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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility, Female

Intervention / Treatment
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* Behavioral: Infertility ACTion Program


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* Seven 15-minutes videos of Acceptance and commitment therapy adapted for women with infertility with assigned homework and summaries of the videos.<br>|
| No Intervention: Waistlist<br>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?
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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) |