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

Sponsor

Oregon Health and Science University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05144893

Collaborator

University of Oregon (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Substance Use Pregnancy Related Mental Health	Behavioral: Virtual Mindfullness-Based Intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Feasibility - Interest [at 1 week]
the number of individuals interested in participation.
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.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oregon Health and Science University	Portland	Oregon	United States	97239

Sponsors and Collaborators

Oregon Health and Science University
University of Oregon

Investigators

Principal Investigator: Kristen Mackiewicz Seghete, PhD, Oregon Health and Science University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kristen Mackiewicz Seghete, Assistant Professor, Oregon Health and Science University

ClinicalTrials.gov Identifier:

NCT05144893

Other Study ID Numbers:

STUDY00022406

First Posted:

Dec 3, 2021

Last Update Posted:

Mar 15, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Substance-Related Disorders

Study Results

No Results Posted as of Mar 15, 2022