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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 is a NA study that has completed, run by Boston University Charles River Campus. The registered enrollment target is 75 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03230006
The ClinicalTrials.gov registry entry for NCT03230006 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston University Charles River Campus, which has 104 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Take Control is the first listed.
NCT03230006 reports 0 study locations.
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.
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