Online Emotional Regulation Group Treatment
2015年10月1日 更新者：Icahn School of Medicine at Mount Sinai
Online Emotional Regulation Group Treatment for Individuals With Traumatic Brain Injury (TBI)
This study will examine the feasibility of online delivery of emotional regulation training to individuals with TBI with emotional dysregulation.
80 subjects with significant emotional dysregulation will be enrolled and will receive 24 60-minute emotional regulation sessions twice a week for 12 weeks, delivered online in group modality.
Attendance and compliance will be tracked, and outcomes will be monitored using online data collection methods.
Treatment satisfaction and participant subjective experience will also be assessed.
研究概览
详细说明
This study will examine the feasibility of online delivery of emotional regulation training to individuals with Traumatic Brain Injury who also have emotional dysregulation.
80 subjects with significant emotional dysregulation will be enrolled and will receive 24 60-minute emotional regulation sessions twice a week for 12 weeks, delivered online via a group meeting software.
Study participation will last 28 weeks: 4 weeks of baseline, 12 weeks of treatment (24 sessions) and 12 weeks of follow-up.
Assessments will be conducted at each of four timepoints: T1 (baseline), T2 (pre-treatment assessment), T3 (end-of-treatment assessment) and T4 (follow-up assessment).
In addition, a subset of the measures will be administered bi-weekly for the duration of the study.
Assessments will consist of a variety of measures designed to measure executive functioning, problem solving skills, and quality of life.
All assessments will be completed online, using a web-based data collection.
Attendance and treatment compliance will be tracked, and outcomes will be monitored using online data collection methods.
Treatment satisfaction and participant subjective experience (including technical difficulties that make access to web-delivered treatment impossible) will also be assessed.
研究类型
介入性
注册 (实际的)
147
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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New York
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New York、New York、美国、10029
- The Brain Injury Research Center at Icahn School of Medicine at Mount Sinai
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Documented TBI of any severity and being at least 6 months post injury
- Presence of executive dysfunction, manifested as self-reported difficulties with emotional and behavioral self-regulation, operationalized as endorsement of 25% or more of the symptoms on the Difficulties in Emotion Regulation Scale (DERS, Gratz & Roemer, 2004).
- Currently aged 18 or older
- English speaking
- At least low average intellectual functioning, operationalized as a minimum Verbal IQ score of 80 on the Wechsler Abbreviated Scale of Intelligence
- Ownership of and relative facility with use of a computer, webcam, and microphone
- Access to a broadband internet connection at sufficiently high speed to allow videoconference
Exclusion Criteria:
- DSM-IV-TR diagnosis of alcohol or substance abuse within past 6 months
- DSM-IV-TR of psychosis within past 6 months
- High suicidality, operationalized as a score of 17 or higher on the Mini International Neuropsychiatric Interview (M.I.N.I., Sheehan et al., 2008)
Participation in this study will not preclude participation in other treatments.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Online Emotional Regulation Treatment
Participants will receive 24 treatment sessions, with baseline, post-treatment screening and follow-up screening, and bi-weekly assessments
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Emotional Regulation Training (EmReg) is a cognitive-behavioral approach which aims to increase awareness, and self-monitoring of affective states to improve self-regulation.
EmReg combines didactic and experiential training, and emphasizes skill acquisition and generalization through examination of incidents of emotional dysregulation in one's life and completion of homework assignments.
The treatment is divided into two phases: knowledge provision and practice facilitation.
During the knowledge provision phase participants are introduced to the objectives and the main concepts of the treatment, to increase their familiarity with the terminology, and to the emotional regulation skills they acquire during the practice facilitation phase.
During the practice facilitation phase participants receive training in emotional regulation skills, which they practice in-session with the guidance of the therapist and feedback from the group, as well as out-of-session as homework assignments.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Difficulties in Emotion Regulation Scale(DERS)
大体时间：up to 28 weeks
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36-item self-report questionnaire that focuses on emotional awareness, acceptance, ability to control impulsivity, and flexible use of strategies
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up to 28 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The Brain Injury Rehabilitation Trust Regulation of Emotions Questionnaire (BREQ)
大体时间：up to 28 weeks
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32 item self-report questionnaire assessing deficits in emotion regulation, developed specifically to assess emotional dysregulation related to TBI
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up to 28 weeks
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Problem Solving Inventory
大体时间：up to 28 weeks
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35-item self-report questionnaire assessing problem solving capability
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up to 28 weeks
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Social Problem Solving Inventory-Revised: Short Form
大体时间：up to 28 weeks
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25-item self-report questionnaire assessing problem solving in everyday living
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up to 28 weeks
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Positive Affect Negative Affect Scale
大体时间：up to 28 weeks
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20-item self-report measure of positive and negative affect within a specified time frame
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up to 28 weeks
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Satisfaction with Life Scale
大体时间：T1 (baseline)
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5- item measure of global satisfaction with life
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T1 (baseline)
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Satisfaction with Life Scale
大体时间：T2 (week 4)
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5- item measure of global satisfaction with life
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T2 (week 4)
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Satisfaction with Life Scale
大体时间：T3 (week 16)
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5- item measure of global satisfaction with life
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T3 (week 16)
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Satisfaction with Life Scale
大体时间：T4 (week 28)
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5- item measure of global satisfaction with life
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T4 (week 28)
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Satisfaction with Therapy and Therapist Scale
大体时间：T3 (week 16)
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12-item scale that assesses satisfaction with treatment and therapist
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T3 (week 16)
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Satisfaction with Therapy and Therapist Scale
大体时间：T4 (week 28)
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12-item scale that assesses satisfaction with treatment and therapist
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T4 (week 28)
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Treatment Compliance
大体时间：up to 28 weeks
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therapist's ratings of participant on each of the following areas at each session: attendance, participation, homework completion, skill acquisition, skill generalization, ease of use of technology, and interpersonal behavior
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up to 28 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年11月1日
初级完成 (实际的)
2015年10月1日
研究完成 (实际的)
2015年10月1日
研究注册日期
首次提交
2012年11月15日
首先提交符合 QC 标准的
2012年11月15日
首次发布 (估计)
2012年11月21日
研究记录更新
最后更新发布 (估计)
2015年10月2日
上次提交的符合 QC 标准的更新
2015年10月1日
最后验证
2015年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.