sizes and multi-center clinical trials. Abbreviations MDD: Major depressive disorder; BAT: behavioral activation therapy; GPA: gamified physical activities; BAPT: behavioral activation play therapy; RCT: randomized controlled trial; CBT: cognitive behavioral therapy; WHO: World Health Organization; PA: physical activity; NICE: UK’s National Institute for Health and Care Excellence; BA: behavioral activation; DCAP: Department of Child and Adolescent Psychiatry; MADRS: Montgomery-Asberg Depression Rating Scale; ANSAQ: Adolescent Non-suicidal Self-injury Assessment Questionnaire; BDI-II-C: Baker Depression Scale, second Chinese version; BADS-SF: Behavioral Activation for Depression Scale Short Form; ISI: Insomnia Severity Index; IPAQ-SF: International Physical Activity Questionnaire-Short Forms; MET: metabolic equivalent; CRF: Case Report Form; ITT: intention to treat; SMD: standardized mean difference Declarations Acknowledgments We would like to acknowledge Prof. Liang Zhou and Dr. Shao-Ling Zhong for their guidance in the early stages of the study. Authors’ contributions XLH designed the study protocol and wrote the manuscript, YQC and JCL reviewed and edited the manuscript, YLZ and CJY critically reviewed the manuscript and provided financial support, WL and DDW provided a methodological review for this study. Funding This study was supported by Science and Technology Program of Guangzhou (grant No. 205171098044), Guangzhou Municipal Key Discipline in Medicine (2021-2023), Guangzhou High-level Clinical Key Specialty, and Guangzhou Research-oriented Hospital. Availability of data and materials Not applicable. Ethics approval and consent to participate The study (clinical trial number ChiCTR2300072671) was approved by the Clinical Research Ethics Committee of the Affiliated Brain Hospital of Guangzhou Medical University on April 27, 2023 (Ethics number: 2023 [027]). Prior to participation in this study, all subjects and their legal guardians must be fully informed about the project and sign a written informed consent form. Consent for publication All authors listed have approved the manuscript that is enclosed. Competing interests The authors declared that they have no competing interests Author details 1 The Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou, China. 2 Key Laboratory of Neurogenetics and Channelopathies of Guangdong Province and the Ministry of Education of China, Guangzhou Medical University, Guangzhou, China. 3 Southern Medical University, Guangzhou, China. 4 Guangzhou Medical University, Guangzhou, China. References Thapar A, Eyre O, Patel V, Brent D: Depression in young people. The Lancet 2022, 400(10352):617-631. Press BSSA: China National Mental Health Development Report (2019-2020) Blue Book; 2021. Li F, Cui Y, Li Y, Guo L, Ke X, Liu J, Luo X, Zheng Y, Leckman JF: Prevalence of mental disorders in school children and adolescents in China: diagnostic data from detailed clinical assessments of 17,524 individuals. Journal of child psychology and psychiatry, and allied disciplines 2022, 63(1):34-46. Clayborne ZM, Varin M, Colman I: Systematic Review and Meta-Analysis: Adolescent Depression and Long-Term Psychosocial Outcomes. Journal of the American Academy of Child and Adolescent Psychiatry 2019, 58(1):72-79. Goldstein BI, Korczak DJ: Links Between Child and Adolescent Psychiatric Disorders and Cardiovascular Risk. The Canadian journal of cardiology 2020, 36(9):1394-1405. Summary of the clinical practice guideline for the treatment of depression across three age cohorts. The American psychologist 2022, 77(6):770-780. Oberste M, Medele M, Javelle F, Lioba Wunram H, Walter D, Bloch W, Bender S, Fricke O, Joisten N, Walzik D et al: Physical Activity for the Treatment of Adolescent Depression: A Systematic Review and Meta-Analysis. Frontiers in physiology 2020, 11:185. Patton GC, Coffey C, Romaniuk H, Mackinnon A, Carlin JB, Degenhardt L, Olsson CA, Moran P: The prognosis of common mental disorders in adolescents: a 14-year prospective cohort study. Lancet (London, England) 2014, 383(9926):1404-1411. Thapar A, Collishaw S, Pine DS, Thapar AK: Depression in adolescence. Lancet (London, England) 2012, 379(9820):1056-1067. WHO Guidelines Approved by the Guidelines Review Committee. In: Global Recommendations on Physical Activity for Health. edn. Geneva: World Health Organization.; 2010. WHO Guidelines Approved by the Guidelines Review Committee. In: WHO Guidelines on Physical Activity and Sedentary Behaviour. edn. Geneva: World Health Organization; 2020. Zhang Y, Li G, Liu C, Guan J, Zhang Y, Shi Z: Comparing the efficacy of different types of exercise for the treatment and prevention of depression in youths: a systematic review and network meta-analysis. Frontiers in psychiatry 2023, 14:1199510. Balchin R, Linde J, Blackhurst D, Rauch HL, Schönbächler G: Sweating away depression? The impact of intensive exercise on depression. Journal of affective disorders 2016, 200:218-221. National Institute for Health and Care Excellence: Guidelines. In: Depression in adults: treatment and management. edn. London: National Institute for Health and Care Excellence (NICE); 2022. Radovic S, Melvin GA, Gordon MS: Clinician perspectives and practices regarding the use of exercise in the treatment of adolescent depression. Journal of sports sciences 2018, 36(12):1371-1377. Pass L, Lejuez CW, Reynolds S: Brief Behavioural Activation (Brief BA) for Adolescent Depression: A Pilot Study. Behavioural and cognitive psychotherapy 2018, 46(2):182-194. Richards DA, Ekers D, McMillan D, Taylor RS, Byford S, Warren FC, Barrett B, Farrand PA, Gilbody S, Kuyken W et al: Cost and Outcome of Behavioural Activation versus Cognitive Behavioural Therapy for Depression (COBRA): a randomised, controlled, non-inferiority trial. Lancet (London, England) 2016, 388(10047):871-880. Kanter JW, Callaghan GM, Landes SJ, Busch AM, Brown KR: Behavior analytic conceptualization and treatment of depression: Traditional models and recent advances. The Behavior Analyst Today 2004, 5(3):255-274. Oxford guide to low intensity CBT interventions. New York, NY, US: Oxford University Press; 2010. Jacobson NS, Martell CR, Dimidjian S: Behavioral activation treatment for depression: Returning to contextual roots: Science and Practice. Clinical psychology 2001, 8(3):255-270. Farrand P, Pentecost C, Greaves C, Taylor RS, Warren F, Green C, Hillsdon M, Evans P, Welsman J, Taylor AH: A written self-help intervention for depressed adults comparing behavioural activation combined with physical activity promotion with a self-help intervention based upon behavioural activation alone: study protocol for a parallel group pilot randomised controlled trial (BAcPAc). Trials 2014, 15:196. D'Elia A, Bawor M, Dennis BB, Bhatt M, Litke K, McCabe K, Whattam J, Garrick L, O'Neill L, Simons S et al: Feasibility of behavioral activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial. Pilot and feasibility studies 2020, 6:61. Cuijpers P, Karyotaki E, Ciharova M, Miguel C, Noma H, Stikkelbroek Y, Weisz JR, Furukawa TA: The effects of psychological treatments of depression in children and adolescents on response, reliable change, and deterioration: a systematic review and meta-analysis. European child & adolescent psychiatry 2023, 32(1):177-192. Hallal PC, Andersen LB, Bull FC, Guthold R, Haskell W, Ekelund U: Global physical activity levels: surveillance progress, pitfalls, and prospects. Lancet (London, England) 2012, 380(9838):247-257. Wang DQ, Zhang JJ, Chen JN, Li RY, Luo YX, Deng W: Exergames improves cognitive functions in adolescents with depression: study protocol of a prospective, assessor-blind, randomized controlled trial. BMC psychiatry 2023, 23(1):507. Kandola A, Ashdown-Franks G, Hendrikse J, Sabiston CM, Stubbs B: Physical activity and depression: Towards understanding the antidepressant mechanisms of physical activity. Neuroscience and biobehavioral reviews 2019, 107:525-539. Wray A, Martin G, Ostermeier E, Medeiros A, Little M, Reilly K, Gilliland J: Physical activity and social connectedness interventions in outdoor spaces among children and youth: a rapid review. Health promotion and chronic disease prevention in Canada : research, policy and practice 2020, 40(4):104-115. Brussoni M, Olsen LL, Pike I, Sleet DA: Risky play and children's safety: balancing priorities for optimal child development. International journal of environmental research and public health 2012, 9(9):3134-3148. Thompson Coon J, Boddy K, Stein K, Whear R, Barton J, Depledge MH: Does participating in physical activity in outdoor natural environments have a greater effect on physical and mental wellbeing than physical activity indoors? A systematic review. Environmental science & technology 2011, 45(5):1761-1772. Kagawa F, Yokoyama S, Takamura M, Takagaki K, Mitsuyama Y, Shimizu A, Jinnin R, Ihara H, Kurata A, Okada G et al: Decreased physical activity with subjective pleasure is associated with avoidance behaviors. Scientific reports 2022, 12(1):2832. Ahola R, Pyky R, Jämsä T, Mäntysaari M, Koskimäki H, Ikäheimo TM, Huotari ML, Röning J, Heikkinen HI, Korpelainen R: Gamified physical activation of young men--a Multidisciplinary Population-Based Randomized Controlled Trial (MOPO study). BMC public health 2013, 13:32. Kellett S, Simmonds-Buckley M, Bliss P, Waller G: Effectiveness of Group Behavioural Activation for Depression: A Pilot Study. Behavioural and cognitive psychotherapy 2017, 45(4):401-418. Lejuez CW, Hopko DR, Acierno R, Daughters SB, Pagoto SL: Ten year revision of the brief behavioral activation treatment for depression: revised treatment manual. Behavior modification 2011, 35(2):111-161. Nijhof SL, Vinkers CH, van Geelen SM, Duijff SN, Achterberg EJM, van der Net J, Veltkamp RC, Grootenhuis MA, van de Putte EM, Hillegers MHJ et al: Healthy play, better coping: The importance of play for the development of children in health and disease. Neuroscience and biobehavioral reviews 2018, 95:421-429. Jurado-Castro JM, Gil-Campos M, Llorente-Cantarero FJ: Methods recently used for the assessment of physical activity in children and adolescents. Current opinion in clinical