A Trauma Informed Adaptation of Mindfulness-Based Relapse Prevention for Women in Substance Use Treatment

NCT03505749 | Completed Results DMC

• 1 other identifier: R36DA043554-01A1
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 5

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.

Conditions

Substance Use Disorders; Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (6)

• Recruitment

  Number of participants who completed informed consent and screening, with at least 30% identifying as racial and/or ethnic minority.

  Baseline

• Enrollment

  Percentage of eligible individuals who completed baseline measures.

  Baseline

• Retention

  Percentage of participants who completed 1-month follow-up measures.

  8-weeks

• Trauma Symptoms by the Posttraumatic Checklist - Civilian (PCL-5) Scores

  20-item screening instrument assessing PTSD symptoms. Each item is scored 0 - 4 (0 = Not at all, 1 = A little bit, 2 = Moderately, 3 = Quite a bit, 4 = Extremely). Total scores range from 0 - 80. Higher values indicate greater PTSD symptom severity.

  Baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks, 36-weeks, 52-weeks

• Craving by the Penn Alcohol Craving Scale (PACS) Scores

  5 items assessing frequency, intensity, and duration of alcohol or drug craving. Each item is scored 0-6 (0 = Never, 1 = Rarely , 2 = Occasionally , 3 = Sometimes, 4 = Often, 5 = Most of the time, 6 = Nearly all the time). Total scale scores range from 0 - 30. Higher scores indicate greater severity of alcohol and substance craving.

  Baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks, 36-weeks, 52-weeks

• Frequency of Alcohol and Substance Use by the NIDA Alcohol, Smoking, and Substance Involvement Test (ASSIST) Scores

  This self-report measure assesses frequency of alcohol and substance use, and misuse of prescription medication over the past 2 weeks, 30 days, and 3 months. Items are on a Likert scale, where 0 = "Not at all", 1 = "One or two days", 2 = "Several days", 3 = "More than half the days", and 4 = "Nearly every day". Total scare scores range from 0 - 44. Higher scores indicate greater frequency of use.

  Baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks, 36-weeks, 52-weeks

Secondary Outcomes (5)

• Psychological Inflexibility and Experiential Avoidance by the Acceptance and Action Questionnaire - Substance Abuse (AAQ-SA) Scores

  Baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks, 36-weeks, 52-weeks

• Difficulties in Emotion Regulation Scale - Non-acceptance (DERS-NA)

  Baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks, 36-weeks, 52-weeks

• Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF)

  Baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks, 36-weeks, 52-weeks

• Coping Responses Inventory (CRI)

  Baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks, 36-weeks, 52-weeks

• Drug Taking Confidence Questionnaire

  Baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks, 36-weeks, 52-weeks

Study Arms (2)

TI-MBRP

EXPERIMENTAL

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.

Behavioral: Trauma Informed Mindfulness-Based Relapse Prevention

Standard MBRP

ACTIVE COMPARATOR

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.

Behavioral: Treatment As Usual (TAU)

Interventions

Trauma Informed Mindfulness-Based Relapse Prevention BEHAVIORAL

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.

Also known as: TI-MBRP

TI-MBRP

Treatment As Usual (TAU) BEHAVIORAL

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.

Also known as: Mindfulness-Based Relapse Prevention (MBRP)

Standard MBRP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Be in the core learning phase of treatment at the Women's Residential Center (WRC)
• \) Have a score of at least 4 on Breslau's Short Screening Scale for PTSD
• \) Be age 18 to 70
• \) Be fluent in speaking and reading English
• \) Agree to randomization and attendance at treatment and assessment sessions
• \) Be cleared for participation by appropriate clinic staff

You may not qualify if:

• \) Endorse screening items indicating hallucinations or intense emotional lability
• \) Have previously participated in an MBRP group in current or past treatment settings
• \) Are in the stabilization or transition phase, versus core learning phase, of treatment
• \) Fail to provide informed consent

Sponsors & Collaborators

• Pacific University: lead

Study Sites (5)

Beavterton Hazelden Betty Ford Foundation

Beaverton, Oregon, 97008, United States

Location

Lifeworks NW Walnut

Hillsboro, Oregon, 97123, United States

Location

Lifeworks NW Mountaindale

Mountaindale, Oregon, 97133, United States

Location

Springbrook Hazelden Betty Ford Foundation

Newberg, Oregon, 97132, United States

Location

Lifeworks NW Project Network

Portland, Oregon, 97212, United States

Location

Related Publications (2)

• 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.

  PMID: 36114577 DERIVED

• 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.

  PMID: 35648046 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Stress Disorders, Post-Traumatic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Results Point of Contact

• Title: Dr. Vanessa Somohano, Postdoctoral Research Fellow
• Organization: VA Portland Health Care System

vanessa.somohano@va.gov

503-220-8262

Study Officials

• Vanessa C Somohano, MA

  Pacific University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were made unaware of whether they were being randomized to the treatment or control group condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Student

Study Record Dates

• First Submitted: April 7, 2018
• First Posted: April 23, 2018
• Study Start: June 18, 2018
• Primary Completion: August 26, 2019
• Study Completion: January 30, 2020
• Last Updated: March 2, 2022
• Results First Posted: October 15, 2021

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)