N/A
N=83
A Trauma Informed Adaptation of Mindfulness-Based Relapse Prevention for Women in Substance Use Treatment
Substance Use Disorders · Post Traumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03505749 ↗Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Recruitment — 96 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Trauma Informed Mindfulness-Based Relapse Prevention (Behavioral); Treatment As Usual (TAU) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Pacific University
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment |
96 | — |
| PRIMARY Enrollment |
83 | — |
| PRIMARY Retention |
22; 28 | — |
| PRIMARY Trauma Symptoms by the Posttraumatic Checklist - Civilian (PCL-5) Scores |
43.51; 48.55; 35.41; 30.50; 28.75; 21.82 | — |
| PRIMARY Craving by the Penn Alcohol Craving Scale (PACS) Scores |
20.5; 21.31; 8.33; 10.36; 8.00; 6.86 | — |
| PRIMARY Frequency of Alcohol and Substance Use by the NIDA Alcohol, Smoking, and Substance Involvement Test (ASSIST) Scores |
.421; 1.15; .454; .105; .333; .000 | — |
| SECONDARY Psychological Inflexibility and Experiential Avoidance by the Acceptance and Action Questionnaire - Substance Abuse (AAQ-SA) Scores |
84.13; 87.36; 94.19; 100.37; 97.77; 105.5 | — |
| SECONDARY Difficulties in Emotion Regulation Scale - Non-acceptance (DERS-NA) |
17.10; 17.55; 14.66; 13.27; 14.26; 11.77 | — |
| SECONDARY Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF) |
74.48; 72.71; 78.19; 81.00; 82.50; 88.10 | — |
| SECONDARY Coping Responses Inventory (CRI) |
15.72; 22.05; 23.52; 28.77; 14.97; 16.51 | — |
| SECONDARY Drug Taking Confidence Questionnaire |
43.36; 39.87; 57.05; 61.22; 55.97; 65.46 | — |
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 substance use treatment settings. The current proposal will evaluate TI-MBRP, using a randomized, pre-post design, with 100 women in residential substance abuse treatment. Participants will be randomly assigned to participate in a 4-week TI-MBRP intervention or to continue with treatment as usual (TAU). Assessments will be collected pretest, posttest, and at one-month follow-up. Data from this study will lay the groundwork for a larger scale clinical trial to determine the efficacy of TI-MBRP.
Eligibility Criteria
Inclusion Criteria
- 1) Be in the core learning phase of treatment at the Women's Residential Center (WRC)
- 2) Have a score of at least 4 on Breslau's Short Screening Scale for PTSD
- 3) Be age 18 to 70
- 4) Be fluent in speaking and reading English
- 5) Agree to randomization and attendance at treatment and assessment sessions
- 6) Be cleared for participation by appropriate clinic staff
Exclusion Criteria
- 1) Report active suicidality as indicated by endorsing "Yes" to questions 5d - 5f in the Inclusion Exclusion Screening Form.
- 2) Endorse screening items indicating hallucinations or intense emotional lability
- 3) Have previously participated in an MBRP group in current or past treatment settings
- 4) Are in the stabilization or transition phase, versus core learning phase, of treatment
- 5) Fail to provide informed consent
Data sourced from ClinicalTrials.gov (NCT03505749). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.