Mindfulness Meditation for the Treatment of Women With Comorbid PTSD and SUD
Condition: Stress Disorders, Post-Traumatic; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Stress Disorders, Post-Traumatic
Study type: Interventional

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.
    

Detailed description: 
      This randomized controlled pilot study will evaluate the feasibility and preliminary efficacy
      of MBRP plus usual community treatment as usual (TAU) compared to TAU alone (TAU) for women
      with substance use disorders(SUD) and PTSD enrolled in community substance abuse treatment.
      Participants will be randomized to eight weekly 90-minute, mixed individual and group-based
      MBRP in addition to TAU or TAU alone. The eight sessions of MBRP will replace 8 sessions of
      seeking safety (SS); a trauma focused integrated therapy currently implemented in TAU.
      Outcomes assessed will be:

        1. PTSD symptom severity as measured by the Clinician's Administered PTSD Scale (CAPS) and
           Post Traumatic Stress Disorder Symptom Scale-Self Report (PSS-SR);

        2. Alcohol and substance use as measured by the Timeline Follow Back (TLFB) assessment and
           corroborated with urine drug screens.

        3. psychosocial functioning;

        4. Measure of emotional regulation and mindfulness awareness, attention and acceptance.

      Recruitment of participants will primarily take place a community treatment program treating
      women with co-occurring PTSD and SUD.

      Following therapist training, certification and piloting, eligible women will be invited to
      participate in the study. Interested potential participants will be screened for major
      inclusion/exclusion criteria including age, alcohol/substance use, history of trauma and
      psychiatric/health/medication status. If potentially eligible, an Institutional Review Board
      (IRB) approved informed consent will be obtained and participants will be scheduled for a
      baseline assessment appointment. If an individual is ineligible to participate in this
      research protocol, she will continue in her usual community treatment program and/or if
      indicated, be referred for additional treatment services. The investigators decided to limit
      the study group to women because they represent the largest percentage of patients with
      comorbid PTSD and SUDs and most have experienced sexual and/or physical trauma. So when
      trauma-focused treatment is delivered in a group setting for this population, single sex
      groups create a safe, comfortable and open atmosphere that is required for MM-based treatment
      and trauma focused work. After having at least 7 days in standard treatment baseline
      assessments will be collected. Women meeting inclusion with no exclusionary criteria will be
      randomized to MBRP plus TAU or TAU alone control. Both groups will attend their standard
      intensive TAU program. The eight MBRP therapy sessions will be integrated into the standard
      TAU program and replace 8 TAU SS sessions. Participants will be introduced to the therapists
      and scheduled for their first individual/small group session.

      The primary outcome measures for the efficacy portion of this study are 1) the effective
      reduction in PTSD symptom severity through the total score on the CAPS at the end of
      treatment between the two study groups and 2) the effective reduction in the proportion of
      days using and amount of use of alcohol/substances during the final 30 days of treatment as
      measured by the TLFB verified by urine drug screens (UDS). In addition, secondary endpoints
      will include CAPS scores at the 3 and 6 month post-intervention follow-up visits, the 7 day
      point prevalence abstinence rates at each treatment, post treatment and follow up visits.
      Also, PSS-SR, Obsessive Compulsive Drinking and Substance Use Scale-Revised (OCDS-R),
      Addiction Severity Index-Lite (ASI-Lite), Difficulties in Emotional Regulation Scale (DERS),
      Mindfulness Acceptance and Awareness Questionnaire (MAAS), Five Facet Mindfulness
      Questionnaire (FFQS) and Cognitive and Affective Regulation Scale (CAMS-R). There will also
      be secondary endpoints and used to gain insight into potential effect modification and
      mediation. Secondary analysis will also include the proportion of days using alcohol/drugs,
      craving, psychosocial functioning and emotional regulation. Participants will be assessed
      weekly throughout the intervention, at the end of the intervention and at 3- and 6- month
      follow-ups.
    

Intervention name(s): Mindfulness Based Relapse Prevention (MBRP)
Intervention type(s): Behavioral
Intervention description(s): MBRP integrates coping skills from cognitive-behavioral relapse prevention therapy with Mindfulness Meditation (MM) practices, raising awareness of substance use triggers and reactive behavioral patterns, and teaching skillful coping responses.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mindfulness; Comorbid PTSD and SUD; Meditation