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NCT05903638 Clinical Trial

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

Quality of Life Clinical Trial

Official title:
A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility Seeking Fertility Treatment at a Single Centre

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05903638
Other study ID # MBSR Pilot RCT
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 30, 2022
Est. completion date September 30, 2023

Study information
Verified date June 2023
Source One Fertility
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 24
Est. completion date September 30, 2023
Est. primary completion date March 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Canada ONE Fertility Hamilton Ontario

Sponsors (1)
Lead Sponsor Collaborator
One Fertility

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary MBSR course participation rate 8-weeks of MBSR course
Primary Survey completion rate Randomization to 3-months after course completion
Secondary Beck Depression Inventory Randomization to 3-months after course completion
Secondary Beck Anxiety Inventory Randomization to 3-months after course completion
Secondary Perceived Stress Scale Randomization to 3-months after course completion
Secondary Fertility Problem Inventory Randomization to 3-months after course completion
Secondary % involvement in fertility treatment 3-months after course completion
Secondary Pregnancy rates 3-months after course completion
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