Transdiagnostic CBT for Comorbid Alcohol Use and Anxiety Disorders
| Status: | Recruiting |
|---|---|
| Conditions: | Anxiety, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 7/18/2018 |
| Start Date: | March 1, 2018 |
| End Date: | August 2022 |
| Contact: | David H Barlow, PhD |
| Email: | dhbarlow@bu.edu |
| Phone: | 617-353-9610 |
Efficacy Evaluation of 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.
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. 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 for DSM-5 (ADIS-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 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.
We found this trial at
1
site
930 Commonwealth Avenue
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Phone: 617-353-9610
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