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A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility

Sponsor
One Fertility (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05903638
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness-Based Stress Reduction course
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Single-blinded pilot randomized control trial with control arm and intervention (virtual MBSR course).Single-blinded pilot randomized control trial with control arm and intervention (virtual MBSR course).
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility Seeking Fertility Treatment at a Single Centre
Actual Study Start Date :
Sep 30, 2022
Actual Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control
Experimental: Virtual Mindfulness-Based Stress Reduction (MBSR) program

Behavioral: Mindfulness-Based Stress Reduction course
8-week, 26-hour, virtual mindfulness course
Other Names:
  • MBSR

    		•

    Outcome Measures

    Primary Outcome Measures

    1. MBSR course participation rate [8-weeks of MBSR course]

    2. Survey completion rate [Randomization to 3-months after course completion]

    Secondary Outcome Measures

    1. Beck Depression Inventory [Randomization to 3-months after course completion]

    2. Beck Anxiety Inventory [Randomization to 3-months after course completion]

    3. Perceived Stress Scale [Randomization to 3-months after course completion]

    4. Fertility Problem Inventory [Randomization to 3-months after course completion]

    5. % involvement in fertility treatment [3-months after course completion]

    6. Pregnancy rates [3-months after course completion]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ONE Fertility Hamilton Ontario Canada L7N 3T1

    Sponsors and Collaborators

    • One Fertility

    Investigators

    • Principal Investigator: Mehrnoosh Faghih, MD, McMaster University, ONE Fertility

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    One Fertility
    ClinicalTrials.gov Identifier:
    NCT05903638
    Other Study ID Numbers:
    • MBSR Pilot RCT
    First Posted:
    Jun 15, 2023
    Last Update Posted:
    Jun 15, 2023
    Last Verified:
    Jun 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infertility

    Study Results

    No Results Posted as of Jun 15, 2023