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Completed

NCT Number: NCT03428490

Treatment 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.

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Anxiety Disorders Chemically-Induced Disorders Mental Disorders Phobia, Social Phobic Disorders Social Anxiety Disorder Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Matrix Institute on Addictions

Los Angeles, California, 90025, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fully integrated treatment

Behavioral

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

Behavioral

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

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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)

  6. 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

  7. 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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Matrix Institute on Addictions
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Acronym: FIT

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Feb 9, 2018
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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