此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

CBT+ 治疗抑郁症 (CBT+)

2026年8月4日 更新者:University of Wisconsin, Madison

ActiveCBT 治疗抑郁症:通过运动启动改变治疗方法

本研究调查了一种新颖的干预方法的效果,即在治疗课程(即认知行为疗法 [CBT])之前有意安排有氧运动,以确定其对 CBT 抗抑郁作用背后的特定和常见因素的影响(即机制)的 CBT)。 为了评估这种治疗增强的效用,研究人员计划进行一项随机对照试验,涉及 40 名患有重度抑郁症的成年人,他们将在安静休息(称为“CalmCBT”)或中等强度运动(“ActiveCBT”)的同时观看自然纪录片。 )在每周 8 次 CBT 课程之前。 据推测,与 CalmCBT 相比,ActiveCBT 将更有效地发挥抗抑郁作用的目标 CBT 机制(即自我报告的工作联盟和行为激活)。

研究概览

详细说明

重度抑郁症 (MDD) 的一线治疗,包括认知行为疗法 (CBT),效果有限,一半患者对 CBT 没有反应,一半患者在 2 年内复发。 需要提高 MDD 治疗效力的策略。 我们正在测试一种新颖的治疗策略,使用有氧运动来启动随后的 CBT 课程(“ActiveCBT”)。 据推测,运动启动可以通过与抑郁结果相关的常见和特定因素,导致 CBT 作用机制的更多参与;这种 CBT 增强方法尚未经过实证检验。 该研究将包括一项为期 8 周的随机对照试验,受试者为 40 名患有 MDD 的成年人,在每周 CBT 课程之前进行 30 分钟的适度运动或安静休息(CalmCBT 与 ActiveCBT)。 使用时间和注意力匹配的控制,所有参与者都将在治疗前的 30 分钟内观看标准化纪录片系列,组间唯一的区别是锻炼或平静休息。 该项目还将通过 Lyssn 平台采用机器学习和自然语言处理来客观评估治疗期间使用的语言和词语。 总体目标是:1) 证明运动启动对目标 CBT 机制的影响,2) 将心理和神经可塑性运动启动与 CBT 机制联系起来,3) 探索 Lyssn 中基于机器学习的客观标记物对 ActiveCBT 引起的治疗差异的敏感性。 该试验将为后续验证性疗效试验建立可能性,以严格测试运动启动增强治疗的潜力。 如果这种创新的生物学方法成功地“启动”后续治疗,则可以用于增强其他治疗和其他疾病,从而显着改善心理健康治疗。

研究类型

介入性

注册 (实际的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Iowa
      • Ames、Iowa、美国、50010
        • Iowa State University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

纳入标准:

  • 诊断患有 DSM-5 MDD,并通过 SCID 确认。
  • 目前具有 HAM-D 评级≥8 定义的至少轻度严重程度的抑郁症状。
  • 年龄在 18 岁至 65 岁之间。
  • 要么不参与任何心理健康治疗(例如药物、心理或行为),要么采用稳定的心理健康治疗方案并愿意在干预期间维持该治疗方案。
  • 根据身体活动准备问卷,愿意且安全地进行锻炼。
  • 未接受 CBT(定义为从未接受过结构化 CBT)。

排除标准:

  • 目前正在怀孕、哺乳或计划怀孕,
  • 严重肥胖(BMI=40)
  • 通过 SCID 诊断患有终生或当前的精神病、躁狂症或双相情感障碍
  • 通过 SCID 诊断患有当前药物滥用障碍
  • 通过 C-SSRS 评估,构成自残或伤害他人的迫在眉睫的风险
  • 由临床研究人员评估,表现出会严重干扰研究参与的行为障碍(例如攻击性、轻度至中度认知障碍)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:主动认知行为治疗
治疗前,参与者将在固定自行车上完成 30 分钟的标准化锻炼。 参与者将在锻炼时观看 8 个标准化的 30 分钟自然纪录片视频之一。
治疗前,参与者将在固定自行车上完成标准化的 30 分钟有氧运动。 监督锻炼课程将包括中等强度的稳态锻炼,对应于感知锻炼的“13”或“有点困难”评级。 在整个运动过程中将持续监测心率、阻力/负荷和 RPE。 为了紧密配合各组,参与者还将在锻炼时观看 30 分钟的自然视频。
有源比较器:平静CBT
参与者将在治疗前安静休息时观看 8 个标准化的 30 分钟自然纪录片视频之一。
参与者将在治疗前安静休息时观看 8 个标准化的 30 分钟自然视频之一。 这些是情感中立的视频,将使两组参与者拥有相同的注意力和接触时间。

