Alcohol Use Disorder, Anxiety Disorders
Conditions
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.
Interventions
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.
BEHAVIORALTake 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.
Sponsors
Boston University Charles River Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Drinks Consumed Per Week | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
The UP will be conducted in a standardized fashion, over 16 sessions, following the published therapist guide with minor refinements for application in the proposed comorbid population. | 51 |
| Take Control 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). Specifically, on a weekly basis for 12 sessions, therapists will review material from TC and offer general advice on implementation of the alcohol reduction skills in daily life. | 24 |
| Total | 75 |
Baseline characteristics
| Characteristic | Unified Protocol | Total | Take Control |
|---|---|---|---|
| Age, Continuous | 43.71 Years | 43.11 Years | 41.83 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 4 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 71 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) White | 39 Participants | 61 Participants | 22 Participants |
| Region of Enrollment United States | 51 participants | 75 participants | 24 participants |
| Sex: Female, Male Female | 29 Participants | 44 Participants | 15 Participants |
| Sex: Female, Male Male | 22 Participants | 31 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 24 |
| other Total, other adverse events | 0 / 51 | 0 / 24 |
| serious Total, serious adverse events | 0 / 51 | 0 / 24 |
Outcome results
Primary
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.
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.
Population: Analyses were carried out using one-way repeated measures ANOVAs. This type of analysis only includes data from participants who completed treatment, and excludes non-completers.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Unified Protocol | Mean Number of Drinks Consumed Per Week | Weekly Average Drinks at Baseline | 40.82 Standard Drinking Units per Week | Standard Deviation 49.07 |
| Unified Protocol | Mean Number of Drinks Consumed Per Week | Weekly Average Drinks at Post-Treatment | 12.12 Standard Drinking Units per Week | Standard Deviation 10.89 |
| Take Control | Mean Number of Drinks Consumed Per Week | Weekly Average Drinks at Baseline | 29.62 Standard Drinking Units per Week | Standard Deviation 20.09 |
| Take Control | Mean Number of Drinks Consumed Per Week | Weekly Average Drinks at Post-Treatment | 23.86 Standard Drinking Units per Week | Standard Deviation 21.54 |
p-value: 0.002ANOVA
p-value: <0.001ANOVA
p-value: 0.309ANOVA
Comparison: After conducting the initial two-way mixed ANOVA, follow-up testing was conducted to determine the simple main effects of time (pre to post) on mean number of drinks per week within each treatment condition, which was examined using one-way repeated measures ANOVAs.p-value: <0.001ANOVA
Comparison: After conducting the initial two-way mixed ANOVA, follow-up testing was conducted to determine the simple main effects of time (pre to post) on mean number of drinks per week within each treatment condition, which was examined using one-way repeated measures ANOVAs.p-value: 0.03ANOVA
Comparison: After conducting the initial two-way mixed ANOVA, the simple main effects for treatment condition on mean number of drinks consumed per week at each timepoint (pre and post) were examined using one-way ANOVAs.p-value: 0.016ANOVA
Comparison: After conducting the initial two-way mixed ANOVA, the simple main effects for treatment condition on mean number of drinks consumed per week at each timepoint (pre and post) were examined using one-way ANOVAs.p-value: 0.007ANOVA