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

Study Overview
=================
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.

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

Conditions
-----------------
Primary Infertility, Mental Health Issue, Quality of Life

Intervention / Treatment
-----------------
* Behavioral: Mindfulness-Based Stress Reduction course


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-blinded pilot randomized control trial with control arm and intervention (virtual MBSR course).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: Virtual Mindfulness-Based Stress Reduction (MBSR) program<br> | Behavioral: Mindfulness-Based Stress Reduction course<br>* 8-week, 26-hour, virtual mindfulness course<br>* Other names: MBSR;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MBSR course participation rate |  | 8-weeks of MBSR course | 
| Survey completion rate |  | Randomization to 3-months after course completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory |  | Randomization to 3-months after course completion | 
| Beck Anxiety Inventory |  | Randomization to 3-months after course completion | 
| Perceived Stress Scale |  | Randomization to 3-months after course completion | 
| Fertility Problem Inventory |  | Randomization to 3-months after course completion | 
| % involvement in fertility treatment |  | 3-months after course completion | 
| Pregnancy rates |  | 3-months after course completion |