T.E.A.M. Feasibility and Efficacy Study 2.0
追踪信息 | |||
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首次提交日期 ICMJE | October 1, 2018 | ||
首次发布日期e ICMJE | October 3, 2018 | ||
最后更新发布日期 | October 3, 2018 | ||
预计研究开始日期 ICMJE | November 1, 2018 | ||
预计主要完成日期 | November 1, 2020 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
NIH PROMIS 4 item depression questionnaire[ Time Frame: 9 months ] |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | T.E.A.M. Feasibility and Efficacy Study 2.0 | ||
正式标题 ICMJE | Feasility Pilot of T.E.A.M. Psychotherapy Using Electronic Capture of Before and After Therapy Measures. | ||
简要概况 | 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. |
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详细说明 | 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. | ||
研究类型 ICMJE | Observational | ||
研究阶段 | |||
研究设计 ICMJE | 分配: 干预模型: 干预模型描述: 盲法: Observational 盲法描述: 主要目的: |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Not yet recruiting | ||
预计入组 ICMJE |
80 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | November 1, 2022 | ||
预计主要完成日期 | November 1, 2020 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - 1. Cognitive functioning at a level and ability to use an electronic tool. 2. Demonstration of decisional capacity in order to participate in psychotherapy. Exclusion Criteria: 1. Under age 18 3. Providers: not TEAM certified at a level 3 or above 2. Patients: Non-fluent English speakers. The tool for now is only available in English | ||
性别 |
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年龄 | 最小年龄:18 Years ,最大年龄:N/A | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | |||
管理信息 | 数据检测委员会 | No | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | Kim Bullock, MD,Stanford University | ||
研究赞助商 ICMJE | Stanford University | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | Stanford University | ||
验证日期 | October 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |