Back to resultsA Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility
Primary Purpose
Primary Infertility, Mental Health Issue, Quality of Life
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mindfulness-Based Stress Reduction course
Sponsored by
About this trial
This is an interventional supportive care trial for Primary Infertility
Eligibility Criteria
Inclusion Criteria: -Primary infertility and no prior fertility treatment Exclusion Criteria: No internet access Non-English speaking History of suicidal ideation/intent, psychotic disorder, eating disorder, substance abuse or dependence, PTSD Psychotropic medication change in the previous month Previously seen at another fertility clinic Previous MBSR course Previous mindfulness meditation retreat
Sites / Locations
- ONE Fertility
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Virtual Mindfulness-Based Stress Reduction (MBSR) program
Arm Description
Outcomes
Primary Outcome Measures
MBSR course participation rate
Survey completion rate
Secondary Outcome Measures
Beck Depression Inventory
Beck Anxiety Inventory
Perceived Stress Scale
Fertility Problem Inventory
% involvement in fertility treatment
Pregnancy rates
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05903638
Brief Title
A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility
Official Title
A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility Seeking Fertility Treatment at a Single Centre
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 30, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
One Fertility
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
We plan to perform a pilot study in which women with primary infertility seeking an initial fertility consultation will be randomized into either a standard treatment group or an 8-week virtual Mindfulness-Based Stress Reduction (MBSR) program. Primary outcomes included retention and survey completion rates. Secondary outcomes included Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Perceived Stress Score (PSS), Fertility Problem Index (FPI), pregnancy rates, intention to pursue treatment and % pursuing treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Infertility, Mental Health Issue, Quality of Life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-blinded pilot randomized control trial with control arm and intervention (virtual MBSR course).
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
Virtual Mindfulness-Based Stress Reduction (MBSR) program
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Stress Reduction course
Other Intervention Name(s)
MBSR
Intervention Description
8-week, 26-hour, virtual mindfulness course
Primary Outcome Measure Information:
Title
MBSR course participation rate
Time Frame
8-weeks of MBSR course
Title
Survey completion rate
Time Frame
Randomization to 3-months after course completion
Secondary Outcome Measure Information:
Title
Beck Depression Inventory
Time Frame
Randomization to 3-months after course completion
Title
Beck Anxiety Inventory
Time Frame
Randomization to 3-months after course completion
Title
Perceived Stress Scale
Time Frame
Randomization to 3-months after course completion
Title
Fertility Problem Inventory
Time Frame
Randomization to 3-months after course completion
Title
% involvement in fertility treatment
Time Frame
3-months after course completion
Title
Pregnancy rates
Time Frame
3-months after course completion
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
-Primary infertility and no prior fertility treatment
Exclusion Criteria:
No internet access
Non-English speaking
History of suicidal ideation/intent, psychotic disorder, eating disorder, substance abuse or dependence, PTSD
Psychotropic medication change in the previous month
Previously seen at another fertility clinic
Previous MBSR course
Previous mindfulness meditation retreat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehrnoosh Faghih, MD
Organizational Affiliation
McMaster University, ONE Fertility
Official's Role
Principal Investigator
Facility Information:
Facility Name
ONE Fertility
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L7N 3T1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility
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