跨诊断个体行为激活和暴露疗法
青少年跨诊断行为激活和暴露疗法的随机临床试验:效果和中介的比较
研究概览
详细说明
焦虑和单相抑郁会导致严重衰弱,并且通常在青少年中同时发生,在 13-14 岁的青少年中,严重抑郁症或心境恶劣的终生患病率估计为 8.4%,任何焦虑症的终生患病率为 31.4%(Merikangas 等人,2010 年) . 认知和行为疗法 (CBT) 在减轻青少年痛苦方面得到了强有力的支持(Silverman、Pina 和 Viswesvaran,2008 年;David-Ferdon 和 Kaslow,2008 年),但焦虑症的疗效峰值约为 50-70%,而抑郁症的疗效率则较低. 越来越多的证据表明,同时解决多个问题的“跨诊断”行为疗法可以通过针对共同出现的问题(如焦虑和抑郁)的潜在机制来提高治疗效果(Chu、Temkin 和 Toffey,2016 年;Temkin、Yadegar , Laurine, & Chu, 出版中)。 此外,整合的跨诊断治疗方案可以提供相同水平的临床益处,同时以更有效的方式提供活性成分,这可以提高治疗效率,并有可能在未来更容易培训新手临床医生(Chu,2012 年;Ehrenreich 和 Chu, 2013)。 虽然成人疾病的证据基础在增加,但跨诊断干预在儿童和青少年人群中的研究较少。 我们的团队已经证明了基于学校的小组跨诊断干预的有效性,该干预利用行为激活 (BA) 和暴露疗法来解决中学生的焦虑和抑郁问题(Chu、Crocco、Esseling、Areizaga、Lindner 和 Skriner, 2016 年)。 BA 指的是一系列干预措施,这些干预措施教会青少年如何评估哪些压力源会触发他们生活中的回避应对反应(即功能评估),并学习如何通过主动解决问题的策略来解决问题。 暴露疗法是指一系列行为干预措施,通过鼓励和加强与使个人感到恐惧的情况的接触来培养新的学习倾向。 这两套策略在治疗青少年焦虑和抑郁方面都得到了大力支持。 Chu 等人(2016 年)的试验表明,这两种治疗成分可以结合使用,并有效治疗报告焦虑或抑郁的青年样本。
楚等人。 (2016) 研究是新颖的,因为大多数形式的循证治疗都被设计为“单一疾病”方案,因此干预措施旨在一次针对一个临床问题。 目前的试验采取了以下创新步骤。 该研究将:(a) 改编 Chu 等人。将基于群体的协议转换为个人格式,(b) 在临床门诊环境中提供该计划,以及 (c) 利用三种比较条件,包括等候名单控制和两种积极的心理干预。 这两种积极的干预措施将是单一障碍认知行为疗法 (CBT),旨在专门解决青年抑郁症(主要和次要控制增强疗法;PASCET;Weisz、Thurber、Sweeney、Proffitt 和 LeGagnoux,1997 年)或青年焦虑症( Coping Cat;肯德尔,1994 年;肯德尔等人,1997 年)。 两者都在文献中获得了大量支持,以支持简短的个人格式(12-16 周)的临床改进。 通过将个体行为激活疗法 (IBAT) 与这些积极干预措施进行比较,该研究旨在证明 (a) 优于等待名单控制的治疗结果,(b) 与 PASCET 和 Coping Cat 相当的治疗结果,以及 (c) 差异四个条件下的中介效应。 调查结果将为 IBAT 的可行性、可接受性和有效性提供支持,并为其所谓的变革调解人提供概念支持。
当前的研究是一项随机对照试验 (RCT),比较了一种新型行为干预(个体行为激活疗法,IBAT)与两种既定的认知行为干预(Coping Cat,PASCET)和 14 周候补名单 (WL) 对照。 参与者将是 160 名被诊断为诊断和统计手册 - 第 5 版(DSM-5;APA,2013 年)焦虑症或抑郁症的青少年(9-16 岁)及其护理人员。 参与者将被随机分配到四个条件中的每一个。 该研究打算在 2.5 年内招募参与者,并在 3 年内完成所有积极参与者的参与。
具体目标包括:
目标 1 - 治疗效果:评估 IBAT、PASCET、CC 和 WL 条件下治疗效果在治疗前、中期和治疗后的差异,重点关注关键诊断和症状结果(即 CGI、主要诊断存在到不存在和临床严重程度、RCADS 焦虑和抑郁评分、MASC、CESD)。
假设 1:IBAT 将产生优于 14 周 WL 控制的结果