nutrition and metabolic care 2022, 25(5):298-303. Ridgers ND, McNarry MA, Mackintosh KA: Feasibility and Effectiveness of Using Wearable Activity Trackers in Youth: A Systematic Review. JMIR mHealth and uHealth 2016, 4(4):e129. Creaser AV, Clemes SA, Costa S, Hall J, Ridgers ND, Barber SE, Bingham DD: The Acceptability, Feasibility, and Effectiveness of Wearable Activity Trackers for Increasing Physical Activity in Children and Adolescents: A Systematic Review. International journal of environmental research and public health 2021, 18(12). Ridgers ND, Timperio A, Brown H, Ball K, Macfarlane S, Lai SK, Richards K, Mackintosh KA, McNarry MA, Foster M et al: Wearable Activity Tracker Use Among Australian Adolescents: Usability and Acceptability Study. JMIR mHealth and uHealth 2018, 6(4):e86. Montgomery SA, Asberg M: A new depression scale designed to be sensitive to change. The British journal of psychiatry : the journal of mental science 1979, 134:382-389. Wang Z, Yuan C-M, Huang J, Li Z-Z, Chen J, Zhang H-Y, Fang Y-R, Xiao Z-P: Reliability and validity of the Chinese version of Beck Depression Inventory-II among depression patients. In., vol. 25. China: Chinese Mental Health; 2011: 476-480. Shudo Y, Yamamoto T: Assessing the relationship between quality of life and behavioral activation using the Japanese Behavioral Activation for Depression Scale-Short Form. PloS one 2017, 12(9):e0185221. Yuhui W, Wan L, Jiahu H, Fangbiao T, Maternal DO, Childamp, Health AJCJoSH: Development and evaluation on reliability and validity of Adolescent Non-suicidal Self-injury Assessment Questionnaire. 2018. Morin CM: Insomnia: Psychological Assessment and Management. In: 1993; 1993. Craig CL, Marshall AL, Sjöström M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF et al: International physical activity questionnaire: 12-country reliability and validity. Medicine and science in sports and exercise 2003, 35(8):1381-1395. Szuhany KL, Otto MW: Efficacy evaluation of exercise as an augmentation strategy to brief behavioral activation treatment for depression: a randomized pilot trial. Cognitive behaviour therapy 2020, 49(3):228-241. Kandola A, Lewis G, Osborn DPJ, Stubbs B, Hayes JF: Depressive symptoms and objectively measured physical activity and sedentary behaviour throughout adolescence: a prospective cohort study. The lancet Psychiatry 2020, 7(3):262-271. Guthold R, Stevens GA, Riley LM, Bull FC: Global trends in insufficient physical activity among adolescents: a pooled analysis of 298 population-based surveys with 1·6 million participants. The Lancet Child & adolescent health 2020, 4(1):23-35. China Sports Daily:Vigorously develop leisure sports and improve youth physical fitness level [https://www.sport.gov.cn/n20001280/n20745751/n20767239/c21761637/content.html]; Accessed 28 Aug. 2023. Weersing VR, Jeffreys M, Do MT, Schwartz KT, Bolano C: Evidence Base Update of Psychosocial Treatments for Child and Adolescent Depression. Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53 2017, 46(1):11-43. Holmes EA, Ghaderi A, Harmer CJ, Ramchandani PG, Cuijpers P, Morrison AP, Roiser JP, Bockting CLH, O'Connor RC, Shafran R et al: The Lancet Psychiatry Commission on psychological treatments research in tomorrow's science. The lancet Psychiatry 2018, 5(3):237-286. Cuijpers P, Karyotaki E, Eckshtain D, Ng MY, Corteselli KA, Noma H, Quero S, Weisz JR: Psychotherapy for Depression Across Different Age Groups: A Systematic Review and Meta-analysis. JAMA psychiatry 2020, 77(7):694-702. Hankin BL, Griffith JM: What Do We Know About Depression Among Youth and How Can We Make Progress Toward Improved Understanding and Reducing Distress? A New Hope. Clinical child and family psychology review 2023:1-24. Malik K, Ibrahim M, Bernstein A, Venkatesh RK, Rai T, Chorpita B, Patel V: Behavioral Activation as an 'active ingredient' of interventions addressing depression and anxiety among young people: a systematic review and evidence synthesis. BMC psychology 2021, 9(1):150. Martin F, Oliver T: Behavioral activation for children and adolescents: a systematic review of progress and promise. European child & adolescent psychiatry 2019, 28(4):427-441. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Published Journal Publication published 20 Jun, 2024 Read the published version in PLOS ONE → Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3498407","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":245303744,"identity":"6f039a39-cf27-4cab-a5ef-a9786d195e56","order_by":0,"name":"Xiaolong Huang","email":"","orcid":"","institution":"The Affiliated Brain Hospital of Guangzhou Medical University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Xiaolong","middleName":"","lastName":"Huang","suffix":""},{"id":245303745,"identity":"200fa457-65ef-4f76-89f8-48a57933e081","order_by":1,"name":"Yuqi Chen","email":"","orcid":"","institution":"Southern Medical University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Yuqi","middleName":"","lastName":"Chen","suffix":""},{"id":245303747,"identity":"498f0932-19fd-4760-b081-41aa67c35dd0","order_by":2,"name":"Jiacheng Luo","email":"","orcid":"","institution":"Guangzhou Medical University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Jiacheng","middleName":"","lastName":"Luo","suffix":""},{"id":245303750,"identity":"2c2cc625-343c-471b-98e0-22592ce043c4","order_by":3,"name":"Wei Luo","email":"","orcid":"","institution":"The Affiliated Brain Hospital of Guangzhou Medical University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Wei","middleName":"","lastName":"Luo","suffix":""},{"id":245303752,"identity":"6ce86433-ca34-4024-b8cd-04a27764cb37","order_by":4,"name":"Dongdong Wang","email":"","orcid":"","institution":"The Affiliated Brain Hospital of Guangzhou Medical University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Dongdong","middleName":"","lastName":"Wang","suffix":""},{"id":245303754,"identity":"9c8b1b0a-611f-4fcb-ad8d-c71305661a3e","order_by":5,"name":"Chanjuan Yang","email":"","orcid":"","institution":"The Affiliated Brain Hospital of Guangzhou Medical University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Chanjuan","middleName":"","lastName":"Yang","suffix":""},{"id":245303756,"identity":"6e228bb4-a81b-4c6c-910f-1362c994fdf6","order_by":6,"name":"Yanling Zhou","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA2ElEQVRIiWNgGAWjYDACCRBRACTZGxgPJBCvxQBI8hxgIEkLiJHAcIAoHfKzm49J8xhYJG64+fjBgYdth/MY2A8f3YBPC+OcY2lALRKJG26nGRxIbDtczMCTlnYDnxZmiRwzkBZjg9sJYC2JDRI8Zni1sMG13Dz+gTgtPFAtcgY3eIi0RUIiLdlyDlCL5JmcggMJ59IT2wj5RX5G8sEbbyrqePiOH9/48EeZdWI/++FjeLWAABMPkFA4ACQY2YC+I6QcBBh/gKxrADH/EKN+FIyCUTAKRhoAAGrvS5xOIgJ4AAAAAElFTkSuQmCC","orcid":"","institution":"The Affiliated Brain Hospital of Guangzhou Medical University","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Yanling","middleName":"","lastName":"Zhou","suffix":""}],"badges":[],"createdAt":"2023-10-27 09:14:23","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3498407/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3498407/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1371/journal.pone.0304084","type":"published","date":"2024-06-20T16:05:44+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":46027172,"identity":"89b44afa-0ecc-4162-b75e-1666acb331cb","added_by":"auto","created_at":"2023-11-07 17:40:02","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":714000,"visible":true,"origin":"","legend":"\u003cp\u003eResearch flow chart\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAbbreviations: \u003c/strong\u003eCollecting the participants' data of physical intensities every week during the research.\u003c/p\u003e","description":"","filename":"fig.1Researchflowchart.png","url":"https://assets-eu.researchsquare.com/files/rs-3498407/v1/9118e0965b40be665d62b5b0.png"},{"id":46027171,"identity":"3e86d650-95c3-4987-9482-6d507f2cd1a8","added_by":"auto","created_at":"2023-11-07 17:40:02","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":343049,"visible":true,"origin":"","legend":"\u003cp\u003eMeasurements and time points\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAbbreviations:\u003c/strong\u003e\u003cem\u003e \u003c/em\u003e\u003cem\u003e\u003cstrong\u003eBMI\u003c/strong\u003e\u003c/em\u003e: Body Mass Index;\u003cem\u003e\u003cstrong\u003e SCID-5\u003c/strong\u003e\u003c/em\u003e: Structured Clinical lnterview for DSM-V; \u003cem\u003e\u003cstrong\u003eMADRS\u003c/strong\u003e\u003c/em\u003e: Montomery-Asberg Depression Rating Scale; \u003cem\u003e\u003cstrong\u003eBDI-Ⅱ-C\u003c/strong\u003e\u003c/em\u003e: Beck Depression Inventory-China; \u003cem\u003e\u003cstrong\u003eBADS-SF\u003c/strong\u003e\u003c/em\u003e: Behavioral Activation for Depression Scale Short Form; \u003cem\u003e\u003cstrong\u003eANSAQ\u003c/strong\u003e\u003c/em\u003e: Adolescent Non-suicidal Self-injury Assessment Questionnaire; \u003cem\u003e\u003cstrong\u003eISI\u003c/strong\u003e\u003c/em\u003e: Insomnia Severity Index; \u003cem\u003e\u003cstrong\u003eIPAQ-SF\u003c/strong\u003e\u003c/em\u003e: International Physical Activity Scale Short Form; \u003cem\u003e\u003cstrong\u003ePhysical activity intensity\u003c/strong\u003e\u003c/em\u003e: collecting data of calorie consumption (kcal) and metabolic equivalants; \u003cem\u003e\u003cstrong\u003eLikert Scale\u003c/strong\u003e\u003c/em\u003e: to assess the acceptance of the intervention by patients and their families.\u003c/p\u003e","description":"","filename":"Fig.2StudyPeriod.png","url":"https://assets-eu.researchsquare.com/files/rs-3498407/v1/4d192e7bfa164ffac131c741.png"},{"id":58823896,"identity":"49c4a595-1c2c-4f78-8694-509bf05d1ec1","added_by":"auto","created_at":"2024-06-21 17:09:48","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1200988,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3498407/v1/3b3d13e8-9604-4a7b-92b1-a839d10487c5.