{"paper_id":"3fd3bfa8-cb6e-4008-95d5-483db23c3401","body_text":"Primary infertility is defined as an inability to conceive\nafter 1 year of unprotected sex (without using contraceptives), and can be related to the male or female partner\nor both ( 1 ). Worldwide, more than 80 million people are\ninfertile ( 2 ).\nThe WHO states that inability to bear a child, either\ndue to the inability to become pregnant or the inability to\ncarry a pregnancy to a live birth following either a previous pregnancy or a previous ability to carry a pregnancy\nto a live birth. In 2010, among women 20-44 Y of age\nwho were exposed to the risk of pregnancy, 1.9% (95%\nuncertainty interval 1.7%, 2.2%) were unable to attain a live birth (primary infertility). Out of women who had had\nat least one live birth and were exposed to the risk of pregnancy, 10.5% (9.5%, 11.7%) were unable to have another\nchild (secondary infertility) ( 3 ).\nPrevalence varies between countries with a global average of 12 to 15%. Infertility can be divided into two\ngroups; primary (no conception occurring over the past\nyear) and secondary infertility (conception without giving\nbirth to a living child). In Iran the prevalence of primary\ninfertility based on the WHO's clinical, epidemiological\nand demographic definitions. is 20.2, 12.8 and 9.2%, respectively ( 2 ,  3 ). At a global level, the primary infertility\nrate is 0.6 to 3.4%, and the secondary infertility rate is 8.7 to 32.6%. In Iran, the mean primary and secondary infertility rates are 10.6% and 2.7%, respectively ( 4 ).\nIn response to the infertility rate, rapid progress in reproductive medicine has contributed to new technologies\nassociated with the care and treatment of infertile couples across the world ( 4 ). Assisted reproductive technology (ART), including a wide range of treatments and approaches, is a common and successful treatment in many\ncountries ( 5 ). One of the techniques is  in vitro  fertilization\n(IVF), a complex series of procedures commencing with\nextreme and controlled ovarian stimulation by exogenous\ngonadotropin, including techniques wherein fertilization\nis undertaken using intra-cytoplasmic injection of sperm,\ngamete transference to the fallopian tube, transfer of zygote into the fallopian tube, and the transfer of the peritoneal tube by laparoscopy ( 6 ). Epidemiological findings\nhave documented high levels of depression in different\ncountries. In 1990, the prevalence of depression was 472\nmillion worldwide with, around 5 million in Iran, showing the high prevalence and importance of depression disorder on both global and national scales ( 7 ). Depression\ncan increase during periods of infertility, and it is estimated that approximately 86% of infertile couple experience depression ( 8 ). One study showed that although the\nevents and conditions that reveal depression, anxiety and\nstress differ from person to person, depression in infertile\nwomen is twice that in fertile women ( 9 ).\nAlthough most people who seek infertility treatment\nseem to be emotionally stable, infertility is known to be\na life-long crisis. Most infertile people have to deal with\ndepression, feelings of loss and guilt, detachment, meaninglessness, and sexual and marriage problems. In addition,\nphysical, psychological and economic problems associated\nwith ART influence the psychological stability of couples\n( 10 ). Psychological treatments administered along side infertility treatment programs, make infertile women more\nresistant to stress, increase the effectiveness of infertility\ntreatments, and encourage infertile patients to follow the\ntreatment by enhancing their mental health ( 11 ).\nStudies conducted in infertile women have indicated the\npositive effect of counseling and psychological interventions on improving life quality ( 12 ). Mindfulness-based\ninterventions are a common type of cognitive-behavioral\ntherapy. Mindfulness is a form of meditation rooted in the\neastern religious rituals, especially those related to Buddhism ( 13 ). Mindfulness is one of which is high awareness, focusing on the reality of the present, accepting and\nacknowledging it, regardless of the thoughts about the\nsituation or emotional reactions to the situation ( 14 ). In\nessence, mindfulness consists of an informed and nonjudgmental sense of what is happening now ( 15 ). Pots et\nal. ( 16 ) document the important role of the learned skills\nof attention control in mindfulness meditation in preventing depression relapse. Based on their information processing theory, those who have experienced major periods of depression are susceptible to relapse when faced\nwith a dysphoric state, because these states can activate\nthe depressed thinking patterns of the period of depression. In this study, Mindfulness-Based Cognitive Therapy\n(MBCT) was employed as it includes meditation techniques for mindfulness and meditation along with daily\nactivities for depression ( 17 ).\nGiven the problems of infertile women, such as depression, the prevalence of infertility and the few studies conducted in Iran, especially on the impact of group\ncounseling on infertility and the lack of comprehensive\ntherapeutic methods in the field of counseling, the present\nstudy aimed to evaluate the effect of mindfulness-based\ngroup counseling on depression in infertile women under\nIVF treatment.