N/A
N=90
Mindfulness Meditation for the Treatment of Women With Comorbid PTSD and SUD
Stress Disorders, Post-Traumatic · Substance-Related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02755103 ↗Enrolled (actual)
90
Serious AEs
7.8%
Results posted
Jan 2023
Primary outcome: Primary: Clinician-Administered Posttraumatic Stress Disorder Scale for DSM-5 — 16.5; 18.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindfulness Based Relapse Prevention (MBRP) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Medical University of South Carolina
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinician-Administered Posttraumatic Stress Disorder Scale for DSM-5 |
16.5; 18.5 | — |
| SECONDARY Clinician Administered Posttraumatic Stress Disorder Scale-5 (CAPS-5) |
13.8; 16.1; 12.7; 13.3 | — |
| SECONDARY Post Traumatic Stress Disorder Symptom Scale- Self Report (PSS-SR) |
30.6; 29.2; 24.7; 28.3; 24; 28.5 | — |
| SECONDARY Time Line Follow Back (TLFB) |
2.5; 3.7 | — |
| SECONDARY Time Line Follow Back (TLFB) |
2.5; 3.7 | — |
| SECONDARY Time Line Follow Back (TLFB) |
2.5; 3.7 | — |
| SECONDARY Time Line Follow Back (TLFB) |
2.5; 3.7 | — |
| SECONDARY Time Line Follow Back (TLFB) |
2.5; 3.7 | — |
| SECONDARY Time Line Follow Back (TLFB) |
2.5; 3.7 | — |
| SECONDARY Five Factor Mindfulness Questionnaire (FFMQ) |
87.4; 79.3 | — |
| SECONDARY Five Factor Mindfulness Questionnaire (FFMQ) |
87.4; 79.3 | — |
| SECONDARY Five Factor Mindfulness Questionnaire (FFMQ) |
87.4; 79.3 | — |
| SECONDARY Difficulty in Emotion Regulation Scale (DERS) |
80.9; 85.7 | — |
| SECONDARY Difficulty in Emotional Regulation Scale (DERS) |
76.4; 81.7 | — |
| SECONDARY Difficulty in Emotional Regulation Scale (DERS) |
76.4; 81.7 | — |
Summary
The current study will modify an already existing therapy for individuals with substance use disorders to address Post Traumatic Stress Disorder (PTSD) in women enrolled in substance use disorders (SUD) treatment who suffer with both PTSD and SUD. Mindfulness meditation has been shown to help individuals to cope with stress and regulate emotions. Through meditation practice women will experience less distress related to PTSD symptoms and reduced substance use in response to emotional triggers. Women enrolled in intensive SUD treatment at a community program will be randomized to receive either 8 weeks of 90 minute Mindfulness Based Relapse Prevention (MBRP) group sessions plus treatment as usual (TAU) or TAU alone. The MBRP group sessions will replace 90 minutes of TAU group therapy. Measures of feasibility of implementation, acceptance and adherence will be obtained. Preliminary efficacy for substance use and PTSD symptom severity will be measured at post treatment and at 3- and 6- months' follow-up.
Eligibility Criteria
Inclusion Criteria
- Women between 18 and 65 years of age enrolled in the Charleston Center (CC) intensive outpatient and New Life program treatment.
- Able to comprehend English.
- Meets fifth edition Diagnostic and Statistical Manual V (DSM V) criteria for current alcohol or substance use disorder and have used alcohol/substances in the 30 days prior to clinic treatment entry.
- Meets DSM V criteria for current PTSD with a score greater than or equal to 25 on the CAPS 5.0.
- Participants may also meet criteria for a mood or anxiety disorder. Participants on psychotropic medications for a mood or anxiety disorder must have been stabilized on medications for at least 4 weeks before therapy initiation.
- Able to adequately provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
- Willing to commit to 8 therapy sessions, baseline, weekly and follow-up assessments.
Exclusion Criteria
- Current primary psychotic or thought disorder (i.e. Schizophrenia or schizoaffective disorder, mania), major depression with suicidal ideation, dissociative identity disorder and/or homicidal ideations.
- Present a serious suicide risk, such as those with severe depression, or who are likely to require hospitalization during the course of the study.
- In ongoing therapy for PTSD either within or outside of the CC, who are not willing to discontinue these therapies for the duration of the study therapy,
- Unstable medical condition or one that may require hospitalization during the course of the study.
- Women who are pregnant or planning to become pregnant.
Data sourced from ClinicalTrials.gov (NCT02755103). 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.