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Completed

NCT Number: NCT05585242

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

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.

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Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Infertility ACTion Program

Behavioral

Seven 15-minutes videos of Acceptance and commitment therapy adapted for women with infertility with assigned homework and summaries of the videos.

Primary outcomes

  1. Fertility Quality of Life tool (Fertiqol)

    Time frame: Pre-to-post intervention change and 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.

  2. Psychological flexibility (MPFI)

    Time frame: Pre-to-post intervention change and in the month following the intervention (post measures assessed 4 weeks after receipt of last module)

    Pre-to-post change in psychological flexibility. Higher scores on the flexibility sub scale indicating better psychological flexibility.

Secondary outcomes

  1. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Pre-to-post intervention change and 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

  2. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Pre-to-post intervention change and 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

Sponsors and collaborators

Lead sponsor

University of Regina

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 18, 2022
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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