\n\nDemographic characteristics were assessed using a\nquestionnaire designed by the researchers. It included\nquestions about the personal characteristics of infertile women and their partners (10 questions), expenditures and the existence of health insurance coverage (2\nquestions), duration of marriage, duration of infertility,\nnumber of infertility years, frequency of IVF use and\nquestions regarding psychiatric history (5 questions).\nPersonal information included: first and last name, place\nof residence, age, employment, and education of the\nwomen and their partners, and monthly family income.\nInfertility was either primary (no pregnancy) or secondary (only pregnant once). Questions related to psychiatric histories included history of admission to psychiatric\nhospitals, history of mental illness, and use of psychiatric drugs and narcotics.\nThe second Beck depression inventory (BDI-II) is a\ndepression inventory and a self-report index for measuring depression symptoms in different clinical and nonclinical populations. Published in 1996 the second edition of BDI-II inventory was developed in response to\nthe American Psychiatric Association’s publication of\nthe Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), which changed many\nof the diagnostic criteria for Major Depressive Disorder\n(American Psychiatric Association, 1994). This inventory is a 21-item self-reported measure of depression with\n15 questions related to psychological symptoms and 6\nquestions related to physical symptoms. Time frame for\nBDI-II is consistent with the 1-2 weeks time frame for\nmajor depressive disorders in DSM-IV. All the questions\nassess the severity of the disorder based on a Likert scale\n(0-3). The total score of a participant is obtained by aggregating the scores of all questions of 0 to 63. Based\non Beck's suggested scoring, a score of 0-9 indicates the\nabsence of depression, 10-18 indicates mild to moderate\ndepression, 19-29 moderate to severe depression, and 30-63 severe depression. Since the results of many studies of the BDI-II have shown its validity and reliability\nin different countries, the same questionnaire was used\nin the present research. Rajabi and Karjo ( 18 ) (according\nto Karmoudi study) obtained a Cronbach’s alpha coefficient of 0.91 for a student sample and reliability coefficients of 0.90, 0.87, and 0.44 for the whole questionnaire, the cognitive-emotional factor, and the physical\nfactor, respectively. In the study of Khormaei et al. ( 19 )\n(according to Dobson and Mohamadkhani study), the\nreliability coefficient measured as Cronbach's alpha was\n0.91 and Goodarzi reported a Cronbach’s alpha of 0.84\nfor internal consistency. In this study, Cronbach’s alpha\ncoefficient for the reliability of the BDI-II was 0.78.\nThe present clinical trial (IRCT2015082013405N14)\nwhich included a pre-test, post-test, and control group\nwas conducted in women with diagnosed primary infertility who were in the early stages of IVF. Inclusion\ncriteria were age 25-40 years, high school education or\nmore, residency in Hamedan, no psychiatric hospital admissions, no addiction, no neurological or other progressive diseases, and no psychiatric drug use. Level of depression [mild mood disturbances, moderate depression,\nand severe depression (up to 63)] were determined using cut-off points of the BDI-II. Exclusion criteria were\nabsence from more than two counseling sessions in the\ntest group, natural pregnancy and no use of ART during\ntreatment, and incidence of physical or psychological\nillness during the study. Women meeting the inclusion\ncriteria and who agreed to participate in the study were\nselected prior to IVF treatment. Based on the eligibility criteria, a convenience sampling approach was used\nto select the participants. Among the 120 women who\nmet the inclusion criteria, 90 women were enrolled in\nthe present study.\nAccording to Khormaei et al. Study, if the first type\nerror is 5% and the study power is 90%, the mean score\nof the first group is 12 and the second group is 10, with a\nstandard deviation of 3 need 41 persons in both groups\n(82 persons in total). On the other hand, the sample size\nis increased to 45 persons in each group in order to counter the probable loss of 10% ( 19 ).\nIt should be noted that applying the above equation is\nequivalent to using the following formula:\nAfter enrollment, the women were divided into intervention and control groups by block randomization,\nand group counseling was delivered to the intervention\ngroup. We constructed 10 blocks of 4 and one block of\n5 (45 women), and randomly assigned the participants\nto the two study groups by assigning the next block\nof participants according to the specified sequence\n( Fig .1 ).\nModified CONSORT flow diagram for individual randomized controlled trials of nonpharmacologic treatments.