Effectiveness of two guided self-administered interventions for psychological distress among women with infertility: a three-armed, randomized controlled trial

Abstract

STUDY QUESTION What is the effect of two guided self-administered interventions on psychological distress in women undergoing IVF or ICSI? SUMMARY ANSWER A brief mindfulness intervention significantly reduced depression and improved sleep quality, while the gratitude journal intervention showed no significant effect on any outcome variables. WHAT IS KNOWN ALREADY Mindfulness and gratitude journal interventions have been found to be beneficial in reducing negative affect and improving well-being. However, there are very few mental health professionals who implement such interventions in low- and middle-income countries. Therefore, two guided self-administered interventions for women with infertility were designed to help them cope with their psychological distress. STUDY DESIGN, SIZE, DURATION A three-armed, randomized controlled trial was designed to evaluate the mindfulness and gratitude journal interventions for women undergoing IVF/ICSI. Between May 2016 and November 2017, at the reproductive center in a public hospital, 234 women were randomly assigned to the brief mindfulness group (BMG, n = 78), gratitude journal group (GJG, n = 78) or control group (CG, n = 78). The inclusion criteria were being a woman undergoing her first cycle of IVF, having at least junior middle school education and having no biological or adopted children. PARTICIPANTS/MATERIALS, SETTING, METHODS Female infertility patients (n = 346) were approached, and 112 did not meet the inclusion criteria. All three randomized groups completed questionnaires on the day of down-regulation (T1), the day before embryo(s) transfer (T2), and 3 days before the pregnancy test (T3). The BMG completed four sessions and listened to a 20-minute audio daily, including guided mindfulness breathing and body scan. The GJG completed four sessions and wrote three gratitude journals daily. The CG received routine care. A generalized estimating equation was used in an intention-to-treat analysis. The primary outcome was depression. Secondary outcomes were anxiety, sleep quality, infertility-related stress, mindfulness and gratitude. MAIN RESULTS AND THE ROLE OF CHANCE Participants of the BMG showed decreased depression (mean difference (MD) = −1.69, [−3.01, −0.37], d = 0.44) and improved sleep quality (MD = −1.24, [−1.95, −0.39], d = 0.43) compared to the CG, but the effect was not significant for anxiety, Fertility Problem Inventory totals, mindfulness, gratitude scores or pregnancy rates. The BMG showed a significant reduction in depression and improvement in sleep quality between T1 and T2, a continuous significant reduction between T1 and T3 and no reduction between T2 and T3. There were no significant effects on any of the variables for the GJG. LIMITATIONS, REASONS FOR CAUTION The inclusion criteria may result in bias because some participants with low education were excluded and only women with infertility were included. A low compliance rate occurred in the gratitude journals group. Moreover, men were not included in this study. Further research should consider including spouses of the target population. WIDER IMPLICATIONS OF THE FINDINGS The brief mindfulness intervention was beneficial in decreasing depression and improving sleep quality. Implementation of guided self-administered mindfulness could make the psychological counseling service more accessible for patients with infertility in resource-poor settings. The efficiency and feasibility of the gratitude journal intervention needs to be investigated further. STUDY FUNDING/COMPETING INTEREST(S) This study was funded by the National Social Science Foundation (17BSH054). The authors have no conflicts of interest. TRIAL REGISTRATION NUMBER ChiCTR-IOR-16008452. TRIAL REGISTRATION DATE 9 May 2016 DATE OF FIRST PATIENT’S ENROLMENT 15 May 2016.

The association between psychosocial interventions and fertility treatment outcome: A systematic review and meta-analysis

“…Al 2015(31) the controls received an introductory letter and instructions on how to complete questionnaires.Two studies were three-armed RCTs(37,38). Bai et al(37) had two intervention groups; a Brief Mindfulness Group (BMG) and Gratitude Journal Group (GJG), and one control group. Outcome data from both intervention groups were included in the meta-analysis.…”

The level of anxiety and depression in patients admitted to an infertility clinic

“…The ESHRE Infertility Declaration recommended that infertility centers should provide psychosocial and emotional support for patients (24). In a recent randomized controlled trial, brief mindfulness intervention has been reported to reduce depression and improve sleep quality in infertile patients (25).…”

Pregnancy or Psychological Outcomes of Psychotherapy Interventions for Infertility: A Meta-Analysis

“…The characteristics of 3,522 adult patients from published parallel 29 RCTs (Sarrel and DeCherney, 1985;Domar et al, 2000a,b;Hosaka et al, 2002;Emery et al, 2003;Shu-Hsin, 2003;de Klerk et al, 2005;Chan et al, 2006Chan et al, , 2012Tuil et al, 2007;Cousineau et al, 2008;Faramarzi et al, 2008;Mori, 2009;Haemmerli et al, 2010;Sexton et al, 2010;Matthiesen et al, 2011a;Skiadas et al, 2011;Gorayeb et al, 2012;Mosalanejad et al, 2012a,b;Domar et al, 2015;Vizheh et al, 2013;Arslan-Özkan et al, 2014;van Dongen et al, 2016;Frederiksen et al, 2017;Nery et al, 2018;Bai et al, 2019;Sahraeian and Lotfi, 2019;Hosseini et al, 2020) were described in the study. The average age ranged from 20 to 40 years.…”

“…A variety of psychotherapy interventions, including CBT (Domar et al, 2000a,b;Hosaka et al, 2002;Shu-Hsin, 2003;Faramarzi et al, 2008;Haemmerli et al, 2010;Sexton et al, 2010;Gorayeb et al, 2012;Mosalanejad et al, 2012a,b;Domar et al, 2015;Sahraeian and Lotfi, 2019), the BMS (Chan et al, 2006(Chan et al, , 2012, and other treatments (Sarrel and DeCherney, 1985;Domar et al, 2000a,b;Emery et al, 2003;de Klerk et al, 2005;Tuil et al, 2007;Cousineau et al, 2008;Mori, 2009;Matthiesen et al, 2011a;Skiadas et al, 2011;Vizheh et al, 2013;Arslan-Özkan et al, 2014;van Dongen et al, 2016;Frederiksen et al, 2017;Nery et al, 2018;Bai et al, 2019;Hosseini et al, 2020), were included in the meta-analysis. Sixteen studies (Shu-Hsin, 2003;de Klerk et al, 2005;Chan et al, 2006Chan et al, , 2012Tuil et al, 2007;Sexton et al, 2010;Matthiesen et al, 2011a;Skiadas et al, 2011;Gorayeb et al, 2012;Mosalanejad et al, 2012a,b;Domar et al, 2015;van Dongen...…”