Testing a New Self-help Intervention for Infertility Related Distress: a Pilot Study

Phase 1

• Conditions: Infertility, Female
• Interventions: Behavioral: Coping with Infertility Program

• Registration Number: NCT05103982
• Lead Sponsor: University of Regina

Brief Summary

This pilot study will test the effect of a 6-week self-help program in improving fertility-related quality of life as well as anxious and depressive symptoms, in women with infertility.

Detailed Description

Twenty women with infertility living in Saskatchewan will be recruited and will be emailed six weekly 10-minute videos, each providing instructions on a new psychological technique that is aimed at addressing the emotional and interpersonal challenges of infertility. Fertility-related quality of life, depressive symptoms, and anxious symptoms will be measured before and after the program. Outcomes will also be measured weekly for three weeks post-intervention. Feedback about how to improve the program will also be collected.

Study Timeline

• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-10-20
• Study Start: 2021-11-01
• Study First Posted: 2021-11-02
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-31
• Last Update Posted: 2022-02-01
• Primary Completion: 2022-03-01
• Study Completion: 2022-04-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Has been trying to get pregnant for 12+ months and has failed OR is currently undergoing fertility treatments due to a diagnosis of infertility
• Lives in Saskatchewan, Canada
• Reports a high level of distress related to infertility, as indicated by a FertiQoL score below 52 or at least mild anxious or depressive symptoms (GAD-7 score of 5 or above or PHQ-9 score of 5 or above)

Exclusion Criteria

• Has a history of suicide attempts
• Is currently experiencing suicidal ideation
• Reports severe depressive symptoms, as indicated by a PHQ-9 score above 19
• Reports severe anxious symptoms, as indicated by a GAD-7 score above 14

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Coping with Infertility Program	Coping with Infertility Program	The program consists of brief weekly videos, each addressing a particular psychological technique to be implemented that week. Participants receive the videos by email from the researcher and watch them on their own. Each video also assigns a "homework" exercise for the participant to complete that week.

Primary Outcome Measures

Name	Time	Method
Fertility Quality of Life tool (Fertiqol)	Pre-to-post change in the month following the intervention (post measures assessed 1, 2, 3, and 4 weeks after receipt of last module)	Pre-to-post change in quality of life related to a diagnosis of infertility. Scores range from 0-100, with higher scores indicating better quality of life

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire-9 (PHQ-9)	Pre-to-post change in the month following the intervention (post measures assessed 1, 2, 3, and 4 weeks after receipt of last module)	Pre-to-post change in depressive symptoms; Scores range from 0-27, with higher scores indicating more severe depressive symptoms
Generalized Anxiety Disorder-7 (GAD-7)	Pre-to-post change in the month following the intervention (post measures assessed 1, 2, 3, and 4 weeks after receipt of last module)	Pre-to-post change in anxious symptoms; Scores range from 0-21, with higher scores indicating more severe anxiety

Trial Locations

Locations (1)

University of Regina; 🇨🇦 Regina, Saskatchewan, Canada