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

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

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05144893
Enrollment
0
Registered
2021-12-03
Start date
2024-05-01
Completion date
2025-09-15
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Health, Pregnancy Related, Substance Use

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.

Interventions

BEHAVIORALVirtual 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.

Sponsors

Oregon Health and Science University
Lead SponsorOTHER
University of Oregon
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility - Interestat 1 weekthe number of individuals interested in participation.
Feasibility - Attendanceup to 2 monthsthe number of individuals who attend group and the average number of groups attended.
Acceptabilityup to 2 monthsAcceptability will be assessed using the Customer Satisfaction Questionnaires (CSQ-8). Scores range from 8-32 with higher scores indicating higher satisfaction.

Secondary

MeasureTime frameDescription
Pregnancy-specific stressup to 2 monthsPregnancy-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 Distressup to 2 monthsOverall 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKristen Mackiewicz Seghete, PhD

Oregon Health and Science University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026