Substance Use Disorders
Conditions
Keywords
substance use, addiction, meditation, mindfulness, relapse prevention
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).
Interventions
BEHAVIORALMindfulness 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.
BEHAVIORALRelapse Prevention
intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants)
BEHAVIORALTreatment 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.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Alcohol and Drug Use Days Out of Past 30 | 30 days previous, assessed at 12-month follow-up | Self reported use of alcohol and or illicit substances over the previous 30 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mindfulness Based Relapse Prevention (MBRP) 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. | 103 |
| 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.
Relapse Prevention: intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants) | 88 |
| 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.
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. | 95 |
| Total | 286 |
Baseline characteristics
| Characteristic | Relapse Prevention (RP) | Treatment as Usual | Mindfulness Based Relapse Prevention (MBRP) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 88 Participants | 95 Participants | 103 Participants | 286 Participants |
| Age, Continuous | 38.9 years STANDARD_DEVIATION 10.9 | 37.2 years STANDARD_DEVIATION 10.8 | 39.1 years STANDARD_DEVIATION 10.9 | 38.5 years STANDARD_DEVIATION 10.9 |
| Region of Enrollment United States | 88 participants | 95 participants | 103 participants | 286 participants |
| Sex: Female, Male Female | 32 Participants | 26 Participants | 27 Participants | 85 Participants |
| Sex: Female, Male Male | 56 Participants | 69 Participants | 76 Participants | 201 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 103 | 0 / 88 | 0 / 95 |
| serious Total, serious adverse events | 0 / 103 | 0 / 88 | 0 / 95 |
Outcome results
Primary
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
Time frame: 30 days previous, assessed at 12-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Based Relapse Prevention (MBRP) | Mean Number of Alcohol and Drug Use Days Out of Past 30 | Mean number of heavy drinking days | 1.44 number of days out of past 30 | Standard Deviation 7.66 |
| Mindfulness Based Relapse Prevention (MBRP) | Mean Number of Alcohol and Drug Use Days Out of Past 30 | Mean number of drug use days | 3.06 number of days out of past 30 | Standard Deviation 15.08 |
| Relapse Prevention (RP) | Mean Number of Alcohol and Drug Use Days Out of Past 30 | Mean number of drug use days | 6.09 number of days out of past 30 | Standard Deviation 19.05 |
| Relapse Prevention (RP) | Mean Number of Alcohol and Drug Use Days Out of Past 30 | Mean number of heavy drinking days | 3.89 number of days out of past 30 | Standard Deviation 12.17 |
| Treatment as Usual (TAU) | Mean Number of Alcohol and Drug Use Days Out of Past 30 | Mean number of heavy drinking days | 4.65 number of days out of past 30 | Standard Deviation 14.93 |
| Treatment as Usual (TAU) | Mean Number of Alcohol and Drug Use Days Out of Past 30 | Mean number of drug use days | 4.63 number of days out of past 30 | Standard Deviation 16.03 |