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Identifying Multiple Mechanisms of Change in Alcoholism Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paul Stasiewicz, State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT01168960
First received: July 22, 2010
Last updated: December 2, 2014
Last verified: December 2014

July 22, 2010
December 2, 2014
January 2010
August 2011   (final data collection date for primary outcome measure)
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 occur at posttreatment and 3-months posttreatment. The timeline followback is a retrospective calendar measure on an individuals self-report of daily alcohol consumption
  • 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.
Complete list of historical versions of study NCT01168960 on ClinicalTrials.gov Archive Site
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Identifying Multiple Mechanisms of Change in Alcoholism Treatment
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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).

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Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Alcohol Dependence
Behavioral: Cognitive behavioral therapy for alcohol dependence
12-session behavioral treatment that incorporates behavioral skills training targeting high-risk drinking behavior.
Cognitive Behavioral Treatment
A single intervention study
Intervention: Behavioral: Cognitive behavioral therapy for alcohol dependence
Kazdin AE. Mediators and mechanisms of change in psychotherapy research. Annu Rev Clin Psychol. 2007;3:1-27. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
August 2012
August 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01168960
5RC1AA018986
Yes
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Paul Stasiewicz, State University of New York at Buffalo
State University of New York at Buffalo
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Principal Investigator: Paul R. Stasiewicz, Ph.D. University at Buffalo
State University of New York at Buffalo
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP