Clinical trial NCT05183568: Mindful Self-Compassion (MSC) for Infertility Related Distress
Official title: Mindful Self-Compassion (MSC) as an Intervention for Infertility Related Distress: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Infertility, Female
Distress, Emotional
Depressive Symptoms
Anxiety
Lead sponsor: University of Regina
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fertility-related quality of life
timeFrame: Immediately post-intervention
measure: Fertility-related quality of life
timeFrame: 1 month post-intervention
Secondary outcomes:
measure: Anxious symptoms
timeFrame: Immediately post-intervention
measure: Anxious symptoms
timeFrame: 1 month post-intervention
measure: Depressive symptoms
timeFrame: Immediately post-intervention
measure: Depressive symptoms
timeFrame: 1 month post-intervention
Other outcomes:
measure: Trait mindfulness
timeFrame: Immediately post-intervention
measure: Trait mindfulness
timeFrame: 1 month post-intervention
measure: Trait self-compassion
timeFrame: Immediately post-intervention
measure: Trait self-compassion
timeFrame: 1 month post-intervention
measure: Relationship quality
timeFrame: Immediately post-intervention
measure: Relationship quality
timeFrame: 1 month post-intervention
Locations:
city: Regina
country: Canada
facility: University of Regina
state: Saskatchewan
Study officials:
References: