Comparing the effectiveness of telehealth to in-person delivery of a combined metacognitive and attention training in Veterans with mTBI/PTSD

比较远程医疗与面对面为患有 mTBI/PTSD 的退伍军人提供元认知和注意力相结合的培训的有效性

• 批准号: 10540131
• 负责人: Julia Kay Waid-Ebbs
• 金额: --
• 依托单位: VETERANS HEALTH ADMINISTRATION
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-11-01 至 2026-10-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10540131
• 关键词: Address; Aftercare; Attention; Awareness; COVID-19 pandemic; Caring; Clinical; Cognition; Cognitive; Combined Modality Therapy; Complex; Control Groups; Cost Savings; Data; Department of Defense; Dissociation; Educational workshop; Effectiveness; Evaluation; Executive Dysfunction; Goals; Health Services Accessibility; Healthcare Systems; Hour; Impaired cognition; Impairment; Intervention; Life; Measures; Methods; Military Personnel; Neuropsychology; Outcome; Performance; Persons; Pilot Projects; Population; Post-Traumatic Stress Disorders; Prediction of Response to Therapy; Problem Solving; Process; Productivity; Protocols documentation; Psyche structure; Quality of Care; Quality of life; Randomized; Randomized, Controlled Trials; Recommendation; Regimen; Rehabilitation therapy; Reporting; Research; Research Design; Services; Shapes; Short-Term Memory; Task Performances; Testing; Training; Translating; Translations; Treatment outcome; United States Department of Veterans Affairs; United States National Institutes of Health; Veterans; Veterans Health Administration; Work; brain health; clinical practice; cognitive control; cognitive process; cognitive rehabilitation; comorbidity; compare effectiveness; computerized; cost effectiveness; current pandemic; directed attention; executive function; experience; flexibility; health goals; improved; indexing; innovation; instrument; mild traumatic brain injury; military veteran; mind control; neurobehavioral; novel; pandemic disease; randomized, controlled study; response; rural area; skills; social; systematic review; telehealth; treatment effect; treatment response; treatment strategy

Background. Over 70% of Veterans with mild traumatic brain injury (mTBI), seeking services at the Veterans’ Health Administration, suffer from comorbid post-traumatic stress disorder (PTSD). These Veterans commonly experience concomitant executive dysfunction in goal setting, concentration, and attention that impairs their performance in complex daily tasks. Others and we have studied Goal Management Training (GMT) to address this problem. Collectively, the data have shown that GMT improved some aspects of executive function in mTBI/PTSD but did not restore cognition to normal during complex tasks. Goal management for performing complex tasks requires cognitive processes such as attention, and direct-attention training may be beneficial in improving cognition. GMT with attention training have been used in other studies, but those did not involve Veterans with either mTBI or mTBI/PTSD. We recently conducted a pilot study combining GMT and direct-attention training (GMT+ATT) in Veterans with mTBI and PTSD. We discovered a large treatment effect (Cohen d=2.23) in the NIH EXAMINER Executive Composite score and a significant treatment response in the NIH EXAMINER Cognitive Control subdomain and the Unstructured Task. GMT or ATT is typically administered in-person. In-person treatment can impose problems such as limited treatment access, poor cost-effectiveness, and unexpected situations (like the COVID-19 pandemic). As an alternative method, telehealth has been used increasingly to meet the need for care in Veterans living in rural areas and during the pandemic. Telehealth delivery of cognitive interventions in Veterans with mTBI or with PTSD has shown effectiveness that is comparable to that of in-person treatment. However, GMT+ATT has not been studied in these Veterans. Therefore, we have recently developed the format for telehealth delivery of GMT+ATT in Veterans with mTBI/PTSD. Our preliminary data demonstrate the feasibility of this delivery platform and similar treatment outcomes as compared to in-person therapy. Objective & Hypotheses. The objective of this randomized controlled trial is to determine and compare the effect of in-person and telehealth delivery of GMT+ATT in Veterans with mTBI/PTSD. Hypothesis 1a. In-person GMT+ATT will improve cognition vs. control group (Brain Health Workshop (BHW). Hypothesis 1b. Telehealth GMT+ATT will improve cognition vs. BHW control group Hypothesis 2. Telehealth delivery of GMT+ATT will produce response comparable to in-person treatment. Primary measure. The NIH EXAMINER executive composite score will assess overall executive function with subdomains such as complex task performance requiring goal management, as well as tests underlying cognitive control such as attention and working memory. Secondary functional measures. 1) Unstructured Task and 2) Test of Grocery Shopping Skills (ToGSS), which captures naturalistic real-world function. Exploratory Objective. To study the capability of the Attention Network Task to predict treatment response to GMT+ATT. Methods. 63 Veterans will be randomized to 10 weeks of in-person or telehealth delivery of GMT+ATT or BHW control. Outcomes will be assessed at pre-, post-, 6 month-post and 1-year post-treatment. GMT and ATT will each be provided in ten, weekly, 2-hour sessions (4hrs/week as combined). Significance. This study uses a novel combinational treatment of GMT+ATT to restore the executive and attentional processes required for complex daily tasks in Veterans with mTBI/PTSD. This work meets a key VA RR&D priority of providing quality care to Veterans. Positive study results may help shape clinical practice of cognitive rehabilitation in terms of treatment strategy, delivery platform, access to care, and means to predict treatment response. Such impacts will translate to significant cost-savings for the VA healthcare system and improvement in quality of life in Veterans.

背景 超过 70% 的退伍军人患有轻度创伤性脑损伤 (mTBI)，正在退伍军人医院寻求服务。 健康管理局称，这些退伍军人通常患有共病创伤后应激障碍（PTSD）。 在目标设定、注意力和注意力方面伴随执行功能障碍，从而损害了他们的能力 我们和其他人研究了目标管理培训（GMT），以提高在复杂日常任务中的表现。 总的来说，数据表明 GMT 改善了执行力的某些方面。 在 mTBI/PTSD 中发挥作用，但在复杂任务的目标管理中不能使认知恢复正常。 执行复杂的任务需要注意力等认知过程，而直接注意力训练可能是 其他研究中已经使用了 GMT 和注意力训练来提高认知能力，但这些研究并没有采用。 涉及患有 mTBI 或 mTBI/PTSD 的退伍军人 我们最近进行了一项结合 GMT 和 PTSD 的试点研究。 我们发现对患有 mTBI 和 PTSD 的退伍军人进行直接注意力训练 (GMT+ATT) 具有很大的治疗效果。 (Cohen d=2.23) 在 NIH Examiner Executive Composite 评分中的表现以及显着的治疗反应 NIH 检查员认知控制子域和非结构化任务。 GMT 或 ATT 通常是面对面进行的。面对面的治疗可能会带来诸如有限等问题。 治疗的可及性、成本效益差以及意外情况（例如 COVID-19 大流行）。 作为替代方法，远程医疗已越来越多地用于满足生活在农村的退伍军人的护理需求 地区和大流行期间为患有 mTBI 或患有 mTBI 的退伍军人提供认知干预。 PTSD 已显示出与面对面治疗相当的效果，但 GMT+ATT 却没有。 因此，我们最近开发了远程医疗服务的格式。 GMT+ATT 在患有 mTBI/PTSD 的退伍军人中的应用 我们的初步数据证明了这种交付的可行性。 与面对面治疗相比，平台和类似的治疗结果。 目的和假设 该随机对照试验的目的是确定和比较 GMT+ATT 现场和远程医疗服务对患有 mTBI/PTSD 的退伍军人的影响。 假设 1a。与对照组相比，现场 GMT+ATT 将改善认知能力（大脑健康研讨会 (BHW)。 假设 1b。与 BHW 对照组相比，远程医疗 GMT+ATT 将改善认知能力 假设 2：GMT+ATT 的远程医疗服务将产生与面对面治疗相当的反应。 NIH 执行综合评分将评估整体执行功能。 子域，例如需要目标管理的复杂任务性能以及底层测试 认知控制，例如注意力和工作记忆 1) 非结构化任务。 2）杂货购物技能测试（ToGSS），捕捉自然的现实世界功能。 目的：研究注意力网络任务预测 GMT+ATT 治疗反应的能力。 方法 63 名退伍军人将被随机分配接受 10 周的现场或远程医疗服务 GMT+ATT 或 BHW 控制结果将在治疗前、治疗后、治疗后 6 个月和治疗后 1 年进行评估。 ATT 将分别提供 10 次、每周 2 小时的课程（每周 4 小时）。 意义：本研究使用 GMT+ATT 的新型组合治疗来恢复执行力和执行能力。 患有 mTBI/PTSD 的退伍军人执行复杂的日常任务所需的注意力过程这项工作符合关键的 VA。 RR&D 优先考虑为退伍军人提供优质护理。积极的研究结果可能有助于塑造临床实践。 认知康复，包括治疗策略、实施平台、获得护理和预测手段 这些影响将转化为退伍军人管理局医疗保健系统的大量成本节省。 改善退伍军人的生活质量。