Transdiagnostic CBT for Comorbid Alcohol Use and Anxiety Disorders

NCT03230006 | Completed Results DMC

• 1 other identifier: R01AA023676
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Use Disorder; Anxiety Disorders

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Study Arms (2)

Unified Protocol

ACTIVE COMPARATOR

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

Take Control

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: UP

Unified Protocol

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.

Also known as: TC

Take Control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston University Charles River Campus: lead

Study Sites (1)

Boston University, Charles River Campus

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

• Sauer-Zavala S, Boswell JF, Gallagher MW, Bentley KH, Ametaj A, Barlow DH. The role of negative affectivity and negative reactivity to emotions in predicting outcomes in the unified protocol for the transdiagnostic treatment of emotional disorders. Behav Res Ther. 2012 Sep;50(9):551-7. doi: 10.1016/j.brat.2012.05.005. Epub 2012 Jun 9.

  PMID: 22738907 BACKGROUND

• Boswell JF, Farchione TJ, Sauer-Zavala S, Murray HW, Fortune MR, Barlow DH. Anxiety sensitivity and interoceptive exposure: a transdiagnostic construct and change strategy. Behav Ther. 2013 Sep;44(3):417-31. doi: 10.1016/j.beth.2013.03.006. Epub 2013 Apr 2.

  PMID: 23768669 BACKGROUND

MeSH Terms

Conditions

Alcoholism; Anxiety Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Todd Farchione
• Organization: Center for Anxiety and Related Disorders, Boston University

tfarchio@bu.edu

6173539610

Study Officials

• Todd Farchione, PhD

  Boston Univeristy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 26, 2017
• Study Start: March 1, 2018
• Primary Completion: August 31, 2023
• Study Completion: January 31, 2024
• Last Updated: April 9, 2025
• Results First Posted: February 25, 2025

Record last verified: 2025-04

Locations

US (1)