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％的退伍军人受到轻度创伤性脑损伤（MTBI），寻求退伍军人的服务 卫生管理，患有创伤后应激障碍（PTSD）。这些退伍军人通常 在目标设定，集中注意力和注意力中经历伴随的执行功能障碍，从而损害了他们的 在复杂的日常任务中的性能。其他人，我们已经研究了目标管理培训（GMT） 解决这个问题。总体而言，数据表明，GMT改善了高管的某些方面 在MTBI/PTSD中的功能，但在复杂的任务过程中没有使认知恢复正常。目标管理 执行复杂的任务需要认知过程，例如注意力，直接注意培训可能是 有益于改善认知。在其他研究中使用了GMT和注意力训练的GMT，但是 参与MTBI或MTBI/PTSD的退伍军人。我们最近进行了一项试点研究，结合了GMT和 MTBI和PTSD的退伍军人的直接注意培训（GMT+ATT）。我们发现了很大的治疗效果 （Cohen d = 2.23）在NIH审查员执行复合评分中，在 NIH审查员认知控制子域和非结构化任务。 GMT或ATT通常是面对面管理的。面对面的治疗可能会引起诸如有限的问题 治疗访问，成本效益差和意外情况（例如COVID-19大流行）。作为 替代方法，远程医疗已被越来越多地用于满足居住在农村的退伍军人的护理需求 区域和大流行期间。通过MTBI或与 PTSD显示出有效性，与亲自治疗相当。但是，GMT+ATT还没有 我们是这些退伍军人的研究。因此，我们最近开发了远程医疗交付的格式 MTBI/PTSD的退伍军人GMT+ATT。我们的初步数据证明了此交付的可行性 与面对面疗法相比，平台和类似的治疗结果。 客观和假设。这项随机对照试验的目的是确定和比较 MTBI/PTSD在退伍军人中的面对面和远程医疗交付的影响。 假设1a。面对面的GMT+ATT将改善认知与对照组（大脑健康研讨会（BHW）。 假设1b。远程医疗GMT+ATT将改善认知与BHW对照组 假设2。GMT+ATT的远程医疗提供将产生与面对面治疗相当的反应。 主要措施。 NIH审查员执行复合分数将通过 子域，例如需要目标管理的复杂任务绩效以及基础测试 认知控制，例如注意力和工作记忆。次级功能度量。 1）非结构化任务 2）杂货店购物技能测试（TOGS），可捕获自然主义的现实世界功能。探索性 客观的。研究注意网络任务的能力，以预测对GMT+ATT的治疗反应。 方法。 63名退伍军人将被随机分配到GMT+ATT或远程医疗10周或 BHW控制。结果将在治疗后，后，6个月和1年后进行评估。 GMT and ATT will each be provided in ten, weekly, 2-hour sessions (4hrs/week as combined). 意义。 This study uses a novel composite 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 治疗反应。 Such impacts will translate to significant cost-savings for the VA healthcare system and improvement in quality of life in Veterans.