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

Not Applicable

Active, not recruiting

• Conditions: Quality of Life; Primary Infertility; Mental Health Issue
• Interventions: Behavioral: Mindfulness-Based Stress Reduction course

• Registration Number: NCT05903638
• Lead Sponsor: One Fertility

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-30
• Primary Completion: 2023-03-31
• Status Verified: 2023-06
• Study First Submitted: 2023-06-05
• Study First Submitted QC: 2023-06-05
• Last Update Submitted: 2023-06-05
• Study First Posted: 2023-06-15
• Last Update Posted: 2023-06-15
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Mindfulness-Based Stress Reduction (MBSR) program	Mindfulness-Based Stress Reduction course	-

Primary Outcome Measures

Name	Time	Method
MBSR course participation rate	8-weeks of MBSR course
Survey completion rate	Randomization to 3-months after course completion

Secondary Outcome Measures

Name	Time	Method
Perceived Stress Scale	Randomization to 3-months after course completion
% involvement in fertility treatment	3-months after course completion
Beck Depression Inventory	Randomization to 3-months after course completion
Beck Anxiety Inventory	Randomization to 3-months after course completion
Fertility Problem Inventory	Randomization to 3-months after course completion
Pregnancy rates	3-months after course completion

Trial Locations

Locations (1)

ONE Fertility; 🇨🇦 Hamilton, Ontario, Canada