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

CPO Pilot: Brief Virtual Mindfulness Based Group Intervention with Social Support

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy Related; Substance Use; Mental Health
• Intervention / Treatment: Behavioral: Virtual Mindfullness-Based Intervention

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olivia J Doyle, BA; Phone Number: 503-933-0608; Email: doyleo@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Virtual Mindfullness-Based Support Group; 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.

Behavioral: Virtual Mindfullness-Based Intervention; Virtual administration of the social support components of an adapted 4-week Mindfulness Based Cognitive Therapy for Postpartum Depression (MBCT-PD) intervention. Each session includes a review of assigned online mindfulness practice and barriers to practice, other homework if also assigned, psychoeducation, and mindfulness practices relevant to the session's theme.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy-specific stress	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.	up to 2 months
Psychological Distress	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.	up to 2 months

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: University of Oregon
• Investigators: Principal Investigator: Kristen Mackiewicz Seghete, PhD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Actual): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: STUDY00022406

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data that underlie the results of this study will be shared with proper approval.
• IPD Sharing Time Frame: 12 months after final data collectins is concluded through 2 years after publications.
• IPD Sharing Access Criteria: The Principal Investigator (PI) will review requests for individual participant data (IPD). IPD will be provided with appropriate Institutional Review Board approval or determination. IPD may be provided to investigators associated with a university or reputable research institution with an associated Institutional Review Board (IRB). De-identified IPD will be provided through a secure sharing mechanism.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No