Evaluation of a Group Compassion-based Program on Perceived Social Isolation and Depression in Family Caregivers of Patients with Multiple Sclerosis: Study Protocol for an Open-label Randomized Controlled Trial

Evaluation of a Group Compassion-based Program on Perceived Social Isolation and Depression in Family Caregivers of Patients with Multiple Sclerosis: Study Protocol for an Open-label 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 Research Article Evaluation of a Group Compassion-based Program on Perceived Social Isolation and Depression in Family Caregivers of Patients with Multiple Sclerosis: Study Protocol for an Open-label Randomized Controlled Trial Fatemeh Nabi, Hojatollah Yousefi, Sima Babaee, Vahid Shaygannejad This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5420701/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 24 Feb, 2026 Read the published version in Trials → Version 1 posted 6 You are reading this latest preprint version Abstract Background Multiple sclerosis (MS) is an autoimmune disorder of the central nervous system that causes neurologic disabilities. People with MS may need continuous care from a family caregiver. Caring is associated with physical and mental challenges, including mental health problems such as social isolation and depression. The health of patients is influenced by their caregiver’s health status. Therefore, this is a serious challenge faced by nurses in family-centered nursing care. Effective interventions, such as compassion-focused therapy (CFT), are required to help caregivers continue caregiving and retain their health. The current study aims to evaluate the effects of a group CFT-based program on perceived social isolation and depression among family caregivers of people with MS. Methods The current study will employ a two-arm, parallel-group randomized controlled trial design. Sixty family caregivers will be recruited via convenience sampling and then allocated into two equal groups. The participants in the intervention group will enroll in six weekly sessions of CFT-based psychoeducation, whereas the participants in the control group will receive no intervention. Data will be collected via a form for demographic information, the UCLA LS3, the and BDI-II at baseline, after intervention, and two months after the end of the program. Statistical analysis will be carried out using descriptive statistics, independent t-test, repeated measures ANOVA, and ANCOVA. Discussion Previous studies have shown CFT effectiveness in several issues experienced by family caregivers, but its impact on social isolation and depression in family caregivers of people with MS is unknown. This study will be the first to evaluate the effectiveness of CFT on social isolation and depression in family caregivers of people with MS, expanding our knowledge about CFT and caregiving challenges. Compassion Social isolation Depression Family caregiver Multiple sclerosis Figures Figure 1 Figure 2 Background Multiple Sclerosis (MS) is an autoimmune, neurodegenerative disease of thr central nervous system [ 1 ]. With a predominantly young onset, MS is a leading cause of neurological disabilities in younger adults [ 2 ]. Currently, approximately 2.8 million people are diagnosed with MS. Approximately 75000 people with MS live in Iran, mostly women, with an average age of 32 years at the time of onset [ 3 ]. Although the exact underlying cause of the disease is unknown, a variety of factors, including genetic elements and environmental exposures, such as infections and smoking, are known to be involved in MS pathogenesis [ 4 ]. Given the disabling nature of the disease, people with MS require continuous care and support [ 5 ]. Caring may be delivered by various providers, from in-home caregiving companies to the relatives of people in need. Informal caregivers, or more commonly known as family caregivers, refer to family members who are well aware of and respond to the patient’s needs and do not expect payments in return [ 6 ]. The care of patients at home alongside other family members as much as possible is an important global policy [ 7 ]. Family caregivers usually experience different challenges depending on their age and relations to the patients [ 8 ]. Given the burden of caregiving, family caregivers may experience mental and physical health problems, resulting in heavy physical, mental, social, and economic challenges for family members [ 9 ]. Studies have shown that MS patients, because of misconceptions about the disease, fear of being pitied, visible disabilities caused by the disease, stigmatization, and economic problems, avoid social interactions, which in turn causes their caregivers to be socially isolated [ 10 , 11 ]. Another study indicated that cognitive impairments of MS patients, such as memory problems, may interrupt their social interactions and render them and their spouses socially disconnected [ 12 ]. A study conducted in Iran revealed that one of the main problems experienced by MS patients is social isolation, which is influenced by numerous factors, one of which is potentially the Islamic teachings of family commitment in Iran [ 10 ]. Social isolation and loneliness have been linked to serious health outcomes, even increasing the risk for mortality [ 13 , 14 ]. The American Heart Association suggests that social isolation is associated with a greater risk of cardiovascular diseases [ 15 ]. It also affects mental health, with depression and anxiety being among the most prevalent outcomes [ 16 , 17 ]. Depression is a mood disorder characterized by feelings of sadness, guilt, loss of pleasure, objective signs of irritability, decreased level of energy, and eating or sleeping disorders for more than two weeks [ 18 , 19 ]. While decreased or loss of social interactions is linked to depression, evidence suggests that depression may also result in social isolation, which is expected as the depressive symptoms can affect beginning, maintaining, and terminating social connections [ 20 ]. Studies indicate that depression is a common issue experienced by caregivers of people with MS [ 8 ]. This is highly important because depression increases caregiving strain and fatigue, and therefore significantly impacts the quality of life as well as the mental and physical health of caregivers [ 21 ]. Given the interrelation of social isolation and depression, and their impact on caregivers’ health, effective interventions are required to optimize the caregiving process. A large body of suggested interventions exists [ 22 , 23 ]. Compassion-focused therapy (CFT) is a promising psychotherapies for psychological conditions [ 24 ]. Although not universally agreed upon, compassion is usually defined as “sensitivity to suffering in self and others with a commitment to try to alleviate and prevent it.” [ 25 , 26 ] This concept was originally emphasized in the Buddhist tradition which considers it a way to achieve happiness and enlightenment, leading the “compassionate” person to positive changes [ 27 ]. Compassion is actually an adaptive capacity that has helped humans regulate negative emotions to survive during their evolution [ 28 ]. Studies suggest that compassion can be taught, reinforced, and trained via education [ 16 , 25 , 29 ]. The teachability of compassion, along with the insufficiency of cognitive behavioral therapy (CBT) to improve negative emotions, such as self-criticism, in clinical cases was the basis and origin of CFT [ 30 ]. Compassion, although teachable, originates from the neurophysiology of the human brain; receiving kindness and compassion in early childhood enhances neural connections associated with compassionate behavior later in life [ 28 ]. CFT does so by helping the client understand that the mind is not a total product of what they have chosen or done in their lives [ 31 ]. It strengthens the ability of the client to acknowledge and confront the feelings and thoughts, and not to avoid them [ 32 ]. In other words, the purpose of CFT is not to disregard suffering, but to deal with it [ 33 ]. In fact, CFT holds that pain and suffering are inseparable parts of human life [ 34 ]. The undesirable outcomes of social isolation and depression for family caregivers raise concerns for family-centered care. The current literature considers supporting families and caregivers of patients with MS as one of the key roles of clinical nurses [ 35 ]. Therefore, nurses are required to learn and employ a variety of skills to support and enable families and caregivers of people with MS [ 35 , 36 ]. CFT may be an effective nursing intervention to improve caregivers’ and eventually patients’ conditions. Given the success of CFT in improving a wide range of psychological issues, including depression, and the importance of mental health in family caregivers on their care quality, the current study examines whether CFT can be employed as a psychoeducational nursing intervention to improve the perceived social isolation and depression of family caregivers of people with MS compared with a control group of same caregivers that receives no intervention. Methods Objectives The current study aims to evaluate the effectiveness of a group compassion-based program on the perceived social isolation and depression of family caregivers of people with MS. We hypothesize that CFT will significantly improve both outcomes in caregivers in the intervention group. We also hypothesize that the improvement will last at least two months after the intervention. Study design This study is an open-label two-arm parallel-group randomized controlled trial with an intervention group in which participants receive a group compassion-based psychoeducational program, and a control group with no intervention. This trial employs an exploratory framework. The allocation of participants will be randomized, at a 1:1 ratio. We used the SPIRIT checklist when writing our protocol (Fig. 1 ; Additional file 1) [ 37 ]. Study settings The CFT-based program for the intervention group is planned to be delivered in the classrooms of the Al-Zahra and Kashani hospitals, two centers with specialized MS clinics in Isfahan, Iran. Both hospitals are referral centers affiliated with Isfahan University of Medical Sciences. People with MS are referred to these centers for treatment follow-up, periodic appointments, and, in some cases, drug administration. Participants and sampling Family caregivers of people with MS referred to the selected hospitals will be recruited via convenience sampling. The required sample size was calculated based on standard deviations of depression scores in a previous similar study [ 38 ]. With S 1 and S 2 being the standard deviations of the depression scores in the intervention and control groups, given the minimum reduction in the mean depression score was 8 units, a 95% confidence interval and 90% power, 26 participants are required for each arm of the study. Considering 20% attrition, a total of thirty family caregivers who meet the eligibility criteria will be recruited for each arm. Recruitment and consent VS will introduce the eligible participants to FN. Family caregivers of patients referred to the selected hospitals will be interviewed during their patients’ appointments. FN will briefly share the