Mindfulness Based Relapse Prevention: Efficacy and Mechanisms

NCT ID: NCT01159535

Last Updated: 2016-08-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Substance Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MBRP

The Mindfulness Based Relapse Prevention (MBRP) 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 mindfulness practices targeting craving, Negative affect, and reactivity, as well as discussion about how to implement practice into high-risk situations and in daily life.

Group Type ACTIVE_COMPARATOR

Mindfulness Based Relapse Prevention

Intervention Type 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.

Relapse Prevention (RP)

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.

Group Type ACTIVE_COMPARATOR

Relapse Prevention

Intervention Type BEHAVIORAL

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

Treatment as Usual

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.

Group Type ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type 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.

Interventions

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Mindfulness Based Relapse Prevention

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.

Intervention Type BEHAVIORAL

Relapse Prevention

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

Intervention Type BEHAVIORAL

Treatment as Usual

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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MBRP RP TAU

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Seema Clifasefi

Assistant Professor/Co-Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarah Bowen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Recovery Centers of King County

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Bowen S, Chawla N, Collins SE, Witkiewitz K, Hsu S, Grow J, Clifasefi S, Garner M, Douglass A, Larimer ME, Marlatt A. Mindfulness-based relapse prevention for substance use disorders: a pilot efficacy trial. Subst Abus. 2009 Oct-Dec;30(4):295-305. doi: 10.1080/08897070903250084.

Reference Type BACKGROUND
PMID: 19904665 (View on PubMed)

Witkiewitz K, Bowen S. Depression, craving, and substance use following a randomized trial of mindfulness-based relapse prevention. J Consult Clin Psychol. 2010 Jun;78(3):362-374. doi: 10.1037/a0019172.

Reference Type BACKGROUND
PMID: 20515211 (View on PubMed)

Bowen S, Witkiewitz K, Dillworth TM, Marlatt GA. The role of thought suppression in the relationship between mindfulness meditation and alcohol use. Addict Behav. 2007 Oct;32(10):2324-8. doi: 10.1016/j.addbeh.2007.01.025. Epub 2007 Jan 23.

Reference Type BACKGROUND
PMID: 17300875 (View on PubMed)

Bowen S, Witkiewitz K, Dillworth TM, Chawla N, Simpson TL, Ostafin BD, Larimer ME, Blume AW, Parks GA, Marlatt GA. Mindfulness meditation and substance use in an incarcerated population. Psychol Addict Behav. 2006 Sep;20(3):343-7. doi: 10.1037/0893-164X.20.3.343.

Reference Type BACKGROUND
PMID: 16938074 (View on PubMed)

Chawla N, Collin S, Bowen S, Hsu S, Grow J, Douglass A, Marlatt GA. The mindfulness-based relapse prevention adherence and competence scale: development, interrater reliability, and validity. Psychother Res. 2010 Jul;20(4):388-97. doi: 10.1080/10503300903544257.

Reference Type BACKGROUND
PMID: 20204916 (View on PubMed)

Collins SE, Chawla N, Hsu SH, Grow J, Otto JM, Marlatt GA. Language-based measures of mindfulness: initial validity and clinical utility. Psychol Addict Behav. 2009 Dec;23(4):743-9. doi: 10.1037/a0017579.

Reference Type BACKGROUND
PMID: 20025383 (View on PubMed)

Somohano VC, Rehder KL, Dingle T, Shank T, Bowen S. PTSD Symptom Clusters and Craving Differs by Primary Drug of Choice. J Dual Diagn. 2019 Oct-Dec;15(4):233-242. doi: 10.1080/15504263.2019.1637039. Epub 2019 Jul 14.

Reference Type DERIVED
PMID: 31304887 (View on PubMed)

Bowen S, Witkiewitz K, Clifasefi SL, Grow J, Chawla N, Hsu SH, Carroll HA, Harrop E, Collins SE, Lustyk MK, Larimer ME. Relative efficacy of mindfulness-based relapse prevention, standard relapse prevention, and treatment as usual for substance use disorders: a randomized clinical trial. JAMA Psychiatry. 2014 May;71(5):547-56. doi: 10.1001/jamapsychiatry.2013.4546.

Reference Type DERIVED
PMID: 24647726 (View on PubMed)

Other Identifiers

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1R01DA025764-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

31183-J

Identifier Type: -

Identifier Source: org_study_id

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