A Trauma Informed Adaptation of Mindfulness-Based Relapse Prevention for Women in Substance Use Treatment
Condition: Substance Use Disorders; Post Traumatic Stress Disorder
MeSH terms: Substance-Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

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.
    

Detailed description: 
      Approximately 4.7 million women in the US experience sexual and/or physical interpersonal
      violence (IPV) each year, and 46% experience IPV in their lifetime. More than 50% of
      interpersonal related violence occurs before age 25. In addition to acute, chronic and fatal
      injuries caused by IPV, women survivors of trauma (WST) are also at greater risk for organ
      and immune system diseases due to chronic stress, reproductive dysfunctions and complications
      during pregnancy, psychological disorders, and the inability to access health care services
      and social support. Estimated medical and mental health care costs for WST are $8.3 billion
      dollars per year, as well as $8 million dollars lost in paid workdays. Additionally, annual
      health care cost of survivors can persist up to 15 years after the cessation of abuse.

      More than 90% of women admitted into substance use treatment settings have experienced IPV,
      and 30-60% meet criteria for comorbid SUD and PTSD. IPV typically precedes the onset of
      substance abuse as a means to cope with intense physiological, psychological, and emotional
      symptoms attributed to the event. Research has demonstrated that for women, PTSD symptoms may
      mediate the relationship between IPV and problematic SU. Women with PTSD symptoms and SUD
      also experience greater severity of addiction symptoms compared to men, and often readmit
      into treatment more frequently than men or women without traumatic histories. Evidence also
      suggests that PTSD symptoms and SU yields poorer treatment outcomes than any other comorbid
      disorder, or than SUD or PTSD alone. Due to these high rates of comorbidity and
      interrelationship of symptoms, particularly in women, integrated treatments targeting both
      substance use and trauma recovery are needed. However, few such evidence-based interventions
      (EBIs) are available for WST in substance use treatment settings. The few EBIs addressing SUD
      and trauma that are available have been mostly validated on males or specifically adapted for
      veteran populations. Mindfulness-Based Relapse Prevention (MBRP) is one evidence-based
      intervention that has demonstrated efficacy in reducing substance craving, relapse, and
      negative affect in a variety of SUD populations. It has also shown efficacy in incarcerated
      populations, ethnic minority women, and women offenders, all of which have higher levels of
      trauma exposure compared to normative samples. Research on Mindfulness-Based Interventions
      (MBIs) with trauma populations suggest that mindfulness skills can help decrease PTSD
      symptoms associated with avoidance and trauma-based cognitions, and that MBIs are not
      iatrogenic for trauma populations. A trauma informed adaptation of MBRP may thus offer an
      integrated intervention targeting both PTSD and SUD symptoms, and addressing the etiologies
      and maintaining factors underlying the comorbidity.

      Given the particular needs and unique presentation of WST in substance use treatment
      settings, effective evidence-based interventions must be developed to improve treatment
      outcomes. The long-term goal of this line of research is to develop, examine and disseminate
      an adapted evidence-based treatment for comorbid SUD and PTSD for women survivors of trauma
      (WST). The primary objective of this study is to develop and evaluate an intervention that
      integrates trauma education and treatment approaches used in Cognitive Processing Therapy
      (CPT), an evidence-based intervention for PTSD, into the standard MBRP protocol to provide a
      trauma-informed approach to treating women in community-based substance use treatment
      settings. The development phase of the study will use focus groups with staff and clients
      from a women's residential treatment center who have completed the MBRP course to inform the
      integration of trauma education using the CPT manual into the MBRP protocol. Using a
      mixed-methods, pre-post, randomized-control design, WST (N=100) enrolled in a residential
      treatment program will be randomized by cluster into an experimental (TI-MBRP) or control
      (TAU) group to determine feasibility, acceptability, preliminary efficacy, and candidate
      mechanisms of TI-MBRP. To accomplish the primary objective, the following three aims are
      proposed:

      Aim 1: Development and refinement of a Trauma Informed-Mindfulness Based Relapse Prevention
      (TI-MBRP) protocol. Informed by focus groups with staff and resident clients, a protocol
      integrating evidence-based practices for SUDs and PTSD will be developed for women in
      substance use treatment endorsing PTSD symptoms.

