Brief Telehealth Cognitive Rehabilitation Following Mild Traumatic Brain Injury: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Feasibility of administering the On-TRACC intervention to individuals with mTBI
研究概览
简要总结
In the United States, more than a million people sustain a mild traumatic brain injury (mTBI) every year. Although many recover fully, emerging literature suggests a high number of individuals report chronic, and functionally disabling, cognitive difficulties. Among Veterans, a nationwide survey found that more than 75% of 55,000 Veterans with a history of mTBI reported persistent moderate to severe levels of forgetfulness and poor concentration.
Reduced cognitive functioning following mTBI contributes to significant functional impairment, including underemployment, relationship difficulties, and reduced community integration for years post injury. Despite the significant individual and societal impact, evidence to guide interventions and treatment for this population remains limited. Even more limited are validated telehealth options for these symptoms, a critical means by which access to care can be improved, especially during the COVID-19 pandemic. The proposed pilot study will address this gap by evaluating the feasibility, acceptability, and preliminary effectiveness of a brief (5-session) cognitive rehabilitation intervention that was developed for individuals with mTBI and that will be administered over video-based telehealth technology. The development of this intervention was supported by a grant from the Department of Defense, with critical elements identified through surveys completed by clinicians and veterans with a history of mTBI, and also the clinical expertise of the team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Read, speak, understand English;
- •History of at least one mTBI;
- •Endorses moderate to severe cognitive difficulties in one or more of Neurobehavioral Symptom Inventory items M-P;
- •Ability and willingness to participate in audio recorded sessions over video telehealth platform in a private setting, including equipment and internet access;
- •Lives within 2 hours of VA Puget Sound or affiliated clinics/University of Washington;
- •Will be in Washington State when engaging in treatment sessions
排除标准
- •Significant cognitive impairment that would limit ability to engage on treatment;
- •Neurologic injury or illness that affects cognitive functioning, including history of moderate or severe TBI;
- •History of TBI in the past 3 months, from the date of screening;
- •History of serious mental illness involving psychotic symptoms;
- •Current psychotic or manic symptoms;
- •Current or active flag, or documentation in medical record, for behavior or suicide risk;
- •Current (within the past 3 months) Substance Use Disorder (not including caffeine or nicotine disorder)
结局指标
主要结局
Feasibility of administering the On-TRACC intervention to individuals with mTBI
时间窗: At the completion of 5 week intervention
Feasibility measures will include rate of enrollment of eligible individuals as well as dropout rate for enrolled participants. We will also evaluate participant adherence, including proportion of treatment sessions attended and number of days that homework was completed.
次要结局
- Preliminary effectiveness of On-TRACC intervention in decreasing post-concussive symptoms(Baseline (pre-treatment) and at the end of the 5-week On-TRACC intervention, 5 week time-frame on average)
- Participant satisfaction with On-TRACC intervention(End of each treatment session and at treatment completion, 5 weeks total.)
- Preliminary effectiveness of On-TRACC intervention at decreasing self-reported cognitive difficulties(Baseline (pre-treatment) and at the end of the 5-week On-TRACC intervention, 5 week time-frame on average)
- Preliminary effectiveness of On-TRACC intervention at improving self-efficacy(Baseline (pre-treatment) and at the end of the 5-week On-TRACC intervention, 5 week time-frame on average)
研究者
Kathleen Pagulayan
Associate Professor, School of Medicine: Psychiatry
University of Washington