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临床试验/NCT01764698
NCT01764698已完成不适用

Adaptation of CALM for Comorbid Anxiety and Substance Use Disorders

University of California, Los Angeles4 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2013年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
98
试验地点
4
主要终点
Brief Symptom Inventory

研究概览

简要总结

Anxiety disorders are highly prevalent among those with substance use disorders, but the majority of addictions treatment centers provide little to no evidence-based treatment for anxiety disorders. Furthermore, tension reduction models suggest that treating anxiety should also improve substance use outcomes. This study is aimed at improving symptoms for people who have substance use and anxiety problems. The study is comparing regular Intensive Outpatient treatment for addiction to Intensive Outpatient treatment for addiction plus treatment for anxiety disorders. Clinicians at a community addictions clinic will participate by receiving training in delivering cognitive behavioral therapy for anxiety disorders and will deliver the treatment to the patient participants. They will also complete some questionnaires. Patient participants will be asked to complete a baseline assessment. Those who are eligible will be randomly assigned to one of the two treatment groups. Those who are assigned to addiction treatment as usual will continue their regular care at the Matrix Institute. Participants who are assigned to also receive the anxiety treatment will be asked to participate in 6, 90-min treatment sessions and an orientation session. All participants will be asked to complete post-treatment and follow-up assessments. The assessments should take approximately 1 hour, and the follow-up assessment will be completed 6 months after treatment is over. It is hypothesized that those who get the additional anxiety disorder treatment will show greater improvement in anxiety and substance use outcomes than those who get Intensive Outpatient Program without the anxiety disorder treatment.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-60 years old
  • speak English
  • meet diagnostic criteria for at least one anxiety disorder
  • score at least an 8 on the OASIS (see Assessments), indicating at least moderate but clinically significant anxiety symptoms
  • be enrolled in the Intensive Outpatient Program (IOP) at the Matrix Institute (community partner)
  • meet diagnostic criteria for substance abuse or dependence

排除标准

  • have unstable medical conditions
  • marked cognitive impairment
  • active suicidal intent or plan
  • active psychosis
  • unstable Bipolar I disorder.

结局指标

主要结局

Brief Symptom Inventory

时间窗: baseline, 6 weeks, 6 months

Change over time is being assessed.

Timeline Follow Back

时间窗: baseline, 6 week, 6 month

Change over time is being assessed

Overall Anxiety Severity and Impairment Scale

时间窗: baseline, 6 week, 6 month

Change over time is being assessed.

次要结局

  • Social Phobia Inventory(baseline, 6 week, 6 month)
  • Posttraumatic Stress Disorder Checklist(baseline, 6 week, 6 month)
  • urine toxicology screen(baseline, 6 week, 6 month)
  • Patient Health Questionnaire-8(baseline, 6 week, 6 month)
  • Anxiety Sensitivity Index(baseline, 6 week, 6 month)
  • Panic Disorder Severity Scale(baseline, 6 week, 6 month)
  • Penn State Worry Questionnaire(baseline, 6 week, 6 month)

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 (4)

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