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NCT Number: NCT05144893

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

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.

Why the study stopped: No participants were enrolled. Study focused on protocol development but was halted due to lack of clinicians available to perform groups.
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Key information

Conditions

Substance Use Behavior Chemically-Induced Disorders Mental Disorders Mental Health Personal Satisfaction Pregnancy Related Psychological Well-Being Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility - Interest

    Time frame: at 1 week

    the number of individuals interested in participation.

  2. Feasibility - Attendance

    Time frame: up to 2 months

    the number of individuals who attend group and the average number of groups attended.

  3. Acceptability

    Time frame: 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 outcomes

  1. Pregnancy-specific stress

    Time frame: 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.

  2. Psychological Distress

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • University of Oregon

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 3, 2021
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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