Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Mindfulness Based Relapse Prevention: Efficacy and Mechanisms (MBRP)

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Seema Clifasefi, University of Washington
ClinicalTrials.gov Identifier:
NCT01159535
First received: July 7, 2010
Last updated: July 1, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention Phase
Substance Use Disorders
Behavioral: Mindfulness Based Relapse Prevention
Behavioral: Relapse Prevention
Behavioral: Treatment as Usual
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mindfulness Based Relapse Prevention: Efficacy and Mechanisms

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Mean Number of Alcohol and Drug Use Days Out of Past 30 [ Time Frame: 30 days previous, assessed at 12-month follow-up ] [ Designated as safety issue: No ]
    Self reported use of alcohol and or illicit substances over the previous 30 days


Enrollment: 286
Study Start Date: October 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
Behavioral: Relapse Prevention
intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants)
Other Name: RP
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.
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

Detailed 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).
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01159535

Locations
United States, Washington
Recovery Centers of King County
Seattle, Washington, United States, 98122
Sponsors and Collaborators
University of Washington
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Sarah Bowen, PhD University of Washington
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seema Clifasefi, Assistant Professor/Co-Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT01159535     History of Changes
Other Study ID Numbers: 31183-J  1R01DA025764-01A1 
Study First Received: July 7, 2010
Results First Received: June 17, 2015
Last Updated: July 1, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by University of Washington:
substance use
addiction
meditation
mindfulness
relapse prevention

Additional relevant MeSH terms:
Recurrence
Substance-Related Disorders
Disease Attributes
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on December 05, 2016