Testing the Efficacy of the 'Coping With Infertility' Self-Help Program: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Fertility Quality of Life (FertiQoL) Score, at Mid-Treatment, Post-Treatment and Biweekly for 16 Weeks Post-Treatment
研究概览
简要总结
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.
详细描述
Infertility is associated with severe psychological consequences; psychiatric disorders are common, particularly in women, yet current psychological interventions are not specialized to this population and are largely ineffective. The 7-week Coping with Infertility (CWI) program is a self-help program based on cognitive behaviour therapy that aims to improve mental health in women and individuals assigned female at birth who are experiencing infertility. This study aims to test the efficacy of the CWI program.
In the proposed study, a single-blind randomized controlled trial, participants will be randomly assigned to either the specialized CWI program or a waitlist/treatment as usual control condition using stratified block randomization. Infertility-related distress, quality of life, depression, anxiety, and relationship quality will be assessed at baseline, midway through the program, post-treatment, and biweekly for 16 weeks after treatment. It is expected that participants assigned to the CWI program will show significantly reduced infertility-related distress, depression, and anxiety, and improved quality of life and relationship quality relative to baseline and the waitlist control condition. Moderation analyses will examine potential treatment moderators including sexual orientation and gender identity, as well as cultural background, disability status, and whether participants are pursuing fertility treatments. Participants who complete the CWI program will also provide qualitative feedback on how the program can be improved. The results of this trial could establish the CWI program as an effective short-term therapy option for women experiencing infertility, addressing a significant gap in infertility treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
A research assistant (RA) who is not involved with this study will use the randomization scheme to prepare opaque envelopes with each participant's treatment assignment, to be opened at the end of each enrolment session. While it is not possible to maintain full blinding of either the participant or the researchers given the nature of the intervention, all outcomes will be collected by an RA who is blind to participants' treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Assigned female at birth
- •Experiencing infertility (defined as [a] lack of conception after 12 or more months of regular, unprotected, heterosexual intercourse, or [b] currently undergoing fertility treatments)
- •Fluent in English
排除标准
- •Under the age of 18
研究组 & 干预措施
Intervention Condition
This arm will receive the Coping with Infertility intervention.
干预措施: Coping with Infertility Self-Help Program (Behavioral)
Waitlist/Treatment as Usual Control Condition
This arm will continue with everyday life-including their attempts to conceive.
结局指标
主要结局
Fertility Quality of Life (FertiQoL) Score, at Mid-Treatment, Post-Treatment and Biweekly for 16 Weeks Post-Treatment
时间窗: 6 months (FertiQoL completed midway through the program (week 4), post-program (week 8), then biweekly up to 16 weeks after the end of treatment)
Fertility-related quality of life will be measured via the 24 items contained within the core FertiQoL scale. Scores range from 0 to 100; participants will be considered to exhibit significantly poorer quality of life if their FertiQoL score is less than or equal to 71.
次要结局
- Mean Depression Scores on the Patient Health Questionnaire-9 (PHQ-9), at Post-Treatment and Biweekly for 16 Weeks Post-Treatment(6 months (PHQ-9 completed midway through the program (week 4), post-program (week 8), then biweekly up to 16 weeks after the end of treatment))
- Mean Infertility-Related Distress Scores on the Copenhagen Multi-Centre Psychosocial Infertility - Fertility Problem Stress Scales (COMPI-FPSS), at Post-Treatment and Biweekly for 16 Weeks Post-Treatment(6 months (COMPI-FPSS completed midway through the program (week 4), post-program (week 8), then biweekly up to 16 weeks after the end of treatment))
- Occurrence of Mood and Anxiety Disorders at Baseline, Post-Treatment, and 16 Weeks After Treatment(6 months (NetSCID completed at enrollment (week 0), post-program (week 8), and 16 weeks after the end of treatment))
- Mean Anxiety Scores on the Generalized Anxiety Disorder-7 (GAD-7), at Post-Treatment and Biweekly for 16 Weeks Post-Treatment(6 months (GAD-7 completed completed midway through the program (week 4), post-program (week 8), then biweekly up to 16 weeks after the end of treatment))
- Mean Relationship Quality on the Relationship Assessment Scale (RAS), at Post-Treatment and Biweekly for 16 Weeks Post-Treatment(6 months (RAS completed midway through the program (week 4), post-program (week 8), then biweekly up to 16 weeks after the end of treatment))
研究者
Jennifer Gordon
Associate Professor
University of Regina