Improving Cognitive Rehabilitation Outcomes for Veterans With mTBI+PTSD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Objective Cognitive Performance
研究概览
简要总结
Posttraumatic stress disorder (PTSD) and mild TBI (mTBI) frequently co-occur in post-9/11 Veterans, and together are associated with worse cognitive performance, mental health, everyday functioning, community integration, quality of life, and treatment response than either condition alone. Additional comorbidities, such as depression and sleep disturbance, are common and further exacerbate these problems. The investigators will investigate Compensatory Cognitive Training (CCT) and Morning Bright Light Therapy (MBLT) vs Negative Ion Generator (ION), to directly target cognition, depression, and sleep disturbance and to improve CCT-associated rehabilitation outcomes. The investigator's randomized controlled trial in 144 Veterans with mTBI+PTSD across two VA sites will compare cognition, functioning, and other secondary outcomes following CCT+MBLT vs. CCT+ION. This study addresses the significant gap in services and evidence-based treatments for Veterans with mTBI+PTSD.
详细描述
The investigators aim to compare CCT+MBLT with CCT+ION for improving cognition, functioning, and secondary outcomes in Veterans with mTBI+PTSD.
Objective cognitive performance and everyday functioning are co-primary outcomes. Depression and sleep disturbance are target mechanisms and secondary outcomes include PTSD symptom severity, post-concussive symptom severity, cognitive symptom severity, and quality of life.
Improvements in mood and sleep will be investigated as mediators. To explore for whom these interventions are most effective, the investigators will evaluate whether individual difference variables (e.g., demographics, premorbid functioning, treatment adherence) or baseline performance on primary and secondary outcome measures moderate intervention-related improvements in objective cognitive performance and everyday functioning.
The investigators will enroll a representative sample of 144 post-9/11 Veterans with mTBI+PTSD at two VA sites (San Diego and Portland). Assessments will be conducted at baseline, mid-treatment (5 weeks), post-treatment (10 weeks), and three-month follow-up.
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
- Double (Participant, 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
- •Post 9/11 Veterans enrolled at VA San Diego or VA Portland
- •Ability to provide informed consent
- •Living independently
- •History of mTBI confirmed by OSU-TBI
- •Current diagnosis of PTSD confirmed by CAPS-5
- •Current cognitive concerns ("Do you have concerns about your cognition, thinking, attention, or memory?")
- •Current concern regarding depression and/or sleep disturbance; defined by a score of 5 on the PHQ-9 and/or 8 on the ISI, respectively (score of 2 or higher on ISI item 1, 2, or 3, reflecting at least "moderate" difficulty with falling asleep, staying asleep, or waking up too early in the morning)
排除标准
- •Current substance use disorder with <30 days abstinence
- •History of primary psychotic disorder
- •History of moderate to severe TBI (loss of consciousness >30 minutes)
- •History of macular degeneration or bipolar disorder (both contraindicated for bright light therapy)
- •Not work night or swing shift schedules
- •Untreated obstructive sleep apnea either via self-report or a score 5 on the STOP-BANG
- •Current engagement in bright light therapy
- •Auditory or visual impairments precluding participation in assessments or treatments
研究组 & 干预措施
CCT+ION
Compensatory Cognitive Training + Negative Ion Generator
干预措施: CCT+ION (Device)
CCT+MBLT
Compensatory Cognitive Training + Morning Bright Light Therapy
干预措施: CCT+MBLT (Device)
结局指标
主要结局
Objective Cognitive Performance
时间窗: baseline, 10 weeks
Composite z score of Hopkins Verbal Learning Test-Revised; Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV) Digit Span; WAIS-IV Coding; Delis-Kaplan Executive Function System (D-KEFS) Trails; D-KEFS Color-Word Interference; and the UCSD Performance-Based Skills Assessment-Brief (UPSA-B). There is no minimum or maximum value of a z score. Higher scores will reflect better outcomes.
Functioning
时间窗: baseline, 10 weeks
Composite z score of Brief Inventory of Psychosocial Functioning and the World Health Organization Disability Assessment Schedule 2.0. There is no minimum or maximum value of a z score. Higher scores will reflect better outcomes.
次要结局
- PTSD Checklist for DSM-5(baseline, 10 weeks)
- Insomnia Severity Index(baseline, 10 weeks)
- Pittsburgh Sleep Quality Index(baseline, 10 weeks)
- Total Sleep Time(baseline, 10 weeks)
- Patient Health Questionnaire-9(baseline, 10 weeks)
- Neurobehavioral Symptom Inventory(baseline, 10 weeks)
- World Health Organization Quality of Life(baseline, 10 weeks)
- Subjective cognitive functioning(baseline, 10 weeks)