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

Randomized Control Trial of Acceptance and Commitment Therapy Adapted for Women With Infertility-related Distress

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.

Study Overview

• Status: Completed
• Conditions: Infertility, Female
• Intervention / Treatment: Behavioral: Infertility ACTion Program

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4S 0A2
      • University of Regina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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.	Behavioral: Infertility ACTion Program; Seven 15-minutes videos of Acceptance and commitment therapy adapted for women with infertility with assigned homework and summaries of the videos.
No Intervention: Waistlist; Participants in the waitlist control condition will complete the same measures as the intervention group. After they have completed their one-month follow-up measures they will be given the opportunity to receive the intervention.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Regina

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2023
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: October 14, 2022
• First Posted (Actual): October 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Infertility; Infertility, Female
• Other Study ID Numbers: REB 2022-026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No