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临床试验/NCT00586001
NCT00586001已完成不适用

Phase 3 of The Development of A Unified Treatment for Anxiety Disorders

Boston University Charles River Campus0 个研究点目标入组 37 人开始时间: 2005年9月1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
发起方
入组人数
37
主要终点
Anxiety Disorders Interview Schedule for DSM-IV

研究概览

简要总结

The purpose of this study is to develop a new psychological therapy for a variety of different types of emotional disorders. The study will compare symptoms and functioning of clients who receive the treatment with those who do not, and will include a number of assessments before, during, and after treatment. We predict that patients receiving active treatment will show improved functioning relative to wait-list control.

详细描述

Emotional disorders, specifically anxiety disorders and depression, are common, chronic, costly, and debilitating to quality of life (Barlow, 2002). Best estimates from various epidemiological studies place the one year prevalence of any anxiety disorder for individuals over 18 at 11.8%, and the one year prevalence of any mood disorder 5.1% (Narrow, Rae, Robins, & Regier, 2002). Lifetime rates are higher. We understand the nature and causes of anxiety and unipolar mood disorders (major depressive disorder and dysthymia) somewhat better than 10 years ago, with evidence pointing to generalized biological and psychological vulnerabilities interacting with specific learning and, sometimes, stressful triggering life events as etiological factors (Barlow, 2002; Brown, Chorpita, & Barlow, 1998). Pharmacological and psychological treatments have been proven effective, at least in the short term, but most studies have ignored the effects of treatment on broad-based patterns of comorbidity that accompany these disorders. Most comorbid disorders are usually additional emotional disorders (Brown, Campbell, Lehman, Grisham, & Mancill, 2001). More importantly, treatment outcomes have been less than satisfactory or ineffective for up to 50% of patients, even for the principal disorder (Nathan & Gorman, 2002). A common pharmacological treatment exists for many emotional disorders, which is selective serotonin re-uptake inhibitors (SSRIs) and closely related compounds. Effective psychological treatments, on the other hand, have been developed to be very specific to each DSM-IV diagnostic category. The purpose of this proposal is to create a unified psychological approach to the emotional disorders. To do, this we will take advantage of recent advances in our understanding of the nature of emotional disorders, as well as emerging knowledge of the process of regulation and change in emotional behavior, in order to distill and refine basic principles of successful psychological treatments. It is expected that this approach will simplify training and dissemination, possibly improve efficacy, and perhaps also shed further light on the nature of emotional disorders. Thus, the specific aims of this proposal are to:

  1. Develop and refine a unified psychological treatment for anxiety and non-bipolar mood disorders derived from distilling the major ingredients of current effective approaches in light of advancing knowledge of emotion regulation and modification.
  2. Revise and develop methods of evaluating adherence and outcome utilizing this new treatment protocol, focusing not only on symptom reduction but also quality of life and adaptive functioning.
  3. Treat a small number of patients with heterogeneous DSM-IV mood and anxiety diagnoses with this new protocol with the purpose of making appropriate modifications for a subsequent pilot study.
  4. Conduct a pilot study testing this unified treatment in comparison to a wait-list control condition in order to determine credibility and efficacy in terms of both symptomatic functioning and quality of life, and relating these outcomes to those from more disorder specific treatments.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary Diagnosis of a DSM-IV Anxiety Disorder

排除标准

  • Previous treatment with cognitive-behavioral therapy
  • Receiving concurrent psychological treatments during study
  • If on psychotropic medicine, requirement for stable dose for at least three months before treatment

研究组 & 干预措施

1

Experimental

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders.

干预措施: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (Behavioral)

2

No Intervention

Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.

结局指标

主要结局

Anxiety Disorders Interview Schedule for DSM-IV

时间窗: Measured at pre-treatment (baseline) and post-treatment (month 3)

DSM-IV diagnoses of anxiety disorders. Principal and additional diagnoses are assigned a clinical severity rating (CSR) on a scale from 0 (no symptoms) to 8 (extremely severe symptoms), with a rating of 4 or above (definitely disturbing/disabling) passing the clinical threshold for DSM-IV diagnostic criteria.

次要结局

  • Structured Interview Guide for the Hamilton Anxiety Rating Scale(Measured at pre-treatment (baseline) and post-treatment (month 3))
  • Structured Interview Guide for the Hamilton Depression Rating Scale(Measured at pre-treatment (baseline) and post-treatment (month 3))
  • Positive and Negative Affect Scale(Measured at pre-treatment (baseline) and post-treatment (month 3))
  • Beck Depression Inventory - II(Measured at pre-treatment (baseline) and post-treatment (month 3))
  • Beck Anxiety Inventory(Measured at pre-treatment (baseline) and post-treatment (month 3))
  • Work and Social Adjustment Scale(Measured at pre-treatment (baseline) and post-treatment (month 3))
  • Panic Disorder Severity Scale - Self Report Version(Measured at pre-treatment (baseline) and post-treatment (month 3))
  • Penn State Worry Questionnaire(Measured at pre-treatment (baseline) and post-treatment (month 3))
  • Social Interaction Anxiety Scale(Measured at pre-treatment (baseline) and post-treatment (month 3))
  • Quality of Life Inventory(Measured at pre-treatment (baseline) and post-treatment (month 3))
  • Yale-Brown Obsessive Compulsive Scale(Measured at pre-treatment (baseline) and post-treatment (month 3))
  • Emotion Regulation Questionnaire - 2(Measured at pre-treatment (baseline) and post-treatment (month 3))
  • BIS/BAS Scales (Carver & White, 1994)(Measured at pre-treatment (baseline) and post-treatment (month 3))
  • Affective Control Scale(Measured at pre-treatment (baseline) and post-treatment (month 3))
  • Anxiety Sensitivity Index(Measured at pre-treatment (baseline) and post-treatment (month 3))
  • The Thought-Action Fusion Scale (Shafran et al., 1996)(Measured at pre-treatment (baseline) and post-treatment (month 3))
  • Intolerance of Uncertainty Scale (IUS)(Measured at pre-treatment (baseline) and post-treatment (month 3))
  • The Trait Meta-Mood Scale (TMMS; Salovey et al., 1995)(Measured at pre-treatment (baseline) and post-treatment (month 3))

研究者

发起方
Boston University Charles River Campus
申办方类型
Other
责任方
Principal Investigator
主要研究者

David H. Barlow

Professor of Psychology and Psychiatry, Emeritus

Boston University Charles River Campus

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