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/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.

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Anxiety Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston University, Charles River Campus

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DSM-5 diagnosis of an alcohol use disorder (AUD)
DSM-5 diagnosis of Social Anxiety Disorder (SAD), Panic Disorder/Agoraphobia (PD/A), Generalized Anxiety Disorder (GAD), and/or Obsessive Compulsive Disorder (OCD) as determined by a clinician-administered diagnostic assessment using the Anxiety Disorder Interview Schedule (ADIS) for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); and are rated as crossing the threshold for a formal DSM-5 diagnosis by assignment of an ADIS clinical severity rating (CSR) of 4 (definitely disturbing/disabling on the 0-8 CSR scale) or higher on at least the principal diagnosis.
Adults 21 years old or older
Expressed desire to stop drinking alcohol completely or to reduce alcohol consumption
Reported drinking an average of at least 15 standard drinks per week for males, or 8 for females occurring over a 28-consecutive day period during the 90 day-long time window that preceded the screening session
Must be willing to discontinue any form of psychotherapy, except Alcoholics Anonymous (AA), that he or she may be receiving for either anxiety or depression prior to screening.

Exclusion criteria

DSM-5 diagnosis of current major depressive disorder (with the exception of substance-induced depressive disorder) that requires immediate treatment with pharmacologic agents, bipolar disorder, schizophrenia, current bulimia/anorexia, dementia, or other substance dependence, with the exception of nicotine, marijuana, and caffeine dependence.
Presence of suicidal ideation or history of suicide attempts
Non-English speakers
Previously received an adequate trial of cognitive-behavioral therapy (CBT; 8 sessions within the past 5 years)
Contraindications to MRI scans
History of head injury with >5-minute loss of consciousness
Pregnancy Note: Women of childbearing potential (not postmenopausal for at least one year) will be required to provide a negative urine pregnancy test prior to each scan.
Implantation of anything containing magnetically sensitive material including metal plates, aneurysm clips, and cardiac pacemakers, stents; history of sheet metal work, claustrophobia
Cognitive impairment (MOCA<21).
Serious medical illness or instability for which hospitalization may be likely within the next year.

Treatment and study plan

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Behavioral

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.

Other names: UP

Take Control

Behavioral

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.

Other names: TC

Primary outcomes

Mean Number of Drinks Consumed Per Week

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.

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.

Sponsors and collaborators

Lead sponsor

Boston University Charles River Campus

Other

Registry information

Official study title

Efficacy Evaluation of Transdiagnostic CBT for Comorbid Alcohol Use and Anxiety Disorders

Important dates

Study start: 2018
Primary completion: 2023
Study completion: 2024
First posted: Jul 26, 2017
Registry last updated: Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed