NCT01159535

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
286

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 9, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

August 15, 2016

Completed
Last Updated

August 15, 2016

Status Verified

July 1, 2016

Enrollment Period

2.8 years

First QC Date

July 7, 2010

Results QC Date

June 17, 2015

Last Update Submit

July 1, 2016

Conditions

Substance Use Disorders

Keywords

substance useaddictionmeditationmindfulnessrelapse prevention

Outcome Measures

Primary Outcomes (1)

  • Mean Number of Alcohol and Drug Use Days Out of Past 30

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

    30 days previous, assessed at 12-month follow-up

Study Arms (3)

MBRP

ACTIVE COMPARATOR

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

Relapse Prevention (RP)

ACTIVE COMPARATOR

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

Treatment as Usual

ACTIVE COMPARATOR

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

Interventions

Mindfulness Based Relapse PreventionBEHAVIORAL

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.

Also known as: MBRP
MBRP
Relapse PreventionBEHAVIORAL

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

Also known as: RP
Relapse Prevention (RP)
Treatment as UsualBEHAVIORAL

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.

Also known as: TAU
Treatment as Usual

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recovery Centers of King County

Seattle, Washington, 98122, United States

Location

Related Publications (8)

  • 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.

    PMID: 19904665BACKGROUND

  • 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.

    PMID: 20515211BACKGROUND

  • 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.

    PMID: 17300875BACKGROUND

  • 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.

    PMID: 16938074BACKGROUND

  • 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.

    PMID: 20204916BACKGROUND

  • 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.

    PMID: 20025383BACKGROUND

  • 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.

    PMID: 31304887DERIVED

  • 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.

    PMID: 24647726DERIVED

MeSH Terms

Conditions

Substance-Related DisordersBehavior, Addictive

Interventions

Secondary PreventionTherapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

Preventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPublic Health PracticePublic HealthEnvironment and Public Health

Results Point of Contact

Title
Dr. Sarah Bowen
Organization
University of Washington
swbowen@uw.edu
(206) 543-3452

Study Officials

  • Sarah Bowen, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor/Co-Investigator

Study Record Dates

First Submitted

July 7, 2010

First Posted

July 9, 2010

Study Start

October 1, 2009

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

August 15, 2016

Results First Posted

August 15, 2016

Record last verified: 2016-07

Locations

US(1)