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Behavioral Intervention

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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fertility Quality of Life (FertiQoL) Score, at Mid-Treatment, Post-Treatment and Biweekly for 16 Weeks Post-Treatment
Secondary outcome measures
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
+2 more
Other outcome measures
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)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ConditionExperimental Treatment1 Intervention
This arm will receive the Coping with Infertility intervention.
Group II: Waitlist/Treatment as Usual Control ConditionActive Control1 Intervention
This arm will continue with everyday life-including their attempts to conceive.

Find a Location

Who is running the clinical trial?

University of CalgaryOTHER
791 Previous Clinical Trials
868,564 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,341 Previous Clinical Trials
26,452,543 Total Patients Enrolled
1 Trials studying Infertility
130 Patients Enrolled for Infertility
Saskatchewan Health Research FoundationOTHER
32 Previous Clinical Trials
4,819 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor presently open to enrollees?

"According to clinicaltrials.gov, this medical research experiment is no longer looking for participants; it was initially advertised on the 1st of September 2023 and last updated 24th August 2023. However, there are still 359 other trials actively enrolling patients currently."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Testing an Evidence-Based Self-Help Program for Infertility-Related Distress in Women
Jennifer Gordon 2023. "Testing an Evidence-Based Self-Help Program for Infertility-Related Distress in Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06006936.
All > Fertility > Mental Health
~113 spots leftby Sep 2025
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