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

NCT05903638 | Unknown

• 1 other identifier: MBSR Pilot RCT
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Infertility; Mental Health Issue; Quality of Life

Outcome Measures

Primary Outcomes (2)

• MBSR course participation rate

  8-weeks of MBSR course

• Survey completion rate

  Randomization to 3-months after course completion

Secondary Outcomes (6)

• 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

Study Arms (2)

Control

NO INTERVENTION

Virtual Mindfulness-Based Stress Reduction (MBSR) program

EXPERIMENTAL

Behavioral: Mindfulness-Based Stress Reduction course

Interventions

Mindfulness-Based Stress Reduction course BEHAVIORAL

8-week, 26-hour, virtual mindfulness course

Also known as: MBSR

Virtual Mindfulness-Based Stress Reduction (MBSR) program

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary infertility and no prior fertility treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• One Fertility: lead

Study Sites (1)

ONE Fertility

Hamilton, Ontario, L7N 3T1, Canada

Location

Study Officials

• Mehrnoosh Faghih, MD

  McMaster University, ONE Fertility

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-blinded pilot randomized control trial with control arm and intervention (virtual MBSR course).

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 15, 2023
• Study Start: September 30, 2022
• Primary Completion: March 31, 2023
• Study Completion: September 30, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

CA (1)