Self-Help Program for Emotional Distress Due to Infertility
Trial Summary
What is the purpose of this trial?
Now affecting one in six couples in Canada, infertility is defined as a lack of conception after 12 or more months of regular, unprotected sexual intercourse. Infertility can result from a number of causes; however, women are responsible for accommodating rigid treatment regimens and carry a disproportionate share of the psychological burden associated with infertility. Thirty to forty percent of women presenting for the evaluation of infertility experiencing clinically significant depression or anxiety. Yet access to infertility-specific mental health resources is extremely limited in Canada; current psychological interventions are not specialized to this population and are largely ineffective at reducing distress. Therefore, there is an enormous need to increase the efficacy and accessibility of mental health resources for this population. To address this need, the 7-week Coping with Infertility (CWI) program was developed in collaboration with women with lived experience with infertility. The CWI program aims to reduce distress related to infertility and was recently tested in a small pilot study, where it was found to be very effective in reducing depression and anxiety and improving quality of life among individuals struggling to get pregnant. The goal of this clinical study is to test the CWI program in adult women experiencing infertility. The main questions it aims to answer are if the CWI program is effective at improving mental health and well-being in women experiencing infertility, and if demographic or lifestyle factors moderate the effect of the treatment. For seven weeks, participants will receive the CWI program and complete online questionnaires and interviews to assess the program's effects on infertility-related distress, quality of life, depressive symptoms, anxiety, and relationship quality. They will then complete these questionnaires biweekly for 16 weeks following the program. Researchers will compare the CWI program to a waitlist/treatment as usual control condition to see if the program reduces psychological distress above and beyond women's ordinary coping strategies. If the program is effective in improving psychological well-being in this clinical study, the researchers will make the program widely and freely available to women throughout Canada and the world.
Research Team
Jennifer L. Gordon, Ph.D.
Principal Investigator
Unviersity of Regina
Eligibility Criteria
This trial is for adult women who have been trying to conceive for over a year or are undergoing fertility treatments, and can communicate fluently in English. It's not suitable for those under 18 years old.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Coping with Infertility Self-Help Program (Behavioral Intervention)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Regina
Lead Sponsor
Dr. Jeff Keshen
University of Regina
Chief Executive Officer since 2021
PhD in Political Science from the University of Toronto
Dr. Cathy Rocke
University of Regina
Chief Medical Officer since 2020
PhD in Social Work from the University of Manitoba
University of Calgary
Collaborator
Dr. Shweta Patel
University of Calgary
Chief Medical Officer since 2020
MD from the University of Baroda Medical College, India
Dr. Edward McCauley
University of Calgary
President and Vice-Chancellor since 2018
PhD in Ecology and Evolutionary Biology from the University of California, Santa Barbara
Canadian Institutes of Health Research (CIHR)
Collaborator
Dr. Paul C. Hébert
Canadian Institutes of Health Research (CIHR)
Chief Executive Officer
MD, University of Ottawa
Dr. Paul C. Hébert
Canadian Institutes of Health Research (CIHR)
Chief Medical Officer
MD, University of Ottawa
Saskatchewan Health Research Foundation
Collaborator