跳至主要内容
临床试验/NCT04200976
NCT04200976
已完成
不适用

Telephone Delivery of Cognitively Augmented Behavioral Activation (CABA) for Traumatic Brain Injury

Portland VA Medical Center1 个研究点 分布在 1 个国家目标入组 94 人2019年9月15日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Traumatic Brain Injury
发起方
Portland VA Medical Center
入组人数
94
试验地点
1
主要终点
Change in the Wechsler Adult Intelligence Scale-4th Edition, Digit Span subtest
状态
已完成
最后更新
4年前

概览

简要总结

Traumatic brain injury (TBI) is highly prevalent and frequently comorbid among Veterans and Service Members. Many of these individuals sustain more than one TBI over the course of their military careers, often with little recovery time between exposures placing them at increased risk for persistent cognitive, psychological, and psychosocial difficulties that impact daily functioning and life satisfaction.

The short-term objective of this study is to examine the efficacy of the manualized, 10-week, telephone delivery of Tele-CABA for improving cognitive and adaptive functioning. The long-term objective of this study is to develop an accessible and acceptable intervention that can be broadly disseminated to address the complex rehabilitation needs of Veterans and Service Members. The overall goal of the Tele-CABA intervention is to reduce negative cognitive and psychiatric health outcomes for Veterans and Service Members with a history of TBI, promote personal resilience, and to design an intervention that is accessible and acceptable to patients struggling to recover from TBI.

注册库
clinicaltrials.gov
开始日期
2019年9月15日
结束日期
2021年8月15日
最后更新
4年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Megan Callahan

Principal Investigator

Portland VA Medical Center

入排标准

入选标准

  • Active Duty Service Members
  • History of TBI (confirmed by TBI interview)
  • Self-reported cognitive complaints (as indicated on the NSI)
  • Able to communicate by telephone

排除标准

  • Active suicidal intent
  • History of bipolar disorder
  • History of psychotic disorder
  • Decisionally impaired
  • Non-English speaking

结局指标

主要结局

Change in the Wechsler Adult Intelligence Scale-4th Edition, Digit Span subtest

时间窗: Baseline; 12 weeks; and 6 months after baseline

Measure of attention and working memory; scaled score range = 0-20 (mean = 10; SS below 2 SD below the mean considered impaired)

Change in the Neurobehavioral Symptom Inventory (NSI)

时间窗: Baseline; 12 weeks; and 6 months after baseline

Measure of postconcussion symptom severity; total score range = 0-88 (higher total score = worse symptoms)

Change in the Satisfaction with Life Scale (SWLS)

时间窗: Baseline; 12 weeks; and 6 months after baseline

Measure of life satisfaction; total score range = 0-35 (higher total score = more satisfied)

次要结局

  • Change in the PTSD Checklist-5 (PCL 5)(Baseline; after 12 weeks; and 6 months after baseline)
  • Change in the Memory Compensation Questionnaire (MCQ)(Baseline; after 12 weeks; and 6 months after baseline)

研究点 (1)

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