- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03428490
Treatment for Comorbid Social Anxiety and Alcohol Use Disorders. (FIT)
Developing and Evaluating a Fully Integrated Treatment Program for Comorbid Social Anxiety and Alcohol Use Disorders
Alcohol use disorders (AUD) and social anxiety disorder (SAD) are highly comorbid and associated with significant impairment. Social anxiety comorbidity is associated with poorer addiction treatment engagement and outcomes. Thus, addressing underlying SAD symptoms that may lead to and maintain alcohol problems, as well as undermine successful treatment for AUD, is warranted. This proposal aims to develop and evaluate a fully integrated outpatient program for comorbid SAD and AUD that weaves evidence-based treatment for SAD (i.e., exposure-based cognitive behavioral therapy) into a traditional, evidence-based treatment for AUD.
First, the investigators will develop the protocol for the fully integrated treatment (FIT). The overarching goal of FIT will be to simultaneously deliver AUD and SAD treatment. Development will be an iterative process guided by previous research (including our own), and by input from clinicians, administrators, and patients in an outpatient substance use disorder treatment clinic. After the protocol is developed, the investigators will use their established clinician training procedures to train clinicians at their community partnered clinic to competently deliver the intervention. After protocol development and clinician training, the investigators will conduct a pilot randomized clinical trial (RCT) comparing the efficacy of our fully integrated treatment (FIT) for comorbid alcohol use and social anxiety disorders to usual care (UC) in the community substance use disorder specialty clinic. The goals of the RCT will be to gather data regarding acceptability, feasibility, and preliminary efficacy of the FIT protocol. The investigators will randomize treatment-seeking participants (N = 60) who have comorbid SAD and AUD. The investigators will assess treatment engagement, social anxiety outcomes, and alcohol use outcomes at baseline, 3-months, and 6-months from baseline. The investigators will also gather qualitative and quantitative acceptability data from patients after completing FIT, which may guide final refinements of FIT prior to testing in a larger-scale grant.
The knowledge gained from this investigation has the potential to significantly improve the treatment of alcohol use disorders and make a significant public health impact. The focus on direct translation to community practice paradigms and the emphasis on full mental health and addiction treatment integration significantly advance the field.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90025
- Matrix Institute on Addictions
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants must be currently enrolled in the IOP at Matrix Institute (our community partner) for the treatment of their alcohol use disorder;
- fluent in English;
- meet the DSM-5 criteria for social anxiety disorder and alcohol use disorder
Exclusion Criteria:
- marked cognitive impairment
- moderate to severe suicidality
- unstable manic or psychotic symptoms.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Fully Integrated Treatment
Evidence-based substance use treatment combined with Cognitive Behavioral Therapy (CBT) for Social Anxiety Disorder Intervention name: Fully integrated treatment
|
Clinicians will be delivering CBT for Social Anxiety Disorder directly into the context of the Matrix's evidence-based treatment for substance use disorders (i.e., The Matrix Model).
|
ACTIVE_COMPARATOR: Usual Intensive Outpatient Care
Evidence-based substance use disorder treatment Intervention name: Stand-alone Intensive Outpatient Program
|
Evidence-based treatment for substance use disorders (i.e., The Matrix Model).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Alcohol consumption at 3 and 6 months
Time Frame: Baseline, 3 months, and 6 months
|
The Timeline Followback (TLFB), a gold standard semi-structured interview measure of alcohol consumption, will be used in order to obtain number of drinking days
|
Baseline, 3 months, and 6 months
|
Change from Baseline Social Anxiety Symptoms in Situations at 3 and 6 months
Time Frame: Baseline, 3 months, and 6 months
|
The Leibowitz Social Anxiety Scale-Self Report (LSAS-SR) will be used to assess the extent to which individuals are anxious in, and avoid, a variety of social situations, including performance based and social-interactional situations.
Anxiety and avoidance are each rated from 1 (none/never) to 4 (extreme/always) Higher scores indicate greater severity of social anxiety.
|
Baseline, 3 months, and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Social anxiety-related drinking motives at 3 and 6 months
Time Frame: Baseline, 3 months, and 6 months
|
This will be assessed using the Drinking to Cope with Social Anxiety Scale (DCSAS), which measures drinking behavior in social situations.
The score on the measure is out of 72, with a minimum score of 0 indicating the least amount of avoidance/drinking to scope in situations, and 72 indicating the most amount of avoidance/drinking to scope in situations
|
Baseline, 3 months, and 6 months
|
Change from Baseline Quality of Life and overall functioning at 3 and 6 months
Time Frame: Baseline, 3 months, and 6 months
|
This will be assessed using the Short Form (SF-8), which is a generic quality of life measure with 8 items.
The total score is out of 41, with a minimum score of 8 indicating best quality of life score and a maximum score or 41 indicating worst quality of life score.
|
Baseline, 3 months, and 6 months
|
Change from Baseline Alcohol Problems at 3 and 6 months
Time Frame: Baseline, 3 months, and 6 months
|
The Short Inventory of Problems, a dimensional measure of alcohol-related consequences, will be used using "past month" as the time frame for each assessment.
|
Baseline, 3 months, and 6 months
|
Change from Baseline Alcohol Drinks per Day at 3 and 6 months
Time Frame: Baseline, 3 months, and 6 months
|
The Timeline Followback (TLFB) will be used in order to obtain average drinks per drinking day
|
Baseline, 3 months, and 6 months
|
Change from Baseline Heavy Alcohol Use Days at 3 and 6 months
Time Frame: Baseline, 3 months, and 6 months
|
The Timeline Followback (TLFB) will be used in order to obtain % of heavy drinking days (defined as ≥4 drinks per day for women and ≥5 drinks per day for men)
|
Baseline, 3 months, and 6 months
|
Change from Baseline Alcohol Abstinence at 3 and 6 months
Time Frame: Baseline, 3 months, and 6 months
|
The Timeline Followback (TLFB) will be used in order to obtain sustained abstinence (v.
not) during the past 30 days
|
Baseline, 3 months, and 6 months
|
Change from Baseline Social Anxiety Symptom Severity at 3 and 6 months
Time Frame: Baseline, 3 months, and 6 months
|
The Behavioral Approach Task (BAT), a validated behavioral assessment of social anxiety severity, will be used.
|
Baseline, 3 months, and 6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kate Wolitzky-Taylor, PhD, University of California, Los Angeles
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SOCANX1
- 1R34AA025364-01 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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