objectives and procedure of the study with their caregivers. If they are unwilling, the interviewed caregivers won’t be included in the study. If willing, and if the interviewed caregivers meet the inclusion criteria, their contact information will be obtained for further steps. FN will take informed, written consent of participants in both groups later in an introductory session. Eligibility criteria The inclusion criteria for caregivers are: 1) aged between 18 and 70 years, 2) a minimum level of literacy needed for reading and writing, 3) consent to participate in the study, 4) if the patient has more than one caregiver, the caregiver who spends more time with the patient, 5) having the physical ability to participate in class sessions for at least two hours, 6) having the mental capacity to participate in the educational program without a self-reported learning or memory disorder, 7) having no history of depression or any other disease affecting social interactions, and 8) being the caregiver of only one patient. Unwillingness to continue to participate, absence in class sessions for more than two sessions, participating in other psychological or psychiatric interventions, and diagnosis of depression or any other disease affecting social interactions during the study will result in exclusion from the study. Although family caregivers are the actual participants in this study, we also considered eligibility criteria for patients, as the situation of patients directly affects the caregiving process and outcomes. We will include family caregivers of patients with an expanded disability status scale (EDSS) score ranging from 2 to 9.5, no history of other chronic diseases, and who have been diagnosed with MS for at least two months. Caregivers of patients who expire or are admitted to a hospital due to a relapse during the study will be excluded. Outcomes and materials Perceived social isolation and depression are the primary outcomes of this study. The primary outcomes will be measured at baseline (i.e. before intervention, T 0 ), immediately after intervention (i.e. after the last session of intervention, T 1 ), and two months after the intervention (i.e. the follow-up, T 2 ). All measurements of primary outcomes will be reported as the mean score and standard deviation. We also obtain the demographic information of caregivers, including their age, gender, marital status, relation to patient, education, and employment status, and disease information of their patient, including disease duration, disease pattern, and EDSS. These data are the background variables of the study. Instruments and data collection The demographic data of caregivers and disease information of patients will be collected via a form developed by the researchers. The EDSS score of patients may need physical examination as it is sometimes not recorded in patients’ files. Perceived social isolation will be measured by Russell’s UCLA Loneliness Scale Version 3 (UCLA LS3). This questionnaire was originally developed in 1978 and was later revised by Russell in 1996 because the scale was criticized for the negative phrasing of all items as it could potentially create a bias for respondents. UCLA LS3 consists of twenty items; eleven items are negatively phrased (i.e. implies feeling excluded) and the rest of them are positively phrased. The Likert scoring of negatively phrased items is from 1 (“Never”) to 4 (“Always”). The positively phrased items are scored oppositely. A higher score indicates greater perceived isolation. UCLA LS3 has shown good psychometric performance in the original study [ 39 ]. The Persian translation of the UCLA LS3 has been validated via factor analysis, and shown to be reliable with a Cronbach’s alpha of 0.91 [ 40 ]. Beck Depression Inventory (BDI-II) will be used to measure depression. Originally developed in 1961 and later revised in 1996, this 21-item scale is a widely used instrument to quantify depression, including depressive mood and symptoms. Each item of BDI-II is scored from 0 to 3, for a total score between 0 and 63. A higher score implies more severe depression [ 41 ]. The validity and reliability of BDI-II were evaluated and confirmed by Beck et al. [ 42 ]. The construct validity of the Persian translation of BDI-II is confirmed by convergent validity and factor analysis. It has also been shown to be internally consistent with a Cronbach’s alpha of 0.91 [ 43 ]. Data will be collected before and after the intervention, and additionally in a two-month follow-up. The UCLA LS3 and BDI-II questionnaires will be printed and delivered to all participants. To collect data at baseline (T 0 ), all participants will be invited to a session held at the Kashani hospital. After a detailed explanation of the study procedure and taking informed consent, the participants will fill out the printed questionnaires as well as the forms of demographic information and disease information. At the end of the last session of the program (T 1 ), the UCLA LS3 and BDI-II questionnaires will again be delivered to the participants. At the follow-up (T 2 ), the questionnaires will be delivered to the participants one last time. The timing and instruments of data collection are the same for all participants, regardless of their assignment to the intervention or the control group. Data monitoring in all phases will be done by the FN. Study procedure After recruitment reaches the calculated sample size, a number between 1 and 60 will be sequentially assigned to each participant. All numbers will be subsequently entered into the random allocating tool of the GraphPad website (available at www.graphpad.com ). The random allocator will assign the numbers into two separate groups. One group will be randomly considered the intervention group, and the other one will be considered the control group (Fig. 2 ). The whole allocation process, including the generation of allocation sequence and participant assignment, will be implemented by FN. All participants will be invited to an in-person, introductory session held at the Kashani hospital classroom via the contact information previously obtained during recruitment. The objectives, procedure, date, and time of the following sessions will be shared and discussed in this session in full detail. Then an informed, written consent will be taken from all participants by FN. Furthermore, baseline data will be collected (T 0 ). At the end of this session, participants in the control group will be discharged and asked to wait until the end of the intervention. The participants in the intervention group will be divided into three equal subgroups of ten participants. Caregivers in each subgroup will participate in six weekly 120-minute sessions held in the classrooms of the selected centers. FN will be responsible for psychoeducation. FN has been trained and certified to devise a CFT-based psychoeducational program. SB, who has contributed to similar studies exploring compassionate nursing care [ 44 ], will be the supervisor and advisor of the intervention. After the sixth and final session of the program (T 1 ), social isolation and depression will be measured in all participants using UCLA LS3 and BDI-II. Two months after the final session (T 2 ), as a follow-up to determine the long-term effectiveness of the program, participants in both groups will be asked to fill out the questionnaires last time. The collected data will be entered into IBM SPSS Statistics version 24 for data analysis. Intervention The intervention consists of six weekly 120-minute sessions, each of which delivered in classrooms of the selected hospital. We chose this timing frame because the strongest effects in previous interventions have been associated with programs with durations over 12 hours [ 45 ]. The program is a psychoeducational CFT intervention developed primarily based on Gilbert’s protocol [ 26 ] (Table 1 ). We incorporated homework-based skill-building into the CFT program outlined by Gilbert, with elements of Neff’s account of self-compassion, to ensure the comprehensiveness of our program. All of content is delivered via face-to-face education, a PowerPoint presentation, pamphlets, and group discussion. Each session consists of a brief review of the previous session and a 10-minute break. Furthermore, homework, which is a practice needed to be trained at home, will be given to participants at the end of each session. Each participant will be asked to verbally report his experience with the homework in the next session. Table 1 The subject and content of each session of CFT-based psychoeducational program in this study Session Content Homework 0 A detailed introduction to the study procedure, taking informed consent, and baseline assessment No homework 1 Preliminary communication, a review of the following sessions, introduction to “compassion,” its general principles and basic concepts Writing a compassionate letter 2 Mindfulness basics, soothing breathing, and body scanning Mindfulness practice 3 Characteristics of a compassionate person Introspection to search for characteristics of a compassionate person, and rating them 4 “Compassionate skills” and how to cultivate these skills Skill-building exercises 5 Readiness and acceptance of future events Self-teaching practice 6 A review of previous session; how to write down a compassionate letter Writing a compassionate letter, and comparing it to the one written after session 1 To encourage participants to enroll in class sessions, every session will include an evening meal. The sessions will be free of charge. The participants will be free to contact FN at any time. They are allowed to ask their questions, report on their homework, or any other problem they may face during the study. The content of each session is presented in detail in Additional file 2. Data analysis Descriptive statistics, including means and standard deviations for quantitative data, and frequencies and percentages for qualitative data, will be used to describe demographic and disease-related variables. The normality of data will be tested via the Kolmogorov-Smirnov test. Independent t-test will determine the significance of the difference in outcome scores between intervention and control groups at T 0 , T 1 , and T 2 . Repeated measures ANOVA will reveal if there are any significant changes in the mean scores of each group from T 0 to T 2 . ANCOVA will be employed to control for covariates and adjust for mean scores between groups. All tests will be two-tailed, and a p value of < 0.05 will be considered statistically significant. IBM SPSS Statistics version 24 will be used for data entry and all analyses. FN will enter gathered data into the spreadsheet of SPSS for data analysis based on the numbers assigned to participants in recruitment. Discussion The main question of the current study is whether CFT, as a group psychoeducational program outlined above, is effective in improving social isolation and depression among family caregivers of people with MS. Only one similar study was found to evaluate the effects of CFT in caregivers of patients with MS. A study conducted in Tehran, Iran, showed that a CFT program consisting of eight one-hour sessions significantly increased resilience and quality of life in caregivers of