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

NCT05144893 | Not Yet Recruiting

• 1 other identifier: STUDY00022406
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use; Pregnancy Related; Mental Health

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Pregnancy-specific stress

  up to 2 months

• Psychological Distress

  up to 2 months

Study Arms (1)

Virtual Mindfullness-Based Support Group

EXPERIMENTAL

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

Interventions

Virtual Mindfullness-Based Intervention BEHAVIORAL

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.

Virtual Mindfullness-Based Support Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Inability to provide consent

Sponsors & Collaborators

• Oregon Health and Science University: lead
• University of Oregon: collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Kristen Mackiewicz Seghete, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivia J Doyle, BA

CONTACT

503-933-0608; doyleo@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: December 3, 2021
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: October 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: 12 months after final data collectins is concluded through 2 years after publications.
• 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.

Locations

US (1)