Clinical trial NCT03230006: Transdiagnostic CBT for Comorbid Alcohol Use and Anxiety Disorders
Official title: Efficacy Evaluation of Transdiagnostic CBT for Comorbid Alcohol Use and Anxiety Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Anxiety Disorders
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
First posted: 2017-07-26
Enrollment: 75
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 1. DSM-5 diagnosis of an alcohol use disorder (AUD)
2. 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.
3. Adults 21 years old or older
4. Expressed desire to stop drinking alcohol completely or to reduce alcohol consumption
5. 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
6. 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:

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.

Primary outcomes:
measure: Mean Number of Drinks Consumed Per Week
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University, Charles River Campus
state: Massachusetts
Study officials:
affiliation: Boston Univeristy
name: Todd Farchione, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.