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Average Self-reported Working Alliance Measured by Working Alliance Inventory (WAI)
大体时间:Weeks 1-8 CBT+ visits
Working Alliance Inventory-Short Revised (WAI) is a 12-item survey on experiences over a therapy session and connection with a therapist. It consists of three subscales: tasks, goals, and therapist-client bond. The total range of scores is from 12-84 with higher scores indicating a better therapeutic alliance.
Weeks 1-8 CBT+ visits
Self-reported Behavioral Activation Measured by Behavioral Activation for Depression Scale (BADS)
大体时间:Intake, Weeks 1-8 CBT+ visits, Week 9 (Post-therapy), 12-week follow up, 1-year follow-up
The Behavioral Activation for Depression Scale (BADS) will be used to assess changes in behavioral activity. The scale is designed to be administered weekly to measure changes over the course of Behavioral Activation for depression. It consists of 25 questions that inquire about Activation, Avoidance/Rumination, Work/School Impairment, and Social Impairment. Each item is rated on a 7-point scale from 0 (Not at all) to 6 (Completely) with total scores ranging: 0-150 where higher scores indicate greater behavioral activation.
Intake, Weeks 1-8 CBT+ visits, Week 9 (Post-therapy), 12-week follow up, 1-year follow-up

次要结果测量

结果测量
措施说明
大体时间
Change in Clinician-rated Depression Symptoms Measured by GRID-Hamilton Depression Rating Scale (GRID-HAM-D) From Intake
大体时间:Intake, Week 9 (Post-therapy), 12-week follow up, 1-year follow up
The GRID-HAM-D is a clinician-completed questionnaire that will be used to rate depressive symptom severity. The questionnaire is designed for adults and is used to rate the intensity and frequency of depressive symptoms by probing mood, feelings of guilt, suicidal ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. As recommended by the Depression Rating Scale Standardization Team, Clinical Interviewers will follow the Structured Interview Guide and use GRID scoring, in which dimensions of intensity and frequency of a symptom are rated independently for each item. Total scores are calculated from each question and range from 0 to 52, with higher scores indicated greater depressive symptom severity.
Intake, Week 9 (Post-therapy), 12-week follow up, 1-year follow up
Change in Self-reported Depression Symptoms Measured by Patient Health Questionnaire-9 (PHQ-9) From Week 1
大体时间:Weeks 1-8 CBT+ visits, Week 9 (Post-therapy), 12-week follow up, 1-year follow-up
The Patient Health Questionnaire-9 (PHQ-9) is a 9-question self-report instrument used to assess presence and severity of depressive symptoms, with scores categorized 0-4, 5-9, 10-14, 15-19, and 20-27 as minimal, mild, moderate, moderately severe, and severe depression, respectively.
Weeks 1-8 CBT+ visits, Week 9 (Post-therapy), 12-week follow up, 1-year follow-up
MDD Diagnosis Measured by Structured Clinical Interview for DSM-5 Disorders (SCID)
大体时间:Intake, Week 9 (Post-therapy), 12-week follow up, 1-year follow up
The SCID is a clinician-administered semi-structured interview guide for making diagnoses according to the diagnostic criteria published in the American Psychiatric Association's Diagnostic and Statistical Manual for Mental Disorders (DSM-5). It provides diagnoses for inclusion and exclusionary diagnoses. Results show number of participants who meet criteria for Major Depressive Disorder (i.e., 'checked') or no longer meet criteria (i.e., 'unchecked').
Intake, Week 9 (Post-therapy), 12-week follow up, 1-year follow up
Average Anhedonia Measured by Dimensional Anhedonia Rating Scale (DARS)
大体时间:Weeks 1-8 CBT+ visits (repeated 3 times [before exercise/calm condition, immediately after exercise/calm condition, and after therapy])
The DARS is a self-report measure that assesses state anhedonia across multiple domains. DARS is a 17-item survey on state anhedonia divided into four domains: hobbies, food/drink, social activities, and sensory experiences. Subjects must list two activities within each of these categories that they consider their favorite and then respond to questions regarding their interest in/enjoyment of those activities on a 5-point Likert scale from "Not at all" (0) to "Very much" (4), with total scores ranging from 0 to 68, with higher scores representing reduced anhedonia.
Weeks 1-8 CBT+ visits (repeated 3 times [before exercise/calm condition, immediately after exercise/calm condition, and after therapy])
Average Anhedonia Measured by an Anhedonia Visual Analogue Scale (Anhedonia VAS)
大体时间:Weeks 1-8 CBT+ visits (repeated 3 times [before exercise/calm condition, immediately after exercise/calm condition, and after therapy])
An anhedonia Visual Analog Scale [VAS] with 0 indicating 'No pleasure at all' and 100 indicating 'Greatest pleasure imaginable' will be used to measure anhedonia. The VAS will be used to provide a supplementary assessment of anhedonia.
Weeks 1-8 CBT+ visits (repeated 3 times [before exercise/calm condition, immediately after exercise/calm condition, and after therapy])
Serum Brain Derived Neurotrophic Factor (BDNF)
大体时间:Weeks 1, 4, and 8 CBT+ visits (before exercise/calm condition, immediately after exercise/calm condition, and after therapy)
Serum BDNF will be quantified from a standard blood draw. Blood samples collected during Visits 1, 4, and 8 will be allowed to clot for 30 minutes and then centrifuged for ten minutes at 5500 RPM and 4 ◦C. Following centrifugation, blood serum will be extracted with samples stored at -80 ◦C until BDNF analysis. Enzyme-linked immunosorbent assay (ELISA) kits will measure the concentration of total BDNF in the serum according to the manufacturer's instructions. Each blood sample will be run in duplicate and averaged.
Weeks 1, 4, and 8 CBT+ visits (before exercise/calm condition, immediately after exercise/calm condition, and after therapy)
Change in Anxiety Measured by Generalized Anxiety Disorder 7 (GAD-7) From Intake
大体时间:Intake, week 4 CBT+ visit, Week 9 (Post-therapy), 12-week follow up, 1-year follow up
Generalized Anxiety Disorder 7 (GAD-7) is a self-reported questionnaire for measuring generalized anxiety disorder. GAD-7 has seven items, which measure the severity of various signs of GAD according to reported response categories of: Not at all (0 points), Several days (1 point), More than half the days (2 points), and Nearly every day (3 points). A total score is calculated ranging from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Intake, week 4 CBT+ visit, Week 9 (Post-therapy), 12-week follow up, 1-year follow up
Average Automatic Thoughts Measured by Automatic Thoughts Questionnaire (ATQ)
大体时间:Intake, weeks 1-8 CBT+ visits, Week 9 (Post-therapy), 12-week follow up, 1-year follow-up
The ATQ is a 30-item instrument that measures the frequency of automatic negative statements about the self. Each item is rated on the frequency of an occurrence from "not at all" to "all the time". Total scores are the sum of all 30 items (ranging 30-150), with higher totals indicating a higher level of automatic negative self-statements.
Intake, weeks 1-8 CBT+ visits, Week 9 (Post-therapy), 12-week follow up, 1-year follow-up
Average Session Effectiveness Measured by Session Evaluation Questionnaire (SEQ)
大体时间:Weeks 1-8 CBT+ visits
Session Evaluation Questionnaire (SEQ) will be used to evaluate session effectiveness. This includes responses to twenty-one items in a 7-point bipolar adjective format questionnaire to assess how the client feels about each CBT session. The questionnaire assesses session depth, smoothness, positivity, and arousal. An overall score of the subscales will be used in this study (ranging 7-28). Higher scores indicate more favorable session evaluations.
Weeks 1-8 CBT+ visits