people with MS [46]. To our knowledge, this study will be the first evaluation of the effects of CFT on social isolation and depression in family caregivers of people with MS. Loneliness has also been subject to CFT-based intervention [47, 48]. Although effective, to our knowledge, no study has evaluated the effectiveness of CFT on loneliness among caregivers. Given the close link between feeling of loneliness and perceived social isolation, we hypothesize that the current study will effectively reduces perceived social isolation in caregivers of people with MS. In conclusion, we believe that the results of the current study will add up to the literature as it will be the first study to demonstrate the effectiveness of CFT in caregivers of people with MS, with perceived social isolation and depression as primary outcomes. Caregivers of people with MS have rarely been the target of CFT interventions in current literature, and the current study will expand our knowledge of both CFT effectiveness and factors affecting caregiving in MS. If effective, compassion-based intervention may be justified for incorporation into comprehensive family-centered care. Abbreviations BDI-II Beck Depression Inventory Version 2 CBT Cognitive Behavioral Therapy CFT Compassion-focused Therapy EDSS Expanded Disability Status Scale IRCT Iranian Registry of Clinical Trials MS Multiple Sclerosis UCLA LS3 UCLA Loneliness Scale Version 3 Declarations Name of the registry : Iranian Registry of Clinical Trials Trial registration Number : IRCT20230823059233N (https://irct.behdasht.gov.ir/trial/73412) Date of registration: 1 November 2021 Protocol version: Current protocol: Version 1 (28 October 2024). Trial status The trial is registered on 1 November 2021 in IRCT (IRCT20230823059233N). the current paper is the first protocol version of the trial to be published. Recruitment is planned to start on 1 December 2024. Ethics approval and consent to participate The Research Ethics Committees of Nursing, Rehabilitation, and Management Schools of Isfahan University of Medical Sciences approved this study (IR.MUI.NUREMA.REC.1402.128). The study procedure has been designed and will be implemented in accordance with the ethical standards of the Isfahan University of Medical Sciences. Written, informed consent to enroll in study will be obtained from all participants by FN. The trial is registered in the Iranian Registry of Clinical Trials (IRCT20230823059233N). Any changes to materials and methods will be reported in the IRCT registration update. Consent for publication Not applicable. Availability of data and materials The results will be subsequently published after analysis, and the data will be available upon request. Confidentiality All data will be de-identified before analysis and final report. Personal information will be used only for contact with participants. Only FN and VS who are involved in recruitment will have access to participants’ personal information. Before publication, only researchers involved in the study and the board of Research Ethics Committee will have access to the final dataset. Competing interests The authors of this study declare that they have no conflicts of interest. Funding The trial will be funded by Vice Chancellery for Research and Technology of Isfahan University of Medical Sciences (Address: No. 81746-73461, Hezar Jerib Street, Isfahan, Iran; E-mail: [email protected] ; Tel: +98-31-36687898). Although the Research Ethics Committees of Isfahan University of Medical Sciences will supervise the intervention, the researchers will conduct the study independently of the funder. The funding body will not be involved in data collection and analysis. Authors ’ contributions The researchers involved in this study meet authorship eligibility criteria, as their involvement will be substantial in the study implementation. Fatemeh Nabi (FN) conceived the study. She will be responsible for data collection and analysis and record meeting reports, assessment of participants, and taking written informed consent. She also wrote drafts of the manuscript. Hojatollah Yousefi (HY) initiated the study design and development of the protocol. Sima Babaee (SB) was involved in the intervention design. She will also supervise the sessions. HY and SB has supervised manuscript writing. Vahid Shaygannejad (VS) will refer family caregivers to FN who will assess them for eligibility. HY will be responsible for all aspects of the Research Ethics Committee of Isfahan University of Medical Sciences and will report the updates to the Iranian Registry of Clinical Trial. All authors contributed to refinement of the study protocol and approved the final manuscript. Presentation of the results All results of the trial without any restrictions will be published. Acknowledgements The authors gratefully acknowledge the review board of Research Ethics Committees of Nursing, Rehabilitation, and Management Schools of Isfahan University of Medical Sciences for their insightful reviews. We are also thankful to the Al-Zahra and Kashani Hospital staff members for their cooperation in following steps of this study. References Stampanoni Bassi M, Iezzi E, Centonze D. Chapter 30 - Multiple sclerosis: Inflammation, autoimmunity and plasticity. In: Quartarone A, Ghilardi MF, Boller F, editors. Handbook of Clinical Neurology. 184: Elsevier; 2022. p. 457-70. Ionescu R-B, Willis C, Nicaise AM, Krzak G, Hamel R, Peruzzotti-Jametti L, et al. Chapter 33 - Multiple sclerosis and neuromyelitis optica spectrum disorders∗. In: Zigmond MJ, Wiley CA, Chesselet M-F, editors. Neurobiology of Brain Disorders (Second Edition): Academic Press; 2023. p. 575-608. The Multiple Sclerosis International Federation. Atlas of MS. 3 ed: The Multiple Sclerosis International Federation; 2020. Shah A, Panchal V, Patel K, Alimohamed Z, Kaka N, Sethi Y, et al. Pathogenesis and management of multiple sclerosis revisited. Disease-a-Month. 2022:101497. Hauser SL, Cree BAC. Treatment of Multiple Sclerosis: A Review. The American Journal of Medicine. 2020;133(12):1380-90.e2. Rajachandrakumar R, Finlayson M. Multiple sclerosis caregiving: A systematic scoping review to map current state of knowledge. Health & Social Care in the Community. 2022;30(4):e874-e97. Soelberg Sorensen P, Giovannoni G, Montalban X, Thalheim C, Zaratin P, Comi G. The Multiple Sclerosis Care Unit. Mult Scler. 2019;25(5):627-36. Maguire R, Maguire P. Caregiver Burden in Multiple Sclerosis: Recent Trends and Future Directions. Current Neurology and Neuroscience Reports. 2020;20(7):18. Tehranineshat B, Yektatalab S, Momennasab M, Bijani M, Mohammadi F. The Experiences of Multiple Sclerosis Patients’ Family Caregivers at the First Hospitalization of Their Patients: A Qualitative Study. Patient Preference and Adherence. 2020;14:1159-72. Takalu MTM, Hosseini SA, Khankeh HR, Pishyareh E, Ebrahimi HA, Bakhshi E. How primary caregivers of individuals with multiple sclerosis cope with social isolation: a grounded theory study in an Iranian context. International Journal of Therapy and Rehabilitation. 2020;27(6):1-13. Sadeghi B, Estebsari F, Ebadi A, Rasouli M, Sadeghi E. The Social Support Needs of Family Caregivers of Patients With Multiple Sclerosis: A Qualitative Study. Archives of Rehabilitation. 2022;23(1):68-87. Halstead EJ, Stanley J, Fiore D, Mueser KT. Impact of Cognitive Impairment on Adults with Multiple Sclerosis and Their Family Caregivers. International Journal of MS Care. 2020;23(3):93-100. Ma R, Mann F, Wang J, Lloyd-Evans B, Terhune J, Al-Shihabi A, et al. The effectiveness of interventions for reducing subjective and objective social isolation among people with mental health problems: a systematic review. Social Psychiatry and Psychiatric Epidemiology. 2020;55(7):839-76. Lennartsson C, Rehnberg J, Dahlberg L. The association between loneliness, social isolation and all-cause mortality in a nationally representative sample of older women and men. Aging & Mental Health. 2022;26(9):1821-8. Cené CW, Beckie TM, Sims M, Suglia SF, Aggarwal B, Moise N, et al. Effects of Objective and Perceived Social Isolation on Cardiovascular and Brain Health: A Scientific Statement From the American Heart Association. Journal of the American Heart Association. 2022;11(16):e026493. Rohde N, D’Ambrosio C, Tang KK, Rao P. Estimating the Mental Health Effects of Social Isolation. Applied Research in Quality of Life. 2016;11(3):853-69. Evans M, Fisher EB. Social Isolation and Mental Health: The Role of Nondirective and Directive Social Support. Community Mental Health Journal. 2022;58(1):20-40. World Health Organization (WHO). International Classification of Disease,11 revision(ICD-11) [Available from: http://icd.who.int/browse11. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders: DSM-5. 5th ed2013. Elmer T, Stadtfeld C. Depressive symptoms are associated with social isolation in face-to-face interaction networks. Scientific Reports. 2020;10(1):1444. Petrikis P, Baldouma A, Katsanos AH, Konitsiotis S, Giannopoulos S. Quality of Life and Emotional Strain in Caregivers of Patients with Multiple Sclerosis. J Clin Neurol. 2019;15(1):77-83. Taheri Zadeh Z, Rahmani S, Alidadi F, Joushi S, Esmaeilpour K. Depresssion, anxiety and other cognitive consequences of social isolation: Drug and non-drug treatments. International Journal of Clinical Practice. 2021;75(12):e14949. Dickens AP, Richards SH, Greaves CJ, Campbell JL. Interventions targeting social isolation in older people: a systematic review. BMC Public Health. 2011;11(1):647. Abbas R, Yaghoub H. Investigating the effectiveness of group therapy based on compassion-focused therapy, on increasing self-compassion in male patients diagnosed with multiple sclerosis in Isfahan. Journal of Analytical - Cognitive Psychology. 2020;10(39):51-62. [Persian] Gilbert P. The Evolution and Social Dynamics of Compassion. Social and Personality Psychology Compass. 2015;9(6):239-54. Gilbert P, Simos G. Compassion focused therapy: Clinical practice and applications. 1st ed. London: Routledge; 2022. Pauley G, McPherson S. The experience and meaning of compassion and self‐compassion for individuals with depression or anxiety. Psychology and Psychotherapy: Theory, Research and Practice. 2010;83(2):129-43. Abolhassani S, Jahani L. Education of Compassion-based Program for Nurses and Paramedics. 1st ed. Isfahan: Maani Publications; 2021. [Persian] Feliu-Soler A, Pascual JC, Elices M, Martín-Blanco A, Carmona C, Cebolla A, et al. Fostering Self-Compassion and Loving-Kindness in Patients With Borderline Personality Disorder: A Randomized Pilot Study. Clinical Psychology & Psychotherapy. 2017;24(1):278-86. Noorbala F, Borjali A, Ahmadian-Attari MM, Noorbala AA. Effectiveness of compassionate mind training on depression, anxiety, and self-criticism in a group of Iranian depressed patients. Iranian journal of psychiatry. 2013;8(3):113. Gilbert P. Compassionate mind training: key themes. In: Gilbert P, Simos G, editors. Compassion focused therapy: Clinical practice and applications. 1st ed. London: Routledge; 2022. p. 273-312. Foroughi AA, Khanjani S, Rafiee S, Taheri AA. Self-compassion: conceptualization, research, and interventions (Brief review). Shenakht journal of psychology & psychiatry. 2020;6(6):77-87. [Persian] Gilbert P. Compassion focused therapy: Distinctive features. 