Clinical trial NCT03505749: A Trauma Informed Adaptation of Mindfulness-Based Relapse Prevention for Women in Substance Use Treatment
Official title: A Trauma Informed Adaptation of Mindfulness-Based Relapse Prevention for Women in Substance Use Treatment: A Randomized-controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Post Traumatic Stress Disorder
Lead sponsor: Pacific University
Sponsor class: OTHER
First posted: 2018-04-23
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Recruitment
timeFrame: Baseline
measure: Enrollment
timeFrame: Baseline
measure: Retention
timeFrame: 8-weeks
measure: Trauma Symptoms by the Posttraumatic Checklist - Civilian (PCL-5) Scores
timeFrame: Baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks, 36-weeks, 52-weeks
measure: Craving by the Penn Alcohol Craving Scale (PACS) Scores
timeFrame: Baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks, 36-weeks, 52-weeks
measure: Frequency of Alcohol and Substance Use by the NIDA Alcohol, Smoking, and Substance Involvement Test (ASSIST) Scores
timeFrame: Baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks, 36-weeks, 52-weeks
Secondary outcomes:
measure: Psychological Inflexibility and Experiential Avoidance by the Acceptance and Action Questionnaire - Substance Abuse (AAQ-SA) Scores
timeFrame: Baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks, 36-weeks, 52-weeks
measure: Difficulties in Emotion Regulation Scale - Non-acceptance (DERS-NA)
timeFrame: Baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks, 36-weeks, 52-weeks
measure: Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF)
timeFrame: Baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks, 36-weeks, 52-weeks
measure: Coping Responses Inventory (CRI)
timeFrame: Baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks, 36-weeks, 52-weeks
measure: Drug Taking Confidence Questionnaire
timeFrame: Baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks, 36-weeks, 52-weeks
Other outcomes:
Locations:
city: Beaverton
country: United States
facility: Beavterton Hazelden Betty Ford Foundation
state: Oregon
city: Hillsboro
country: United States
facility: Lifeworks NW Walnut
state: Oregon
city: Mountaindale
country: United States
facility: Lifeworks NW Mountaindale
state: Oregon
city: Newberg
country: United States
facility: Springbrook Hazelden Betty Ford Foundation
state: Oregon
city: Portland
country: United States
facility: Lifeworks NW Project Network
state: Oregon
Study officials:
affiliation: Pacific University
name: Vanessa C Somohano, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Somohano VC, Kaplan J, Newman AG, O'Neil M, Lovejoy T. Formal mindfulness practice predicts reductions in PTSD symptom severity following a mindfulness-based intervention for women with co-occurring PTSD and substance use disorder. Addict Sci Clin Pract. 2022 Sep 16;17(1):51. doi: 10.1186/s13722-022-00333-2.
citation: Somohano VC, Bowen S. Trauma-Integrated Mindfulness-Based Relapse Prevention for Women with Comorbid Post-Traumatic Stress Disorder and Substance Use Disorder: A Cluster Randomized Controlled Feasibility and Acceptability Trial. J Integr Complement Med. 2022 Sep;28(9):729-738. doi: 10.1089/jicm.2021.0306. Epub 2022 May 31.