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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new self-help program designed to help women manage emotional distress related to infertility. The Coping with Infertility Self-Help Program lasts seven weeks and focuses on reducing depression and anxiety while improving quality of life and relationship satisfaction. Women who have been trying to conceive for over a year or are undergoing fertility treatments and speak English may find this trial suitable. Researchers will compare participants to a control group to determine if the program offers significant benefits. If successful, the program will become widely available for free. As an unphased trial, this study provides participants the chance to contribute to valuable research that may lead to free, accessible support for others facing similar challenges.

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 prior data suggests that the Coping with Infertility Self-Help Program is safe?

A previous study demonstrated promising results for the Coping with Infertility Self-Help Program. Participants appreciated the program, with many reporting reduced depression and anxiety. Importantly, no serious side effects occurred. The program serves as a supportive tool, focusing on self-help and voluntary support, allowing individuals to use it at their own pace, which enhances safety.

The program includes watching short weekly videos and learning coping skills. Its non-invasive and self-directed nature poses minimal risk. The initial study confirmed its effectiveness and tolerability, making it a safe option for those experiencing emotional distress due to infertility. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Coping with Infertility Self-Help Program is unique because it empowers individuals to manage their emotional distress through self-guided techniques, unlike traditional therapy options that often require direct interaction with a therapist. This program is designed to be accessible and flexible, allowing participants to engage at their own pace, which can be particularly beneficial for those who might have limited access to in-person therapy sessions. Researchers are excited about this approach because it could offer an effective, scalable way to support emotional well-being for those dealing with infertility, providing help right when and where it's needed.

What evidence suggests that the Coping with Infertility Self-Help Program is effective for reducing emotional distress due to infertility?

Research has shown that the Coping with Infertility (CWI) self-help program, which participants in this trial may receive, effectively reduces anxiety and depression for those facing infertility challenges. A small initial study found that participants experienced significant improvements in mental health, including reduced distress and enhanced quality of life. Another study found that participants appreciated the program, which helped lower their anxiety and depression symptoms. These findings suggest that the CWI program could be a valuable tool for improving emotional well-being in women dealing with infertility. ^{1 2 3 6 7}

Who Is on the Research Team?

Jennifer L. Gordon, Ph.D.

Principal Investigator

Unviersity of Regina

Are You a Good Fit for This Trial?

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

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

Fluent in English

I was assigned female at birth.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10835586/

Testing an Evidence-Based Self-Help Program for Infertility ... A feasibility study suggests that it is well accepted and highly effective in reducing symptoms of anxiety and depressed mood among distressed ...

2. pilotfeasibilitystudies.biomedcentral.com pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-024-01535-y

Pilot trial of a new self-directed psychological intervention for ... Over the course of the program, participants improved significantly across all distress outcomes. The capacity for the CWI program to increase ...

3. withpower.com withpower.com/trial/phase-infertility-8-2023-c4a98

Self-Help Program for Emotional Distress Due to Infertility A 10-week group behavioral treatment program for 52 infertile women led to significant psychological improvements, including reduced anxiety and depression, as ...

4. nature.com nature.com/articles/s41598-023-41845-4

Perceived stress reduction through an infertility coaching ... This present study was conducted to assess the impact of a supportive stress management program led by an infertility coach for women undergoing fertility ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1877575625000102

The impact of infertility on the mental health of women ... Some researchers have found a clear relationship between anxiety, depression, and the probability of becoming pregnant after IVF/intra-cytoplasmic sperm ...

6. mdpi.com mdpi.com/2673-4184/2/1/8

Emotional Support for Infertility Patients: Integrating Mental ... Patients seeking fertility treatment are at risk of experiencing psychological distress, with both women and men reporting higher levels of ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020748923000196

Online peer support communities in the infertility journey What this paper adds. •. Online peer support communities provided good informational and emotional support that met the psychosocial needs of infertile couples.