Treatment for Comorbid Social Anxiety and Alcohol Use Disorders.

Alcohol Use Disorder Clinical Trial

— FIT  

Official title:

Developing and Evaluating a Fully Integrated Treatment Program for Comorbid Social Anxiety and Alcohol Use Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03428490
• Other study ID #: SOCANX1
• Secondary ID: 1R34AA025364-01
• Status: Completed
• Phase: N/A
• Start date: March 15, 2018
• Est. completion date: April 30, 2021

Study information

• Verified date: October 2022
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: April 30, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Anxiety Disorders
• Disease
• Phobia, Social
• Social Anxiety Disorder

Intervention

Behavioral:
• 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).
• Stand-alone Intensive Outpatient Program
Evidence-based treatment for substance use disorders (i.e., The Matrix Model).

Locations

Country	Name	City	State
United States	Matrix Institute on Addictions	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Los Angeles	Matrix Institute on Addictions, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Alcohol consumption at 3 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
Primary	Change from Baseline Social Anxiety Symptoms in Situations at 3 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	Change from Baseline Social anxiety-related drinking motives at 3 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
Secondary	Change from Baseline Quality of Life and overall functioning at 3 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
Secondary	Change from Baseline Alcohol Problems at 3 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
Secondary	Change from Baseline Alcohol Drinks per Day at 3 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
Secondary	Change from Baseline Heavy Alcohol Use Days at 3 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
Secondary	Change from Baseline Alcohol Abstinence at 3 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
Secondary	Change from Baseline Social Anxiety Symptom Severity at 3 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