跳至主要内容
临床试验/NCT03182101
NCT03182101Unknown不适用

Quality Assessment in Exposure Therapy

Bradley Hospital2 个研究点 分布在 1 个国家目标入组 177 人开始时间: 2017年9月13日最近更新:
适应症

试验速览

阶段
不适用
入组人数
177
试验地点
2
主要终点
Clinical Global Impression Scales

研究概览

简要总结

This project will test a measure of treatment quality, Exposure Guide, for therapists using exposure therapy for youths and young adults with anxiety or OCD. We anticipate that users of this measure will be able to complete it reliably, find it acceptable, and that the measure will predict patient outcome. This project will include 40 therapists treating 300 anxious youth and young adults ages 5-25 at a large community mental health agency. Results of this study will establish the Exposure Guide as a measure of exposure quality in real world settings.

详细描述

Empirically supported behavioral treatments cannot be effectively disseminated without understanding key quality components. Mechanism-informed quality measures have extraordinary potential to enhance pragmatism by eliminating unnecessary elements and targeting multiple problems and populations, and to enhance predictive value by detecting mechanism engagement early in treatment. Community Mental Health Agencies (CMHAs), however, are often ill-equipped to use such measures of treatment quality due to burden and limited resources. Exposure therapy for anxiety is an ideal prototype for testing a practical, mechanism-informed quality measure in CMHAs given its potential for public health impact and clear theory of mechanism. The Exposure Guide (EG), a brief quality tool measuring therapist behaviors and mechanism, was developed based on microanalytic coded data showing a strong link between therapist behavior and patient outcome across three RCTs of exposure therapy in youth. Initial psychometrics for the EG using these RCT data are promising showing reliability, construct validity, and predictive validity, and pilot data suggests it may be acceptable and feasible in a community setting. Building upon these findings, we propose to test this novel measure of exposure quality, EG, in a community setting including its reliability and validity, its pragmatism, and which community end-users can become reliable and valid reporters. Therapists at a large local CMHA (N = 40) treating anxious youth and young adults ages 5-25 (N = 300) will participate in this study. The EG will be completed by 1) agency supervisors monthly, 2) therapists per session, 3) patient/families per session, and 4) study raters per session. Results from this study will establish an innovative model for measuring therapeutic elements that trigger mechanism of change in real-world therapy as well as inform future use of EG as a training tool to improve exposure quality in community settings.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patient at a Community Mental Health Agency that is partnering with this study
  • Primary or co-primary diagnosis of OCD, Separation Anxiety, Social Anxiety, Panic Disorder, or Specific Phobia.
  • Children < age 12 have a caretaker available to participate in treatment
  • Patient and parent/legal guardian are English speaking

排除标准

  • Concurrent psychotherapy for treatment of anxiety
  • Psychosis, Pervasive Developmental Disorder, or Mental Retardation

结局指标

主要结局

Clinical Global Impression Scales

时间窗: Through study completion, an average of 6 months

The Clinical Global Impression Scales (CGI) are brief, clinician-rated measures of global severity and improvement in treatment for children and adults.

次要结局

未报告次要终点

研究者

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

Kristen Benito

Principle Investigator

Bradley Hospital

研究点 (2)

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