Mindful Self-Compassion (MSC) for Infertility Related Distress

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

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

Intervention / Treatment
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* Behavioral: Mindful Self-Compassion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindful Self-Compassion<br>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<br>* Self-guided bibliotherapy (specific chapters to read each week) and daily use of a meditation app for 45 minutes<br>|

What is the study measuring?
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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 |