1st ed. London: Routledge; 2010. MirMoeini P, Bayazi MH, Khalatbari J. Comparing the effectiveness of Acceptance and Commitment Therapy with Compassion Focused Therapy on loneliness in patients with Multiple Sclerosis. scientific magazine yafte. 2021;22(4):132-45. Meehan M, Doody O. The role of the clinical nurse specialist multiple sclerosis, the patients' and families' and carers' perspective: An integrative review. Mult Scler Relat Disord. 2020;39:101918. Tagharrobi Z, Mohammadkhan Kermanshahi S, Mohammadi E. The Facilitators of Using Complementary Therapies in Clinical Nursing: A Qualitative Content Analysis. Journal of Rafsanjan University of Medical Sciences. 2016;15(8):691-714. [Persian] Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. Bmj. 2013;346:e7586. Mousavi MS, Bakhshipour A, Mahdian H. Comparing the Effectiveness of “Acceptance and Commitment Therapy” and “Compassion-Focused Therapy” and “Compassion-Enriched Acceptance and Commitment Therapy” on Communication Patterns of Married Women Suffering from Depression and Marital Conflicts. Journal of Health Promotion Management. 2023;12(1):95-112. [Persian] Russell D. UCLA Loneliness Scale (Version 3): Reliability, Validity, and Factor Structure. Journal of personality assessment. 1996;66:20-40. Zarei S, Memari AH, Moshayedi P, Shayestehfar M. Validity and reliability of the UCLA loneliness scale version 3 in Farsi. Educational Gerontology. 2016;42(1):49-57. Beck AT, Steer RA, Ball R, Ranieri WF. Comparison of Beck Depression Inventories-IA and-II in Psychiatric Outpatients. Journal of Personality Assessment. 1996;67(3):588-97. Beck AT, Steer, R.A., Brown, G.K. Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation; 1996. Stefan-Dabson K, Mohammadkhani P, Massah-Choulabi O. Psychometrics Characteristic of Beck Depression Inventory-II in Patients with Major Depressive Disorder. Archives of Rehabilitation. 2007;8(0):82-0. [Persian] Jahani L, Abolhassani S, Babaee S, Omranifard V. Effects of a compassion-based program on the grief experienced by caregivers of people suffering from dementia: a randomized controlled clinical trial. BMC Nursing. 2022;21(1):198. Craig C, Hiskey S, Spector A. Compassion focused therapy: a systematic review of its effectiveness and acceptability in clinical populations. Expert Review of Neurotherapeutics. 2020;20(4):385-400. Aghili SM, Tighdast S, Babaee E. The Effectiveness of Compassion-Focused Therapy on the Quality of Life and Resilience of Caregivers of Patients with MS. Journal of Applied Research in Behavioral Sciences. 2023;14(52):69-84. [Persian] Tohidifar M, Kazemian Moghadam K, Haroon Rashidi H. The Effectiveness of Compassion-Focused Therapy on Loneliness and Cognitive Flexibility in Elderly Men. Quarterly Journal of Psychological Studies. 2021;17(2):97-116. [Persian] Kazemi A, Ahadi H, Nejat H. Effectiveness of Compassion Focused Therapy on Loneliness, Self-care Behaviors and Blood Sugar in Diabetes Patients. ijrn. 2020;6(3):42-9. [Persian] Additional File 3 Additional File 3 is not available with this version. Supplementary Files Additionalfile1.docx · File name: Additional file 1 · File format: .DOCX · Title of data: SPIRIT Checklist for Trials · Description of data: SPIRIT Checklist Additionalfile2.docx · File name: Additional file 2 · File format: .DOCX · Title of data: Content of sessions · Description of data: The content of each session of our CFT-based psychoeducational program is presented in details in the Additional File 2. Cite Share Download PDF Status: Published Journal Publication published 24 Feb, 2026 Read the published version in Trials → Version 1 posted Reviewers agreed at journal 27 Mar, 2025 Reviewers invited by journal 27 Mar, 2025 Editor invited by journal 18 Mar, 2025 Editor assigned by journal 10 Mar, 2025 First submitted to journal 08 Mar, 2025 Editorial decision: Major revision 13 Feb, 2025 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-5420701","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":434917209,"identity":"df7a641f-0a6e-45f1-9904-80fbe578b00c","order_by":0,"name":"Fatemeh Nabi","email":"","orcid":"","institution":"Isfahan University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Fatemeh","middleName":"","lastName":"Nabi","suffix":""},{"id":434917210,"identity":"66b56202-765f-496f-8e09-fefa774fbdf5","order_by":1,"name":"Hojatollah Yousefi","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA1ElEQVRIiWNgGAWjYNACGwk5CMMARDA2EKElTcKYZC0MicQogxp7vMf4w4cEi/TtYgdYN/MUMMjzNzC3fcCr5cwZM8kZCRK5O2cnsN3mMWAwnHGAsXkGXi03csyYeX9I5G64DdHCuIGBsRm/w27kGH/+kyCRbgDVYk+MFgNphgSJBJiWRIJaJM8cK5PsSZAw3HA7se3mHAOJ5BmHCWjhO968+cOPhDp5g9vJx268+WNj29/e/hivFoUDcCY4BiUYGJjxamBgkG8goGAUjIJRMApGAQMAdNBFxJC3Ji8AAAAASUVORK5CYII=","orcid":"https://orcid.org/0000-0002-7727-3520","institution":"Isfahan University of Medical Sciences","correspondingAuthor":true,"prefix":"","firstName":"Hojatollah","middleName":"","lastName":"Yousefi","suffix":""},{"id":434917211,"identity":"bef8676f-4f49-45ed-ac4c-38905340fd21","order_by":2,"name":"Sima Babaee","email":"","orcid":"","institution":"Isfahan University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Sima","middleName":"","lastName":"Babaee","suffix":""},{"id":434917212,"identity":"2401d279-fa3c-4c01-a20e-a6c3087a7f04","order_by":3,"name":"Vahid Shaygannejad","email":"","orcid":"","institution":"Isfahan University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Vahid","middleName":"","lastName":"Shaygannejad","suffix":""}],"badges":[],"createdAt":"2024-11-09 08:28:28","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5420701/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5420701/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s13063-026-09547-0","type":"published","date":"2026-02-24T15:59:33+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":80814014,"identity":"a1849701-3f72-45d3-a67d-b9abb89a7d6d","added_by":"auto","created_at":"2025-04-17 10:45:25","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":277296,"visible":true,"origin":"","legend":"\u003cp\u003eSPIRIT guidance figure\u003c/p\u003e","description":"","filename":"Figure1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-5420701/v1/c80f301e706a8327d8692296.jpg"},{"id":80812356,"identity":"675378d9-3488-4ced-baf4-fbffb2f5c62a","added_by":"auto","created_at":"2025-04-17 10:37:25","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":120431,"visible":true,"origin":"","legend":"\u003cp\u003eFlow diagram showing the study procedure\u003c/p\u003e","description":"","filename":"Figure2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-5420701/v1/d964defde68366a87a2b0d6a.jpg"},{"id":103766092,"identity":"947fbb0b-54e3-4bfe-b8ca-300cb8520e35","added_by":"auto","created_at":"2026-03-02 16:12:09","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1089179,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5420701/v1/80b3f6bb-0f24-46c8-a7c2-3d6a6bee7a92.pdf"},{"id":80811773,"identity":"dca048ac-b1c9-4656-84a6-34afb0ebaca0","added_by":"auto","created_at":"2025-04-17 10:29:25","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":41090,"visible":true,"origin":"","legend":"\u003cp\u003e· File name: Additional file 1\u003c/p\u003e\n\u003cp\u003e· File format: .DOCX\u003c/p\u003e\n\u003cp\u003e· Title of data: SPIRIT Checklist for Trials\u003c/p\u003e\n\u003cp\u003e· Description of data: SPIRIT Checklist\u003c/p\u003e","description":"","filename":"Additionalfile1.docx","url":"https://assets-eu.researchsquare.com/files/rs-5420701/v1/9df9e71e526015e6d6c57194.docx"},{"id":80814013,"identity":"778a1441-ddb7-480d-b72d-316e83107734","added_by":"auto","created_at":"2025-04-17 10:45:25","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":20910,"visible":true,"origin":"","legend":"\u003cp\u003e· File name: Additional file 2\u003c/p\u003e\n\u003cp\u003e· File format: .DOCX\u003c/p\u003e\n\u003cp\u003e· Title of data: Content of sessions\u003c/p\u003e\n\u003cp\u003e· Description of data: The content of each session of our CFT-based psychoeducational program is presented in details in the Additional File 2.\u003c/p\u003e","description":"","filename":"Additionalfile2.docx","url":"https://assets-eu.researchsquare.com/files/rs-5420701/v1/4f4ee2dd6666279bcaa3b4f4.docx"}],"financialInterests":"","formattedTitle":"Evaluation of a Group Compassion-based Program on Perceived Social Isolation and Depression in Family Caregivers of Patients with Multiple Sclerosis: Study Protocol for an Open-label Randomized Controlled Trial","fulltext":[{"header":"Background","content":"\u003cp\u003eMultiple Sclerosis (MS) is an autoimmune, neurodegenerative disease of thr central nervous system [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. With a predominantly young onset, MS is a leading cause of neurological disabilities in younger adults [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. Currently, approximately 2.8\u0026nbsp;million people are diagnosed with MS. Approximately 75000 people with MS live in Iran, mostly women, with an average age of 32 years at the time of onset [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Although the exact underlying cause of the disease is unknown, a variety of factors, including genetic elements and environmental exposures, such as infections and smoking, are known to be involved in MS pathogenesis [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. Given the disabling nature of the disease, people with MS require continuous care and support [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eCaring may be delivered by various providers, from in-home caregiving companies to the relatives of people in need. Informal caregivers, or more commonly known as family caregivers, refer to family members who are well aware of and respond to the patient\u0026rsquo;s needs and do not expect payments in return [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. The care of patients at home alongside other family members as much as possible is an important global policy [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. Family caregivers usually experience different challenges depending on their age and relations to the patients [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Given the burden of caregiving, family caregivers may experience mental and physical health problems, resulting in heavy physical, mental, social, and economic challenges for family members [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eStudies have shown that MS patients, because of misconceptions about the disease, fear of being pitied, visible disabilities caused by the disease, stigmatization, and economic problems, avoid social interactions, which in turn causes their caregivers to be socially isolated [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. Another study indicated that cognitive impairments of MS patients, such as memory problems, may interrupt their social interactions and render them and their spouses socially disconnected [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. A study conducted in Iran revealed that one of the main problems experienced by MS patients is social isolation, which is influenced by numerous factors, one of which is potentially the Islamic teachings of