\nBefore starting the study, the aim of the study was explained and verbal and written informed consent was obtained from the women. First, the 45-member intervention group was divided into three 8-member groups and\nthree 7-member groups to increase the efficiency of group\ncounseling sessions. After that, eight 90-minute group\ncounseling sessions were held twice a week (the IVF process can last for 4 to 6 weeks) using mindfulness training packages. Counseling axes included auto-guidance,\nconfrontation with obstacles, breathing with mindfulness,\nstaying in the moment, the untruthfulness of thoughts, and\nhow to take optimal care of oneself ( Table 1 ). These counseling sessions were organized by a researcher trained by\na senior researcher with a Ph.D. in clinical psychology,\noverseen by the professor of psychology in the research\nteam. At the end of each session, an educational note and\na CD related to that session were given to participants.\nDuring the counseling sessions, participants were divided\ninto small class groups to interact with group members,\nand state and explain their problems. We used R software\n(version 3.5.2), a free and open source software for the\nstatistical analysis.\nThe participants in the intervention group were asked to\npractice conscious yoga exercises at home and present the\nprinciples of counseling, goals, and exercises of the previous session at the beginning of each session. Moreover, in\norder to resolve possible ambiguities, women in the intervention group were asked to do all exercises in class with\nthe researcher. This resulted in more repetition and training, and helped the creation of a new mindset. During the\ncounseling sessions, we tried to fully explain the meaning\nand concept of mindfulness through daily routine examples, stories, and conscious yoga exercises. This method\nwas also employed in the infertility center while the women were undergoing their IVF treatment. The control group\nreceived routie programs of infertility center and did not\nrecive any intervention. Due to ethical considerations at\nthe end of the study the educational pamphlets and the CD\nwere administered to the control group. Pre-test assessments were conducted on the 90 randomised participants\nprior to commencing IVF treatments, meaning all members\nof both groups completed the demographic information\nand Beck depression inventories. After the intervention the\npost-test was performed using the BDI-II 3-7 days before\nthe embryo transfer stage. At this point depression is at its\nminimum and the effect of the intervention on intervention\ngroup can be determined better. The counseling sessions\nare shown in Table 1.\nMindfulness training taken from Crane R. Mindfulness-based cognitive therapy ( 20 )\nThe Kolmogorov-Smirnov test was used to confirm\nthe normal distribution of all the variables. Data were\nanalyzed includes independent t test and using IBM SPSS\nV.21, (http://www.meta-analysis.com), to provide descriptive statistics, such as mean and standard deviation,\nfor the quantitative data. Independent tests and Chi-square\ntests were employed to compare the variables before and\nafter the intervention; paired t tests were employed to\ncompare variations between the groups. The significance\nlevel was assumed to be P<0.050.\nThis study code IR.UMSHA.REC.1395.336 was approved by the Ethics Committee and Research Council\nof Hamedan University of Medical Sciences. For ethical\nconsiderations, at the end of the study, educational notes\nand CDs were given to the control group.\n\nIn the present study, 90 women meeting the inclusion\ncriteria were divided into two groups of intervention (45\nwomen) and control (45 women); and the effect of mindfulness-based group counseling on depression in infertile women undergoing IVF treatment was evaluated.\nThe mean age of the infertile women in the intervention\nand control groups was 30.28 ± 5.39 and 29.64 ± 4.71\nyears, respectively and the mean age of their partners\nwas 34.82 ± 4.97 and 34.37 ± 5.39 years, respectively.\nMean marriage duration in the intervention and control\ngroup was 8.28 and 8.16 years, and the mean infertile\nperiod was 5.26 and 4.39 years, respectively. The majority of infertile women in the intervention (84.4%) and\ncontrol (71.1%) group were unemployed and most of\ntheir partners were employed, 97.8% in the intervention\ngroup and 95.6% in the control group. The majority of\ninfertile women in the intervention (57.8%) and control group (57.8%) had a high school diploma. Others\nhad a license and master’s degree; intervention group\n(40.0-2.2%) and control group (35.6-6.7%) (P=0.08).\nMost of their partners, 66.7% in the intervention group\nand 44.4% in the control group, had high school diploma. Others had a license and master’s degree; intervention group (24.4-8.9%) and control group (33.3-\n22.2) (P=0.63). Most of the patients in the intervention\n(86.7%) and control group (62.2%) had health insurance,\nalthough most of the treatment costs in both groups were\nnot paid by their health insurance [intervention group\n(73.3%) and control group (84.4%)]. The frequency of\nIVF was divided into five categories (0-1, 2, 3, 4 or 5\ntimes): the majority of women in the intervention group\nhad used 0 and 1 times (37.8%) and the majority of subjects in the control group had used 0 times (35.6%) of\nthe IVF treatment. The mean number of previous IVF\ntreatments in the intervention and control groups was\n1.11 and 1.24 respectively ( Table 2 ). Mean depressive\nsymptoms scores in the intervention and control group\nbefore and after the intervention (the intervention in\nmindfulness counseling in the intervention group) were\n20.77, 10.82, and 17.95, 21.33, respectively ( Table 3 ).