Mindful Self-Compassion (MSC) for Infertility Related Distress

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05183568
• Other study ID #: REB #2021-133
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: December 2021
• Source: University of Regina
• Contact: Maria Halleran, BA
• Phone: 306-585-4992
• Email: wmh.research[@]uregina.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Symptoms
• Distress, Emotional
• Infertility
• Infertility, Female

Intervention

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

Locations

Country	Name	City	State
Canada	University of Regina	Regina	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Regina

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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