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临床试验/NCT03694106
NCT03694106Unknown不适用

Feasility Pilot of T.E.A.M. Psychotherapy Using Electronic Capture of Before and After Therapy Measures.

Feeling Good Institute1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年4月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
NIH PROMIS 4 item depression questionnaire

研究概览

简要总结

T.E.A.M. psychotherapy was developed by one of the founders of cognitive therapy, David Burns and builds on traditional CBT with an emphasis on T = Testing, E = Empathy, A = Agenda Setting (assessing and building motivation) and M = Methods (including cognitive and behavioral methods). Because TEAM therapy is a data-driven therapy, its delivery hinges on the use of symptom measures and measures of the therapeutic alliance at every session with every patient. These measures are now available for collection thru computerized forms, making their collection and review considerably more accessible and efficient for the patient and therapist.

The following hypotheses will be tested:

  1. TEAM psychotherapy using computerized measurement collection is safe and feasible.
  2. TEAM psychotherapy using computerized measurement collection shows evidence of efficacy by exploratory non inferiority testing compared to benchmark studies with similar psychotherapeutic modalities
  3. Evidence for efficacy is strong enough to justify pursuit of an experimental randomized controlled clinical trial of TEAM therapy for major depressive disorder versus treatment as usual.

详细描述

A gap currently exists between the technology available for collecting psychotherapy data and the application of this technology to psychotherapeutic settings to enhance treatment outcomes. A novel integration of Cognitive Behavior Therapy (CBT) informed psychotherapy and digitized data collection systems called T.E.A.M. therapy exists that bridges this gap and has yet to be tested. The purpose of this study is to explore whether TEAM CBT appears safe and feasible and has results similar to comparable and similar benchmark studies. This outcome will provide pilot data and a rationale for whether to pursue a separate randomized controlled trial in the future. We will compare the results of TEAM therapy using electronic data collection to similar psychotherapeutic treatments for common psychiatric problems such as depression, anxiety, relationship conflicts and maladaptive behaviors. We will also explore the data for its use in predictive modeling. This study is part of a wider goal of developing best practices in dissemination of standardized measurement based psychotherapies that are effective and use technology via computerized delivery systems guided by therapists. It is hoped that with computer based measurement systems for psychotherapy, more accurate and frequent information for therapists is available to modify earlier and more effectively their approaches. The measurement based systems will also allow performance by psychotherapists to be measured accurately and enable a type of machine based learning environment with feedback systems in place to improve providers' patient care in a more precise and personalized way.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • •Cognitive functioning at a level and ability to use an electronic tool.
  • •Demonstration of decisional capacity in order to participate in psychotherapy.

排除标准

  • •Under age 18
  • •Providers: not TEAM certified at a level 3 or above
  • •Patients: Non-fluent English speakers. The tool for now is only available in English

结局指标

主要结局

NIH PROMIS 4 item depression questionnaire

时间窗: 9 months

次要结局

未报告次要终点

研究者

发起方
Feeling Good Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alex Clarke

Director of Research and Development

Feeling Good Institute

研究点 (1)

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