FIT: Treatment for Comorbid Social Anxiety and Alcohol Use Disorders.

Sponsor

University of California, Los Angeles (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03428490

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH), Matrix Institute on Addictions (Other)

Enrollment

Location

Arms

37.5

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Use Disorder Social Anxiety Disorder	Behavioral: Fully integrated treatment Behavioral: Stand-alone Intensive Outpatient Program	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Eligible participants will be randomized to the Fully Integrated Treatment (FIT; N =30) or usual care in the Matrix Institute IOP (UC; N = 30).Eligible participants will be randomized to the Fully Integrated Treatment (FIT; N =30) or usual care in the Matrix Institute IOP (UC; N = 30).

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 15, 2018

Actual Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Apr 30, 2021

Arms and Interventions

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	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).
Active Comparator: Usual Intensive Outpatient Care Evidence-based substance use disorder treatment Intervention name: Stand-alone Intensive Outpatient Program	Behavioral: Stand-alone Intensive Outpatient Program Evidence-based treatment for substance use disorders (i.e., The Matrix Model).

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

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).

Active Comparator: Usual Intensive Outpatient Care

Evidence-based substance use disorder treatment Intervention name: Stand-alone Intensive Outpatient Program

Behavioral: Stand-alone Intensive Outpatient Program

Evidence-based treatment for substance use disorders (i.e., The Matrix Model).

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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