Mindfulness-Based Relapse Prevention for Alcohol Use Disorders in Remission

NCT02147483 | Completed DMC

• 1 other identifier: 16363
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

We propose to conduct a pilot study that will examine the utility and mechanisms of Mindfulness-Based Relapse Prevention in reducing alcohol consumption, relapse rates, and physiological arousal to stress in adults 21 years of age and older who have met DSM-IV-TR diagnostic criteria for alcohol dependence within the past year but have abstained from drinking for the last thirty days. MBRP is designed to improve one's ability to self-regulate emotions, thoughts and physical states, thus reducing the need to alleviate associated discomfort through substance use. Participants assigned to the intervention group will receive an 8-week training course of MBRP over a period of nine weeks; participants assigned to the Treatment As Usual (TAU) group will continue treatment as usual, which includes utilizing their own effective strategies to refrain from alcohol use. All participants will be assessed for pretreatment severity of psychological abuse/trauma as well as pre and posttreatment psychosocial functioning (e.g., alcohol consumption, symptoms of depression and anxiety, emotion regulation/coping). The outcome of treatment will be evaluated using a) Timeline Followback drinking data and b) self-report ratings of acquisition of MBRP skills (e.g., state/trait mindfulness, acceptance and awareness, and perceived stress) and depressive and anxiety symptom severity. We hypothesize that participants who receive MBRP training will demonstrate greater acceptance and awareness, reduced cravings, and have a lower likelihood of relapse than participants in the TAU group. It is also expected that MBRP participants will demonstrate greater improvements on psychological measures of depression, anxiety, emotion regulation and coping, and show less perceived stress and physiological arousal to stress compared to TAU participants. Finally, little is known about which types of individuals are most likely to benefit from MBRP. Thus, secondary analyses will help to clarify for whom MBRP may be most effective.

Conditions

Alcohol Use Disorders

Keywords

Mindfulness; Alcohol use disorders

Outcome Measures

Primary Outcomes (1)

• Mindfulness levels

  Difference scores on mindfulness scales (session 04 minus baseline, session 08 minus baseline, two-month follow-up minus baseline, four-month follow-up minus baseline) will be calculated. 2 group (intervention, TAU) x 5 interval (baseline, session 04, session 08, two-months follow-up, four-months follow-up) repeated measures analyses of variance (ANOVAs) will be conducted.

  up to 4 months post treatment

Secondary Outcomes (1)

• cravings; symptoms of depression, anxiety, and perceived stress; obsessive thoughts of alcohol/compulsive drinking

  up to 4 months post treatment

Other Outcomes (1)

• drinking behavior

  up to 4 months post treatment

Study Arms (2)

Treatment as usual

ACTIVE COMPARATOR

Treatment as usual as prescribed by clinician.

Behavioral: Treatment as usual

Mindfulness Based Relapse Prevention

EXPERIMENTAL

Mindfulness based relapse prevention will be provided in eight in person sessions to prevent alcohol use.

Behavioral: Mindfulness Based Relapse Prevention

Interventions

Mindfulness Based Relapse Prevention BEHAVIORAL

Mindfulness based relapse prevention therapy provided over eight sessions in person to prevent alcohol relapse.

Mindfulness Based Relapse Prevention

Treatment as usual BEHAVIORAL

Treatment usually provided by clinician

Treatment as usual

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females who have given written informed consent
• years of age or older
• DSM-IV-TR diagnosis of alcohol dependence within the last year, but have abstained from drinking for the last thirty days
• Literate in English and able to read, understand, and complete the rating scales and questionnaires accurately, follow instructions, and make use of mindfulness techniques
• Express a wish to remain abstinent from drinking
• Willingness to participate in mindfulness techniques
• Able to attend all clinic visits without interruption

You may not qualify if:

• Any current Axis I DSM-IV-TR psychiatric disorder other than alcohol or nicotine dependence that, in the clinician's opinion, warrants treatment or would preclude safe participation in the protocol, including, but not limited to: psychosis, schizophrenia, dementia, schizotypal personality disorder, borderline personality disorder, bipolar disorder, primary diagnosis of eating disorder, or chronic suicidality or homicidality
• Current use of Antabuse (Disulfiram) to pharmacologically treat alcohol dependence
• Serious medical comorbidity requiring medical intervention or close supervision, including a history of dangerous symptoms of withdrawal from alcohol (e.g., seizures), pacemakers, heart transplant, severe arrhythmias, or active atrial fibrillation
• Suicide attempt in the last thirty days
• Gross neurological disease
• Mental retardation, which will be assessed by the PI, postdoctoral fellows, and doctoral students in clinical psychology)
• Minors below the legal drinking age will not be included.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia School of Medicine

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Jennifer K Penberthy, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 14, 2013
• First Posted: May 26, 2014
• Study Start: August 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2018
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)