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NCT01168960 · ClinicalTrials.gov registry record · Phase 4
Identifying Multiple Mechanisms of Change in Alcoholism Treatment
A Phase 4 study, sponsored by State University of New York at Buffalo.
- Completed
- Registry status
- Phase 4
- Development phase
- 61
- Enrollment target
NCT01168960: Completed Phase 4 study, sponsored by State University of New York at Buffalo.
NCT01168960 is a Phase 4 study that has completed, run by State University of New York at Buffalo. The registered enrollment target is 61 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01168960, a Phase 4 study, has completed, sponsored by State University of New York at Buffalo.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 61 participants
- Enrollment target
Study 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 {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 c
Primary Outcome
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
Interventions
- BEHAVIORAL Cognitive behavioral therapy for alcohol dependence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2010-01 |
| Est. Completion | 2012-08 |
| Phase | Phase 4 |
What the finished NCT01168960 record still lists
NCT01168960 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which Cognitive behavioral therapy for alcohol dependence is the first listed.
NCT01168960 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01168960 about?
NCT01168960 is a clinical study titled "Identifying Multiple Mechanisms of Change in Alcoholism Treatment". 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, i...
What is the current status of trial NCT01168960?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 61 participants. The study started on 2010-01. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01168960?
The interventions under investigation include: Cognitive behavioral therapy for alcohol dependence (BEHAVIORAL).
Who is sponsoring clinical trial NCT01168960?
This trial is sponsored by State University of New York at Buffalo, which has 243 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01168960's enrollment target sits among peer trials
61 1119th of 2000 higher than 876 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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