Testing the efficacy of a self-guided psychotherapy intervention for infertility-related distress: a randomized controlled trial.

study questionIs the online 7-week self-help Coping with Infertility (CWI) program more effective than treatment as usual (TAU) at improving mental health for individuals assigned female at birth (AFAB) who are experiencing infertility? SUMMARY ANSWER: AFAB individuals who participated in the CWI program experienced improvements in quality of life, distress, depression, and anxiety relative to TAU; these effects were large among those with poorer quality of life or greater symptoms of depressed mood and anxiety at baseline. WHAT IS KNOWN ALREADY: Existing psychological interventions are associated with small improvements in mental health relative to TAU for individuals experiencing infertility. A newly developed, brief tailored intervention has been well received, yet has not been rigorously tested in a randomized controlled trial (RCT). STUDY DESIGN, SIZE, DURATION: A parallel RCT was conducted between January and November 2024 (start of recruitment and end of data collection, respectively). AFAB adults experiencing infertility were randomly assigned to either the CWI program or a waitlist/TAU control group using a predetermined stratified block randomization scheme. The sample (n = 173) was powered to detect a medium effect on continuous outcomes. PARTICIPANTS/MATERIALS, SETTING,

methodsThere was an approximately equal number of participants assigned to the CWI program (n = 87) as to the waitlist/TAU control group (n = 86). Participants assigned to the CWI program were emailed one 10-minute video module every week for 7 weeks or received access to the videos on a mobile app. Participants in the waitlist/TAU control group continued with their everyday life until the conclusion of the study. Psychological outcomes were assessed at baseline, post-treatment, and biweekly for 16 weeks post-treatment. Fourteen participants were either excluded from analyses or lost to follow-up, leaving 160 (CWI program n = 77, waitlist/TAU control group n = 83) for intent-to-treat analyses. MAIN RESULTS AND THE ROLE OF CHANCE: Participants who engaged with the CWI program reported higher fertility-related quality of life throughout the follow-up period relative to those assigned to the waitlist/TAU control group, M (SE) = 63.2 (0.5) versus 54.5 (0.5), Cohen's d = .53, P < .001; as well as lower infertility-related distress, M (SE) = 21.6 (0.2) versus 23.9 (0.2), d = .35, P < .001; depressed mood, M (SE) = 5.3 (0.2) versus 7.7 (0.2), d = .56, P < .001; and anxiety, M (SE) = 5.1 (0.2) versus 7.7 (0.2), d = .66, P < .001. Treatment effects were pronounced for participants with poorer quality of life or clinically significant symptoms of depressed mood and anxiety at baseline, with large effect sizes ranging between Cohen's d = 0.91-1.10 in these subgroups. Treatment effects on relationship quality, mood and anxiety disorders, and pregnancy rates were not statistically significant (P > .05). LIMITATIONS, REASONS FOR CAUTION: The lack of an active control condition, use of self-report data, heterogenous population, and limited follow-up period limit the empirical conclusions that can be drawn from this study. WIDER IMPLICATIONS OF THE

findingsThese results establish the CWI program as an effective short-term therapy option for AFAB individuals who are experiencing reduced quality of life or increased distress, depressed mood, and anxiety during infertility, addressing a significant gap in infertility treatment. STUDY FUNDING/COMPETING INTEREST(S): The development and pilot of the CWI program was supported by a Saskatchewan Health Research Foundation (SHRF) Patient-Oriented Leader Award (#4577). The current study was supported by a Canadian Institutes of Health Research Project Grant (#PJT186221) and a SHRF Research Connections Grant (#6447). Neither funding agency was involved in the study design; collection, management, analysis, and interpretation of data; writing of the report; or the decision to submit the report for publication. The authors are fully responsible for the content of this manuscript, and the views and opinions described reflect solely those of the authors. J.L.G. also receives salary support as a Canadian Institutes of Health Research Canada Research Chair. All authors declare that they have no financial, personal, or professional competing interests in the writing of this project. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT06006936. TRIAL REGISTRATION DATE: 17 August 2023. DATE OF FIRST PATIENT’S ENROLLMENT: 8 January 2024.