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

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05585242
• Other study ID #: REB 2022-026
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: April 2023
• Source: University of Regina
• Contact: Jennifer L Gordon, PhD
• Phone: 3063514976
• Email: jennifer.gordon[@]uregina.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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)

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Behavioral:
• Infertility ACTion Program
Seven 15-minutes videos of Acceptance and commitment therapy adapted for women with infertility with assigned homework and summaries of the videos.

Locations

Country	Name	City	State
Canada	University of Regina	Regina	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Regina

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)