Acceptance and Commitment Therapy (ACT) Adapted for Women With Infertility-related Distress

Not Applicable

Completed

• Conditions: Infertility, Female
• Interventions: Behavioral: Infertility ACTion Program

• Registration Number: NCT05585242
• Lead Sponsor: University of Regina

Brief Summary

This RCT will test the effect of a 7-week self-help ACT-based program in improving fertility-related quality of life and psychological flexibility, in women with infertility.

Detailed Description

Ninety women with infertility living in Canada and the United States will be recruited. They will be emailed seven weekly 15-minute videos, each providing instructions on a new Acceptance and Commitment Therapy-based technique that addresses the impact of infertility on psychological inflexibility and distress. Fertility-related quality of life and psychological flexibility will be measured before and after the program. Outcomes will also be measured at one-month follow-up. Feedback about how to improve the program will also be collected.

Study Timeline

• Study First Submitted: 2022-10-14
• Study First Submitted QC: 2022-10-14
• Study First Posted: 2022-10-18
• Study Start: 2023-03-13
• Status Verified: 2023-04
• Primary Completion: 2023-11-01
• Study Completion: 2023-12-01
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• Has been trying to get pregnant for 12+ months and has failed OR is currently undergoing fertility treatments
• Lives in Canada or the United States
• Reports a high level of distress related to infertility, as indicated by a FertiQoL score below 71

Exclusion Criteria

• Is currently experiencing active suicidal ideation, as indicated by a score of 7 or above on the Suicide Behaviours Questionnaire - Revised (SBQ-R)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Infertility ACTion Program	The program consists of brief weekly videos, each addressing a particular Acceptance and Commitment Therapy 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 and includes a summary of the module.

Primary Outcome Measures

Name	Time	Method
Fertility Quality of Life tool (Fertiqol)	Pre-to-post intervention change and in the month following the intervention (post measures assessed 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.
Psychological flexibility (MPFI)	Pre-to-post intervention change and in the month following the intervention (post measures assessed 4 weeks after receipt of last module)	Pre-to-post change in psychological flexibility. Higher scores on the flexibility sub scale indicating better psychological flexibility.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Regina; 🇨🇦 Regina, Saskatchewan, Canada