Substance UseNCT05144893
Brief Virtual Mindfulness-based Group Intervention With Social Support for Perinatal Individuals
A study testing Virtual Mindfullness-Based Intervention in people with Substance Use and Pregnancy Related, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Substance Use, Pregnancy Related, Mental Health
- What is being tested?
- Virtual Mindfullness-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Inability to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: CPO Pilot: Brief Virtual Mindfulness Based Group Intervention With Social Support
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.
- Conditions
- Substance Use, Pregnancy Related, Mental Health
- Being tested
- Virtual Mindfullness-Based Intervention
- Medical subject headings
- Substance-Related Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Mindfullness-Based InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Mindfullness-Based Support Group | Experimental | 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. Receives: Behavioral: Virtual Mindfullness-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Interest
the number of individuals interested in participation.
Measured: at 1 week
Feasibility - Attendance
the number of individuals who attend group and the average number of groups attended.
Measured: up to 2 months
Acceptability
Acceptability will be assessed using the Customer Satisfaction Questionnaires (CSQ-8). Scores range from 8-32 with higher scores indicating higher satisfaction.
Measured: up to 2 months
Secondary outcomes (2)
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.
Measured: up to 2 months
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.
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 May 2024
- Primary completion31 Jul 2025
- Study completion15 Sep 2025
Why it stopped: No participants were enrolled. Study focused on protocol development but was halted due to lack of clinicians available to perform groups.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oregon
- Responsible party
- Principal investigator, Kristen Mackiewicz Seghete, Oregon Health and Science University
- Investigators
- Kristen Mackiewicz Seghete, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144893
- Sponsor's protocol ID
- STUDY00022406
- Status last verified
- Aug 2026
- First submitted
- 8 Nov 2021
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results of this study will be shared with proper approval.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CPO Pilot: Brief Virtual Mindfulness Based Group Intervention With Social Support
- ClinicalTrials.gov ID
- NCT05144893
- Acronym / sponsor ID
- STUDY00022406
- Conditions
- Substance Use, Pregnancy Related, Mental Health
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants were enrolled. Study focused on protocol development but was halted due to lack of clinicians available to perform groups.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- University of Oregon
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Mindfullness-Based Support Group | Experimental | Behavioral: Virtual Mindfullness-Based InterventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Inability to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Mindfullness-Based InterventionVirtual 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. | Behavioural | Virtual Mindfullness-Based Support Group |
Primary outcome
Feasibility - Interest
Time frame: at 1 week
the number of individuals interested in participation.
Feasibility - Attendance
Time frame: up to 2 months
the number of individuals who attend group and the average number of groups attended.
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.
2 secondary outcomes
Pregnancy-specific stress
Time frame: up to 2 months
Psychological Distress
Time frame: up to 2 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results of this study will be shared with proper approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen Mackiewicz Seghete, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Mindfullness-Based Intervention in people with Substance Use and Pregnancy Related, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Interest (time frame: at 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.