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"The effect of behavioral activation play therapy in adolescents with depression: a study protocol for a randomized controlled trial","fulltext":[{"header":"Background","content":"\u003cp\u003eFrom 2012 to 2022, the incidence of depression in adolescents increased dramatically [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. In 2020, 17.2% and 7.4% of adolescents in China were found to have mild and severe depressive symptoms, respectively, and the lifetime prevalence is expected to be 11\u0026ndash;20% [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. In 2022, the overall incidence of mental disorders in China was 17.5% [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. This included major depressive disorder (MDD), which is one of the most common mental disorders. The high prevalence of depression in adolescents is a public health issue because it can interrupt the developmental process and have negative effects throughout life [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. Adolescent MDD can lead to serious consequences such as dropping out of school, drug use, self-harm, and suicide, and it is the main cause of illness and disability among adolescents. Currently, clinical guidelines recommend psychotherapy and medication for adolescents with depression [6]. However, there exist potential problems with psychotherapy, such as the inaccessibility of cognitive behavioral therapy (CBT), high costs, and minimal effects. Several medications such as fluoxetine and venlafaxine, have the side effects of increasing suicidal thoughts and behaviors in adolescents. In short, some adolescents with depression do not benefit from medication and psychotherapies [7]. Accordingly, effective interventions are an important focus for mental health researchers around the world [8, 9].\u003c/p\u003e \u003cp\u003eIn the early 2000s, the World Health Organization (WHO) recommended that children and adolescents engage in physical activity (PA) because of the benefits of improved physical fitness and reduced depressive symptoms [10]. In 2020, the guidelines specified that adolescents should get moderate to high intensity PA for at least 60 minutes per day [11]. Exercise therapy has attracted worldwide attention because of its simplicity and strong effects [12]. For instance, the effects of high and moderate intensity exercise have been shown to be comparable to antidepressant treatment [13]. As a result, physical activity is recommended as the standard treatment for depression by the WHO and the UK National Institute for Health and Care Excellence (NICE) [14]. In recent years, clinicians have held an increasingly positive attitude towards exercise in the treatment of adolescents with MDD [15].\u003c/p\u003e \u003cp\u003eBehavioral activation therapy (BAT), a therapeutic intervention that emphasizes identifying and changing patient behavior patterns to maintain low levels of everyday depressive symptoms, is clinically as effective as cognitive behavioral therapy (CBT) and costs up to 21% less [16]. BAT is safe and acceptable for adolescents, and was recommended as an effective psychotherapy for depression by the WHO. Some researchers have additionally suggested that BAT could be a first-line treatment for depression, given that it can be provided even by inexperienced primary mental health workers [17]. Different behavioral activation (BA) models are based on unique behavioral models of depression [18], and psychotherapists can customize BA according to the needs of individual patients. As a global psychological intervention, BA can reduce depressive symptoms as well as promote mental and physical health. It uses a systematic and hierarchical approach to help patients overcome negative reinforcement associated with avoidance and grasp sources of positive reinforcement existing in the environment. This can help them to reduce non-adaptive behaviors such as social avoidance and promote the return to normal life. Thus, the treatment can function as a short-term structured treatment for depression [19, 20].\u003c/p\u003e \u003cp\u003eBA, including the completion of PA to improve mood, has many benefits as a form of exercise enhancement. It is beneficial for patients with depression to increase their habitual amount of exercise [16]. Studies have shown that BA interventions combined with PA have a high completion rate, and that they can significantly reduce depressive symptoms of patients. BA and PA are highly consistent in terms of techniques and methods, such as self-monitoring, goal setting, and problem-solving techniques. Both interventions have been independently found to be effective strategies for behavioral change, and combining them can overcome the limitations of using each intervention alone, as well as reduce the recurrence rate of depression after treatment [21]. Recent studies have shown that group BA substantially benefited patients with major depression, and it is practical, simple, easy to manage, and cost-effective in the treatment of depression [22].\u003c/p\u003e \u003cp\u003eAlthough BAT is an effective treatment for adolescents with depression, it is difficult to conduct in the adolescent population and the outcome has been found to be insufficient [23]. Similarly, only 20% of children and adolescents aged 13\u0026ndash;15 comply with the WHO's guidance regarding participating in moderate-to-vigorous exercise for at least 60 minutes per day [24]. Given that depression symptoms can decrease motivation for exercise [25], more effective treatment strategies are urgently needed.\u003c/p\u003e \u003cp\u003eStudies have shown that interventions that focus on light activity (such as play) may be a practical way to reduce sedentary behavior and depression risk in adolescents [26]. In most adolescents, play is a vital element of PA interventions, and the integration of play-centered activities in the outdoors is likely to be an effective method for increasing the level of PA and improving social connections. Indeed, encouraging adolescents to participate in active, stimulating, and adventurous play could enable them to test their abilities independently, thus improving social resilience [27\u0026ndash;29]. Therefore, it is crucial to increase the degree to which physical activities are perceived as pleasurable [30]. Using competition and rewards may help to promote physical activity, along with other more innovative approaches [31].\u003c/p\u003e \u003cp\u003eTo date, no empirical studies have verified the effects of interventions that integrate GPA into BAT with the goal of improving depressive symptoms in adolescents with depression in clinical settings in China. As a result, there are no guidelines regarding the parameters of exercise necessary for anti-depressive effects. To address this, our research group integrated BAT and GPA into BAPT, and developed an RCT to evaluate the efficacy of BAPT for treating adolescents with depression. We plan to assess the effectiveness of BAPT in increasing levels of physical activity, reducing non-suicidal self-injury behavior, and ameliorating sleep quality. We also hope to discern the adaptability of this treatment in terms of clinical applications. We hypothesize that BAPT (intervention group) will be more effective than BAT (control group) in relieving depressive symptoms and enhancing treatment adherence in adolescents with depression.\u003c/p\u003e"},{"header":"Methods and design","content":"\u003ch3\u003eStudy design and\u0026nbsp;setting\u003c/h3\u003e\n\u003cp\u003eThis study is a two-arm single-blind RCT. The intervention group will receive nine sessions of BAPT and the control group will receive\u0026nbsp;nine sessions of\u0026nbsp;BAT.\u0026nbsp;Because adolescents with depression who are hospitalized generally have a relatively short stay in the hospital, the participants in this study will complete the first four sessions during hospitalization and then will be asked to return to the department for the remaining five sessions after they are discharged.\u003c/p\u003e\n\u003cp\u003eThis study was approved by the ethics committee of the Affiliated Brain Hospital of Guangzhou Medical University on April 27, 2023 (Ethics number: 2023 [027]) and registered with the China Clinical Trials Center under the registration number ChiCTR2300072671. The study will be supervised by the Department of Child and Adolescent Psychiatry (DCAP) and the Academic Management Committee of the Affiliated Brain Hospital of Guangzhou Medical University.\u0026nbsp;\u003c/p\u003e\n\u003ch3\u003eRecruitment\u003c/h3\u003e\n\u003cp\u003eParticipants will be recruited at the Department of Child and Adolescent Psychiatry in\u0026nbsp;the Affiliated Brain Hospital of Guangzhou Medical University. Prior to screening, researchers will offer an explanation of the study process to the participants\u0026nbsp;and their legal guardians, along with the significance of the study, risks, and benefits. All participants and their legal guardians will to partake the study voluntarily, as indicated by signing an informed consent form, and will be able to withdraw at any time in the process of the study.\u0026nbsp;The interventions provided in the study will be free of charge.\u003c/p\u003e\n\u003ch3\u003eParticipants\u003c/h3\u003e\n\u003cp\u003eListed in Table 1 are the inclusion and exclusion criteria for adolescents with depression. The investigator may decide to withdraw participants from the study if they have a medical emergency or their medical condition changes during the study period.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 1\u0026nbsp;\u003c/strong\u003eInclusion and exclusion criteria\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"555\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"100%\" colspan=\"2\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eSubject eligibility\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"10.63063063063063%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eInclusion\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003ecriteria\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eExclusion criteria\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"89.36936936936937%\" valign=\"top\"\u003e\n \u003col\u003e\n \u003cli\u003eMet the criteria for a DSM-5 diagnosis of depression without psychotic features;\u003c/li\u003e\n \u003cli\u003eMADRS scores \u0026ge; 12;\u003c/li\u003e\n \u003cli\u003eAge 12\u0026ndash;17 years inpatients;\u003c/li\u003e\n \u003cli\u003eParticipants with intelligence level in the normal range, normal perception,self-expression ability, can complete the baseline scale assessment;\u003c/li\u003e\n \u003cli\u003eInformed consent is signed by the participants and their legal guardians.