family commitment in Iran [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eSocial isolation and loneliness have been linked to serious health outcomes, even increasing the risk for mortality [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. The American Heart Association suggests that social isolation is associated with a greater risk of cardiovascular diseases [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. It also affects mental health, with depression and anxiety being among the most prevalent outcomes [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eDepression is a mood disorder characterized by feelings of sadness, guilt, loss of pleasure, objective signs of irritability, decreased level of energy, and eating or sleeping disorders for more than two weeks [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. While decreased or loss of social interactions is linked to depression, evidence suggests that depression may also result in social isolation, which is expected as the depressive symptoms can affect beginning, maintaining, and terminating social connections [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. Studies indicate that depression is a common issue experienced by caregivers of people with MS [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. This is highly important because depression increases caregiving strain and fatigue, and therefore significantly impacts the quality of life as well as the mental and physical health of caregivers [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eGiven the interrelation of social isolation and depression, and their impact on caregivers\u0026rsquo; health, effective interventions are required to optimize the caregiving process. A large body of suggested interventions exists [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. Compassion-focused therapy (CFT) is a promising psychotherapies for psychological conditions [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eAlthough not universally agreed upon, compassion is usually defined as \u0026ldquo;sensitivity to suffering in self and others with a commitment to try to alleviate and prevent it.\u0026rdquo; [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e] This concept was originally emphasized in the Buddhist tradition which considers it a way to achieve happiness and enlightenment, leading the \u0026ldquo;compassionate\u0026rdquo; person to positive changes [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e]. Compassion is actually an adaptive capacity that has helped humans regulate negative emotions to survive during their evolution [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]. Studies suggest that compassion can be taught, reinforced, and trained via education [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e, \u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]. The teachability of compassion, along with the insufficiency of cognitive behavioral therapy (CBT) to improve negative emotions, such as self-criticism, in clinical cases was the basis and origin of CFT [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]. Compassion, although teachable, originates from the neurophysiology of the human brain; receiving kindness and compassion in early childhood enhances neural connections associated with compassionate behavior later in life [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eCFT does so by helping the client understand that the mind is not a total product of what they have chosen or done in their lives [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e]. It strengthens the ability of the client to acknowledge and confront the feelings and thoughts, and not to avoid them [\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e]. In other words, the purpose of CFT is not to disregard suffering, but to deal with it [\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e]. In fact, CFT holds that pain and suffering are inseparable parts of human life [\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe undesirable outcomes of social isolation and depression for family caregivers raise concerns for family-centered care. The current literature considers supporting families and caregivers of patients with MS as one of the key roles of clinical nurses [\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e]. Therefore, nurses are required to learn and employ a variety of skills to support and enable families and caregivers of people with MS [\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e, \u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e]. CFT may be an effective nursing intervention to improve caregivers\u0026rsquo; and eventually patients\u0026rsquo; conditions.\u003c/p\u003e \u003cp\u003eGiven the success of CFT in improving a wide range of psychological issues, including depression, and the importance of mental health in family caregivers on their care quality, the current study examines whether CFT can be employed as a psychoeducational nursing intervention to improve the perceived social isolation and depression of family caregivers of people with MS compared with a control group of same caregivers that receives no intervention.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\n \u003ch2\u003eObjectives\u003c/h2\u003e\n \u003cp\u003eThe current study aims to evaluate the effectiveness of a group compassion-based program on the perceived social isolation and depression of family caregivers of people with MS. We hypothesize that CFT will significantly improve both outcomes in caregivers in the intervention group. We also hypothesize that the improvement will last at least two months after the intervention.\u003c/p\u003e\n\u003c/div\u003e\n\u003ch3\u003eStudy design\u003c/h3\u003e\n\u003cp\u003eThis study is an open-label two-arm parallel-group randomized controlled trial with an intervention group in which participants receive a group compassion-based psychoeducational program, and a control group with no intervention. This trial employs an exploratory framework. The allocation of participants will be randomized, at a 1:1 ratio. We used the SPIRIT checklist when writing our protocol (Fig. \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e; Additional file 1) [\u003cspan class=\"CitationRef\"\u003e37\u003c/span\u003e].\u003c/p\u003e\n\u003ch3\u003eStudy settings\u003c/h3\u003e\n\u003cp\u003eThe CFT-based program for the intervention group is planned to be delivered in the classrooms of the Al-Zahra and Kashani hospitals, two centers with specialized MS clinics in Isfahan, Iran. Both hospitals are referral centers affiliated with Isfahan University of Medical Sciences. People with MS are referred to these centers for treatment follow-up, periodic appointments, and, in some cases, drug administration.\u003c/p\u003e\n\u003ch3\u003eParticipants and sampling\u003c/h3\u003e\n\u003cp\u003eFamily caregivers of people with MS referred to the selected hospitals will be recruited via convenience sampling. The required sample size was calculated based on standard deviations of depression scores in a previous similar study [\u003cspan class=\"CitationRef\"\u003e38\u003c/span\u003e]. With S\u003csub\u003e1\u003c/sub\u003e and S\u003csub\u003e2\u003c/sub\u003e being the standard deviations of the depression scores in the intervention and control groups, given the minimum reduction in the mean depression score was 8 units, a 95% confidence interval and 90% power, 26 participants are required for each arm of the study. Considering 20% attrition, a total of thirty family caregivers who meet the eligibility criteria will be recruited for each arm.\u003c/p\u003e\n\u003cdiv id=\"Equa\" class=\"Equation\"\u003e\n \u003cdiv class=\"mathdisplay\" id=\"FileID_Equa\" name=\"EquationSource\"\u003e\u003cimg src=\"data:image/png;base64,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\"\u003e\u003c/div\u003e\n\u003c/div\u003e\n\u003ch3\u003eRecruitment and consent\u003c/h3\u003e\n\u003cp\u003eVS will introduce the eligible participants to FN. Family caregivers of patients referred to the selected hospitals will be interviewed during their patients\u0026rsquo; appointments. FN will briefly share the objectives and procedure of the study with their caregivers. If they are unwilling, the interviewed caregivers won\u0026rsquo;t be included in the study. If willing, and if the interviewed caregivers meet the inclusion criteria, their contact information will be obtained for further steps. FN will take informed, written consent of participants in both groups later in an introductory session.\u003c/p\u003e\n\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\n \u003ch2\u003eEligibility criteria\u003c/h2\u003e\n \u003cp\u003eThe inclusion criteria for caregivers are: 1) aged between 18 and 70 years, 2) a minimum level of literacy needed for reading and writing, 3) consent to participate in the study, 4) if the patient has more than one caregiver, the caregiver who spends more time with the patient, 5) having the physical ability to participate in class sessions for at least two hours, 6) having the mental capacity to participate in the educational program without a self-reported learning or memory disorder, 7) having no history of depression or any other disease affecting social interactions, and 8) being the caregiver of only one patient. Unwillingness to continue to participate, absence in class sessions for more than two sessions, participating in other psychological or psychiatric interventions, and diagnosis of depression or any other disease affecting social interactions during the study will result in exclusion from the study.\u003c/p\u003e\n \u003cp\u003eAlthough family caregivers are the actual participants in this study, we also considered eligibility criteria for patients, as the situation of patients directly affects the caregiving process and outcomes. We will include family caregivers of patients with an expanded disability status scale (EDSS) score ranging from 2 to 9.5, no history of other chronic diseases, and who have been diagnosed with MS for at least two months. Caregivers of patients who expire or are admitted to a hospital due to a relapse during the study will be excluded.\u003c/p\u003e\n\u003c/div\u003e\n\u003ch3\u003eOutcomes and materials\u003c/h3\u003e\n\u003cp\u003ePerceived social isolation and depression are the primary outcomes of this study. The primary outcomes will be measured at baseline (i.e. before intervention, T\u003csub\u003e0\u003c/sub\u003e), immediately after intervention (i.e. after the last session of intervention, T\u003csub\u003e1\u003c/sub\u003e), and two months after the intervention (i.e. the follow-up, T\u003csub\u003e2\u003c/sub\u003e). All measurements of primary outcomes will be reported as the mean score and standard deviation. We also obtain the demographic information of caregivers, including their age, gender, marital status, relation to patient, education, and employment status, and disease information of their patient, including disease duration, disease pattern, and EDSS. These data are the background variables of the study.