Novel neural circuit biomarkers of depression response to computer-augmented CBT

计算机增强 CBT 抑郁反应的新型神经回路生物标志物

基本信息

批准号：
9908160
负责人：
YVETTE I SHELINE
金额：
$ 55.06万
依托单位：
UNIVERSITY OF PENNSYLVANIA
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-06-05 至 2022-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9908160
关键词：
Adult Algorithms Ambulatory Care Facilities American Amygdaloid structure Anterior Antidepressive Agents Biological Markers Brain Caring Clinical Clinical Management Clinical Trials Cognitive Cognitive Therapy Computer Models Computers Conflict (Psychology)Consumption Control Groups Coping Behavior Data Depressed mood Diagnosis Disease Dorsal Emotional FDA approved Future Hour Image Individual Inferior frontal gyrus Lateral Magnetic Resonance Imaging Major Depressive Disorder Measures Mental Depression National Institute of Mental Health Outcome Outpatients Participant Patients Pennsylvania Placebos Population Prefrontal Cortex Protocols documentation Psychological Tests Randomized Recovery Research Personnel Rest Risk Site-Directed Mutagenesis Structure Thick Thinking Time Training Treatment Efficacy Treatment outcome Universities University Hospitals Variant Waiting Lists Work active method base cingulate cortex clinical decision support computer program computerized cost cost effective effective therapy efficacy testing evidence base executive function functional MRI scan improved negative affect neural circuit novel novel marker programs recruit reduce symptoms rehearsal response skills training treatment effect treatment response

项目摘要

Every year more than 20% (55 million) of the adult American population suffers from major depression. (MDD). While effective treatments are available, depression remains under-diagnosed and under-treated, in part due to cost and availability of treatment. In the current application in response to NIMH NOT-14-007 we propose a clinical trial to study potential novel biomarkers of depression treatment response rather than to test efficacy of an efficient, cost-effective form of computer-augmented cognitive behavioral therapy (CCBT) which already has proven efficacy. We present pilot data supporting CBT-induced improvements in functional connectivity and task-induced activation in MDD. We also have found in previous work that this model of CCBT, known as Good Days Ahead (GDA), has efficacy for MDD that is not inferior to conventional individual CBT therapy across 8 and 16 weeks of treatment, despite reducing average therapist contact from 16 hours to less than 5 hours. We now propose that this new variation of cognitive therapy, which substitutes intensive, computer- administered skills training for hours of therapist contact, will engage the same brain targets we have previously seen with CBT. We hypothesize that it is rehearsal time during which an individual actively engages in corrective skills training that “mends” the brain connectivity and promotes recovery. We will recruit a total of 60 patients with MDD and 40 matched comparison healthy participants from the outpatient clinics of the Hospitals of the University of Pennsylvania. To take into account the impact of nonspecific factors, half of the MDD participants will be randomized to receive CCBT immediately after baseline assessments and half will first receive 8 weeks of Depression Care Management (DCM) (a clinically responsible alternative to a traditional wait-list control group that includes support and clinical management) before subsequently receiving CCBT. Aim 1: Compare baseline resting state functional connectivity and task-induced activity between MDD and controls. Aim 2: Assess CCBT treatment effects on resting state functional connectivity and task- induced activation in MDD comparing CCBT-treated participants to DCM –treated participants. Exploratory Aim: 1a:Predict the effects of baseline imaging measures on treatment outcomes; 1b: Predict the effects of baseline executive function on treatment outcomes.

每年有超过 20%（5500 万）的美国成年人患有重度抑郁症 (MDD)。尽管有有效的治疗方法，但抑郁症的诊断和治疗仍然不足，部分原因是在当前响应 NIMH NOT-14-007 的申请中，我们提出了一项治疗费用和可用性。临床试验旨在研究抑郁症治疗反应的潜在新型生物标志物，而不是测试其疗效一种高效、经济的计算机增强认知行为疗法（CCBT）我们提供了支持 CBT 引起的功能连接改善的试点数据。我们在之前的工作中也发现了这种 CCBT 模型，称为 MDD 中的任务诱导激活。 Good Days Ahead (GDA)，对MDD的疗效不逊色于传统个体CBT疗法尽管治疗师的平均接触时间从 16 小时减少到不到 5 小时，但在 8 周和 16 周的治疗中我们现在提出这种新的认知疗法，它取代了强化的、计算机治疗。与治疗师接触数小时的管理技能培训，将涉及我们拥有的相同大脑目标我们之前在 CBT 中看到过，这是一个人积极参与的排练时间。我们将招募一批能够“修复”大脑连接并促进康复的纠正技能培训。 60 名 MDD 患者和 40 名来自该诊所门诊的匹配健康对照参与者宾夕法尼亚大学医院考虑到非特异性因素的影响，一半。 MDD 参与者将在基线评估后立即随机接受 CCBT，其中一半将首先接受 8 周的抑郁症护理管理 (DCM)（一种临床上负责任的替代疗法）传统的等候名单对照组，包括支持和临床管理），然后再接受 CCBT。目标 1：比较 MDD 之间的基线静息状态功能连接和任务诱发活动目标 2：评估 CCBT 治疗对静息状态功能连接和任务的影响。将 CCBT 治疗的参与者与 DCM 治疗的参与者进行 MDD 诱导激活比较。探索性目标：1a：预测基线影像测量对治疗结果的影响；1b：预测基线执行功能对治疗结果的影响。