其他结果措施

结果测量
措施说明
大体时间
自然关联指数 (NCI)
大体时间:摄入量,第 1、4 和 8 周 CBT+ 就诊(运动/平静状态前、运动/平静状态后立即以及治疗后)
NCI 包含 6 个与自然连通性相关的问题。 参与者使用 7 点李克特量表进行回答,范围从 1(非常不同意)到 7(非常同意),分数越高表明自然联系程度越高。
摄入量,第 1、4 和 8 周 CBT+ 就诊(运动/平静状态前、运动/平静状态后立即以及治疗后)
健康史问题
大体时间:录取
健康史将被自我报告。 此外,参与者将被要求列出他们当前的药物。
录取
人口统计调查问卷
大体时间:录取
将记录或测量人口特征,包括年龄、性别、种族、教育、婚姻状况、职业状况和家庭收入,以表征样本。
录取
不良童年经历调查(ACES)
大体时间:录取
ACES 包含 16 个问题,涉及受访者生命的前 18 年。 参与者对于是否发生儿童不良事件回答“是”或“否”。 不良事件问题按类别分组。 参与者会针对他们所接触的每个事件类别进行评分,分数范围从 0(未接触)到 7(接触所有类别)。
录取
Average Lyssn Generated Scores
大体时间:Weeks 1-8 CBT+ visits
Lyssn is an AI-powered assessment platform for recording and managing session files, and all clinical interviews and therapy sessions will be recorded on the Lyssn platform. Lyssn will process the audio files from therapy sessions to generate session-level data regarding collaboration and empathy as metrics related to the primary client ratings of working alliance, as well as generating CTRS fidelity metrics which will be used in the ongoing supervision and fidelity monitoring of all sessions.
Weeks 1-8 CBT+ visits
Change in Monitor-assessed Physical Activity Measured by Accelerometry
大体时间:Intake, weeks 4 & 8 CBT+ visits (monitors worn 1 week following each time point)
Participants will place an activPAL on the midline of the thigh on either leg and wear the monitor during all waking hours, removing it only for water-based activities (e.g., swimming). For data to be valid, the monitor must have been worn for 20 hours on at least 4 days, including a minimum of 3 weekdays and 1 weekend day. Sleep time will be parsed out from each day's sitting/lying time automatically using PALanalysis. From these data, average minutes of sitting per day will be used to assess total sedentary time, minutes of stepping time with a cadence ≥75 and <100 will be used to assess minutes of light-intensity physical activity and minutes of stepping time with a cadence ≥100 will be used to assess minutes of moderate to vigorous physical activity (MVPA).
Intake, weeks 4 & 8 CBT+ visits (monitors worn 1 week following each time point)
Change in Quality of Life Measured by the 36-Item Short Form Health Survey (SF-36)
大体时间:Intake, week 4 CBT+ visit, Week 9 (Post-therapy), 12-week follow up, 1-year follow up
The SF-36 assesses health-related quality of life. It consists of eight scaled scores (including vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The higher the score the less disability (i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability).
Intake, week 4 CBT+ visit, Week 9 (Post-therapy), 12-week follow up, 1-year follow up
Change in Self-reported Physical Activity Measured by the International Physical Activity Questionnaire - Short Form (IPAQ-SF)
大体时间:Intake, week 4 CBT+ visit, Week 9 (Post-therapy), 12-week follow up, 1-year follow up
The IPAQ is a physical activity questionnaire that inquires about average amounts of walking, moderate physical activity, vigorous physical activity, and sitting time per week.
Intake, week 4 CBT+ visit, Week 9 (Post-therapy), 12-week follow up, 1-year follow up
Change in Suicidal Thoughts Measured by the Columbia-Suicide Severity Rating Scale (CSSRS)
大体时间:Intake, weeks 1-8 CBT+ visits, Week 9 (Post-therapy), 12-week follow up, 1-year follow-up
The C-SSRS will be used to assess and monitor suicide ideation and behavior. The severity of the ideation subscale is rated on a 5-point ordinal scale: 1 = wish to be dead, 2 = nonspecific active suicidal thoughts, 3 = suicidal thoughts with methods, 4 =suicidal intent, and 5 = suicidal intent with plan. Suicide behaviors are rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and non-suicidal,self-injurious behavior.
Intake, weeks 1-8 CBT+ visits, Week 9 (Post-therapy), 12-week follow up, 1-year follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年9月1日

初级完成 (实际的)

2025年6月1日

研究完成 (实际的)

2025年6月1日

研究注册日期

首次提交

2023年8月14日

首先提交符合 QC 标准的

2023年8月14日

首次发布 (实际的)

2023年8月21日

研究记录更新

最后更新发布 (实际的)

2026年8月26日

上次提交的符合 QC 标准的更新

2026年8月4日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • 1R61MH129407 (美国 NIH 拨款/合同)
  • 1R61MH129407-01A1 (美国 NIH 拨款/合同)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