Mindful Self-Compassion (MSC) for Infertility Related Distress

Mindful Self-Compassion (MSC) as an Intervention for Infertility Related Distress: A Pilot Study

This study will test a psychological intervention for the treatment of distress related to infertility. The intervention will pair reading a book "The Mindful Self-Compassion Workbook" by Kristin Neff with guided meditations using the Centre for Mindfulness Studies mobile app. Individuals with infertility will complete the 8-week program and complete psychological outcome measures before and after.

Study Overview

• Status: Completed
• Conditions: Anxiety; Depressive Symptoms; Infertility, Female; Distress, Emotional
• Intervention / Treatment: Behavioral: Mindful Self-Compassion

Detailed Description

The investigators will recruit 50 women struggling with infertility across Canada and the United States via a paid Facebook ad as well as advertising via online infertility support groups. Participants will undergo an 8-week self-help program consisting of assigned weekly chapters in the workbook entitled "The Mindful Self-Compassion Workbook: A Proven Way to Accept Yourself, Build Inner Strength, and Thrive" (Neff & Germer, 2018), paired with daily guided meditations provided through a free smartphone app that was developed by the Centre for Mindfulness Studies, a Canadian-based mental health charity. The app is free to download on the app store for iPhone and Android. After completing a Zoom-faciliated enrollment session during which eligibility will be confirmed and informed consent obtained, participants will be mailed a copy of the workbook and instructed to complete three chapters per week for a total eight weeks. Each chapter is approximately 5-7 pages long but includes reflection exercises that may take some time - each chapter is therefore expected to take participants approximately 20 minutes to read. Participants will be sent a weekly email to remind them of their assigned chapters to read each week by the graduate student researcher.

Before starting the program, participants will be asked to complete a demographics form and the Credibility/Expectancy Questionnaire (CEQ) pre-intervention, as well as a series of questionnaires both before and after the intervention. The questionnaires are as follows: Fertility Quality of life Questionnaire (FertQoL), State-Trait Anxiety Inventory (STAI), the Generalised Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), The Five Facet Mindfulness Questionnaire-15 (FFMQ-15), The Self-Compassion Scale, The Compassion Scale, the Revised Dyadic Adjustment Scale (RDAS) and a brief survey about what participants liked or disliked about the program. These surveys will be completed at baseline, at the end of the 8th intervention week, and then one month after the program is over. Participants' app usage will be tracked by the Centre for Mindfulness Studies and shared with our research team, allowing us to assess adherence to the assigned homework.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4S 0A2
      • University of Regina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female
• Undergoing fertility treatments or who have failed to conceive despite a 12 month period without the use of contraception
• Reporting distress related to infertility, as indicated by Fertility Quality of Life Questionnaire score below 70, which is indicative of below-average quality of life

Exclusion Criteria:

• Currently seeking psychological treatment
• Participation in a formal mindfulness program within 6 months of recruitment
• Endorsement of active suicidal ideation, indicated by a score of 8 or above on the Suicidal Behaviors Questionnaire
• GAD-7 score of 15-21, indicating severe generalized anxiety
• PHQ-9 score of 20-27, indicating severe depressive symptoms.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Mindful Self-Compassion; Participants will undergo an 8-week self-help program consisting of assigned weekly chapters in the workbook entitled "The Mindful Self-Compassion Workbook: A Proven Way to Accept Yourself, Build Inner Strength, and Thrive" (Neff & Germer, 2018), paired with daily guided meditations provided through a free smartphone app that was developed by the Centre for Mindfulness Studies, a Canadian-based mental health charity.

Behavioral: Mindful Self-Compassion; Self-guided bibliotherapy (specific chapters to read each week) and daily use of a meditation app for 45 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fertility-related quality of life	Score on the FertiQoL (fertility-related Quality of Life tool) - scores range from 0 to 100 and higher scores indicate better quality of life	Immediately post-intervention
Fertility-related quality of life	Score on the FertiQoL (fertility-related Quality of Life tool) - scores range from 0 to 100 and higher scores indicate better quality of life	1 month post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxious symptoms	Scores on the GAD-7 (Generalized Anxiety Disorder-7) - scores range from 0 to 21 and higher scores indicate more severe anxiety	Immediately post-intervention
Anxious symptoms	Scores on the GAD-7 (Generalized Anxiety Disorder-7) - scores range from 0 to 21 and higher scores indicate more severe anxiety	1 month post-intervention
Depressive symptoms	Scores on the PHQ-9 (Patient History Questionnaire-9) - scores range from 0 to 27 and higher scores indicate more severe symptoms	Immediately post-intervention
Depressive symptoms	Scores on the PHQ-9 (Patient History Questionnaire-9) - scores range from 0 to 27 and higher scores indicate more severe symptoms	1 month post-intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trait mindfulness	Scores on the FFMQ-15 (Five Facet Mindfulness Questionnaire-15) - scores range from 3 to 15 and higher scores indicate higher levels of mindfulness	Immediately post-intervention
Trait mindfulness	Scores on the FFMQ-15 (Five Facet Mindfulness Questionnaire-15) - scores range from 3 to 15 and higher scores indicate higher levels of mindfulness	1 month post-intervention
Trait self-compassion	Scores on the SCS (Self-Compassion Scale) - scores range from 1 to 5, with higher scores indicating higher self-compassion	Immediately post-intervention
Trait self-compassion	Scores on the SCS (Self-Compassion Scale) - scores range from 1 to 5, with higher scores indicating higher self-compassion	1 month post-intervention
Relationship quality	Scores on the RDAS (Revised Dyadic Adjustment Scale) - scores range from 0 to 69 and higher scores indicate better relationship quality	Immediately post-intervention
Relationship quality	Scores on the RDAS (Revised Dyadic Adjustment Scale) - scores range from 0 to 69 and higher scores indicate better relationship quality	1 month post-intervention

Collaborators and Investigators

• Sponsor: University of Regina

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: December 21, 2021
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Behavioral Symptoms; Genital Diseases, Female; Depression; Infertility; Infertility, Female
• Other Study ID Numbers: REB #2021-133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No