      Aim 2: Determine feasibility and acceptability of TI-MBRP. Based on prior studies of MBRP in
      similar populations, we hypothesize TI-MBRP will be feasible and acceptable, as measured by
      recruitment and retention rates, weekly homework compliance, client participation in groups,
      and post-intervention client feedback.

      Aim 3: Determine meaningful changes at pre-, post-, 1-, 3-, 6-, 9-, and 12-month follow-up
      assessment time points in SUD and trauma-related outcomes, and identify candidate mechanisms.
      We hypothesize that, as compared to TAU, participation in TI-MBRP will result in:

        1. Significantly reduced trauma-related symptomology, craving, substance use, reactivity to
           negative affect, and experiential avoidance at post-intervention, and maintenance of
           treatment outcomes at 12-month follow-up.

        2. Significant improvements in self-efficacy, coping skills, and mindfulness at
           post-intervention, and maintenance of treatment outcomes at 12-month follow-up.

      Interested residents will be screened for eligibility based on the Inclusion/Exclusion
      Screening Tool, Breslau's Short Screening Scale, and Suicidal Behaviors Questionnaire.
      Eligible participants will be provided with a written informed consent. The PI will review
      the informed consent with participants and answer any questions or concerns that participants
      may have about study procedures, confidentiality, data analysis, and dissemination of
      results. Once written informed consent is obtained, participants will be notified of the
      group start date within one week of signing the consent form. Participants will be asked to
      complete a battery of paper-and-pencil assessments within one week prior to the start of the
      first session. Paper-and-pencil assessments will take no more than 60 minutes to complete.

      Experimental and Treatment-As-Usual (TAU) groups will be implemented simultaneously for
      maximization of participants within the given time frame, totaling 10 groups over a 10-month
      period. Participants will complete a battery of self-report assessments at baseline. Then,
      using computer randomizing software, participants will be randomized by cluster into either
      an experimental or TAU group before the start of the first session. After the first session,
      all participants will be given an iPod touch with audio-recordings of guided meditation
      practices used in the intervention (i.e., body scan, breath awareness) to use as a part of
      their daily homework requirements. All iPod touch devices will include iMINDr, a software
      application developed to track frequency and duration of home meditation practice.
      Participants will then complete a post-course assessment battery within one week of the
      completion of the 4-week course. If participants are unable to be physically present to
      complete the post-course assessment, they will be offered a phone interview during which they
      will be administered self-report assessment measures orally.

      One week after post-course assessment, participants will be invited to participate in an hour
      long, audio-recorded focus group to discuss helpful aspects of the intervention as well as
      what could be changed. Focus group audio recordings will be transcribed verbatim and analyzed
      in NVivo 11 by independent coders using a Constant Comparative Analysis.

      Participants will be asked to complete additional paper-and-pencil assessments at 1-, 3-, 6-,
      9-, and 12-months following post course. If participants are unable to physically attend
      follow-up assessment, they will be offered a phone interview with self-report assessments
      administered orally.
    

Intervention name(s): Trauma Informed Mindfulness-Based Relapse Prevention; Treatment As Usual (TAU)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Trauma Informed-Mindfulness-Based Relapse Prevention (TI-MBRP) will be a 4-week intervention integrating trauma intervention approaches based on Cognitive Processing Therapy (CPT) into standard Mindfulness-Based Relapse Prevention (MBRP). TI-MBRP honors the spirit and cognitive-behavioral foundation of MBRP while introducing components of CPT. Each TI-MBRP session will include mindfulness practices that bring awareness to cognitive and behavioral processes of substance abuse, and how substance use may function as a mechanism to cope with trauma symptoms. Clients are trained to observe internal, triggering stimuli without reactively attempting to avoid these experiences through substance use as well as complete exercises that promote cognitive and emotional processing of traumatic events.; The Treatment as Usual (TAU) group implemented for this trial will be the standard protocol for Mindfulness-Based Relapse Prevention (MBRP). MBRP is a 4-week exposure-based intervention that integrates integrating mindfulness and acceptance-based techniques with cognitive-behavioral approaches and psycho-education to increase awareness of patterns associated with addictive behaviors and individual factors precipitating and maintaining substance use. These skills are also used to train individuals in responding skillfully in high-risk situations associated with use.
Other intervention name(s): TI-MBRP; Mindfulness-Based Relapse Prevention (MBRP)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment