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NCT03505749 · ClinicalTrials.gov registry record · NA
A Trauma Informed Adaptation of Mindfulness-Based Relapse Prevention for Women in Substance Use Treatment
A NA study, sponsored by Pacific University.
- Completed
- Registry status
- NA
- Development phase
- 96
- Enrollment target
NCT03505749: Completed NA study, sponsored by Pacific University.
NCT03505749 is a NA study that has completed, run by Pacific University. The registered enrollment target is 96 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03505749, a NA study, has completed, sponsored by Pacific University.
- COMPLETED
- Registry status
- NA
- Development phase
- 96 participants
- Enrollment target
Study Summary
More than 90% of women in substance use treatment report history of physical and/or sexual trauma, and up to 60% meet criteria for both substance use disorder (SUD) and Post Traumatic Stress Disorder (PTSD). PTSD typically precedes onset of SUD, with substances used as a means to cope with physiological, psychological, and emotional symptoms resulting from the trauma. Women with PTSD experience greater severity of addiction symptoms, readmit into treatment more frequently than women without PTSD, and tend to have poorer treatment outcomes. Due to increased risk for exacerbation of PTSD on SUD severity and treatment success, and the specific vulnerabilities and needs of women with this comorbidity, SUD treatments that target both substance use and trauma recovery are needed. However, few interventions target both SUD and PTSD concurrently, and fewer still are specific to women. Mindfulness-Based Relapse Prevention (MBRP) has been shown to decrease craving, relapse rates, and quantity/frequency of use across several substances, and has shown acceptability in diverse populations. MBRP integrates mindfulness practices with cognitive behavioral and exposure-based approaches to increase self-regulatory skills while experiencing triggers previously associated with substance use, including challenging affective states such as those common to experienced trauma. Adapting MBRP to incorporate trauma education and treatment approaches has the potential to effectively treat women with the dual vulnerabilities of trauma history and SUD. The current study is thus designed to determine feasibility, acceptability, and initial efficacy of an adapted Trauma-Informed Mindfulness-Based Relapse Prevention (TI-MBRP) intervention for women in substance use treatment settings who have PTSD. TI-MBRP integrates trauma education and treatment approaches drawn from Cognitive Processing Therapy (CPT) into the standard MBRP protocol to provide a trauma-informed approach to treating women in sub
Primary Outcome
Number of participants who completed informed consent and screening, with at least 30% identifying as racial and/or ethnic minority.
Interventions
- BEHAVIORAL Treatment As Usual (TAU)
- BEHAVIORAL Trauma Informed Mindfulness-Based Relapse Prevention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2018-06-18 |
| Est. Completion | 2020-01-30 |
| Phase | NA |
What the finished NCT03505749 record still lists
NCT03505749 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Treatment As Usual (TAU) is the first listed.
NCT03505749 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03505749 about?
NCT03505749 is a clinical study titled "A Trauma Informed Adaptation of Mindfulness-Based Relapse Prevention for Women in Substance Use Treatment". More than 90% of women in substance use treatment report history of physical and/or sexual trauma, and up to 60% meet criteria for both substance use disorder (SUD) and Post Traumatic Stress Disorder (PTSD). PTSD typically precedes onset of SUD, with substances used as a means to cope with physiolog...
What is the current status of trial NCT03505749?
This trial is currently completed. It is a NA study. The enrollment target is 96 participants. The study started on 2018-06-18. Estimated completion is 2020-01-30.
What interventions are being tested in trial NCT03505749?
The interventions under investigation include: Treatment As Usual (TAU) (BEHAVIORAL), Trauma Informed Mindfulness-Based Relapse Prevention (BEHAVIORAL).
Who is sponsoring clinical trial NCT03505749?
This trial is sponsored by Pacific University, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03505749's enrollment target sits among peer trials
96 925th of 2000 higher than 1,070 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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