\u003c/p\u003e\n\u003ch3\u003eInstruments and data collection\u003c/h3\u003e\n\u003cp\u003eThe demographic data of caregivers and disease information of patients will be collected via a form developed by the researchers. The EDSS score of patients may need physical examination as it is sometimes not recorded in patients\u0026rsquo; files.\u003c/p\u003e\n\u003cp\u003ePerceived social isolation will be measured by Russell\u0026rsquo;s UCLA Loneliness Scale Version 3 (UCLA LS3). This questionnaire was originally developed in 1978 and was later revised by Russell in 1996 because the scale was criticized for the negative phrasing of all items as it could potentially create a bias for respondents. UCLA LS3 consists of twenty items; eleven items are negatively phrased (i.e. implies feeling excluded) and the rest of them are positively phrased. The Likert scoring of negatively phrased items is from 1 (\u0026ldquo;Never\u0026rdquo;) to 4 (\u0026ldquo;Always\u0026rdquo;). The positively phrased items are scored oppositely. A higher score indicates greater perceived isolation. UCLA LS3 has shown good psychometric performance in the original study [\u003cspan class=\"CitationRef\"\u003e39\u003c/span\u003e]. The Persian translation of the UCLA LS3 has been validated via factor analysis, and shown to be reliable with a Cronbach\u0026rsquo;s alpha of 0.91 [\u003cspan class=\"CitationRef\"\u003e40\u003c/span\u003e].\u003c/p\u003e\n\u003cp\u003eBeck Depression Inventory (BDI-II) will be used to measure depression. Originally developed in 1961 and later revised in 1996, this 21-item scale is a widely used instrument to quantify depression, including depressive mood and symptoms. Each item of BDI-II is scored from 0 to 3, for a total score between 0 and 63. A higher score implies more severe depression [\u003cspan class=\"CitationRef\"\u003e41\u003c/span\u003e]. The validity and reliability of BDI-II were evaluated and confirmed by Beck et al. [\u003cspan class=\"CitationRef\"\u003e42\u003c/span\u003e]. The construct validity of the Persian translation of BDI-II is confirmed by convergent validity and factor analysis. It has also been shown to be internally consistent with a Cronbach\u0026rsquo;s alpha of 0.91 [\u003cspan class=\"CitationRef\"\u003e43\u003c/span\u003e].\u003c/p\u003e\n\u003cp\u003eData will be collected before and after the intervention, and additionally in a two-month follow-up. The UCLA LS3 and BDI-II questionnaires will be printed and delivered to all participants. To collect data at baseline (T\u003csub\u003e0\u003c/sub\u003e), all participants will be invited to a session held at the Kashani hospital. After a detailed explanation of the study procedure and taking informed consent, the participants will fill out the printed questionnaires as well as the forms of demographic information and disease information. At the end of the last session of the program (T\u003csub\u003e1\u003c/sub\u003e), the UCLA LS3 and BDI-II questionnaires will again be delivered to the participants. At the follow-up (T\u003csub\u003e2\u003c/sub\u003e), the questionnaires will be delivered to the participants one last time. The timing and instruments of data collection are the same for all participants, regardless of their assignment to the intervention or the control group. Data monitoring in all phases will be done by the FN.\u003c/p\u003e\n\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\n \u003ch2\u003eStudy procedure\u003c/h2\u003e\n \u003cp\u003eAfter recruitment reaches the calculated sample size, a number between 1 and 60 will be sequentially assigned to each participant. All numbers will be subsequently entered into the random allocating tool of the GraphPad website (available at \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ewww.graphpad.com\u003c/span\u003e\u003c/span\u003e). The random allocator will assign the numbers into two separate groups. One group will be randomly considered the intervention group, and the other one will be considered the control group (Fig. \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e). The whole allocation process, including the generation of allocation sequence and participant assignment, will be implemented by FN.\u003c/p\u003e\n \u003cp\u003eAll participants will be invited to an in-person, introductory session held at the Kashani hospital classroom via the contact information previously obtained during recruitment. The objectives, procedure, date, and time of the following sessions will be shared and discussed in this session in full detail. Then an informed, written consent will be taken from all participants by FN. Furthermore, baseline data will be collected (T\u003csub\u003e0\u003c/sub\u003e). At the end of this session, participants in the control group will be discharged and asked to wait until the end of the intervention. The participants in the intervention group will be divided into three equal subgroups of ten participants. Caregivers in each subgroup will participate in six weekly 120-minute sessions held in the classrooms of the selected centers. FN will be responsible for psychoeducation. FN has been trained and certified to devise a CFT-based psychoeducational program. SB, who has contributed to similar studies exploring compassionate nursing care [\u003cspan class=\"CitationRef\"\u003e44\u003c/span\u003e], will be the supervisor and advisor of the intervention.\u003c/p\u003e\n \u003cp\u003eAfter the sixth and final session of the program (T\u003csub\u003e1\u003c/sub\u003e), social isolation and depression will be measured in all participants using UCLA LS3 and BDI-II. Two months after the final session (T\u003csub\u003e2\u003c/sub\u003e), as a follow-up to determine the long-term effectiveness of the program, participants in both groups will be asked to fill out the questionnaires last time. The collected data will be entered into IBM SPSS Statistics version 24 for data analysis.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\n \u003ch2\u003eIntervention\u003c/h2\u003e\n \u003cp\u003eThe intervention consists of six weekly 120-minute sessions, each of which delivered in classrooms of the selected hospital. We chose this timing frame because the strongest effects in previous interventions have been associated with programs with durations over 12 hours [\u003cspan class=\"CitationRef\"\u003e45\u003c/span\u003e]. The program is a psychoeducational CFT intervention developed primarily based on Gilbert\u0026rsquo;s protocol [\u003cspan class=\"CitationRef\"\u003e26\u003c/span\u003e] (Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e). We incorporated homework-based skill-building into the CFT program outlined by Gilbert, with elements of Neff\u0026rsquo;s account of self-compassion, to ensure the comprehensiveness of our program. All of content is delivered via face-to-face education, a PowerPoint presentation, pamphlets, and group discussion. Each session consists of a brief review of the previous session and a 10-minute break. Furthermore, homework, which is a practice needed to be trained at home, will be given to participants at the end of each session. Each participant will be asked to verbally report his experience with the homework in the next session.\u003c/p\u003e\n \u003cdiv class=\"gridtable\"\u003e\u0026nbsp;\u003ctable id=\"Tab1\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eThe subject and content of each session of CFT-based psychoeducational program in this study\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003ccolgroup cols=\"3\"\u003e\u003c/colgroup\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eSession\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eContent\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eHomework\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eA detailed introduction to the study procedure, taking informed consent, and baseline assessment\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eNo homework\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePreliminary communication, a review of the following sessions, introduction to \u0026ldquo;compassion,\u0026rdquo; its general principles and basic concepts\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eWriting a compassionate letter\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMindfulness basics, soothing breathing, and body scanning\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMindfulness practice\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCharacteristics of a compassionate person\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eIntrospection to search for characteristics of a compassionate person, and rating them\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026ldquo;Compassionate skills\u0026rdquo; and how to cultivate these skills\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSkill-building exercises\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eReadiness and acceptance of future events\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSelf-teaching practice\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eA review of previous session; how to write down a compassionate letter\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eWriting a compassionate letter, and comparing it to the one written after session 1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n \u003c/div\u003e\n \u003cp\u003eTo encourage participants to enroll in class sessions, every session will include an evening meal. The sessions will be free of charge. The participants will be free to contact FN at any time. They are allowed to ask their questions, report on their homework, or any other problem they may face during the study.\u003c/p\u003e\n \u003cp\u003eThe content of each session is presented in detail in Additional file 2.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec13\" class=\"Section2\"\u003e\n \u003ch2\u003eData analysis\u003c/h2\u003e\n \u003cp\u003eDescriptive statistics, including means and standard deviations for quantitative data, and frequencies and percentages for qualitative data, will be used to describe demographic and disease-related variables. The normality of data will be tested via the Kolmogorov-Smirnov test. Independent t-test will determine the significance of the difference in outcome scores between intervention and control groups at T\u003csub\u003e0\u003c/sub\u003e, T\u003csub\u003e1\u003c/sub\u003e, and T\u003csub\u003e2\u003c/sub\u003e. Repeated measures ANOVA will reveal if there are any significant changes in the mean scores of each group from T\u003csub\u003e0\u003c/sub\u003e to T\u003csub\u003e2\u003c/sub\u003e. ANCOVA will be employed to control for covariates and adjust for mean scores between groups. All tests will be two-tailed, and a p value of \u0026lt;\u0026thinsp;0.05 will be considered statistically significant. IBM SPSS Statistics version 24 will be used for data entry and all analyses. FN will enter gathered data into the spreadsheet of SPSS for data analysis based on the numbers assigned to participants in recruitment.