Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 12, 2023
Date Accepted: Nov 23, 2023
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Testing an Evidence-Based Self-Help Program for Infertility-Related Distress: Trial Protocol
ABSTRACT
Background and Importance. One in six couples experience infertility, defined as the inability to achieve pregnancy despite 12 or more months of focused attempts to conceive. Although male and female-factor infertility are equally prevalent, women carry a disproportionate share of the psychological burden associated with infertility, experiencing poor quality of life and 30-40% experiencing clinically significant depressed mood and/or anxiety. Goal. Our team has designed a self-help intervention for infertility-related distress involving seven weekly 10-minute videos addressing the cognitive, behavioral, and interpersonal challenges associated with infertility, delivered via a mobile app. Our feasibility study suggests that it is well accepted and effective in reducing symptoms of anxiety and depressed mood among distressed individuals dealing with infertility. The current study is a fully powered randomized controlled trial comparing the intervention to a waitlist control group. Approach. We will recruit 170 individuals struggling to become pregnant in Canada or the United States to participate in an RCT comparing our 7-week self-help program to a treatment-as-usual condition. The primary outcome will be fertility quality of life while secondary outcomes will include depressive symptoms, anxious symptoms, and relationship quality, assessed before and after the program as well as bi-weekly for four months following completion of the program. Multilevel modeling will compare the intervention arm to the treatment-as-usual condition in terms of all outcomes across the nine measurement points. Baseline fertility quality of life score will be examined as a moderator of treatment effects. Expected Outcomes. We expect results to reveal that our intervention is more effective than treatment-as-usual in improving all mental health parameters assessed. Effects will be larger with decreasing baseline quality of life. Trial Registration: clinicaltrials.gov #NCT06006936 Funding: Canadian Institutes of Health Project Grant #PJT186221
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