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Identifying Multiple Mechanisms of Change in Alcoholism Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01168960
First Posted: July 23, 2010
Last Update Posted: December 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Paul Stasiewicz, State University of New York at Buffalo
  Purpose

Cognitive-behavioral therapy (CBT) is an effective treatment for alcohol dependence, but little is known about how CBT works to achieve these effects. Although several possible mechanisms have been proposed to explain the effects of CBT, it is rare that more than one mechanism is studied. However, it may be the case that similar outcomes (e.g., abstinence) may be reached through multiple paths. Therefore, essential to conducting work on behavioral change mechanisms is distinguishing different courses or paths and moderating influences (Kazdin, 2007). In the present study, we will focus on 2 key mechanisms posited to underlie the effectiveness of CBT specifically, increasing self-efficacy and self-confidence and reducing positive outcome expectancies for alcohol use, and 2 key mechanisms posited to underlie the effectiveness of a wide range of therapeutic interventions, increasing the therapeutic alliance and reducing/regulating negative emotional states. For the present study, participants will be 72 alcohol dependent men and women who agree to participate in a 12-week trial of CBT for alcohol dependence. In addition, comprehensive research assessments will be conducted with patients at baseline, end of treatment, and 3-months posttreatment.

Specific Aim 1. To examine the within-treatment week-to-week relationship between ratings of 4 key therapeutic mechanisms and alcohol involvement (operationalized as percent days abstinent {PDA} and drinks per drinking day {DDD}) during treatment. It is hypothesized that self-efficacy, outcome expectancies, therapeutic alliance (as rated by the patient and therapist), and negative affect assessed after any given treatment session will each predict alcohol involvement during the following week. Exploratory analyses also will investigate the relationship of a given week's alcohol involvement on each of the four key variables as assessed the following week.

Specific Aim 2. To examine profiles of the four key mechanisms over the course of treatment in relation to alcohol involvement during treatment and during the 3-month follow-up period. These analyses will be descriptive/exploratory. It is expected that profiles will emerge with the key mechanisms that are associated with decreased alcohol involvement (for example, when the alliance is relatively strong throughout treatment or when the alliance grows stronger over the course of treatment, or when positive outcome expectancies grow weaker over the course of treatment, etc.). Similarly, it is hypothesized that profiles will emerge that are associated with little improvement in alcohol involvement (for example, when negative affect is relatively high throughout treatment or when self-efficacy weakens over the course of treatment).


Condition Intervention Phase
Alcohol Dependence Behavioral: Cognitive behavioral therapy for alcohol dependence Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Paul Stasiewicz, State University of New York at Buffalo:

Primary Outcome Measures:
  • Timeline Followback for alcohol [ Time Frame: 3-months posttreatment ]
    Follow-up assessments of drinks per drinking day and percent heavy drinking days will occur at posttreatment and 3-months posttreatment. The timeline followback is a retrospective calendar measure on an individuals self-report of daily alcohol consumption


Enrollment: 61
Study Start Date: January 2010
Study Completion Date: August 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cognitive Behavioral Treatment
A single intervention study
Behavioral: Cognitive behavioral therapy for alcohol dependence
12-session behavioral treatment that incorporates behavioral skills training targeting high-risk drinking behavior.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Alcohol Dependent; live within commuting distance of program site; willing to sign informed consent.

Exclusion Criteria:

  • Diagnosis of schizophrenia or other psychotic disorder; present with gross neurocognitive impairment; have a current drug use diagnosis other than nicotine or marijuana abuse; have been in substance abuse treatment over the previous 6 months.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01168960


Locations
United States, New York
Research Institue on Addictions
Buffalo, New York, United States, 14203
Sponsors and Collaborators
State University of New York at Buffalo
Investigators
Principal Investigator: Paul R. Stasiewicz, Ph.D. University at Buffalo
  More Information

Publications:
Responsible Party: Paul Stasiewicz, Senior Research Scientist, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT01168960     History of Changes
Other Study ID Numbers: 5RC1AA018986 ( U.S. NIH Grant/Contract )
First Submitted: July 22, 2010
First Posted: July 23, 2010
Last Update Posted: December 3, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders