Self-Help Program for Emotional Distress Due to Infertility

Overseen By Megan Poulter, B.A. (Hons.)

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Regina

Disqualifiers: Under 18

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 7 weeks

170 Participants Needed

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on a self-help program for emotional distress, so it's unlikely that medication changes are required, but you should confirm with the trial organizers.

What data supports the effectiveness of the treatment Coping with Infertility Self-Help Program for emotional distress due to infertility?

Research shows that both emotion-focused and problem-focused coping strategies can help women with infertility feel better emotionally. Group interventions that include education and skills training, like relaxation, are particularly effective in improving well-being. ^{1 2 3 4 5}

Is the Self-Help Program for Emotional Distress Due to Infertility safe for participants?

Self-help programs, including those for various health conditions, are generally considered safe for participants. Most people report positive changes, and only a small minority (1-4%) mention any negative impacts. ^{6 7 8 9 10}

How does the Coping with Infertility Self-Help Program differ from other treatments for emotional distress due to infertility?

The Coping with Infertility Self-Help Program is unique because it emphasizes self-help and voluntary support, allowing individuals to develop coping skills and access resources independently, which can increase self-awareness and confidence without the need for intensive therapist involvement. ^{7 11 12 13 14}

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

Fluent in English

Experiencing infertility (defined as lack of conception after 12 or more months of regular, unprotected, heterosexual intercourse, or currently undergoing fertility treatments)

I was assigned female at birth.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the 7-week Coping with Infertility (CWI) program, including online questionnaires and interviews to assess the program's effects

7 weeks

Weekly online assessments

Follow-up

Participants complete biweekly questionnaires for 16 weeks to monitor the program's long-term effects on infertility-related distress, quality of life, depressive symptoms, anxiety, and relationship quality

16 weeks

Biweekly online assessments

Treatment Details

Interventions

• Coping with Infertility Self-Help Program

Trial Overview The study tests the 'Coping with Infertility' (CWI) program, designed to help reduce emotional distress from infertility. Over seven weeks, participants will engage with this self-help program and their mental well-being will be assessed through questionnaires and interviews.

Participant Groups

Group I: Intervention Condition Experimental Treatment 1 Intervention

This arm will receive the Coping with Infertility intervention.

Group II: Waitlist/Treatment as Usual Control Condition Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Regina

Lead Sponsor

Trials

59

Recruited

9,100+

University of Calgary

Collaborator

Trials

827

Recruited

902,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Saskatchewan Health Research Foundation

Collaborator

Trials

33

Recruited

5,100+

Findings from Research

A 10-week group behavioral treatment program for 52 infertile women led to significant psychological improvements, including reduced anxiety and depression, as measured by validated psychological instruments.

The results showed statistically significant decreases in various negative psychological symptoms, indicating that behavioral treatment can be an effective intervention for improving mental health in women undergoing infertility treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological improvement in infertile women after behavioral treatment: a replication. Domar, AD., Zuttermeister, PC., Seibel, M., et al.[2017]

The demonstration project successfully tested a self-help model for female single parents, leading to increased membership and improved self-awareness, confidence, and leadership skills among participants.

Key factors contributing to the project's success included initial individual contact, informal agreements, and strong community support, which helped enhance coping skills and access to resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive group action for women: a self-help strategy. Stewart, M.[2009]

The 'early support' intervention program, Babylotse-Plus, significantly reduced the incidence of depression in mothers facing high psychosocial burdens, with an adjusted odds ratio of 0.25 after 12 months.

Mothers in the intervention group also reported lower stress levels related to their child's demands and improved relationships with their parenting partners, indicating the program's effectiveness in enhancing maternal well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How effective is the early support program Babylotse-Plus for psychosocially burdened mothers and their infants? A comparative intervention study. Klapp, C., Fisch, S., Keller, T., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of emotion-focused and problem-focused group therapies for women with fertility problems. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Psychological improvement in infertile women after behavioral treatment: a replication. [2017]

3. Pakistan pubmed.ncbi.nlm.nih.gov

The association between coping method and distress in infertile woman: A cross-sectional study from Turkey. [2020]

4. England pubmed.ncbi.nlm.nih.gov

A review of psychosocial interventions in infertility. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Development and validation of the Infertility Self-Efficacy scale. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Benefits of self-help groups: a survey of 232 members from 65 disease-related groups. [2019]

7. Canada pubmed.ncbi.nlm.nih.gov

Supportive group action for women: a self-help strategy. [2009]

8. Germany pubmed.ncbi.nlm.nih.gov

[Not alone with a rare disease. The importance of self-help given by the example of anorectal malformations]. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Self-help and mental health. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

A conceptual framework for understanding self-help groups. [2019]

11. Germany pubmed.ncbi.nlm.nih.gov

Effects of a brief worksite stress management program on coping skills, psychological distress and physical complaints: a controlled trial. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Primary and secondary effects of parenting and stress management interventions for parents of children with developmental disabilities: a meta-analysis. [2018]

13. England pubmed.ncbi.nlm.nih.gov

Self-help parenting interventions for childhood behaviour disorders: a review of the evidence. [2019]

14. England pubmed.ncbi.nlm.nih.gov

How effective is the early support program Babylotse-Plus for psychosocially burdened mothers and their infants? A comparative intervention study. [2022]