Transdiagnostic CBT for Comorbid Alcohol Use and Anxiety Disorders

NCT ID: NCT03230006

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2024-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Unified Protocol

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.

Group Type: ACTIVE_COMPARATOR

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Intervention Type: 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.

Take Control

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).

Group Type: PLACEBO_COMPARATOR

Take Control

Intervention Type: 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.

Interventions

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

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.

Intervention Type: BEHAVIORAL

Take Control

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

UP; TC

Eligibility Criteria

Exclusion Criteria

1. 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.

2. Presence of suicidal ideation or history of suicide attempts

3. Non-English speakers

4. Previously received an adequate trial of cognitive-behavioral therapy (CBT; 8 sessions within the past 5 years)

5. Contraindications to MRI scans

6. History of head injury with >5-minute loss of consciousness

7. 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.

8. Implantation of anything containing magnetically sensitive material including metal plates, aneurysm clips, and cardiac pacemakers, stents; history of sheet metal work, claustrophobia

9. Cognitive impairment (MOCA<21).

10. Serious medical illness or instability for which hospitalization may be likely within the next year.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston University Charles River Campus

OTHER

Sponsor Role: lead

Responsible Party

Todd Farchione

Research Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Todd Farchione, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston Univeristy

Locations

Boston University, Charles River Campus

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22738907 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23768669 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

R01AA023676

Identifier Type: NIH

Identifier Source: org_study_id

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