假设 2:三种积极的治疗条件(IBAT、PASCET、CC)将证明优于 14 周 WL 控制的治疗结果,但彼此之间没有差异。
目标 2 - 调解员分析:与 14 周 WL 相比以及相互比较,检查推定调解员在解释积极治疗(IBAT、CC、PASCET)的效果时的强度。 推定的调解人将包括多个领域:(a) 青少年社会情感功能(认知、行为和情感反应),(b) 通过计算机任务评估的压力容忍度,(c) 家庭环境和互动,(d) 照顾者压力和功能,(e)客户和治疗师对心理治疗过程的看法,(f)生态瞬时评估和被动传感器数据。
假设 3:与 WL 对照相比,每个域都将证明为每个治疗提供重要的中介。
假设 4:认知调解员将证明对 CC 和 PASCET 治疗效果提供显着调解,但不一定对 IBAT 有效。
假设 5:压力耐受性将证明为 IBAT 治疗效果提供重要的中介,但不一定对 CC 或 PASCET。
目标 3. 注意在青少年焦虑和抑郁诊所接受的治疗之外,家庭寻求的额外青少年心理健康服务和辅助服务的模式。
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Brian C Chu, Ph.D.
- 电话号码:848-445-3905
- 邮箱:yadc@gsapp.rutgers.edu
学习地点
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New Jersey
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Piscataway、New Jersey、美国、08854
- 招聘中
- Youth Anxiety and Depression Clinic
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接触:
- Brian Chu, PhD
- 电话号码:848-445-3905
- 邮箱:yadc@gsapp.rutgers.edu
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
我们预计 200 名患有原则性焦虑症 (n=100) 或单相抑郁症 (n=100) 的青少年(9-17 岁)及其父母/照顾者将作为参与者。
纳入标准:
要参与,青少年必须符合以下任何一项的主要 DSM-5(美国精神病学协会,2003 年)诊断标准:
- 广泛性焦虑症 (GAD)
- 分离焦虑症 (SEP)
- 社交焦虑症(SAD)
- 特定恐惧症(SP)
- 恐慌症 (PD)
- 广场恐惧症
- 重度抑郁症 (MDD)
- 抑郁症 - 症状不足(DD-不足)
- 持续性抑郁症 (PDD)
共病(非主要)疾病是可以接受的,包括存在上面未列出的疾病。 诊断将基于独立评估员 (IE) 半结构化访谈期间青少年和家长的报告。 如果出现以下情况,青少年也可能参与这些疾病的亚临床诊断:(a) 青少年表现出足够的症状,但尚未达到临床损伤水平,或者 (b) 青少年仅表现出与上述疾病相关的几种症状,但表现出临床症状障碍,并且 (c) 同意的父母同意焦虑或情绪问题适合作为治疗的临床重点。 允许青少年进行亚临床诊断将使该研究能够调查各种临床严重程度的疗法的有效性。 这种设计模拟了通常的社区护理,在这种情况下,严重程度范围更大,许多年轻人可能不符合正式诊断的所有标准。 在 T1 接受初步诊断评估后,父母必须同意,青少年必须同意继续参与研究,包括随机分配到治疗条件,并且必须愿意在青少年焦虑和抑郁诊所 (YAD-C) 接受心理治疗),罗格斯大学应用与专业心理学研究生院 (GSAPP) 门诊部的一项专业课程。
排除标准:
患有除上述焦虑症或抑郁症之一以外的主要 DSM-5 障碍(例如,神经性厌食症、创伤后应激障碍、注意力缺陷多动障碍)或已接受以下任何诊断的青少年:
- 智力残疾
- 自闭症谱系障碍
- 精神分裂症
- 躁郁症。
表现出自杀意念或意图(根据儿童或父母报告)严重到需要当前住院治疗的青少年,或在过去 3 个月内企图自杀的青少年,也将被排除在外。 这些临床问题需要 YAD-C 不准备提供的专门治疗。 青年人不会因性别或种族/族裔出身而被排除在外。 但是,青少年和至少一位家长将被要求能说足够的英语,以便用英语完成学习程序和调查。 将要求参与者在研究期间不要进行任何其他门诊心理治疗;这对于提高研究的内部有效性并符合最佳临床实践以避免相互冲突的治疗建议很重要。 但是,当前使用抗抑郁药或抗焦虑药不会被排除在外。 在研究开始之前,将要求参与者在与他们的主治医师或精神科医生协商后确定稳定的药物剂量和时间表。 在研究参与期间将评估药物和任何其他治疗方式的使用,并在治疗和 WL 条件下进行比较。
