Self-Help Program for Emotional Distress Due to Infertility

N/A

Waitlist Available

Led By Jennifer L. Gordon, Ph.D.

Research Sponsored by University of Regina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up taas completed one week after the end of treatment (week 8)

Awards & highlights

No Placebo-Only Group

Summary

This trial is researching a 7-week program to reduce distress for women struggling with infertility. Results will help make the program widely available to improve mental health and well-being for women with infertility.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention involves a psychological support program rather than medication, traditional side effects are not expected. However, discussing sensitive topics may cause temporary emotional discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ neq completed one week after the end of treatment (week 8)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~neq completed one week after the end of treatment (week 8)

This trial's timeline: 3 weeks for screening, Varies for treatment, and neq completed one week after the end of treatment (week 8) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Mean Anxiety Scores on the Generalized Anxiety Disorder-7 (GAD-7), at Post-Treatment and Biweekly for 16 Weeks Post-Treatment

Mean Depression Scores on the Patient Health Questionnaire-9 (PHQ-9), at Post-Treatment and Biweekly for 16 Weeks Post-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

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Other study objectives

Mean Adverse Events Perceived to be Related to the Intervention Post-Treatment, Using the Negative Effects Questionnaire (NEQ)

Mean Healthcare Utilization, Medical and Productivity Costs in the 16 Weeks After Treatment, Using the Treatment Inventory of Costs in Patients with Psychiatric Disorders (TiC-P)

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

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