Identifying Multiple Mechanisms of Change in Alcoholism Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by State University of New York at Buffalo.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT01168960
First received: July 22, 2010
Last updated: April 4, 2011
Last verified: April 2011
  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: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Timeline Followback for alcohol [ Time Frame: 3-months posttreatment ] [ Designated as safety issue: No ]
    Follow-up assessments of drinks per drinking day and percent heavy drinking days will occcur at posttreatment and 3-months postreatment. The timeline followback is a retrospective calendar measure on an individuals self-report of daily alcohol consumption

  • Timeline Followback for alcohol [ Time Frame: 3-month follow-up ] [ Designated as safety issue: No ]
    The alcohol timelines uses a calendar method to assess retrospectively an individual's self-report of daily alcohol use.


Estimated Enrollment: 72
Study Start Date: January 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Cognitive behavioral therapy for alcohol dependence
    12-session behavioral treatment that incorporates behavioral skills training targeting high-risk drinking behavior.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01168960

Contacts
Contact: Gregory Gudleski, Ph.D. 716-887-3300 ggudleski@ria.buffalo.edu

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

Publications:
Responsible Party: Paul R. Stasiewicz, Ph.D., University at Buffalo
ClinicalTrials.gov Identifier: NCT01168960     History of Changes
Other Study ID Numbers: 5RC1AA018986
Study First Received: July 22, 2010
Last Updated: April 4, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 16, 2014