Mindful Self-Compassion (MSC) for Infertility Related Distress

NCT05183568 | Completed Phase 1

• 1 other identifier: REB #2021-133
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility, Female; Distress, Emotional; Depressive Symptoms; Anxiety

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Anxious symptoms

  Immediately post-intervention

• Anxious symptoms

  1 month post-intervention

• Depressive symptoms

  Immediately post-intervention

• Depressive symptoms

  1 month post-intervention

Other Outcomes (6)

• Trait mindfulness

  Immediately post-intervention

• Trait mindfulness

  1 month post-intervention

• Trait self-compassion

  Immediately post-intervention

Study Arms (1)

Mindful Self-Compassion

EXPERIMENTAL

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

Interventions

Mindful Self-Compassion BEHAVIORAL

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

Mindful Self-Compassion

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Regina: lead

Study Sites (1)

University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

Location

MeSH Terms

Conditions

Infertility, Female; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility; Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: January 10, 2022
• Study Start: December 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: July 1, 2022
• Last Updated: April 8, 2025

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)