Brief Virtual Mindfulness-based Group Intervention With Social Support for Perinatal Individuals
Primary Purpose
Substance Use, Pregnancy Related, Mental Health
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Mindfullness-Based Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Substance Use
Eligibility Criteria
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
Sites / Locations
- Oregon Health and Science University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Virtual Mindfullness-Based Support Group
Arm Description
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.
Outcomes
Primary Outcome Measures
Feasibility - Interest
the number of individuals interested in participation.
Feasibility - Attendance
the number of individuals who attend group and the average number of groups attended.
Acceptability
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
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
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.
Full Information
NCT ID
NCT05144893
First Posted
November 8, 2021
Last Updated
May 3, 2023
Sponsor
Oregon Health and Science University
Collaborators
University of Oregon
1. Study Identification
Unique Protocol Identification Number
NCT05144893
Brief Title
Brief Virtual Mindfulness-based Group Intervention With Social Support for Perinatal Individuals
Official Title
CPO Pilot: Brief Virtual Mindfulness Based Group Intervention With Social Support
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
University of Oregon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, Pregnancy Related, Mental Health
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual Mindfullness-Based Support Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Mindfullness-Based Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility - Interest
Description
the number of individuals interested in participation.
Time Frame
at 1 week
Title
Feasibility - Attendance
Description
the number of individuals who attend group and the average number of groups attended.
Time Frame
up to 2 months
Title
Acceptability
Description
Acceptability will be assessed using the Customer Satisfaction Questionnaires (CSQ-8). Scores range from 8-32 with higher scores indicating higher satisfaction.
Time Frame
up to 2 months
Secondary Outcome Measure Information:
Title
Pregnancy-specific stress
Description
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.
Time Frame
up to 2 months
Title
Psychological Distress
Description
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.
Time Frame
up to 2 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivia J Doyle, BA
Phone
503-933-0608
Email
doyleo@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen Mackiewicz Seghete, PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Brief Virtual Mindfulness-based Group Intervention With Social Support for Perinatal Individuals
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