Treatment for Comorbid Social Anxiety and Alcohol Use Disorders.

NCT03428490 | Completed

• 2 other identifiers: SOCANX11R34AA025364-01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder; Social Anxiety Disorder

Keywords

Integrated Treatment; Alcohol Use Disorder; Social Anxiety Disorder; Comorbidity; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• Change from Baseline Social anxiety-related drinking motives at 3 and 6 months

  Baseline, 3 months, and 6 months

• Change from Baseline Quality of Life and overall functioning at 3 and 6 months

  Baseline, 3 months, and 6 months

• Change from Baseline Alcohol Problems at 3 and 6 months

  Baseline, 3 months, and 6 months

• Change from Baseline Alcohol Drinks per Day at 3 and 6 months

  Baseline, 3 months, and 6 months

• Change from Baseline Heavy Alcohol Use Days at 3 and 6 months

  Baseline, 3 months, and 6 months

Study Arms (2)

Fully Integrated Treatment

EXPERIMENTAL

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

Behavioral: Fully integrated treatment

Usual Intensive Outpatient Care

ACTIVE COMPARATOR

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

Behavioral: Stand-alone Intensive Outpatient Program

Interventions

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).

Fully Integrated Treatment

Stand-alone Intensive Outpatient Program BEHAVIORAL

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

Usual Intensive Outpatient Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• Matrix Institute on Addictions: collaborator

Study Sites (1)

Matrix Institute on Addictions

Los Angeles, California, 90025, United States

Location

MeSH Terms

Conditions

Alcoholism; Phobia, Social

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Phobic Disorders; Anxiety Disorders

Study Officials

• Kate Wolitzky-Taylor, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

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

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: February 9, 2018
• Study Start: March 15, 2018
• Primary Completion: December 1, 2020
• Study Completion: April 30, 2021
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)