Overview

This trial is active, not recruiting.

Condition substance use disorders
Treatments mindfulness based relapse prevention, relapse prevention, treatment as usual
Phase phase 1/phase 2
Sponsor University of Washington
Start date October 2009
End date May 2012
Trial size 225 participants
Trial identifier NCT01159535, 1R01DA025764-01A1, 31183-J

Summary

The broad, long-term objective of the proposed randomized clinical trial is to evaluate the efficacy, moderators and mechanisms of change of two cognitive-behavioral aftercare treatments for alcohol and other drug (AOD) use disorders in preventing AOD relapse compared to treatment as usual (TAU) offered in the community. The two cognitive-behavioral aftercare treatments are relapse prevention (RP) and Mindfulness-Based Relapse Prevention (MBRP), which integrates mindfulness meditation and RP aftercare components.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Mindfulness Based Relapse Prevention, Relapse Prevention, Treatment as Usual
mindfulness based relapse prevention MBRP
The MBRP intervention comprises 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments.
(Active Comparator)
The RP intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions will be team-taught by two therapists and will include discussions of personal high-risk situations, coping skills assessment, and exercises to evaluate expectancies, self-efficacy, and craving.
relapse prevention RP
intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants)
(Active Comparator)
All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis.
treatment as usual TAU
All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis.

Primary Outcomes

Measure
Quantity and Frequency of Alcohol and Drug Use
time frame: 12 months

Secondary Outcomes

Measure
Craving
time frame: 12 months
Negative Affect
time frame: 12 months

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - completion or scheduled completion (i.e., within 2 weeks) of Inpatient or Intensive Outpatient treatment - fluency in English - enrollment in a substance abuse aftercare program - medical clearance by referring provider - willingness to accept random assignment to treatment condition Exclusion Criteria: - already participated in the pilot MBRP trial conducted by this research team - participation in the comorbid disorders or relapse prevention groups offered at partner agency - comorbid psychosis (including schizophrenia, schizoaffective or other schizophreniform disorder)and/or dementia, acute suicidality/intent to harm others, severe cognitive impairment, and high risk of withdrawal or medical complications stemming from relapse which would require a higher level of care.

Additional Information

Official title Mindfulness Based Relapse Prevention: Efficacy and Mechanisms
Principal investigator Sarah Bowen, PhD
Description Relapse to alcohol and other drug use (AOD) following treatment continues to be a costly problem for individual, society, and the substance abuse treatment community, and thus warrants the continued development of innovative and efficacious interventions designed to prevent AOD relapse. Mindfulness based relapse prevention (MBRP; Bowen, Chawla, & Marlatt, 2008) is one such promising intervention: it incorporates mindfulness meditation on the foundation of cognitive-behavioral relapse prevention (RP;Daley & Marlatt, 2006). RP is an established substance abuse treatment, yet as treatment developers, we believe RP can continue to be enhanced. Based on the results of an initial pilot trial, MBRP has demonstrated both feasibility and empirical promise as an aftercare treatment for AOD disorders in further enhancing long-term behavior change and reducing risk of relapse and related consequences. In the proposed study, MBRP and RP will be compared to the treatment as usual (TAU) as delivered by the Recovery Centers of King County (RCKC), in a population of individuals who have received community-based intensive inpatient (IP) or outpatient (IOP) treatment. RCKC is a community treatment agency that provides a range of addiction treatment services and has previously supported our efforts to recruit and retain sufficient numbers of the target population. The proposed study will examine whether structured mindfulness practice results in fewer AOD use days and fewer problems related to AOD use compared to TAU over a longer-term followup than in the previous pilot study. Given the high prevalence of AOD abuse in the population and the high rates of relapse following AOD treatment, the proposed research will provide a valuable next step in evaluating the efficacy of MBRP as an aftercare treatment for AOD disorders and in understanding the mechanisms of treatment efficacy. To our knowledge, no prior substance abuse treatment studies have evaluated the effect of adding a mindfulness-based component (e.g., MBRP) to an existing empirically supported treatment (i.e., RP).
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by University of Washington.