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Mindfulness Based Relapse Prevention: Efficacy and Mechanisms (MBRP)

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ClinicalTrials.gov Identifier: NCT01159535
Recruitment Status : Completed
First Posted : July 9, 2010
Results First Posted : August 15, 2016
Last Update Posted : August 15, 2016
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Seema Clifasefi, University of Washington

July 7, 2010
July 9, 2010
June 17, 2015
August 15, 2016
August 15, 2016
October 2009
July 2012   (Final data collection date for primary outcome measure)
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
Quantity and Frequency of Alcohol and Drug Use [ Time Frame: 6months ]
Self reported use of alcohol and or illicit substances
Complete list of historical versions of study NCT01159535 on ClinicalTrials.gov Archive Site
Not Provided
  • Craving [ Time Frame: 6 months ]
    Self reported frequency and intensity of craving for alcohol and other drugs
  • Negative Affect [ Time Frame: 6 months ]
    Self reported anxiety and/or depression symptoms
Not Provided
Not Provided
 
Mindfulness Based Relapse Prevention: Efficacy and Mechanisms
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.
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).
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Substance Use Disorders
  • Behavioral: 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.
    Other Name: MBRP
  • Behavioral: Relapse Prevention
    intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants)
    Other Name: RP
  • 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.
    Other Name: TAU
  • Active Comparator: 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.
    Intervention: Behavioral: Mindfulness Based Relapse Prevention
  • Active Comparator: 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.
    Intervention: Behavioral: Relapse Prevention
  • Active Comparator: 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: Behavioral: Treatment as Usual

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
286
225
July 2012
July 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01159535
31183-J
1R01DA025764-01A1 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: Undecided
Seema Clifasefi, University of Washington
University of Washington
National Institute on Drug Abuse (NIDA)
Principal Investigator: Sarah Bowen, PhD University of Washington
University of Washington
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP