Computer-Aided Learning for Managing Stress (CALMS)
2018年2月22日 更新者：Kristen Woodberry、Beth Israel Deaconess Medical Center
A Pilot Study of Computerized Biofeedback Games With Young People Experiencing Psychotic-Spectrum Symptoms
The purpose of this study is to learn whether a new family therapy using computer games with biofeedback might help people at clinical high risk for psychosis and their family members learn to experience less stress and have fewer mental health challenges.
研究概览
详细说明
CALMS revolves around the use of Emotional Manipulatives (EM) developed at Boston Children's Hospital (BCH). EM are single and multi-user biofeedback games designed to enhance executive control of emotion. The intervention and EM in CALMS were adapted from those used in Anger Control Training (ACT) with Regulate and Gain Emotional Control (RAGE-Control). In a randomized controlled trial at BCH, ACT and RAGE-Control relative to "sham" video-game play without biofeedback led to significantly greater reductions of aggression in adolescents and greater improvement in family functioning.
In this feasibility study, family dyads will participate in 12 sessions aimed at
- enhancing engagement through the use of video and other games,
- enhancing stress resilience through biofeedback, education, and individualized stress-reduction practice, and
- harnessing the power of the family to enhance contextual learning and the generality and duration of effects.
Clinical, self-report, and heart rate measures will be assessed at baseline, 4, 8, and 12 week assessments.
研究类型
介入性
注册 (实际的)
25
阶段
- 不适用
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
-
-
Massachusetts
-
Boston、Massachusetts、美国、02115
- Beth Israel Deaconess Medical Center
-
-
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
12年 至 30年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Currently Meet or Have Met Criteria of Prodromal Syndromes (COPS) according to the SIPS within the past 2 years
- Estimated IQ > 70
- Speak fluent English
- Have at least one parent or adult family member who also speaks fluent English and is willing to participate
Exclusion Criteria:
- Physical limitations precluding effective use of biofeedback videogames
- Co-morbid psychiatric disorders, including substance disorders, but only if they better explain COPS symptoms or make participation counter-indicated.
- Active suicidal ideation or attempts within the past 2 months unless being actively monitored and treated for this by a clinician
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 |
|---|---|
|
实验性的：CALMS
12 session family therapy using multi-user biofeedback games
|
Family Therapy; Multi-user Biofeedback Videogames
|
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 |
|---|---|---|
|
Feasibility: Percent of referred who consent and meet study criteria
大体时间：Up to six months
|
Enrollment
|
Up to six months
|
|
Feasibility: Percent of 12 sessions completed
大体时间：Up to six months
|
Engagement: Percent of sessions completed by consented and eligible participants
|
Up to six months
|
|
Feasibility: Counts of premature termination of intervention
大体时间：Up to six months
|
Up to six months
|
|
|
Feasibility: Self-report of Credibility/Satisfaction
大体时间：12 week assessment or last assessment completed
|
Individual and family member self-report
|
12 week assessment or last assessment completed
|
|
Feasibility: Self-report of User Experience
大体时间：12 week assessment or last assessment completed
|
Self-report of ability to learn/use technology to lower stress reactivity
|
12 week assessment or last assessment completed
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Perceived Stress relative to Baseline
大体时间：Weeks 4, 8, and 12 Assessments
|
Self-report via Perceived Stress Scale
|
Weeks 4, 8, and 12 Assessments
|
|
Change relative to Baseline in Youth Perceptions of Relationship with Family Member
大体时间：Weeks 4, 8, 12 Assessments
|
Self-report of conflict, criticism, and warmth in relationship with participating family member
|
Weeks 4, 8, 12 Assessments
|
|
Change relative to Baseline in Parent Perceptions of Relationship with Adolescent or Young Adult
大体时间：Weeks 4, 8, 12 Assessments
|
Self-report of conflict, criticism, and warmth in relationship with youth
|
Weeks 4, 8, 12 Assessments
|
|
Positive Symptom Score Change relative to Baseline
大体时间：Weeks 4,8, and 12 Assessments
|
Total positive symptom score according to the Structured Interview of Psychosis-risk Syndromes (SIPS)
|
Weeks 4,8, and 12 Assessments
|
|
Change in Social and Role Functioning relative to Baseline
大体时间：Weeks 4, 8, and 12 Assessments
|
Global Functioning: Social & Role Scales;
|
Weeks 4, 8, and 12 Assessments
|
|
Change in Global Functioning relative to Baseline
大体时间：Weeks 4, 8, and 12 Assessments
|
SIPS Global Assessment of Functioning
|
Weeks 4, 8, and 12 Assessments
|
|
Safety: Change in Hostility/Aggression relative to Baseline
大体时间：Weeks 4, 8, and 12
|
Self-report
|
Weeks 4, 8, and 12
|
|
Safety: Change in Video-game Addiction relative to Baseline
大体时间：Weeks 4, 8, and 12
|
Self-report
|
Weeks 4, 8, and 12
|
|
Difference in reaction times for emotional and calm faces on an Emotional Go/NoGo Task
大体时间：Baseline, Weeks 4,8, and 12
|
Executive Control of Emotion
|
Baseline, Weeks 4,8, and 12
|
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。
调查人员
- 首席研究员：Kristen Woodberry, MSW, Ph.D.、Beth Israel Deaconess Medical Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2015年9月1日
初级完成 (实际的)
2018年1月5日
研究完成 (实际的)
2018年1月5日
研究注册日期
首次提交
2015年7月13日
首先提交符合 QC 标准的
2015年8月21日
首次发布 (估计)
2015年8月24日
研究记录更新
最后更新发布 (实际的)
2018年2月23日
上次提交的符合 QC 标准的更新
2018年2月22日
最后验证
2018年2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.