Testing an Evidence-Based Self-Help Program for Infertility-Related Distress in Women

NCT06006936 | Unknown

• 3 other identifiers: REB #2023-210DCO150GP6447
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility; Distress, Emotional; Mental Health Issue

Keywords

infertility; women; mental health; distress; quality of life; depression; anxiety; relationship quality; randomized controlled trial; intervention; treatment; self-help

Outcome Measures

Primary Outcomes (1)

• Fertility Quality of Life (FertiQoL) Score, at Mid-Treatment, Post-Treatment and Biweekly for 16 Weeks Post-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.

  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)

Secondary Outcomes (5)

• 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)

• 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 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)

• 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)

Other Outcomes (5)

• Mean Intervention Credibility and Participant Expectancy at Baseline, Using the Credibility and Expectancy Questionnaire (CEQ)

  CEQ completed at enrollment (week 0)

• Mean Quality of Homework Completion on the Homework Rating Scale (HRS)

  7 weeks (HRS completed weekly throughout the program)

• Mean Treatment Acceptability Post-Treatment, Using the Treatment Acceptability/Adherence Scale (TAAS)

  TAAS completed one week after the end of treatment (week 8)

Study Arms (2)

Intervention Condition

EXPERIMENTAL

This arm will receive the Coping with Infertility intervention.

Behavioral: Coping with Infertility Self-Help Program

Waitlist/Treatment as Usual Control Condition

NO INTERVENTION

This arm will continue with everyday life-including their attempts to conceive.

Interventions

Coping with Infertility Self-Help Program BEHAVIORAL

The CWI program consists of seven 10-minute videos, each with accompanying homework assignments. The first module, cognitive restructuring, includes instructions on challenging extreme or unhelpful automatic thoughts. The second module, challenging negative core beliefs, includes looking for patterns in thinking that illustrate core beliefs. The third module features behavioural activation techniques and emphasizes the importance of regular pleasure and skill-based activities. The fourth module highlights coping with grief and factors that contribute to grief, such as individual differences in grieving style. The fifth module supports strengthening relationships through responding to requests for affection and outlines several common relationship mistakes. The sixth module demonstrates how to identify and use values to make decisions and guide behaviour. The seventh module summarizes how thoughts, actions, and interactions can contribute to well-being when experiencing infertility.

Intervention Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Under the age of 18

Sponsors & Collaborators

• University of Regina: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Saskatchewan Health Research Foundation: collaborator
• University of Calgary: collaborator

Study Sites (1)

University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

Location

Related Publications (2)

• Poulter MML, Wahl TD, Kiviharju MJ, Campbell TS, Gordon JL. Testing the efficacy of a self-guided psychotherapy intervention for infertility-related distress: a randomized controlled trial. Hum Reprod. 2025 Dec 16:deaf237. doi: 10.1093/humrep/deaf237. Online ahead of print.

  PMID: 41401817 DERIVED

• Gordon JL, Poulter MML, Balsom AA, Campbell TS. Testing an Evidence-Based Self-Help Program for Infertility-Related Distress: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Jan 18;13:e52662. doi: 10.2196/52662.

  PMID: 38236638 DERIVED

MeSH Terms

Conditions

Infertility; Psychological Well-Being; Depression; Anxiety Disorders

Interventions

Coping Skills

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Personal Satisfaction; Behavior; Behavioral Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jennifer L. Gordon, Ph.D.

  Unviersity of Regina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer L. Gordon, Ph.D.

CONTACT

306-585-4389; Jennifer.Gordon@uregina.ca

Megan Poulter, B.A. (Hons.)

CONTACT

204-391-9440; MeganPoulter@uregina.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomly assigned to either receive the CWI program or to remain in a treatment-as-usual (TAU) control condition using stratified block randomization. The two arms will be stratified based on whether participants are attempting to conceive naturally or undergoing fertility treatments. Participants in the intervention condition will receive one 10-minute video module from the CWI program every week for seven weeks. Each video module will include a homework assignment encouraging participants to integrate the module content into everyday life. Participants in the TAU control condition will not receive video modules or homework; instead, they will continue with everyday life-including their attempts to conceive-until the conclusion of the study. TAU participants will be offered the intervention following the conclusion of the study.

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 23, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)