Telephone Delivery of Cognitively Augmented Behavioral Activation (CABA) for Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •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
研究组 & 干预措施
Tele-CABA
Participants who engage in the Tele-CABA intervention.
干预措施: Tele-CABA (Behavioral)
Usual Care
Participants who do not engage in the Tele-CABA intervention during their time in the study. They will be eligible to receive Tele-CABA following completion of the 6-month questionnaires and cognitive assessment (as a courtesy).
干预措施: Usual Care (Behavioral)
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)
研究者
Megan Callahan
Principal Investigator
Portland VA Medical Center