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

One Fertility

Status: Active, not recruiting

Conditions: Quality of Life; Mental Health Issue; Primary Infertility

Treatments: Behavioral: Mindfulness-Based Stress Reduction course

Study type: Interventional

Funder types: Other

Identifiers

NCT05903638

MBSR Pilot RCT

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups

Control

No Intervention group

Virtual Mindfulness-Based Stress Reduction (MBSR) program

Experimental group

Treatment:

Behavioral: Mindfulness-Based Stress Reduction course