Brief Virtual Mindfulness-based Group Intervention with Social Support for Perinatal Individuals

Not Applicable

Not yet recruiting

• Conditions: Substance Use; Pregnancy Related; Mental Health
• Interventions: Behavioral: Virtual Mindfullness-Based Intervention

• Registration Number: NCT05144893
• Lead Sponsor: Oregon Health and Science University

Brief Summary

This is a feasibility and acceptability study for 4- week virtual mindfulness-based intervention with social support for perinatal individuals at higher risk for substance use. This study builds on the longitudinal collection of questionnaire data from pregnant and postpartum people during the COVID-19 pandemic. Each closed virtual support group will meet weekly for 4 weeks using a video conference platform. Groups will be focused on grounding, thinking patterns, self-compassion and self-care. This approach will foster increase awareness of wellbeing as well as social support between group participants. Primary outcomes include the feasibility and acceptability of this group-based intervention for perinatal individuals.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-08
• Study First Submitted QC: 2021-12-01
• Study First Posted: 2021-12-03
• Status Verified: 2024-04
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26
• Study Start: 2025-01-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

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

Inclusion Criteria

• Currently pregnant
• Have a single gestation pregnancy
• Fluently speak English
• A history of significant substance use or currently in treatment for a substance use disorder.

Exclusion Criteria

• Inability to provide consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Virtual Mindfullness-Based Support Group	Virtual Mindfullness-Based Intervention	The virtual mindfulness-based intervention with social support groups will meet once a week for 4 weeks, each session will be 60 minutes. Each group will have 3-8 participants. The groups will be closed, meaning the same group of participants meet with the same instructor (unless a backup instructor is needed due to unavoidable reasons). Groups will be completed using the video conferencing application.

Primary Outcome Measures

Name	Time	Method
Feasibility - Attendance	up to 2 months	the number of individuals who attend group and the average number of groups attended.
Acceptability	up to 2 months	Acceptability will be assessed using the Customer Satisfaction Questionnaires (CSQ-8). Scores range from 8-32 with higher scores indicating higher satisfaction.
Feasibility - Interest	at 1 week	the number of individuals interested in participation.

Secondary Outcome Measures

Name	Time	Method
Pregnancy-specific stress	up to 2 months	Pregnancy-specific stress will be measured using and the Prenatal Distress Questionnaire (PDQ). Scores range from 0 to 46 with higher scores indicating higher distress.
Psychological Distress	up to 2 months	Overall psychological distress will be measured using the Center for Epidemiological Studies Depression - Revised (CESD-R). Scores range from 0 to 60 with higher scores indicating more severe depressive symptomatology.

Trial Locations

Locations (1)

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States