Clinical trial NCT01159535: Mindfulness Based Relapse Prevention: Efficacy and Mechanisms
Official title: Mindfulness Based Relapse Prevention: Efficacy and Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Substance Use Disorders
Keywords: substance use
addiction
meditation
mindfulness
relapse prevention
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-07-09
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Mean Number of Alcohol and Drug Use Days Out of Past 30
timeFrame: 30 days previous, assessed at 12-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Recovery Centers of King County
state: Washington
Study officials:
affiliation: University of Washington
name: Sarah Bowen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.