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Treatment for Comorbid Social Anxiety and Alcohol Use Disorders. (FIT)

Primary Purpose

Alcohol Use Disorder, Social Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fully integrated treatment
Stand-alone Intensive Outpatient Program
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring Integrated Treatment, Alcohol Use Disorder, Social Anxiety Disorder, Comorbidity, Cognitive Behavioral Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Exclusion Criteria:

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

Sites / Locations

  • Matrix Institute on Addictions

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fully Integrated Treatment

Usual Intensive Outpatient Care

Arm Description

Evidence-based substance use treatment combined with Cognitive Behavioral Therapy (CBT) for Social Anxiety Disorder Intervention name: Fully integrated treatment

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

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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
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.
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.
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
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)
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
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.

Full Information

First Posted
November 16, 2017
Last Updated
October 31, 2022
Sponsor
University of California, Los Angeles
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Matrix Institute on Addictions
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1. Study Identification

Unique Protocol Identification Number
NCT03428490
Brief Title
Treatment for Comorbid Social Anxiety and Alcohol Use Disorders.
Acronym
FIT
Official Title
Developing and Evaluating a Fully Integrated Treatment Program for Comorbid Social Anxiety and Alcohol Use Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Matrix Institute on Addictions

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Social Anxiety Disorder
Keywords
Integrated Treatment, Alcohol Use Disorder, Social Anxiety Disorder, Comorbidity, Cognitive Behavioral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fully Integrated Treatment
Arm Type
Experimental
Arm Description
Evidence-based substance use treatment combined with Cognitive Behavioral Therapy (CBT) for Social Anxiety Disorder Intervention name: Fully integrated treatment
Arm Title
Usual Intensive Outpatient Care
Arm Type
Active Comparator
Arm Description
Evidence-based substance use disorder treatment Intervention name: Stand-alone Intensive Outpatient Program
Intervention Type
Behavioral
Intervention Name(s)
Fully integrated treatment
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Stand-alone Intensive Outpatient Program
Intervention Description
Evidence-based treatment for substance use disorders (i.e., The Matrix Model).
Primary Outcome Measure Information:
Title
Change from Baseline Alcohol consumption at 3 and 6 months
Description
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
Time Frame
Baseline, 3 months, and 6 months
Title
Change from Baseline Social Anxiety Symptoms in Situations at 3 and 6 months
Description
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.
Time Frame
Baseline, 3 months, and 6 months
Secondary Outcome Measure Information:
Title
Change from Baseline Social anxiety-related drinking motives at 3 and 6 months
Description
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
Time Frame
Baseline, 3 months, and 6 months
Title
Change from Baseline Quality of Life and overall functioning at 3 and 6 months
Description
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.
Time Frame
Baseline, 3 months, and 6 months
Title
Change from Baseline Alcohol Problems at 3 and 6 months
Description
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.
Time Frame
Baseline, 3 months, and 6 months
Title
Change from Baseline Alcohol Drinks per Day at 3 and 6 months
Description
The Timeline Followback (TLFB) will be used in order to obtain average drinks per drinking day
Time Frame
Baseline, 3 months, and 6 months
Title
Change from Baseline Heavy Alcohol Use Days at 3 and 6 months
Description
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)
Time Frame
Baseline, 3 months, and 6 months
Title
Change from Baseline Alcohol Abstinence at 3 and 6 months
Description
The Timeline Followback (TLFB) will be used in order to obtain sustained abstinence (v. not) during the past 30 days
Time Frame
Baseline, 3 months, and 6 months
Title
Change from Baseline Social Anxiety Symptom Severity at 3 and 6 months
Description
The Behavioral Approach Task (BAT), a validated behavioral assessment of social anxiety severity, will be used.
Time Frame
Baseline, 3 months, and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate Wolitzky-Taylor, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Matrix Institute on Addictions
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment for Comorbid Social Anxiety and Alcohol Use Disorders.

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