Identifying Multiple Mechanisms of Change in Alcoholism Treatment

Sponsor
State University of New York at Buffalo (Other)
Overall Status
Completed
CT.gov ID
NCT01168960
Collaborator
(none)
61
1
1
31
2

Study Details

Study Description

Brief Summary

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 and drinks per drinking day ) 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 or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive behavioral therapy for alcohol dependence
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
61 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Aug 1, 2011
Actual Study Completion Date :
Aug 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Timeline Followback for alcohol [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Paul Stasiewicz, Senior Research Scientist, State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT01168960
Other Study ID Numbers:
  • 5RC1AA018986
First Posted:
Jul 23, 2010
Last Update Posted:
Dec 3, 2014
Last Verified:
Dec 1, 2014
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 3, 2014