\u003c/li\u003e\n \u003cli\u003eParticipants with a DSM-5 diagnosis of other mental disorders, including addictive disorders, developmental disorders, bipolar disorder, substance-related disorders and schizophrenia (except anxiety disorders);\u003c/li\u003e\n \u003cli\u003eParticipants\u0026nbsp;with\u0026nbsp;severely disruptive or aggressive behaviors, or positive suicidal ideation (suicide item scores of the MADRS \u0026gt; 4);\u003c/li\u003e\n \u003cli\u003eParticipants with severe psychotic symptoms (presence of painfulness or common hallucinations and/or delusions);\u003c/li\u003e\n \u003cli\u003eParticipants with clinically significant and uncontrolled pulmonary, endocrine, immunological, cardiovascular diseases (judgement based on ancillary examination, physical examination, medical history);\u003c/li\u003e\n \u003cli\u003eAccording to the research group, participants who could not cooperate with the cognitive function tests or will not be suitable for this study.\u003c/li\u003e\n \u003c/ol\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cstrong\u003eAbbreviations\u003c/strong\u003e: \u003cstrong\u003e\u003cem\u003eDSM-5\u003c/em\u003e\u003c/strong\u003e: Diagnostic and Statistical Manual of Mental Disorders; \u003cstrong\u003e\u003cem\u003eMADRS\u003c/em\u003e\u003c/strong\u003e: Montgomery-Asberg Depression Rating Scale.\u003c/p\u003e\n\u003ch3\u003eRandomization\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eRandom sequences will be generated by a specially recruited staff member, who will use the SPSS Rv.Uniform function to generate a random number table. The random seed parameters and groupings will be sealed as confidential data in an opaque envelope. The random sequence and grouping data will be kept by one designated person, who will open the envelope after the subjects meeting the criteria are selected to enter the study and have signed the informed consent form. The investigator will be informed regarding the participants\u0026rsquo; treatment allocation, and the participants will be randomized according to a pre-defined randomization protocol.\u0026nbsp;\u003c/p\u003e\n\u003ch3\u003e\u0026nbsp;Blinding\u003c/h3\u003e\n\u003cp\u003eThis study will use a single-blind approach because in this intervention, the participants and health care professionals cannot be blinded to the study conditions. Therefore, to minimize the impact of information bias, the researcher administering the outcome measurement will be unaware of the group assignment. To maintain researcher blindness regarding group assignment, the same researcher will not conduct follow-up measurements on the same pair of elements.\u003c/p\u003e\n\u003ch3\u003eIntervention\u003c/h3\u003e\n\u003cp\u003eAll interventions will be conducted in a group format and delivered by a psychotherapist.\u0026nbsp;The course of BAPT will include a combination of\u0026nbsp;BAT\u0026nbsp;and\u0026nbsp;GPA.\u0026nbsp;The participants will complete an educational course in which they receive an explanation of the theory of the\u0026nbsp;BAT. BAT interventions were adapted from\u0026nbsp;the protocol\u0026nbsp;of\u0026nbsp;Kellett et al.\u0026nbsp;[32]\u0026nbsp;and Lejuez et al.\u0026nbsp;[33],\u0026nbsp;as well as appropriate modifications according to the actual situation.\u0026nbsp;In the course, participants will receive information about the core principles of\u0026nbsp;BA, which can be summarized\u0026nbsp;as nine topics as follows. (1)\u0026nbsp;Initiation of BA: the sense of values and\u0026nbsp;connection; (2) the BA model and\u0026nbsp;emotional monitoring;\u0026nbsp;(3) getting motivated: goal-oriented behavior;\u0026nbsp;(4) getting activated: situation-action-emotion;\u0026nbsp;(5)\u0026nbsp;problem solving skills;\u0026nbsp;(6) goal setting and adjustment;\u0026nbsp;(7)\u0026nbsp;identifying obstacles and overcoming avoidance;\u0026nbsp;(8)\u0026nbsp;thinking: worrying, ruminating;\u0026nbsp;(9)\u0026nbsp;prevention of recurrence. Each session contains one topic, and there are nine sessions in total. The specific\u0026nbsp;GPA\u0026nbsp;that is related to each topic will be scheduled to take place after the theory session. The BAPT scheme is shown in Table\u0026nbsp;2.\u0026nbsp;All GPAs are competitive, adventurous, interactive, and follow certain rules that are in line with the physical and mental development characteristics of adolescents\u0026nbsp;[34]. The GPA sessions will be\u0026nbsp;conducted\u0026nbsp;by experienced psychotherapists. For example,\u0026nbsp;\u0026ldquo;Cat catches mouse\u0026rdquo;\u0026nbsp;is a type of exciting chase game in which participants are asked to choose one of three roles:\u0026nbsp;one pair of participants are the cat and mouse, while the others are fences. All of the fences form a circle such that the participants are standing about 1 meter apart. The mouse is inside the circle and the cat is outside, and when the game starts, the cat attempts to enter the circle to catch the mouse. To avoid being captured, the mouse can choose a fence by touching that participant. Then, the original fence becomes the cat, the original cat becomes a mouse, and the cycle continues until the cat catches the mouse. The game is\u0026nbsp;interesting\u0026nbsp;and challenging because of the constantly changing roles of the participants in the game. The researchers\u0026nbsp;selected this and the other GPAs after experiencing the activities and rating them\u0026nbsp;as moderately to highly intensely physical via electronic exercise wristbands.\u0026nbsp;Meanwhile, the team prepared a complete risk plan, which passed the review of the ethics committee of the Affiliated Brain Hospital of Guangzhou Medical University. The goal of this plan was to protect the safety of the participants to the greatest extent.\u0026nbsp;After each lesson, the participants will receive homework,\u0026nbsp;and they\u0026nbsp;will be\u0026nbsp;encouraged\u0026nbsp;to schedule activities\u0026nbsp;that are\u0026nbsp;enjoyable, rewarding,\u0026nbsp;and offer a sense of\u0026nbsp;control\u0026nbsp;during the following week. They will also be asked\u0026nbsp;to monitor the impact of these activities on their personal mood.\u003c/p\u003e\n\u003cp\u003eAll participants in both the intervention and control groups will use electronic exercise wristbands (Beijing Xiaomi Technology Co., LTD. Product number: Xiaomi Band 7pro, M2140B1) to record the daily intensity of their physical activities, and the researchers will collect this information once per week. The electronic exercise wristbands utilize photocapacitance pulse wave tracing (PPG) and acceleration sensors to measure the intensity of physical activity in adolescents [35-38]. Participants who complete the homework and exercise at a moderate intensity for 150 minutes or above per week will be rewarded with small gifts for activation and positive reinforcement. The electronic exercise wristbands will be purchased by the project team to ensure the consistency of monitoring.\u003c/p\u003e\n\u003cp\u003eDuring the study period, the participants will only receive conventional clinical medication and care, and will not be involved in any other psychological therapy programs.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 2\u003c/strong\u003e The Scheme of BAPT\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"553\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"16.817359855334537%\" valign=\"top\"\u003e\n \u003cp\u003eTime\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.1374321880651%\" valign=\"top\"\u003e\n \u003cp\u003eSession\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"44.30379746835443%\" valign=\"top\"\u003e\n \u003cp\u003eContent theoretical courses\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"30.741410488245933%\" valign=\"top\"\u003e\n \u003cp\u003eGamily physical activities\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"16.817359855334537%\" rowspan=\"4\" valign=\"top\"\u003e\n \u003cp\u003eWeeks 1 - 2\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e(During hospitalization)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.1374321880651%\" valign=\"top\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"44.30379746835443%\" valign=\"top\"\u003e\n \u003cp\u003eInitiate BA: the sense of values and connection\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"30.741410488245933%\" valign=\"top\"\u003e\n \u003cp\u003eStrong Winds Blow\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.782608695652174%\" valign=\"top\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"53.26086956521739%\" valign=\"top\"\u003e\n \u003cp\u003eThe model of BA and emotional monitoring\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"36.95652173913044%\" valign=\"top\"\u003e\n \u003cp\u003eBalloon Missile\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.782608695652174%\" valign=\"top\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"53.26086956521739%\" valign=\"top\"\u003e\n \u003cp\u003eGet motivated: goal-oriented behavior\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"36.95652173913044%\" valign=\"top\"\u003e\n \u003cp\u003eGiant\u0026apos;s Hat\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.782608695652174%\" valign=\"top\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"53.26086956521739%\" valign=\"top\"\u003e\n \u003cp\u003eGet activated: situation-action-emotion\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"36.95652173913044%\" valign=\"top\"\u003e\n \u003cp\u003eOvercome The Obstacle\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"16.817359855334537%\" rowspan=\"5\" valign=\"top\"\u003e\n \u003cp\u003eWeeks 3 - 4\u003c/p\u003e\n \u003cp\u003e(Returning to the\u003c/p\u003e\n \u003cp\u003edepartment after\u003c/p\u003e\n \u003cp\u003edischarge)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"8.1374321880651%\" valign=\"top\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"44.30379746835443%\" valign=\"top\"\u003e\n \u003cp\u003eProblem solving skills\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"30.741410488245933%\" valign=\"top\"\u003e\n \u003cp\u003eTransmitting Things By Sole\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.782608695652174%\" valign=\"top\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"53.26086956521739%\" valign=\"top\"\u003e\n \u003cp\u003eGoal\u0026rsquo;s setting and adjustment\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"36.95652173913044%\" valign=\"top\"\u003e\n \u003cp\u003eBlindfolded Communication\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.782608695652174%\" valign=\"top\"\u003e\n \u003cp\u003e7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"53.26086956521739%\" valign=\"top\"\u003e\n \u003cp\u003eIdentify obstacles and overcome avoidance\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"36.95652173913044%\" valign=\"top\"\u003e\n \u003cp\u003eCat Catches Mouse\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.782608695652174%\" valign=\"top\"\u003e\n \u003cp\u003e8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"53.26086956521739%\" valign=\"top\"\u003e\n \u003cp\u003eThinking: worrying, ruminating\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"36.95652173913044%\" valign=\"top\"\u003e\n \u003cp\u003eKnee Pat\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.782608695652174%\" valign=\"top\"\u003e\n \u003cp\u003e9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"53.26086956521739%\" valign=\"top\"\u003e\n \u003cp\u003ePrevention of recurrence\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"36.95652173913044%\" valign=\"top\"\u003e\n \u003cp\u003eQueen Ant Game\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cstrong\u003eAbbreviations:\u0026nbsp;\u003c/strong\u003eWeeks 1 - 2: completed the sessions 1 - 4; Weeks 3 - 4: completed the sessions 5 - 9.\u003c/p\u003e\n\u003ch3\u003eIntervention Fidelity\u003c/h3\u003e\n\u003cp\u003eThe BAT or BAPT interventions will be delivered by psychotherapists recruited from the clinical staff of the Affiliated Brain Hospital of Guangzhou Medical University. All psychotherapists will complete a two-week consistency training program, followed by weekly sessions. Group supervision will be conducted by an experienced senior clinical psychologist throughout the study, and all sessions will be recorded so that the treatment adherence can be assessed. Fig.1 represents the research procedure schematically.\u003c/p\u003e\n\u003ch3\u003eControl group: BAT\u003c/h3\u003e\n\u003cp\u003eThe control group will receive nine BAT sessions, twice a week, for 60 minutes each time. This intervention will consists of two parts: (1) the BAT sessions that are 1 hour long; (2) homework, in which the\u0026nbsp;adolescents\u0026nbsp;will be\u0026nbsp;encouraged\u0026nbsp;to schedule activities\u0026nbsp;that are\u0026nbsp;enjoyable, rewarding,\u0026nbsp;and offer a sense of\u0026nbsp;control\u0026nbsp;during the following week. The participants will be asked\u0026nbsp;to monitor the impact of these activities on their personal mood.\u003c/p\u003e\n\u003ch3\u003eIntervention group: BAPT\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eThe intervention group will receive nine BAPT sessions, twice a week, for 60 minutes each time. This intervention will consist of three parts: (1) the BAT sessions that are 30 minutes long; (2) the GPA sessions immediately after each meeting, for 30 minutes long; and (3) homework, in which the\u0026nbsp;adolescents\u0026nbsp;will be\u0026nbsp;encouraged\u0026nbsp;to schedule\u0026nbsp;activities (social exercise games, etc.) which feel enjoyable, rewarding, and offer a sense of control over the following week, and to monitor the impact of these activities on their personal mood.\u003c/p\u003e\n\u003ch3\u003eSafety and\u0026nbsp;monitoring\u003c/h3\u003e\n\u003cp\u003eBefore each intervention session, the subjects will complete the 10th item of the clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) for suicidal risk. If the scores are \u0026gt; 4, the subjects will be temporarily withdrawn from the study. During the intervention, if the subjects show severe self-injury or suicidal behavior, they also will be temporarily withdrawn from the study. Subsequently, the doctors on the project team will conduct suicide crisis interventions and follow-up visits, organize expert discussions regarding the incident, and make modifications to the intervention for that participant according to the situation to avoid recurrence of similar incidents.\u003c/p\u003e\n\u003ch3\u003eEfficacy evaluations\u003c/h3\u003e\n\u003cp\u003eFrom week 0 to week 16,\u0026nbsp;researchers will utilize\u0026nbsp;MADRS\u0026nbsp;scores\u0026nbsp;as a primary outcome\u0026nbsp;to assess\u0026nbsp;changes in\u0026nbsp;depressive\u0026nbsp;symptoms. A\u0026nbsp;total score of 0\u0026ndash;60\u0026nbsp;is obtained by completing\u0026nbsp;10 items with scores ranging from 0 to 6\u0026nbsp;[39]. The depressive symptoms will be grouped as extreme, major, moderate, or mild according to the following scores: MADRS \u0026gt; 35, 30 \u0026le; MADRS \u0026lt; 35, 22 \u0026le; MADRS \u0026lt; 30, 12 \u0026le; MADRS \u0026lt; 22, respectively, and MADRS \u0026lt; 12 indicates no depressive symptoms. Compared with the baseline, a MADRS total score reduction of 50% will be defined as a significant antidepressant response, while a reduction of 20% will be defined as an improvement.\u003c/p\u003e\n\u003cp\u003eSecondary outcome measures include: (1) Self-rated depressive symptoms on the Baker Depression Scale, second Chinese version (BDI-II-C): This scale has high internal consistency, and reflects the severity of depression in the past two weeks. It contains 21 items, each rated on a 0\u0026ndash;3 scale, with an overall score of 0\u0026ndash;63 points. The levels of depression will be grouped as severe, moderate, or mild according to the following ranges of scores: 29\u0026ndash;63, 20\u0026ndash;28, and 14\u0026ndash;19, respectively, and a score of 0\u0026ndash;13 will be classified as no depression\u0026nbsp;[40]. (2) Behavioral Activation for Depression Scale Short Form (BADS-SF): This scale consists of nine items that measure changes in behavioral activation during the past week, including the measurement day. The activation (AC) subscale includes questions 1, 2, 3, 4, 5, and 9, while the avoidance (AV) subscale includes questions 6, 7, and 8. The scale uses a 7-level scoring method, which ranges from 0 (not at all) to 6 (completely). A higher score for an item represents an answer that is closer to the item statement. The scale has been demonstrated to have robust reliability and validity\u0026nbsp;[41]\u0026nbsp;(3) Adolescent Non-suicidal Self-injury Assessment Questionnaire (ANSAQ): This questionnaire is divided into two parts: a behavioral questionnaire (12 items) and a functional questionnaire (19 items) to evaluate self-injury behavior\u0026nbsp;[42]. It uses the Likert 5-point scale, where \u0026ldquo;1 to 5\u0026rdquo; corresponds with \u0026ldquo;no, occasionally, sometimes, often, always\u0026rdquo;, respectively. A higher score represents a more serious degree of self-injury. The questionnaire has high internal consistency, while that of the functional questionnaire was 0.905. In this study, we will only use the behavioral dimension of the questionnaire (12 questions in total) to assess whether the depressed adolescents engage in self-injury behavior. (4) Insomnia Severity Index (ISI): this is used to evaluate the severity of insomnia in patients.\u0026nbsp;Total scores of 0\u0026ndash;28\u0026nbsp;are obtained according to responses to\u0026nbsp;7\u0026nbsp;items with scores ranging from 0 to\u0026nbsp;4\u0026nbsp;[43].\u0026nbsp;According to the scoring guide, scores for mild, moderate, and severe clinical insomnia range from 8\u0026ndash;14, 15\u0026ndash;21, and 22\u0026ndash;28, respectively, while scores less than 7 are considered to represent non-clinical insomnia. (5) International Physical Activity Questionnaire-Short Forms (IPAQ-SF): This short form records activity for four intensity levels: 1) vigorous-intensity activity such as aerobics, 2) moderate-intensity activity such as leisure cycling, 3) walking, and 4) sitting\u0026nbsp;[44]. These four intensity levels (except sitting) can be determined and reported as MET-minutes per week. The IPAQ-SF has good internal consistency. (6) Custom 5-point Likert score acceptance questionnaire: to assess the acceptance of the intervention by patients and their families.\u003c/p\u003e\n\u003cp\u003eAt the baseline, week 2 (the end of the basic intervention), week 4 (the end of all the high-order intervention), week 8, and week 16, participants from the two groups will be evaluated with the corresponding scales to assess the degree of depression, behavioral activation level, non-suicidal self-injury behavior, and sleep quality scores. We will also calculate the improvement of symptoms for each dimension in each group at each time point, and then compare the divergences between the two groups. Fig. 2 represents the measures and time points of the study.\u003c/p\u003e\n\u003ch3\u003eDemographic and clinical data\u003c/h3\u003e\n\u003cp\u003eDemographic data (age, sex, occupation, culture, residence, family structure, economic income, etc.), medical expenses, growth history, history of tobacco, alcohol and other psychoactive substance use, sleep status, psychiatric symptoms, length of hospital stay, and diagnosis will be collected during the screening stage. All participants and their families will volunteer to participate and sign informed consent.\u0026nbsp;\u003c/p\u003e\n\u003ch3\u003eAuxiliary inspection:\u003c/h3\u003e\n\u003cp\u003eElectrocardiograms, routine blood analysis, and biochemical indexes of clinical treatment will be completed at the baseline assessment.