Treatment for Comorbid Social Anxiety and Alcohol Use Disorders.

Not Applicable

Completed

• Conditions: Alcohol Use Disorder; Social Anxiety Disorder
• Interventions: Behavioral: Fully integrated treatment; Behavioral: Stand-alone Intensive Outpatient Program

• Registration Number: NCT03428490
• Lead Sponsor: University of California, Los Angeles

Brief Summary

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.

Detailed Description

In this study, potential participants will be screened either by University of California, Los Angeles (UCLA) staff or at the Matrix Institute on Addiction to determine whether they may have social anxiety and alcohol use disorder symptoms. If they screen positive for these symptoms, they will be invited to come in for a comprehensive baseline assessment consisting of interviews, questionnaires, and a behavioral assessment. Eligible participants will be randomly assigned to either receive standard Matrix treatment consisting of a 9-hour per week Intensive Outpatient Program (IOP) lasting approximate 2-3 months; or FIT, an Intensive Outpatient Program (also 9 hours per week for approximately 2-3 months) consisting of cognitive behavioral therapy (CBT) for social anxiety disorder that is woven into the alcohol recovery program. After treatment, participants will complete another assessment, and then will complete one several months later.

Study Timeline

• Study First Submitted: 2017-11-16
• Study First Submitted QC: 2018-02-03
• Study First Posted: 2018-02-09
• Study Start: 2018-03-15
• Primary Completion: 2020-12-01
• Study Completion: 2021-04-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

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Exclusion Criteria

• marked cognitive impairment
• moderate to severe suicidality
• unstable manic or psychotic symptoms.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fully Integrated Treatment	Fully integrated treatment	Evidence-based substance use treatment combined with Cognitive Behavioral Therapy (CBT) for Social Anxiety Disorder Intervention name: Fully integrated treatment
Usual Intensive Outpatient Care	Stand-alone Intensive Outpatient Program	Evidence-based substance use disorder treatment Intervention name: Stand-alone Intensive Outpatient Program

Primary Outcome Measures

Name	Time	Method
Change from Baseline Alcohol consumption at 3 and 6 months	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
Change from Baseline Social Anxiety Symptoms in Situations at 3 and 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Social anxiety-related drinking motives at 3 and 6 months	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
Change from Baseline Quality of Life and overall functioning at 3 and 6 months	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.
Change from Baseline Alcohol Problems at 3 and 6 months	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.
Change from Baseline Alcohol Drinks per Day at 3 and 6 months	Baseline, 3 months, and 6 months	The Timeline Followback (TLFB) will be used in order to obtain average drinks per drinking day
Change from Baseline Heavy Alcohol Use Days at 3 and 6 months	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)
Change from Baseline Alcohol Abstinence at 3 and 6 months	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
Change from Baseline Social Anxiety Symptom Severity at 3 and 6 months	Baseline, 3 months, and 6 months	The Behavioral Approach Task (BAT), a validated behavioral assessment of social anxiety severity, will be used.

Trial Locations

Locations (1)

Matrix Institute on Addictions; 🇺🇸 Los Angeles, California, United States