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Completed

NCT Number: NCT01159535

Mindfulness Based Relapse Prevention: Efficacy and Mechanisms

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Recovery Centers of King County

Seattle, Washington, 98122, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness Based Relapse Prevention

Behavioral

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.

Other names: MBRP

Relapse prevention

Behavioral

intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants)

Other names: RP

Treatment as Usual

Behavioral

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.

Other names: TAU

Primary outcomes

  1. Mean Number of Alcohol and Drug Use Days Out of Past 30

    Time frame: 30 days previous, assessed at 12-month follow-up

    Self reported use of alcohol and or illicit substances over the previous 30 days

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: MBRP

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jul 9, 2010
Registry last updated
Aug 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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