\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003ch3\u003eBA data acquisition\u003c/h3\u003e\n\u003cp\u003eA homework assignment will be given at the end of each session to encourage the participants to take part in one or more behaviors associated with feeling less depressed and to monitor the effect on their individual mood. Homework will be collected by the researchers once per week.\u0026nbsp;\u003c/p\u003e\n\u003ch3\u003ePhysical activity intensity\u0026nbsp;\u003c/h3\u003e\n\u003cp\u003eThe Metabolic Equivalent (MET) can be used to express the relative energy metabolism level of physical activity. Depending on the intensity of the exercise, which can be divided into light, medium, or heavy grade, it can be represented by a score of 0\u0026ndash;3, 3\u0026ndash;6, and more than 6, respectively.\u003c/p\u003e\n\u003cp\u003eThe participants will use electronic exercise wristbands to record the daily intensity of their physical activities, and the researchers will collect information once per week.\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003ch3\u003eData management\u003c/h3\u003e\n\u003cp\u003eThe Case Report Form (CRF) will be utilized to document the demographic information and clinical symptoms of all participants, which will subsequently be stored in the database through a process of double data entry. The primary responsibility of the study leader will be to ensure the integrity, accuracy, and promptness of the data inputting process. In an effort not to disclose the privacy of participants, researchers will remove the names, phone numbers, and addresses that are not related to the study. Numbers will be used to identify the participants. In addition, the original CRF will be securely stored throughout the study and will be accessible to the project leader. A dedicated physician (Prof. Yanling Zhou) will monitor the wholeness, uniformity and plausibility of the data. We have mapped out a complete risk prevention scenario, and once an adverse event occurs, it will be recorded and reported to the ethics committee.\u0026nbsp;The study leader will organize any necessary discussions.\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003ch3\u003eStatistical analysis\u003c/h3\u003e\n\u003ch4\u003eSample size calculation\u003c/h4\u003e\n\u003cp\u003eThe depressive symptom scores of the study subjects will be used as the main outcome index, with a bilateral \u0026alpha; = 0.05 and a 90% confidence interval. In a previous study on the effects of BA combined with traditional exercise therapy, the depression scores of the intervention group at the baseline and at the 16-week follow-up period were 27.3 \u0026plusmn; 8.0 and 16.0 \u0026plusmn; 9.5, respectively\u0026nbsp;[45]. Therefore, we expect that the depression score of the experimental group in the present study could be decreased by 11.3 points compared with the baseline and 4.8 points compared with the control group. We used PASS 15 software to calculate the sample size of the experimental group: N1 = N2 = 84. Considering the expectation that 10%\u0026shy;\u0026ndash;20% of the cases will be lost during the period following the study, the number of\u0026nbsp;participants\u0026nbsp;needed in the intervention group and control group will be about 100,\u0026nbsp;respectively,\u0026nbsp;with a total of 200 participants.\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003ch3\u003eData analysis\u003c/h3\u003e\n\u003cp\u003eThe study is based on the intention-to-treat principle. SPSS 28.0 will be used for data analysis. First, to ensure comparability after randomization, we will compare the differences between the groups at the baseline. The continuous variables will be analyzed by a t-test when the data have a normal distribution, and non-normally distributed data will be analyzed using the Mann-Whitney U test. Baseline differences between groups in terms of sociodemographic and clinical variables will be assessed using Chi-square tests for categorical variables and an analysis of variance (ANOVA) for continuous data. To compare intervention effects, a mixed-effect regression model will be used. Group (BAPT or BAT) will be used as an inter-subject factor, and time (baseline, post-treatment, and follow-up) as an intra-subject factor. We will utilize Cohen\u0026apos;s d to achieve both the intra- and intergroup analyses. P \u0026lt; 0.05 was set as statistically significant.\u0026nbsp;\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eA close relationship between physical activities and depression has been repeatedly confirmed by numerous studies. Kandola et al. used objective measures to find that declining levels of light activity and increasing periods of sedentary behavior between the ages of 12 and 16 years were related to greater depressive symptoms at age 18 years.\u0026nbsp;Compared with\u0026nbsp;those with consistently low levels of sedentary behavior, depression scores were 24.9%\u0026ndash;28.2% higher in those with consistently high levels of sedentary behavior.\u0026nbsp;Increasing light activity by one hour every day has previously been found to decrease depression scores by 8\u0026ndash;11%, and sustained heavy physical activity was also related to lower depression scores\u0026nbsp;[46].\u0026nbsp;Furthermore,\u0026nbsp;PA, whether low, moderate, or high intensity, was found to be effective in treating mild to moderate depression\u0026nbsp;[18].\u0026nbsp;Although physical activity can boost mental health, a pooled analysis of 16 million adolescents in more than 140 countries showed low rates of participation in physical activity among adolescents\u0026nbsp;[47], such that nearly 85% of young people in China lacked adequate physical activity. Only approximately 20% of students tested met the standard of one hour of PA per day. In addition, PA levels in adolescents tend to decline with age because of excessive academic pressure, a lack of interest in sports and self-exercise habits, inadequate guidance, changes in leisure and entertainment methods, and insufficient sports venues and equipment\u0026nbsp;[48]. Particularly,\u0026nbsp;adolescents with depression on account of persistent low mood, loss of interest, and other disease symptoms had lower adherence to physical activity guidelines\u0026nbsp;[25].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eMany guidelines recommend psychotherapy as an evidence-based treatment for adolescent with depression [49]. Psychotherapy in this group has been found to have a significant effect compared with a control group, but the effect sizes tend to be relatively small [50]. Specifically, the overall response rates for psychotherapy at 2 (\u0026plusmn;1) months after baseline were only 39% (95% CI: 34\u0026ndash;45) and 24% (95% CI: 0.19\u0026ndash;28), and over 60% of adolescents who had received relevant psychological treatment did not respond to it \u0026nbsp;[23]. Some researchers analyzed the effects of psychological treatment in individuals with depression across all ages, and found that the effect size was small in adolescents, especially those younger than 13 years, compared with adults [51]. However, it is difficult to estimate the long-term efficacy of psychotherapy. Despite the best efforts of researchers, the current interventions do not adequately satisfy the needs of adolescents with depression [52]. This may be the reason for the small therapeutic effect. Adolescents habitually use some behavioral strategies (rather than cognitive ones) to alleviate depression [53]. A meta-analysis using data from 23 RCTs [53] showed that the pooled standardized mean difference (SMD) for a BA intervention was 0.7, (95% CI -1.20, -0.20), with high heterogeneity (I\u003csup\u003e2\u0026nbsp;\u003c/sup\u003e= 0.79) [53, 54]. These findings indicate that to further reduce the burden of adolescents with depression, effective and innovative treatments are essential.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAlthough studies have demonstrated that BA combined with PA is feasible and acceptable for improving depressive symptoms in adults, no studies have been conducted in adolescents until now. People of different ages may choose different forms of PA. In contrast to traditional forms of PA, adolescents are more inclined to select game forms of PA [34]. BAPT, as an innovative intervention therapy, includes both psychological intervention techniques and GPA, and thus may be more suitable for adolescents. We anticipate that our BAPT intervention study will determine its feasibility and acceptability for adolescents with depression. Furthermore, we will compare the benefits of BAPT with those of BA in terms of improving depressive symptoms, behavioral activation level, and sleep quality, as well as decreasing non-suicidal self-injury in adolescents, and further explore whether BAPT has clinical value.\u0026nbsp;\u003c/p\u003e\n\u003ch3\u003eAdvantages and limitations\u003c/h3\u003e\n\u003cp\u003eThis is a preliminary investigation of the effects of a new innovative intervention for depression known as BAPT. This study is the first to compare the intervention effects \u0026nbsp; \u0026nbsp; \u0026nbsp;of BAPT and BAT in adolescents with depression.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThere are some limitations to this study. First, because of the short hospitalization period, participants are unlikely to complete all the intervention sessions in the hospital. Thus, we will ask them to return to the hospital for the remaining five sessions after they have been discharged. This carries a risk of an increased participant drop-out rate. Second, we will only compare BAPT with BA, but not with traditional exercise. Follow-up studies may compare BAPT with traditional exercise, along with changes in biochemical indicators and imaging data to explore the mechanisms of the BAPT intervention.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis study is a pragmatic RCT focused on examining the utility of BAPT in improving depression symptoms as an effective adjuvant therapy. We hope to provide evidence for the clinical implementation of a new mental health treatment for adolescents with depression. Future studies should employ larger sample sizes and multi-center clinical trials.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eMDD: Major depressive disorder; BAT: behavioral activation therapy; GPA: gamified physical activities; BAPT: behavioral activation play therapy; RCT: randomized controlled trial; CBT: cognitive behavioral therapy; WHO: World Health Organization; PA: physical activity; NICE: UK\u0026rsquo;s National Institute for Health and Care Excellence; BA: behavioral activation; DCAP: Department of Child and Adolescent Psychiatry; MADRS: Montgomery-Asberg Depression Rating Scale; ANSAQ: Adolescent Non-suicidal Self-injury Assessment Questionnaire; BDI-II-C: Baker Depression Scale, second Chinese version; BADS-SF: Behavioral Activation for Depression Scale Short Form; ISI: Insomnia Severity Index; IPAQ-SF: International Physical Activity Questionnaire-Short Forms; MET: metabolic equivalent; CRF: Case Report Form; ITT: intention to treat; SMD: standardized mean difference\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003eAcknowledgments\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWe would like to acknowledge Prof. Liang Zhou and Dr. Shao-Ling Zhong for their guidance in the early stages of the study.\u003c/p\u003e\n\u003cp\u003eAuthors\u0026rsquo; contributions\u003c/p\u003e\n\u003cp\u003eXLH designed the study protocol and wrote the manuscript, YQC and JCL reviewed and edited the manuscript, YLZ and CJY critically reviewed the manuscript and provided financial support, WL and DDW provided a methodological review for this study.\u003c/p\u003e\n\u003cp\u003eFunding\u003c/p\u003e\n\u003cp\u003eThis study was supported by Science and Technology Program of Guangzhou\u0026nbsp;(grant No.\u0026nbsp;205171098044), Guangzhou Municipal Key Discipline in Medicine (2021-2023),\u0026nbsp;Guangzhou High-level Clinical Key Specialty, and\u0026nbsp;Guangzhou Research-oriented Hospital.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003eEthics approval and consent to participate\u003c/p\u003e\n\u003cp\u003eThe study (clinical trial number ChiCTR2300072671) was approved by the Clinical Research Ethics Committee of the Affiliated Brain Hospital of Guangzhou Medical University on April 27, 2023 (Ethics number: 2023 [027]). Prior to participation in this study, all subjects and their legal guardians must be fully informed about the project and sign a written informed consent form.\u003c/p\u003e\n\u003cp\u003eConsent for publication\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAll authors listed have approved the manuscript that is enclosed.\u003c/p\u003e\n\u003cp\u003eCompeting interests\u003c/p\u003e\n\u003cp\u003eThe authors declared that they have no competing interests\u003c/p\u003e\n\u003cp\u003eAuthor details\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e1\u003c/sup\u003eThe Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou, China. \u003csup\u003e2\u003c/sup\u003eKey Laboratory of Neurogenetics and Channelopathies of Guangdong Province and the Ministry of Education of China, Guangzhou Medical University, Guangzhou, China. \u003csup\u003e3\u003c/sup\u003eSouthern Medical University, Guangzhou, China. \u003csup\u003e4\u003c/sup\u003eGuangzhou Medical University, Guangzhou, China.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eThapar A, Eyre O, Patel V, Brent D: Depression in young people. The Lancet 2022, 400(10352):617-631.\u003c/li\u003e\n\u003cli\u003ePress BSSA: China National Mental Health Development Report (2019-2020) Blue Book; 2021.\u003c/li\u003e\n\u003cli\u003eLi F, Cui Y, Li Y, Guo L, Ke X, Liu J, Luo X, Zheng Y, Leckman JF: Prevalence of mental disorders in school children and adolescents in China: diagnostic data from detailed clinical assessments of 17,524 individuals. Journal of child psychology and psychiatry, and allied disciplines 2022, 63(1):34-46.\u003c/li\u003e\n\u003cli\u003eClayborne ZM, Varin M, Colman I: Systematic Review and Meta-Analysis: Adolescent Depression and Long-Term Psychosocial Outcomes. Journal of the American Academy of Child and Adolescent Psychiatry 2019, 58(1):72-79.\u003c/li\u003e\n\u003cli\u003eGoldstein BI, Korczak DJ: Links Between Child and Adolescent Psychiatric Disorders and Cardiovascular Risk. The Canadian journal of cardiology 2020, 36(9):1394-1405.\u003c/li\u003e\n\u003cli\u003eSummary of the clinical practice guideline for the treatment of depression across three age cohorts. The American psychologist 2022, 77(6):770-780.\u003c/li\u003e\n\u003cli\u003eOberste M, Medele M, Javelle F, Lioba Wunram H, Walter D, Bloch W, Bender S, Fricke O, Joisten N, Walzik D et al: Physical Activity for the Treatment of Adolescent Depression: A Systematic Review and Meta-Analysis. Frontiers in physiology 2020, 11:185.\u003c/li\u003e\n\u003cli\u003ePatton GC, Coffey C, Romaniuk H, Mackinnon A, Carlin JB, Degenhardt L, Olsson CA, Moran P: The prognosis of common mental disorders in adolescents: a 14-year prospective cohort study. Lancet (London, England) 2014, 383(9926):1404-1411.\u003c/li\u003e\n\u003cli\u003eThapar A, Collishaw S, Pine DS, Thapar AK: Depression in adolescence. Lancet (London, England) 2012, 379(9820):1056-1067.\u003c/li\u003e\n\u003cli\u003eWHO Guidelines Approved by the Guidelines Review Committee. In: Global Recommendations on Physical Activity for Health. edn. Geneva: World Health Organization.; 2010.\u003c/li\u003e\n\u003cli\u003eWHO Guidelines Approved by the Guidelines Review Committee. In: WHO Guidelines on Physical Activity and Sedentary Behaviour. edn. Geneva: World Health Organization; 2020.\u003c/li\u003e\n\u003cli\u003eZhang Y, Li G, Liu C, Guan J, Zhang Y, Shi Z: Comparing the efficacy of different types of exercise for the treatment and prevention of depression in youths: a systematic review and network meta-analysis. Frontiers in psychiatry 2023, 14:1199510.\u003c/li\u003e\n\u003cli\u003eBalchin R, Linde J, Blackhurst D, Rauch HL, Sch\u0026ouml;nb\u0026auml;chler G: Sweating away depression? The impact of intensive exercise on depression. Journal of affective disorders 2016, 200:218-221.\u003c/li\u003e\n\u003cli\u003eNational Institute for Health and Care Excellence: Guidelines. In: Depression in adults: treatment and management. edn. London: National Institute for Health and Care Excellence (NICE); 2022.\u003c/li\u003e\n\u003cli\u003eRadovic S, Melvin GA, Gordon MS: Clinician perspectives and practices regarding the use of exercise in the treatment of adolescent depression. Journal of sports sciences 2018, 36(12):1371-1377.\u003c/li\u003e\n\u003cli\u003ePass L, Lejuez CW, Reynolds S: Brief Behavioural Activation (Brief BA) for Adolescent Depression: A Pilot Study. Behavioural and cognitive psychotherapy 2018, 46(2):182-194.\u003c/li\u003e\n\u003cli\u003eRichards DA, Ekers D, McMillan D, Taylor RS, Byford S, Warren FC, Barrett B, Farrand PA, Gilbody S, Kuyken W et al: Cost and Outcome of Behavioural Activation versus Cognitive Behavioural Therapy for Depression (COBRA): a randomised, controlled, non-inferiority trial. Lancet (London, England) 2016, 388(10047):871-880.\u003c/li\u003e\n\u003cli\u003eKanter JW, Callaghan GM, Landes SJ, Busch AM, Brown KR: Behavior analytic conceptualization and treatment of depression: Traditional models and recent advances. The Behavior Analyst Today 2004, 5(3):255-274.\u003c/li\u003e\n\u003cli\u003eOxford guide to low intensity CBT interventions. New York, NY, US: Oxford University Press; 2010.\u003c/li\u003e\n\u003cli\u003eJacobson NS, Martell CR, Dimidjian S: Behavioral activation treatment for depression: Returning to contextual roots: Science and Practice. Clinical psychology 2001, 8(3):255-270.\u003c/li\u003e\n\u003cli\u003eFarrand P, Pentecost C, Greaves C, Taylor RS, Warren F, Green C, Hillsdon M, Evans P, Welsman J, Taylor AH: A written self-help intervention for depressed adults comparing behavioural activation combined with physical activity promotion with a self-help intervention based upon behavioural activation alone: study protocol for a parallel group pilot randomised controlled trial (BAcPAc). Trials 2014, 15:196.\u003c/li\u003e\n\u003cli\u003eD\u0026apos;Elia A, Bawor M, Dennis BB, Bhatt M, Litke K, McCabe K, Whattam J, Garrick L, O\u0026apos;Neill L, Simons S et al: Feasibility of behavioral activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial. Pilot and feasibility studies 2020, 6:61.\u003c/li\u003e\n\u003cli\u003eCuijpers P, Karyotaki E, Ciharova M, Miguel C, Noma H, Stikkelbroek Y, Weisz JR, Furukawa TA: The effects of psychological treatments of depression in children and adolescents on response, reliable change, and deterioration: a systematic review and meta-analysis. European child \u0026amp; adolescent psychiatry 2023, 32(1):177-192.\u003c/li\u003e\n\u003cli\u003eHallal PC, Andersen LB, Bull FC, Guthold R, Haskell W, Ekelund U: Global physical activity levels: surveillance progress, pitfalls, and prospects. Lancet (London, England) 2012, 380(9838):247-257.\u003c/li\u003e\n\u003cli\u003eWang DQ, Zhang JJ, Chen JN, Li RY, Luo YX, Deng W: Exergames improves cognitive functions in adolescents with depression: study protocol of a prospective, assessor-blind, randomized controlled trial. BMC psychiatry 2023, 23(1):507.\u003c/li\u003e\n\u003cli\u003eKandola A, Ashdown-Franks G, Hendrikse J, Sabiston CM, Stubbs B: Physical activity and depression: Towards understanding the antidepressant mechanisms of physical activity. Neuroscience and biobehavioral reviews 2019, 107:525-539.\u003c/li\u003e\n\u003cli\u003eWray A, Martin G, Ostermeier E, Medeiros A, Little M, Reilly K, Gilliland J: Physical activity and social connectedness interventions in outdoor spaces among children and youth: a rapid review. Health promotion and chronic disease prevention in Canada : research, policy and practice 2020, 40(4):104-115.\u003c/li\u003e\n\u003cli\u003eBrussoni M, Olsen LL, Pike I, Sleet DA: Risky play and children\u0026apos;s safety: balancing priorities for optimal child development. International journal of environmental research and public health 2012, 9(9):3134-3148.