Clinical trial NCT03428490: Treatment for Comorbid Social Anxiety and Alcohol Use Disorders.
Official title: Developing and Evaluating a Fully Integrated Treatment Program for Comorbid Social Anxiety and Alcohol Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Social Anxiety Disorder
Keywords: Integrated Treatment
Alcohol Use Disorder
Social Anxiety Disorder
Comorbidity
Cognitive Behavioral Therapy
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Matrix Institute on Addictions
First posted: 2018-02-09
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from Baseline Alcohol consumption at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
measure: Change from Baseline Social Anxiety Symptoms in Situations at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
Secondary outcomes:
measure: Change from Baseline Social anxiety-related drinking motives at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
measure: Change from Baseline Quality of Life and overall functioning at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
measure: Change from Baseline Alcohol Problems at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
measure: Change from Baseline Alcohol Drinks per Day at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
measure: Change from Baseline Heavy Alcohol Use Days at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
measure: Change from Baseline Alcohol Abstinence at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
measure: Change from Baseline Social Anxiety Symptom Severity at 3 and 6 months
timeFrame: Baseline, 3 months, and 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Matrix Institute on Addictions
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Kate Wolitzky-Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
References: