search
Back to results

Mindful Self-Compassion (MSC) for Infertility Related Distress

Primary Purpose

Infertility, Female, Distress, Emotional, Depressive Symptoms

Status
Recruiting
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Mindful Self-Compassion
Sponsored by
University of Regina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of ReginaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mindful Self-Compassion

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Anxious symptoms
Scores on the GAD-7 (Generalized Anxiety Disorder-7) - scores range from 0 to 21 and higher scores indicate more severe anxiety
Anxious symptoms
Scores on the GAD-7 (Generalized Anxiety Disorder-7) - scores range from 0 to 21 and higher scores indicate more severe anxiety
Depressive symptoms
Scores on the PHQ-9 (Patient History Questionnaire-9) - scores range from 0 to 27 and higher scores indicate more severe symptoms
Depressive symptoms
Scores on the PHQ-9 (Patient History Questionnaire-9) - scores range from 0 to 27 and higher scores indicate more severe symptoms

Full Information

First Posted
December 7, 2021
Last Updated
December 21, 2021
Sponsor
University of Regina
search

1. Study Identification

Unique Protocol Identification Number
NCT05183568
Brief Title
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

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
May 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Regina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female, Distress, Emotional, Depressive Symptoms, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindful Self-Compassion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindful Self-Compassion
Intervention Description
Self-guided bibliotherapy (specific chapters to read each week) and daily use of a meditation app for 45 minutes
Primary Outcome Measure Information:
Title
Fertility-related quality of life
Description
Score on the FertiQoL (fertility-related Quality of Life tool) - scores range from 0 to 100 and higher scores indicate better quality of life
Time Frame
Immediately post-intervention
Title
Fertility-related quality of life
Description
Score on the FertiQoL (fertility-related Quality of Life tool) - scores range from 0 to 100 and higher scores indicate better quality of life
Time Frame
1 month post-intervention
Secondary Outcome Measure Information:
Title
Anxious symptoms
Description
Scores on the GAD-7 (Generalized Anxiety Disorder-7) - scores range from 0 to 21 and higher scores indicate more severe anxiety
Time Frame
Immediately post-intervention
Title
Anxious symptoms
Description
Scores on the GAD-7 (Generalized Anxiety Disorder-7) - scores range from 0 to 21 and higher scores indicate more severe anxiety
Time Frame
1 month post-intervention
Title
Depressive symptoms
Description
Scores on the PHQ-9 (Patient History Questionnaire-9) - scores range from 0 to 27 and higher scores indicate more severe symptoms
Time Frame
Immediately post-intervention
Title
Depressive symptoms
Description
Scores on the PHQ-9 (Patient History Questionnaire-9) - scores range from 0 to 27 and higher scores indicate more severe symptoms
Time Frame
1 month post-intervention
Other Pre-specified Outcome Measures:
Title
Trait mindfulness
Description
Scores on the FFMQ-15 (Five Facet Mindfulness Questionnaire-15) - scores range from 3 to 15 and higher scores indicate higher levels of mindfulness
Time Frame
Immediately post-intervention
Title
Trait mindfulness
Description
Scores on the FFMQ-15 (Five Facet Mindfulness Questionnaire-15) - scores range from 3 to 15 and higher scores indicate higher levels of mindfulness
Time Frame
1 month post-intervention
Title
Trait self-compassion
Description
Scores on the SCS (Self-Compassion Scale) - scores range from 1 to 5, with higher scores indicating higher self-compassion
Time Frame
Immediately post-intervention
Title
Trait self-compassion
Description
Scores on the SCS (Self-Compassion Scale) - scores range from 1 to 5, with higher scores indicating higher self-compassion
Time Frame
1 month post-intervention
Title
Relationship quality
Description
Scores on the RDAS (Revised Dyadic Adjustment Scale) - scores range from 0 to 69 and higher scores indicate better relationship quality
Time Frame
Immediately post-intervention
Title
Relationship quality
Description
Scores on the RDAS (Revised Dyadic Adjustment Scale) - scores range from 0 to 69 and higher scores indicate better relationship quality
Time Frame
1 month post-intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Halleran, BA
Phone
306-585-4992
Email
wmh.research@uregina.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer L Gordon, PhD
Phone
306-351-4976
Email
jennifer.gordon@uregina.ca
Facility Information:
Facility Name
University of Regina
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4S 0A2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Halleran, BA
Phone
306-585-4992
Email
wmh.research@uregina.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Mindful Self-Compassion (MSC) for Infertility Related Distress

We'll reach out to this number within 24 hrs