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

U

University of Regina

Status

Completed

Conditions

Infertility, Female

Treatments

Behavioral: Infertility ACTion Program

Study type

Interventional

Funder types

Other

Identifiers

NCT05585242
REB 2022-026

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

Female

Ages

18 to 42 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 2 patient groups

Intervention
Experimental group
Description:
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.
Treatment:
Behavioral: Infertility ACTion Program
Waistlist
No Intervention group
Description:
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.

Trial contacts and locations

1

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Central trial contact

Ashley A Balsom, MA; Jennifer L Gordon, PhD

Data sourced from clinicaltrials.gov

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