CClinicalTrials.gg
WithdrawnNCT05144893Updated Aug 31, 2026

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

An interventional study of Virtual Mindfullness-Based Intervention in Substance Use, Pregnancy Related and Mental Health, sponsored by Oregon Health and Science University. Withdrawn at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Supportive care

Why this study was withdrawn
No participants were enrolled. Study focused on protocol development but was halted due to lack of clinicians available to perform groups.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Substance Use
  • Pregnancy Related
  • Mental Health
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In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

Browse Substance-Related Disorders studies →

Lead sponsor

Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts 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

Exclusion Criteria:

  • Inability to provide consent
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

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.

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What researchers measure

Primary outcomes

  1. Feasibility - Interest

    the number of individuals interested in participation.

    Time frame: at 1 week

  2. Feasibility - Attendance

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

    Time frame: up to 2 months

  3. Acceptability

    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 outcomes

  1. 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.

    Time frame: up to 2 months

  2. 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.

    Time frame: up to 2 months

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Study locations

1 site
  • Oregon Health and Science University
    Portland, Oregon 97239, United States
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References and documents

Individual participant data

Plan to share: Yes — De-identified individual participant data that underlie the results of this study will be shared with proper approval.

Supporting information: Sap

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05144893
Lead sponsor
Oregon Health and Science University
Collaborators
University of Oregon
Responsible party
Kristen Mackiewicz Seghete (Assistant Professor, Oregon Health and Science University) — Principal investigator
First posted
Dec 3, 2021
Start date
May 1, 2024
Primary completion
Jul 31, 2025
Completion
Sep 15, 2025
Last update
Aug 31, 2026

Study contacts

Kristen Mackiewicz Seghete, PhD
principal investigator · Oregon Health and Science University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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