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Completed

NCT Number: NCT05183568

Mindful Self-Compassion (MSC) for Infertility Related Distress

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.

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Key information

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Mindful Self-Compassion

Behavioral

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

Primary outcomes

  1. Fertility-related quality of life

    Time frame: Immediately post-intervention

    Score on the FertiQoL (fertility-related Quality of Life tool) - scores range from 0 to 100 and higher scores indicate better quality of life

  2. Fertility-related quality of life

    Time frame: 1 month post-intervention

    Score on the FertiQoL (fertility-related Quality of Life tool) - scores range from 0 to 100 and higher scores indicate better quality of life

Secondary outcomes

  1. Anxious symptoms

    Time frame: Immediately post-intervention

    Scores on the GAD-7 (Generalized Anxiety Disorder-7) - scores range from 0 to 21 and higher scores indicate more severe anxiety

  2. Anxious symptoms

    Time frame: 1 month post-intervention

    Scores on the GAD-7 (Generalized Anxiety Disorder-7) - scores range from 0 to 21 and higher scores indicate more severe anxiety

  3. Depressive symptoms

    Time frame: Immediately post-intervention

    Scores on the PHQ-9 (Patient History Questionnaire-9) - scores range from 0 to 27 and higher scores indicate more severe symptoms

  4. Depressive symptoms

    Time frame: 1 month post-intervention

    Scores on the PHQ-9 (Patient History Questionnaire-9) - scores range from 0 to 27 and higher scores indicate more severe symptoms

Other outcomes

  1. Trait mindfulness

    Time frame: Immediately post-intervention

    Scores on the FFMQ-15 (Five Facet Mindfulness Questionnaire-15) - scores range from 3 to 15 and higher scores indicate higher levels of mindfulness

  2. Trait mindfulness

    Time frame: 1 month post-intervention

    Scores on the FFMQ-15 (Five Facet Mindfulness Questionnaire-15) - scores range from 3 to 15 and higher scores indicate higher levels of mindfulness

  3. Trait self-compassion

    Time frame: Immediately post-intervention

    Scores on the SCS (Self-Compassion Scale) - scores range from 1 to 5, with higher scores indicating higher self-compassion

  4. Trait self-compassion

    Time frame: 1 month post-intervention

    Scores on the SCS (Self-Compassion Scale) - scores range from 1 to 5, with higher scores indicating higher self-compassion

  5. Relationship quality

    Time frame: Immediately post-intervention

    Scores on the RDAS (Revised Dyadic Adjustment Scale) - scores range from 0 to 69 and higher scores indicate better relationship quality

  6. Relationship quality

    Time frame: 1 month post-intervention

    Scores on the RDAS (Revised Dyadic Adjustment Scale) - scores range from 0 to 69 and higher scores indicate better relationship quality

Sponsors and collaborators

Lead sponsor

University of Regina

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 10, 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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