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

Sponsor

University of Regina (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05585242

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This RCT will test the effect of a 6-week self-help ACT-based program in improving fertility-related quality of life and psychological flexibility, in women with infertility.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female	Behavioral: Infertility ACTion Program	N/A

Detailed Description

Ninety women with infertility living in Canada and the United States will be recruited. They will be emailed six 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, including a hair cortisol sample comparing cortisol levels prior to the intervention and following completion of the intervention. Feedback about how to improve the program will also be collected.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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 Six 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.

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

Six 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.

Outcome Measures

Primary Outcome Measures

Fertility Quality of Life tool (Fertiqol) [Pre-to-post change in the month following the intervention (post measures assessed 4 weeks after receipt of last module)]
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
Hair Cortisol [At the 1-month post-intervention follow-up time point, participants will be asked to collect a small lock of hair for the measurement of chronic cortisol exposure.]
As hair grows 1 cm on average, hair cortisol levels will be measured using two separate sections of the hair sample. For the assessment of cortisol levels during the month prior to the ACT intervention, hair that is between 3 and 4 cm away from the scalp will be used. For the assessment of cortisol levels during the month following the ACT intervention, hair that is within 1 cm of the scalp will be used.

Secondary Outcome Measures

Generalized Anxiety Disorder-7 (GAD-7) [Pre-to-post change in the month following the intervention (post measures assessed 4 weeks after receipt of last module)]
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 the month following the intervention (post measures assessed 4 weeks after receipt of last module)]
Pre-to-post change in depressive symptoms; Scores range from 0-27, with higherscores indicating more severe depressive symptoms

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 42 Years

Sexes Eligible for Study:

Female

Accepts 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 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Regina	Regina	Saskatchewan	Canada	S4S 0A2

Sponsors and Collaborators

University of Regina

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jennifer Gordon, Principal Investigator, University of Regina

ClinicalTrials.gov Identifier:

NCT05585242

Other Study ID Numbers:

REB 2022-026

First Posted:

Oct 18, 2022

Last Update Posted:

Oct 18, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infertility

Infertility, Female

Study Results

No Results Posted as of Oct 18, 2022