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

NCT05585242 | Completed

• 1 other identifier: REB 2022-026
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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)

• 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)

Study Arms (2)

Intervention

EXPERIMENTAL

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

Waistlist

NO INTERVENTION

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.

Interventions

Infertility ACTion Program BEHAVIORAL

Seven 15-minutes videos of Acceptance and commitment therapy adapted for women with infertility with assigned homework and summaries of the videos.

Intervention

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Regina: lead

Study Sites (1)

University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding will not be implemented as condition assignment through randomization will be obvious to both the participants and the primary investigator. Participants will be provided with an introduction and rationale for the respective condition they are assigned to. Participants in the waitlist control condition will be given the opportunity to enroll in the intervention after completing the follow-up measures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Eligible participants will be randomized either to the ACT conditions or to the waitlist control condition. Randomization will occur using a 1:1 allocation ratio and random block sizes to ensure comparable condition sizes while minimizing the ability to predict condition assignment.

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 18, 2022
• Study Start: March 13, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 8, 2025

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)