\u003c/p\u003e\n\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe main question of the current study is whether CFT, as a group psychoeducational program outlined above, is effective in improving social isolation and depression among family caregivers of people with MS. Only one similar study was found to evaluate the effects of CFT in caregivers of patients with MS. A study conducted in Tehran, Iran, showed that a CFT program consisting of eight one-hour sessions significantly increased resilience and quality of life in caregivers of people with MS [46]. To our knowledge, this study will be the first evaluation of the effects of CFT on social isolation and depression in family caregivers of people with MS.\u003c/p\u003e\n\u003cp\u003eLoneliness has also been subject to CFT-based intervention [47, 48]. Although effective, to our knowledge, no study has evaluated the effectiveness of CFT on loneliness among caregivers. Given the close link between feeling of loneliness and perceived social isolation, we hypothesize that the current study will effectively reduces perceived social isolation in caregivers of people with MS.\u003c/p\u003e\n\u003cp\u003eIn conclusion, we believe that the results of the current study will add up to the literature as it will be the first study to demonstrate the effectiveness of CFT in caregivers of people with MS, with perceived social isolation and depression as primary outcomes. Caregivers of people with MS have rarely been the target of CFT interventions in current literature, and the current study will expand our knowledge of both CFT effectiveness and factors affecting caregiving in MS. If effective, compassion-based intervention may be justified for incorporation into comprehensive family-centered care.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eBDI-II\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eBeck Depression Inventory Version 2\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eCBT\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eCognitive Behavioral Therapy\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eCFT\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eCompassion-focused Therapy\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eEDSS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eExpanded Disability Status Scale\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eIRCT\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eIranian Registry of Clinical Trials\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eMS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eMultiple Sclerosis\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eUCLA LS3\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eUCLA Loneliness Scale Version 3\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eName of the registry\u003c/strong\u003e: Iranian Registry of Clinical Trials\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration Number\u003c/strong\u003e: IRCT20230823059233N (https://irct.behdasht.gov.ir/trial/73412)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDate of registration:\u0026nbsp;\u003c/strong\u003e1 November 2021\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eProtocol version:\u0026nbsp;\u003c/strong\u003eCurrent protocol: Version 1 (28 October 2024).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial status\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe trial is registered on 1 November 2021 in IRCT (IRCT20230823059233N). the current paper is the first protocol version of the trial to be published. Recruitment is planned to start on 1 December 2024.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eEthics approval and consent to participate\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe Research Ethics Committees of Nursing, Rehabilitation, and Management Schools of Isfahan University of Medical Sciences approved this study (IR.MUI.NUREMA.REC.1402.128). The study procedure has been designed and will be implemented in accordance with the ethical standards of the Isfahan University of Medical Sciences. Written, informed consent to enroll in study will be obtained from all participants by FN. The trial is registered in the Iranian Registry of Clinical Trials (IRCT20230823059233N). Any changes to materials and methods will be reported in the IRCT registration update.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eConsent for publication\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAvailability of data and materials\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe results will be subsequently published after analysis, and the data will be available upon request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eConfidentiality\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll data will be de-identified before analysis and final report. Personal information will be used only for contact with participants. Only FN and VS who are involved in recruitment will have access to participants’ personal information. Before publication, only researchers involved in the study and the board of Research Ethics Committee will have access to the final dataset.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eCompeting interests\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors of this study declare that they have no conflicts of interest.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eFunding\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe trial will be funded by Vice Chancellery for Research and Technology of Isfahan University of Medical Sciences (Address: No. 81746-73461, Hezar Jerib Street, Isfahan, Iran; E-mail: [email protected]; Tel: +98-31-36687898). Although the Research Ethics Committees of Isfahan University of Medical Sciences will supervise the intervention, the researchers will conduct the study independently of the funder. The funding body will not be involved in data collection and analysis.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAuthors\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e’\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e\u0026nbsp;contributions\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe researchers involved in this study meet authorship eligibility criteria, as their involvement will be substantial in the study implementation. Fatemeh Nabi (FN) conceived the study. She will be responsible for data collection and analysis and record meeting reports, assessment of participants, and taking written informed consent. She also wrote drafts of the manuscript. Hojatollah Yousefi (HY) initiated the study design and development of the protocol. Sima Babaee (SB) was involved in the intervention design. She will also supervise the sessions. HY and SB has supervised manuscript writing. Vahid Shaygannejad (VS) will refer family caregivers to FN who will assess them for eligibility. HY will be responsible for all aspects of the Research Ethics Committee of Isfahan University of Medical Sciences and will report the updates to the Iranian Registry of Clinical Trial. All authors contributed to refinement of the study protocol and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003ePresentation of the results\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll results of the trial without any restrictions will be published.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eAcknowledgements\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors gratefully acknowledge the review board of Research Ethics Committees of Nursing, Rehabilitation, and Management Schools of Isfahan University of Medical Sciences for their insightful reviews. We are also thankful to the Al-Zahra and Kashani Hospital staff members for their cooperation in following steps of this study.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eStampanoni Bassi M, Iezzi E, Centonze D. Chapter 30 - Multiple sclerosis: Inflammation, autoimmunity and plasticity. In: Quartarone A, Ghilardi MF, Boller F, editors. Handbook of Clinical Neurology. 184: Elsevier; 2022. p. 457-70.\u003c/li\u003e\n\u003cli\u003eIonescu R-B, Willis C, Nicaise AM, Krzak G, Hamel R, Peruzzotti-Jametti L, et al. Chapter 33 - Multiple sclerosis and neuromyelitis optica spectrum disorders\u0026lowast;. In: Zigmond MJ, Wiley CA, Chesselet M-F, editors. Neurobiology of Brain Disorders (Second Edition): Academic Press; 2023. p. 575-608.\u003c/li\u003e\n\u003cli\u003eThe Multiple Sclerosis International Federation. Atlas of MS. 3 ed: The Multiple Sclerosis International Federation; 2020.\u003c/li\u003e\n\u003cli\u003eShah A, Panchal V, Patel K, Alimohamed Z, Kaka N, Sethi Y, et al. Pathogenesis and management of multiple sclerosis revisited. Disease-a-Month. 2022:101497.\u003c/li\u003e\n\u003cli\u003eHauser SL, Cree BAC. Treatment of Multiple Sclerosis: A Review. The American Journal of Medicine. 2020;133(12):1380-90.e2.\u003c/li\u003e\n\u003cli\u003eRajachandrakumar R, Finlayson M. Multiple sclerosis caregiving: A systematic scoping review to map current state of knowledge. Health \u0026amp; Social Care in the Community. 2022;30(4):e874-e97.\u003c/li\u003e\n\u003cli\u003eSoelberg Sorensen P, Giovannoni G, Montalban X, Thalheim C, Zaratin P, Comi G. The Multiple Sclerosis Care Unit. Mult Scler. 2019;25(5):627-36.\u003c/li\u003e\n\u003cli\u003eMaguire R, Maguire P. Caregiver Burden in Multiple Sclerosis: Recent Trends and Future Directions. Current Neurology and Neuroscience Reports. 2020;20(7):18.\u003c/li\u003e\n\u003cli\u003eTehranineshat B, Yektatalab S, Momennasab M, Bijani M, Mohammadi F. The Experiences of Multiple Sclerosis Patients\u0026rsquo; Family Caregivers at the First Hospitalization of Their Patients: A Qualitative Study. Patient Preference and Adherence. 2020;14:1159-72.\u003c/li\u003e\n\u003cli\u003eTakalu MTM, Hosseini SA, Khankeh HR, Pishyareh E, Ebrahimi HA, Bakhshi E. How primary caregivers of individuals with multiple sclerosis cope with social isolation: a grounded theory study in an Iranian context. International Journal of Therapy and Rehabilitation. 2020;27(6):1-13.\u003c/li\u003e\n\u003cli\u003eSadeghi B, Estebsari F, Ebadi A, Rasouli M, Sadeghi E. The Social Support Needs of Family Caregivers of Patients With Multiple Sclerosis: A Qualitative Study. Archives of Rehabilitation. 2022;23(1):68-87.\u003c/li\u003e\n\u003cli\u003eHalstead EJ, Stanley J, Fiore D, Mueser KT. Impact of Cognitive Impairment on Adults with Multiple Sclerosis and Their Family Caregivers. International Journal of MS Care. 2020;23(3):93-100.\u003c/li\u003e\n\u003cli\u003eMa R, Mann F, Wang J, Lloyd-Evans B, Terhune J, Al-Shihabi A, et al. The effectiveness of interventions for reducing subjective and objective social isolation among people with mental health problems: a systematic review. Social Psychiatry and Psychiatric Epidemiology. 2020;55(7):839-76.\u003c/li\u003e\n\u003cli\u003eLennartsson C, Rehnberg J, Dahlberg L. The association between loneliness, social isolation and all-cause mortality in a nationally representative sample of older women and men. Aging \u0026amp; Mental Health. 2022;26(9):1821-8.\u003c/li\u003e\n\u003cli\u003eCen\u0026eacute; CW, Beckie TM, Sims M, Suglia SF, Aggarwal B, Moise N, et al. Effects of Objective and Perceived Social Isolation on Cardiovascular and Brain Health: A Scientific Statement From the American Heart Association. Journal of the American Heart Association. 2022;11(16):e026493.\u003c/li\u003e\n\u003cli\u003eRohde N, D\u0026rsquo;Ambrosio C, Tang KK, Rao P. Estimating the Mental Health Effects of Social Isolation. Applied Research in Quality of Life. 2016;11(3):853-69.