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NCT03230006 · ClinicalTrials.gov registry record · NA
Transdiagnostic CBT for Comorbid Alcohol Use and Anxiety Disorders
A NA study, sponsored by Boston University Charles River Campus.
- Completed
- Registry status
- NA
- Development phase
- 75
- Enrollment target
NCT03230006: Completed NA study, sponsored by Boston University Charles River Campus.
NCT03230006 is a NA study that has completed, run by Boston University Charles River Campus. The registered enrollment target is 75 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03230006, a NA study, has completed, sponsored by Boston University Charles River Campus.
- COMPLETED
- Registry status
- NA
- Development phase
- 75 participants
- Enrollment target
Study Summary
Almost 18 million US adults have alcohol use disorders (AUD), with one third of these individuals also diagnosed with anxiety disorders (AXD). The coexistence of AUD and AXD imposes a high burden via healthcare costs and lost productivity. To date, existing treatment approaches for addressing AUD/AXD comorbidity have been only modestly effective and there is a lack of adequate research to guide treatment decisions. The Unified Protocol (UP) is a transdiagnostic, cognitive-behavioral therapy that has shown efficacy in treating emotional disorders. The efficacy of the UP to facilitate abstinence from alcohol consumption in individuals with comorbid AUD/AXD has also been examined, with results from this study indicating a reduction from baseline in drinks consumed per day. However, further evaluation of the UP for managing AUD/AXD is warranted. In this clinical trial, the investigators will further assess the UP's effectiveness in reducing alcohol consumption in patients with comorbid AUD/AXD. Participants will be randomized to one of two conditions: 1) treatment with the UP or 2) treatment with therapist-guided Take Control (TC; a computerized alcohol reduction program). In addition, in a subset of twenty-five participants, functional magnetic resonance scanning (fMRI) will be used to examine the effects of the UP on changes in brain activity in areas important to regulation of emotional and reward processes implicated in excessive alcohol consumption. The researchers' primary hypotheses are that the UP group will, compared to the TC group: 1) be superior in acute symptom reduction from pre- to post-treatment, and 2) evidence greater reductions in percent days heavy drinking, percent days of drinking per week, and alcohol craving.
Primary Outcome
The Timeline Followback (TLFB) was used to estimate participants' daily drinking during the 90-day period preceding the baseline assessment and was subsequently administered at the beginning of each psychotherapy session and during the follow-up sessions.
Interventions
- BEHAVIORAL Take Control
- BEHAVIORAL Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2024-01-31 |
| Phase | NA |
What the finished NCT03230006 record still lists
NCT03230006 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Take Control is the first listed.
NCT03230006 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03230006 about?
NCT03230006 is a clinical study titled "Transdiagnostic CBT for Comorbid Alcohol Use and Anxiety Disorders". Almost 18 million US adults have alcohol use disorders (AUD), with one third of these individuals also diagnosed with anxiety disorders (AXD). The coexistence of AUD and AXD imposes a high burden via healthcare costs and lost productivity. To date, existing treatment approaches for addressing AUD/AX...
What is the current status of trial NCT03230006?
This trial is currently completed. It is a NA study. The enrollment target is 75 participants. The study started on 2018-03-01. Estimated completion is 2024-01-31.
What interventions are being tested in trial NCT03230006?
The interventions under investigation include: Take Control (BEHAVIORAL), Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (BEHAVIORAL).
Who is sponsoring clinical trial NCT03230006?
This trial is sponsored by Boston University Charles River Campus, which has 104 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03230006's enrollment target sits among peer trials
75 1069th of 2000 higher than 919 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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