\nBefore the intervention the mean depression score was\nlower in the control group than in the intervention group\n(P=0.046). As seen in Table 3, there is a significant relationship between before and after intervention in the intervention group (P<0.001), meaning after intervention, the mean depression was significantly reduced.\nAfter the intervention the mean depression score in the\nintervention group was reduced by 48% (P<0.001). In\ncontrast, the mean depression score in the control group\nhad increased by 19% (P<0.001), so that the depression\nscore among women in the intervention group after the\nintervention was less than half that in the control group\n(P<0.001). The heterogeity and bias in base line data were\nsolved by using ANCOVA Test.\nComparison of the mean and standard deviation of certain demographic characteristics (age of men and women, male income, duration of\nmarriage and duration of infertility) in the two groups\nData are presented as mean ± SD.\nComparison of average depression scores in infertile women before and after intervention in the experimental and control groups\nData are presented as mean ± SD.\n\nThe aim of the present study was to evaluate the effect\nof mindfulness-based group counseling on depression in\ninfertile women undergoing IVF treatment. Our results\nshowed that mindfulness-based group counseling reduced\ndepression scores in infertile women. This findings is in\nline with Hoveyda et al. ( 21 ) who measured the effect of\nstress reduction-based mindfulness and conscious yoga\non anxiety, depression, and stress in infertile women, and\nobserved a significant reduction in depression from before to after the intervention in the intervention group.\nIn the present study, 8 X 90-minute sessions of cognitive\ntherapy-based mindfulness counseling were held, while\nin the mentioned study, there were 8 X 120-minute sessions. However, the content of mindfulness sessions was\nthe same in both studies.\nGalhardo et al. ( 22 ) studied the effectiveness of mindfulness programs in infertility, and showed a reduction in\ndepression symptoms after the intervention in the intervention group in line with the current study. In addition,\ntheir study, like ours, showed an increase in depression\nscores in the control group after the intervention. Hoveyda et al. ( 21 ), in contrast, found no significant difference in depression scores before and after the intervention in the control group. In the present study, there was\nsignificant difference between the intervention and control groups regarding the symptoms of depression prior\nto the intervention. Mentioned study demonstrated that\nthere was no significant difference concerning depression\nbetween the intervention and control groups before and\nafter the intervention, which is against of the current results. The study of Galhardo et al. ( 22 ) consisted of 55\ninfertile women in the intervention group and 37 in the\ncontrol group. The content of this study is similar to that\nof the present study, including body checking meditation, 3-minute body space, thought and sound meditation,\nand staying in the present. However, in the study, 10 X\n120-minute counseling sessions were held.\nPanahi and Faramarzi ( 17 ) found a significant improvement in depression symptoms in premenstrual women of\nthe intervention group using mindfulness-based cognitive\ntreatment, compared with the control. Also in findings\nsimilar to ours, they found mindfulness-based cognitive\ntreatment to produce a significant improvement in depression symptoms in premenstrual women, P=0.007 compared to control women. Strege et al. ( 23 ) showed that\ndepression scores of pregnant women in the intervention\ngroup (Positive Affect and Social Anxiety Symptoms)\nwere considerably less than in the control group. We conclude that a counseling approach can play a major role in\nthe reduction of mental disorders such as depression ( 24 )\nand suggest that it should be included as routine during\nIVF treatment in infertile women.\nOne of the limitations of this study was the inadequate\ncompletion of the questionnaires (due to their anxiety) by\nthe study sample. In an attempt minimize the error rate in\nthis case, the investigators talked to the participants in the\nstudy to resolve this problem and inspire confidence that\ninformation would remain confidential. Finally, it was explained to infertile women that reducing anxiety may have\nthe effect of speeding up their pregnancy. Also, due to the\nlength of the counseling sessions (8 sessions), some of the\nwomen in the study were not able to attend all the scheduled sessions. To minimize this problem, meeting times\nwere adjusted based on the participants’ suggested time.\n\nThe findings of the present study point to the effectiveness of mindfulness-based cognitive group therapy on\ndepression in infertile women undergoing IVF treatment. Mindfulness counseling reduced depression in the intervention group. In the control group, where no intervention was performed, the depression score increased. As\nmindfulness-based cognitive group therapy results in a\nsignificant decrease in depression symptoms in infertile\nwomen under IVF treatment, it is suggested that it should\nbe available to all depressed women undergoing IVF\ntreatment.","source_license":"CC-BY-4.0","license_restricted":false}