\u003c/li\u003e\n\u003cli\u003eEvans M, Fisher EB. Social Isolation and Mental Health: The Role of Nondirective and Directive Social Support. Community Mental Health Journal. 2022;58(1):20-40.\u003c/li\u003e\n\u003cli\u003eWorld Health Organization (WHO). International Classification of Disease,11 revision(ICD-11) [Available from: http://icd.who.int/browse11.\u003c/li\u003e\n\u003cli\u003eAmerican Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders: DSM-5. 5th ed2013.\u003c/li\u003e\n\u003cli\u003eElmer T, Stadtfeld C. Depressive symptoms are associated with social isolation in face-to-face interaction networks. Scientific Reports. 2020;10(1):1444.\u003c/li\u003e\n\u003cli\u003ePetrikis P, Baldouma A, Katsanos AH, Konitsiotis S, Giannopoulos S. Quality of Life and Emotional Strain in Caregivers of Patients with Multiple Sclerosis. J Clin Neurol. 2019;15(1):77-83.\u003c/li\u003e\n\u003cli\u003eTaheri Zadeh Z, Rahmani S, Alidadi F, Joushi S, Esmaeilpour K. Depresssion, anxiety and other cognitive consequences of social isolation: Drug and non-drug treatments. International Journal of Clinical Practice. 2021;75(12):e14949.\u003c/li\u003e\n\u003cli\u003eDickens AP, Richards SH, Greaves CJ, Campbell JL. Interventions targeting social isolation in older people: a systematic review. BMC Public Health. 2011;11(1):647.\u003c/li\u003e\n\u003cli\u003eAbbas R, Yaghoub H. Investigating the effectiveness of group therapy based on compassion-focused therapy, on increasing self-compassion in male patients diagnosed with multiple sclerosis in Isfahan. Journal of Analytical - Cognitive Psychology. 2020;10(39):51-62. [Persian]\u003c/li\u003e\n\u003cli\u003eGilbert P. The Evolution and Social Dynamics of Compassion. Social and Personality Psychology Compass. 2015;9(6):239-54.\u003c/li\u003e\n\u003cli\u003eGilbert P, Simos G. Compassion focused therapy: Clinical practice and applications. 1st ed. London: Routledge; 2022.\u003c/li\u003e\n\u003cli\u003ePauley G, McPherson S. The experience and meaning of compassion and self‐compassion for individuals with depression or anxiety. Psychology and Psychotherapy: Theory, Research and Practice. 2010;83(2):129-43.\u003c/li\u003e\n\u003cli\u003eAbolhassani S, Jahani L. Education of Compassion-based Program for Nurses and Paramedics. 1st ed. Isfahan: Maani Publications; 2021. [Persian]\u003c/li\u003e\n\u003cli\u003eFeliu-Soler A, Pascual JC, Elices M, Mart\u0026iacute;n-Blanco A, Carmona C, Cebolla A, et al. Fostering Self-Compassion and Loving-Kindness in Patients With Borderline Personality Disorder: A Randomized Pilot Study. Clinical Psychology \u0026amp; Psychotherapy. 2017;24(1):278-86.\u003c/li\u003e\n\u003cli\u003eNoorbala F, Borjali A, Ahmadian-Attari MM, Noorbala AA. Effectiveness of compassionate mind training on depression, anxiety, and self-criticism in a group of Iranian depressed patients. Iranian journal of psychiatry. 2013;8(3):113.\u003c/li\u003e\n\u003cli\u003eGilbert P. Compassionate mind training: key themes. In: Gilbert P, Simos G, editors. Compassion focused therapy: Clinical practice and applications. 1st ed. London: Routledge; 2022. p. 273-312.\u003c/li\u003e\n\u003cli\u003eForoughi AA, Khanjani S, Rafiee S, Taheri AA. Self-compassion: conceptualization, research, and interventions (Brief review). Shenakht journal of psychology \u0026amp; psychiatry. 2020;6(6):77-87. [Persian]\u003c/li\u003e\n\u003cli\u003eGilbert P. Compassion focused therapy: Distinctive features. 1st ed. London: Routledge; 2010.\u003c/li\u003e\n\u003cli\u003eMirMoeini P, Bayazi MH, Khalatbari J. Comparing the effectiveness of Acceptance and Commitment Therapy with Compassion Focused Therapy on loneliness in patients with Multiple Sclerosis. scientific magazine yafte. 2021;22(4):132-45.\u003c/li\u003e\n\u003cli\u003eMeehan M, Doody O. The role of the clinical nurse specialist multiple sclerosis, the patients\u0026apos; and families\u0026apos; and carers\u0026apos; perspective: An integrative review. Mult Scler Relat Disord. 2020;39:101918.\u003c/li\u003e\n\u003cli\u003eTagharrobi Z, Mohammadkhan Kermanshahi S, Mohammadi E. The Facilitators of Using Complementary Therapies in Clinical Nursing: A Qualitative Content Analysis. Journal of Rafsanjan University of Medical Sciences. 2016;15(8):691-714. [Persian]\u003c/li\u003e\n\u003cli\u003eChan AW, Tetzlaff JM, G\u0026oslash;tzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. Bmj. 2013;346:e7586.\u003c/li\u003e\n\u003cli\u003eMousavi MS, Bakhshipour A, Mahdian H. Comparing the Effectiveness of \u0026ldquo;Acceptance and Commitment Therapy\u0026rdquo; and \u0026ldquo;Compassion-Focused Therapy\u0026rdquo; and \u0026ldquo;Compassion-Enriched Acceptance and Commitment Therapy\u0026rdquo; on Communication Patterns of Married Women Suffering from Depression and Marital Conflicts. Journal of Health Promotion Management. 2023;12(1):95-112. [Persian]\u003c/li\u003e\n\u003cli\u003eRussell D. UCLA Loneliness Scale (Version 3): Reliability, Validity, and Factor Structure. Journal of personality assessment. 1996;66:20-40.\u003c/li\u003e\n\u003cli\u003eZarei S, Memari AH, Moshayedi P, Shayestehfar M. Validity and reliability of the UCLA loneliness scale version 3 in Farsi. Educational Gerontology. 2016;42(1):49-57.\u003c/li\u003e\n\u003cli\u003eBeck AT, Steer RA, Ball R, Ranieri WF. Comparison of Beck Depression Inventories-IA and-II in Psychiatric Outpatients. Journal of Personality Assessment. 1996;67(3):588-97.\u003c/li\u003e\n\u003cli\u003eBeck AT, Steer, R.A., Brown, G.K. Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation; 1996.\u003c/li\u003e\n\u003cli\u003eStefan-Dabson K, Mohammadkhani P, Massah-Choulabi O. Psychometrics Characteristic of Beck Depression Inventory-II in Patients with Major Depressive Disorder. Archives of Rehabilitation. 2007;8(0):82-0. [Persian]\u003c/li\u003e\n\u003cli\u003eJahani L, Abolhassani S, Babaee S, Omranifard V. Effects of a compassion-based program on the grief experienced by caregivers of people suffering from dementia: a randomized controlled clinical trial. BMC Nursing. 2022;21(1):198.\u003c/li\u003e\n\u003cli\u003eCraig C, Hiskey S, Spector A. Compassion focused therapy: a systematic review of its effectiveness and acceptability in clinical populations. Expert Review of Neurotherapeutics. 2020;20(4):385-400.\u003c/li\u003e\n\u003cli\u003eAghili SM, Tighdast S, Babaee E. The Effectiveness of Compassion-Focused Therapy on the Quality of Life and Resilience of Caregivers of Patients with MS. Journal of Applied Research in Behavioral Sciences. 2023;14(52):69-84. [Persian]\u003c/li\u003e\n\u003cli\u003eTohidifar M, Kazemian Moghadam K, Haroon Rashidi H. The Effectiveness of Compassion-Focused Therapy on Loneliness and Cognitive Flexibility in Elderly Men. Quarterly Journal of Psychological Studies. 2021;17(2):97-116. [Persian]\u003c/li\u003e\n\u003cli\u003eKazemi A, Ahadi H, Nejat H. Effectiveness of Compassion Focused Therapy on Loneliness, Self-care Behaviors and Blood Sugar in Diabetes Patients. ijrn. 2020;6(3):42-9. [Persian]\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Additional File 3","content":"\u003cp\u003eAdditional File 3 is not available with this version.\u003c/p\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":true,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Compassion, Social isolation, Depression, Family caregiver, Multiple sclerosis","lastPublishedDoi":"10.21203/rs.3.rs-5420701/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5420701/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cb\u003eBackground\u003c/b\u003e\u003c/p\u003e \u003cp\u003eMultiple sclerosis (MS) is an autoimmune disorder of the central nervous system that causes neurologic disabilities. People with MS may need continuous care from a family caregiver. Caring is associated with physical and mental challenges, including mental health problems such as social isolation and depression. The health of patients is influenced by their caregiver\u0026rsquo;s health status. Therefore, this is a serious challenge faced by nurses in family-centered nursing care. Effective interventions, such as compassion-focused therapy (CFT), are required to help caregivers continue caregiving and retain their health. The current study aims to evaluate the effects of a group CFT-based program on perceived social isolation and depression among family caregivers of people with MS.\u003c/p\u003e\u003cp\u003e\u003cb\u003eMethods\u003c/b\u003e\u003c/p\u003e \u003cp\u003eThe current study will employ a two-arm, parallel-group randomized controlled trial design. Sixty family caregivers will be recruited via convenience sampling and then allocated into two equal groups. The participants in the intervention group will enroll in six weekly sessions of CFT-based psychoeducation, whereas the participants in the control group will receive no intervention. Data will be collected via a form for demographic information, the UCLA LS3, the and BDI-II at baseline, after intervention, and two months after the end of the program. Statistical analysis will be carried out using descriptive statistics, independent t-test, repeated measures ANOVA, and ANCOVA.\u003c/p\u003e\u003cp\u003e\u003cb\u003eDiscussion\u003c/b\u003e\u003c/p\u003e \u003cp\u003ePrevious studies have shown CFT effectiveness in several issues experienced by family caregivers, but its impact on social isolation and depression in family caregivers of people with MS is unknown. This study will be the first to evaluate the effectiveness of CFT on social isolation and depression in family caregivers of people with MS, expanding our knowledge about CFT and caregiving challenges.\u003c/p\u003e","manuscriptTitle":"Evaluation of a Group Compassion-based Program on Perceived Social Isolation and Depression in Family Caregivers of Patients with Multiple Sclerosis: Study Protocol for an Open-label Randomized Controlled Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-04-17 10:29:20","doi":"10.21203/rs.3.rs-5420701/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"","date":"2025-03-27T20:14:26+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-03-27T15:10:49+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"Trials","date":"2025-03-18T05:45:34+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-03-10T05:36:12+00:00","index":"","fulltext":""},{"type":"submitted","content":"Trials","date":"2025-03-08T13:08:39+00:00","index":"","fulltext":""},{"type":"decision","content":"Major revision","date":"2025-02-13T21:08:09+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"a45bfb13-5a87-4958-82e6-7721ea4364b7","owner":[],"postedDate":"April 17th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2026-03-02T16:09:14+00:00","versionOfRecord":{"articleIdentity":"rs-5420701","link":"https://doi.org/10.1186/s13063-026-09547-0","journal":{"identity":"trials","isVorOnly":false,"title":"Trials"},"publishedOn":"2026-02-24 15:59:33","publishedOnDateReadable":"February 24th, 2026"},"versionCreatedAt":"2025-04-17 10:29:20","video":"","vorDoi":"10.1186/s13063-026-09547-0","vorDoiUrl":"https://doi.org/10.1186/s13063-026-09547-0","workflowStages":[]},"version":"v1","identity":"rs-5420701","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5420701","identity":"rs-5420701","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}