Acceptance and Commitment Therapy (ACT) Adapted for Women With Infertility-related Distress
Primary Purpose
Infertility, Female
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Infertility ACTion Program
Sponsored by
About this trial
This is an interventional treatment trial for Infertility, Female
Eligibility Criteria
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 52
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)
Sites / Locations
- University of ReginaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Waistlist
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Psychological flexibility (MPFI)
Pre-to-post change in psychological flexibility. Higher scores on the flexibility sub scale indicating better psychological flexibility.
Secondary Outcome Measures
Generalized Anxiety Disorder-7 (GAD-7)
Pre-to-post change in anxious symptoms; Scores range from 0-21, with higher scoresindicating more severe anxiety
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05585242
Brief Title
Acceptance and Commitment Therapy (ACT) Adapted for Women With Infertility-related Distress
Official Title
Randomized Control Trial of Acceptance and Commitment Therapy Adapted for Women With Infertility-related Distress
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Regina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
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.
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Waistlist
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Infertility ACTion Program
Intervention Description
Seven 15-minutes videos of Acceptance and commitment therapy adapted for women with infertility with assigned homework and summaries of the videos.
Primary Outcome Measure Information:
Title
Fertility Quality of Life tool (Fertiqol)
Description
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.
Time Frame
Pre-to-post intervention change and in the month following the intervention (post measures assessed 4 weeks after receipt of last module)
Title
Psychological flexibility (MPFI)
Description
Pre-to-post change in psychological flexibility. Higher scores on the flexibility sub scale indicating better psychological flexibility.
Time Frame
Pre-to-post intervention change and in the month following the intervention (post measures assessed 4 weeks after receipt of last module)
Secondary Outcome Measure Information:
Title
Generalized Anxiety Disorder-7 (GAD-7)
Description
Pre-to-post change in anxious symptoms; Scores range from 0-21, with higher scoresindicating more severe anxiety
Time Frame
Pre-to-post intervention change and in the month following the intervention (post measures assessed 4 weeks after receipt of last module)
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
Pre-to-post change in depressive symptoms; Scores range from 0-27, with higherscores indicating more severe depressive symptoms
Time Frame
Pre-to-post intervention change and in the month following the intervention (post measures assessed 4 weeks after receipt of last module)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer L Gordon, PhD
Phone
3063514976
Email
jennifer.gordon@uregina.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley A Balsom, MA
Phone
3065708709
Email
ashleyannebalsom@gmail.com
Facility Information:
Facility Name
University of Regina
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4S 0A2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer L Gordon, PhD
Phone
3063514976
Email
jennifer.gordon@uregina.ca
First Name & Middle Initial & Last Name & Degree
Ashley A Balsom, MA
Phone
3065708709
Email
ashleyannebalsom@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Acceptance and Commitment Therapy (ACT) Adapted for Women With Infertility-related Distress
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