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

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ClinicalTrials.gov Identifier: NCT03505749
Recruitment Status : Not yet recruiting
First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Vanessa Somohano, Pacific University

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 an 8-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.


Condition or disease Intervention/treatment Phase
Substance Use Disorders Post Traumatic Stress Disorder Behavioral: Trauma Informed Mindfulness-Based Relapse Prevention Behavioral: Treatment As Usual (TAU) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trauma Informed Adaptation of Mindfulness-Based Relapse Prevention for Women in Substance Use Treatment: A Randomized-controlled Pilot Trial
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TI-MBRP
Trauma Informed-Mindfulness-Based Relapse Prevention (TI-MBRP) will be an 8-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
Trauma Informed-Mindfulness-Based Relapse Prevention (TI-MBRP) will be an 8-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.
Other Name: TI-MBRP

Active Comparator: Standard MBRP
The Treatment as Usual (TAU) group implemented for this trial will be the standard protocol for Mindfulness-Based Relapse Prevention (MBRP). MBRP is an 8-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)
The Treatment as Usual (TAU) group implemented for this trial will be the standard protocol for Mindfulness-Based Relapse Prevention (MBRP). MBRP is an 8-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 Name: Mindfulness-Based Relapse Prevention (MBRP)




Primary Outcome Measures :
  1. Change in trauma symptoms by the Posttraumatic Checklist - Civilian (PCL-5) [ Time Frame: Baseline, 8-weeks, 12-weeks ]
    17-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).

  2. Change in craving by the Penn Alcohol Craving Scale (PACS) [ Time Frame: Baseline, 8-weeks, 12-weeks ]
    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).

  3. Change in substance use by the Timeline Follow Back (TFB) [ Time Frame: Baseline, 8-weeks, 12-weeks ]
    This self-report measure assesses whether an individual has used different substances over the past 7 days. The individual marks yes or no next to each substance category.


Secondary Outcome Measures :
  1. Acceptance and Action Questionnaire - Substance Abuse (AAQ-SA) [ Time Frame: Baseline, 8-weeks, 12-weeks ]
    7-item self-report measure of experiential avoidance and psychological inflexibility related to substance abuse behaviors. Each item is scaled from 1 - 7, where 1 = "Never true", 2 = "Very seldom true", 3 = "Seldom true", 4 = "Sometimes true", 5 = "Frequently true", 6 = "Almost always true", and 7 = "Always true"

  2. Difficulties in Emotion Regulation Scale - Non-acceptance (DERS-NA) [ Time Frame: Baseline, 8-weeks, 12-weeks ]
    36-item self-report measure of reaction to negative affect. This measure contains 6 subscales and a total score, and has shown acceptable internal consistency (α = 0.86) and test-retest reliability (r = .74). Only the 6-item non-acceptance of emotion subscale (α = 0.85) will be used, which measures the degree to which an individual accepts their reaction to negative emotions. Items are scaled from 1 - 6, where 1 = "Almost never (1 - 10%)", 2 = "Sometimes (11 - 35%)", 3 = About half the time (36 - 65%)", 4 = "Most of the time (66 - 90%)", and 5 = "Almost always (91 - 99%)".

  3. Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF) [ Time Frame: Baseline, 8-weeks, 12-weeks ]
    24-item, self-report measure of mindfulness. The FFMQ-SF contains a total mindfulness score and 5 subscale scores measuring awareness, non-judgment, describing, observing, and non-reactivity. Items are scaled from 1 - 5, where 1 = "Never or very rarely true", 2 = "Rarely true", 3 = "Sometimes true", 4 = "Often true", and 5 = "Very often or always true".

  4. Coping Responses Inventory (CRI) [ Time Frame: Baseline, 8-weeks, 12-weeks ]
    The CRI is a self-report, 48-item questionnaire assessing coping resources in stressful situations, with subscales measuring approach-based coping and avoidant coping in difficult situations. Items are on a 4-point Likert scale varying from "Not at all" to "Fairly often".

  5. Drug Taking Confidence Questionnaire [ Time Frame: Baseline, 8-weeks, 12-weeks ]
    8-item brief self-report questionnaire measuring confidence in avoiding, abstaining or moderating substance use across 8 categories of relapse precipitants. Items are scaled from 0 - 100 in increments of 20, where 0 = "Not confident at all" and 100 = "Very confident".



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 a score of ≥ 7 on the Suicidal Behaviors Questionnaire (SBQ)
  • 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 at the WRC
  • 5) Fail to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505749


Contacts
Contact: Vanessa C Somohano, MA 5628798374 somo3462@pacificu.edu

Sponsors and Collaborators
Pacific University
Investigators
Principal Investigator: Vanessa C Somohano, MA Pacific University

Responsible Party: Vanessa Somohano, Graduate Student, Pacific University
ClinicalTrials.gov Identifier: NCT03505749     History of Changes
Other Study ID Numbers: R36DA043554-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Substance-Related Disorders
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Chemically-Induced Disorders