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临床试验/NCT03428490
NCT03428490已完成不适用

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

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2018年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
Change from Baseline Alcohol consumption at 3 and 6 months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

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

研究组 & 干预措施

Fully Integrated Treatment

Experimental

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

干预措施: Fully integrated treatment (Behavioral)

Usual Intensive Outpatient Care

Active Comparator

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

干预措施: Stand-alone Intensive Outpatient Program (Behavioral)

结局指标

主要结局

Change from Baseline Alcohol consumption at 3 and 6 months

时间窗: 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

时间窗: 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.

次要结局

  • 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)
  • Change from Baseline Alcohol Abstinence at 3 and 6 months(Baseline, 3 months, and 6 months)
  • Change from Baseline Social Anxiety Symptom Severity at 3 and 6 months(Baseline, 3 months, and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kate Taylor

Assistant Professor

University of California, Los Angeles

研究点 (1)

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