An interventional study of Unified Protocol for Transdiagnostic Treatment of Emotional Disorders and Take Control in Alcohol Use Disorder and Anxiety Disorders, sponsored by Boston University Charles River Campus. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-04-09.
Sponsored by Boston University Charles River Campus · Not applicable, Interventional, and Treatment
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.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 75 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.
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Of its 14 completed or terminated interventional studies of FDA-regulated products, 8 (57%) have results posted.
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Exclusion Criteria:
The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) consists of 5 core skills modules based on cognitive behavioral treatment elements of proven effectiveness. As noted above, these core skills modules were designed to target (and have been shown to address) negative emotionality and aversive reactivity to emotional experiences when they occur. These modules are preceded by an introductory session that reviews the patient's presenting symptoms and provides a therapeutic rationale, as well as a module on motivational enhancement. A final module consists of relapse prevention. As the treatment proceeds, the domains of thoughts, feelings, and behaviors are each explored in detail, focusing specifically on elucidating dysfunctional emotion regulation strategies that the patient has developed over time within each of these domains, and teaching patients more adaptive emotion regulation skills.
Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
TC is a psychotherapy platform derived from the National Institute on Alcohol Abuse and Alcoholism's (NIAAA) self-help approach, Rethinking Drinking. In this study, TC, originally designed as a computerized treatment has been modified to be administered by the therapist to control for effects that may be related to patient-therapist interaction (as opposed to elements of the treatment itself).
Behavioral: Take Control
The UP will be conducted in a standardized fashion over 16 sessions, in a minimum of 16- and a maximum of 21-weeks, following the published therapist guide with minor refinements for application in the proposed comorbid population.
Also known as: UP
TC will be conducted over 12 sessions, in a minimum of 12- and a maximum of 16-weeks. Therapists will review material from TC and offer general advice on implementation of the alcohol reduction skills in daily life.
Also known as: TC
Mean Number of Drinks Consumed Per Week
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.
Time frame: Change from baseline following 12-sessions (Take Control Arm), up to 16 weeks, or 16-sessions (Unified Protocol Arm), up to 21 weeks, of treatment.
| Milestone | Unified Protocol | Take Control |
|---|---|---|
| Started | 51 | 24 |
| Completed | 38 | 21 |
| Not completed | 13 | 3 |
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.
| Standard Drinking Units per Week | Unified Protocol | Take Control |
|---|---|---|
| Weekly Average Drinks at Baseline | 40.82 ± 49.07 | 29.62 ± 20.09 |
| Weekly Average Drinks at Post-Treatment | 12.12 ± 10.89 | 23.86 ± 21.54 |
Collected over Adverse event data were collected throughout treatment (12 or 16 sessions), up to 21 weeks, through to the 6-month follow-up.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Unified Protocol | 0/51 (0%) | 0/51 (0%) | 0/51 (0%) |
| Take Control | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Age, Continuous(Years) | Unified Protocol | Take Control | Total |
|---|---|---|---|
| Mean | 43.71 (24 to 71) | 41.83 (21 to 66) | 43.11 (21 to 71) |
| Sex: Female, Male(Participants) | Unified Protocol | Take Control | Total |
|---|---|---|---|
| Female | 29 | 15 | 44 |
| Male | 22 | 9 | 31 |
| Ethnicity (NIH/OMB)(Participants) | Unified Protocol | Take Control | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 1 | 4 |
| Not Hispanic or Latino | 48 | 23 | 71 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Unified Protocol | Take Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 1 | 5 |
| White | 39 | 22 | 61 |
| More than one race | 3 | 1 | 4 |
| Unknown or Not Reported | 3 | 0 | 3 |
| Region of Enrollment(participants) | Unified Protocol | Take Control | Total |
|---|---|---|---|
| United States | 51 | 24 | 75 |
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Boston University Charles River Campus