\u003c/li\u003e\n\u003cli\u003eThompson Coon J, Boddy K, Stein K, Whear R, Barton J, Depledge MH: Does participating in physical activity in outdoor natural environments have a greater effect on physical and mental wellbeing than physical activity indoors? A systematic review. Environmental science \u0026amp; technology 2011, 45(5):1761-1772.\u003c/li\u003e\n\u003cli\u003eKagawa F, Yokoyama S, Takamura M, Takagaki K, Mitsuyama Y, Shimizu A, Jinnin R, Ihara H, Kurata A, Okada G et al: Decreased physical activity with subjective pleasure is associated with avoidance behaviors. Scientific reports 2022, 12(1):2832.\u003c/li\u003e\n\u003cli\u003eAhola R, Pyky R, J\u0026auml;ms\u0026auml; T, M\u0026auml;ntysaari M, Koskim\u0026auml;ki H, Ik\u0026auml;heimo TM, Huotari ML, R\u0026ouml;ning J, Heikkinen HI, Korpelainen R: Gamified physical activation of young men--a Multidisciplinary Population-Based Randomized Controlled Trial (MOPO study). BMC public health 2013, 13:32.\u003c/li\u003e\n\u003cli\u003eKellett S, Simmonds-Buckley M, Bliss P, Waller G: Effectiveness of Group Behavioural Activation for Depression: A Pilot Study. Behavioural and cognitive psychotherapy 2017, 45(4):401-418.\u003c/li\u003e\n\u003cli\u003eLejuez CW, Hopko DR, Acierno R, Daughters SB, Pagoto SL: Ten year revision of the brief behavioral activation treatment for depression: revised treatment manual. Behavior modification 2011, 35(2):111-161.\u003c/li\u003e\n\u003cli\u003eNijhof SL, Vinkers CH, van Geelen SM, Duijff SN, Achterberg EJM, van der Net J, Veltkamp RC, Grootenhuis MA, van de Putte EM, Hillegers MHJ et al: Healthy play, better coping: The importance of play for the development of children in health and disease. Neuroscience and biobehavioral reviews 2018, 95:421-429.\u003c/li\u003e\n\u003cli\u003eJurado-Castro JM, Gil-Campos M, Llorente-Cantarero FJ: Methods recently used for the assessment of physical activity in children and adolescents. Current opinion in clinical nutrition and metabolic care 2022, 25(5):298-303.\u003c/li\u003e\n\u003cli\u003eRidgers ND, McNarry MA, Mackintosh KA: Feasibility and Effectiveness of Using Wearable Activity Trackers in Youth: A Systematic Review. JMIR mHealth and uHealth 2016, 4(4):e129.\u003c/li\u003e\n\u003cli\u003eCreaser AV, Clemes SA, Costa S, Hall J, Ridgers ND, Barber SE, Bingham DD: The Acceptability, Feasibility, and Effectiveness of Wearable Activity Trackers for Increasing Physical Activity in Children and Adolescents: A Systematic Review. International journal of environmental research and public health 2021, 18(12).\u003c/li\u003e\n\u003cli\u003eRidgers ND, Timperio A, Brown H, Ball K, Macfarlane S, Lai SK, Richards K, Mackintosh KA, McNarry MA, Foster M et al: Wearable Activity Tracker Use Among Australian Adolescents: Usability and Acceptability Study. JMIR mHealth and uHealth 2018, 6(4):e86.\u003c/li\u003e\n\u003cli\u003eMontgomery SA, Asberg M: A new depression scale designed to be sensitive to change. The British journal of psychiatry : the journal of mental science 1979, 134:382-389.\u003c/li\u003e\n\u003cli\u003eWang Z, Yuan C-M, Huang J, Li Z-Z, Chen J, Zhang H-Y, Fang Y-R, Xiao Z-P: Reliability and validity of the Chinese version of Beck Depression Inventory-II among depression patients. In., vol. 25. China: Chinese Mental Health; 2011: 476-480.\u003c/li\u003e\n\u003cli\u003eShudo Y, Yamamoto T: Assessing the relationship between quality of life and behavioral activation using the Japanese Behavioral Activation for Depression Scale-Short Form. PloS one 2017, 12(9):e0185221.\u003c/li\u003e\n\u003cli\u003eYuhui W, Wan L, Jiahu H, Fangbiao T, Maternal DO, Childamp, Health AJCJoSH: Development and evaluation on reliability and validity of Adolescent Non-suicidal Self-injury Assessment Questionnaire. 2018.\u003c/li\u003e\n\u003cli\u003eMorin CM: Insomnia: Psychological Assessment and Management. In: 1993; 1993.\u003c/li\u003e\n\u003cli\u003eCraig CL, Marshall AL, Sj\u0026ouml;str\u0026ouml;m M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF et al: International physical activity questionnaire: 12-country reliability and validity. Medicine and science in sports and exercise 2003, 35(8):1381-1395.\u003c/li\u003e\n\u003cli\u003eSzuhany KL, Otto MW: Efficacy evaluation of exercise as an augmentation strategy to brief behavioral activation treatment for depression: a randomized pilot trial. Cognitive behaviour therapy 2020, 49(3):228-241.\u003c/li\u003e\n\u003cli\u003eKandola A, Lewis G, Osborn DPJ, Stubbs B, Hayes JF: Depressive symptoms and objectively measured physical activity and sedentary behaviour throughout adolescence: a prospective cohort study. The lancet Psychiatry 2020, 7(3):262-271.\u003c/li\u003e\n\u003cli\u003eGuthold R, Stevens GA, Riley LM, Bull FC: Global trends in insufficient physical activity among adolescents: a pooled analysis of 298 population-based surveys with 1\u0026middot;6 million participants. The Lancet Child \u0026amp; adolescent health 2020, 4(1):23-35.\u003c/li\u003e\n\u003cli\u003eChina Sports Daily:Vigorously develop leisure sports and improve youth physical fitness level [https://www.sport.gov.cn/n20001280/n20745751/n20767239/c21761637/content.html]; Accessed 28 Aug. 2023.\u003c/li\u003e\n\u003cli\u003eWeersing VR, Jeffreys M, Do MT, Schwartz KT, Bolano C: Evidence Base Update of Psychosocial Treatments for Child and Adolescent Depression. Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53 2017, 46(1):11-43.\u003c/li\u003e\n\u003cli\u003eHolmes EA, Ghaderi A, Harmer CJ, Ramchandani PG, Cuijpers P, Morrison AP, Roiser JP, Bockting CLH, O\u0026apos;Connor RC, Shafran R et al: The Lancet Psychiatry Commission on psychological treatments research in tomorrow\u0026apos;s science. The lancet Psychiatry 2018, 5(3):237-286.\u003c/li\u003e\n\u003cli\u003eCuijpers P, Karyotaki E, Eckshtain D, Ng MY, Corteselli KA, Noma H, Quero S, Weisz JR: Psychotherapy for Depression Across Different Age Groups: A Systematic Review and Meta-analysis. JAMA psychiatry 2020, 77(7):694-702.\u003c/li\u003e\n\u003cli\u003eHankin BL, Griffith JM: What Do We Know About Depression Among Youth and How Can We Make Progress Toward Improved Understanding and Reducing Distress? A New Hope. Clinical child and family psychology review 2023:1-24.\u003c/li\u003e\n\u003cli\u003eMalik K, Ibrahim M, Bernstein A, Venkatesh RK, Rai T, Chorpita B, Patel V: Behavioral Activation as an \u0026apos;active ingredient\u0026apos; of interventions addressing depression and anxiety among young people: a systematic review and evidence synthesis. BMC psychology 2021, 9(1):150.\u003c/li\u003e\n\u003cli\u003eMartin F, Oliver T: Behavioral activation for children and adolescents: a systematic review of progress and promise. European child \u0026amp; adolescent psychiatry 2019, 28(4):427-441.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Behavioral activation, Gamified physical activity, Adolescents, Depression, Randomized controlled trial, Protocol","lastPublishedDoi":"10.21203/rs.3.rs-3498407/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3498407/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eDepression is a common psychological problem in adolescents worldwide. Although the World Health Organization recommends physical activity to reduce depressive symptoms in this population, compliance with this recommendation is often low. Furthermore, although behavioral activation therapy (BAT) is recommended as a treatment for adolescents with depression, the reported effect size is small. Compared with traditional exercises, gamified physical activities (GPA) can be particularly appealing to adolescents because they are considered to be enjoyable experiences. Thereby, they often have good uptake in adolescent populations. In this study, we integrated BAT and GPA to create behavioral activation play therapy (BAPT). We designed a clinical trial to investigate the feasibility, acceptability, and effectiveness of this treatment in adolescents with depression.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThe study is a randomized controlled trial (RCT) with a single-blind, two-arm design, conducted to validate the effectiveness and applicability of BAPT for adolescent depression. On the basis of conventional treatment and care, we will compare the outcomes of BAPT and BAT. The intervention group and control group will receive nine sessions of BAPT or BAT, respectively. The number of adolescents recruited will be 200, with a 1:1 distribution ratio.\u003c/p\u003e\u003ch2\u003eDiscussion\u003c/h2\u003e \u003cp\u003eThis is the first RCT to explore the effectiveness and adaptability of BAPT in adolescents with depression. This study will provide evidence that may help to decrease depressive symptoms in adolescents, and will demonstrate the treatment effectiveness in terms of increasing levels of physical activity, reducing the rate of non-suicidal self-injury behaviors, and improving sleep quality. We also hope to assess other possible clinical effects of BAPT.\u003c/p\u003e\u003ch2\u003eTrial registration:\u003c/h2\u003e \u003cp\u003eChinese Clinical Trial Register Center, ChiCTR2300072671. Registered on 20 June 2023.\u003c/p\u003e","manuscriptTitle":"The effect of behavioral activation play therapy in adolescents with depression: a study protocol for a randomized controlled trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2023-11-07 17:39:57","doi":"10.21203/rs.3.rs-3498407/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"7b802e5c-053a-4907-b1db-a564d8a525e2","owner":[],"postedDate":"November 7th, 2023","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2024-06-21T16:05:44+00:00","versionOfRecord":{"articleIdentity":"rs-3498407","link":"https://doi.org/10.1371/journal.pone.0304084","journal":{"identity":"plos-one","isVorOnly":true,"title":"PLOS ONE"},"publishedOn":"2024-06-20 16:05:44","publishedOnDateReadable":"June 20th, 2024"},"versionCreatedAt":"2023-11-07 17:39:57","video":"","vorDoi":"10.1371/journal.pone.0304084","vorDoiUrl":"https://doi.org/10.1371/journal.pone.0304084","workflowStages":[]},"version":"v1","identity":"rs-3498407","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3498407","identity":"rs-3498407","version":["v1"]},"buildId":"7rjqhiLT3MXkJMwkYKINL","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}