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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05144893
• Other study ID #: STUDY00022406
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: April 2024
• Source: Oregon Health and Science University
• Contact: Olivia J Doyle, BA
• Phone: 503-933-0608
• Email: doyleo[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: January 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Health
• Pregnancy Related
• Substance Use
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	University of Oregon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility - Interest	the number of individuals interested in participation.	at 1 week
Primary	Feasibility - Attendance	the number of individuals who attend group and the average number of groups attended.	up to 2 months
Primary	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	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
Secondary	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