学习计划
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:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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其他:主要焦虑症
患有主要焦虑症的青少年
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IBAT 是一种基于手册的个人行为激活加暴露疗法,旨在治疗患有焦虑、抑郁和愤怒的青少年。
该计划包括每周 10-14 节 60 分钟的课程。
它使用行为激活 (BA) 策略,通过对众多生活领域(包括家庭和同伴互动、学校、课外活动以及健康和自我保健)的功能评估,帮助青少年识别他们生活中的障碍点,从而达到回避目标。
“应对猫”计划(Kendall & Hedtke,2006 年;Kendall、Choudhury、Hudson 和 Webb,2002 年)在儿童(9-13 岁)和青少年(12-17 岁)中的疗效得到了大量实证支持) (Kendall, 1994; Kendall et al., 1997; Kendall et al., 2008) 并涉及 (1) 教孩子们识别他们自己的焦虑情绪和焦虑的生理迹象,(2) 教孩子们识别他们自己的焦虑-激发认知,(3) 制定一个指导应对的计划——一个涉及改变孩子的想法(变成积极的自我对话)和行动(变成自我发起的暴露)的计划,以及 (4) 自我评价和自我奖励。
在为期 14 周的 WL 期间,分配到 14 周 WL 的青少年将不会从研究治疗师那里获得任何特定的治疗服务。
但是,参与者将被指派一名 WL 联络员,在临床恶化的情况下,家属可以联系该联络员。
联络员还将负责发送链接并监督每周和中期 WL 在线调查 (Qualtrics) 的完成情况。
独立评估员将在 14 周的 WL 结束时进行 WL 后诊断访谈。
WL 参与者将因完成评估而获得补偿。
完成 WL 后,将邀请参与者继续研究,并随机分配到三种行为治疗(IBAT、PASCET 或 Coping Cat)中的一种。
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其他:主要抑郁症
患有主要单相抑郁症的青少年
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IBAT 是一种基于手册的个人行为激活加暴露疗法,旨在治疗患有焦虑、抑郁和愤怒的青少年。
该计划包括每周 10-14 节 60 分钟的课程。
它使用行为激活 (BA) 策略,通过对众多生活领域(包括家庭和同伴互动、学校、课外活动以及健康和自我保健)的功能评估,帮助青少年识别他们生活中的障碍点,从而达到回避目标。
在为期 14 周的 WL 期间,分配到 14 周 WL 的青少年将不会从研究治疗师那里获得任何特定的治疗服务。
但是,参与者将被指派一名 WL 联络员,在临床恶化的情况下,家属可以联系该联络员。
联络员还将负责发送链接并监督每周和中期 WL 在线调查 (Qualtrics) 的完成情况。
独立评估员将在 14 周的 WL 结束时进行 WL 后诊断访谈。
WL 参与者将因完成评估而获得补偿。
完成 WL 后,将邀请参与者继续研究,并随机分配到三种行为治疗(IBAT、PASCET 或 Coping Cat)中的一种。
主要和次要控制增强疗法(PASCET;Weisz、Southam-Gerow、Gordis 和 Connor-Smith,2003 年;Weisz、Southam-Gerow 等人,2009 年;Weisz、Thurber、Sweeney、Proffitt 和 LeGagnoux,1997 年)是一个简短的(通常为 11-15 节课)CBT 计划,针对通常 8-15 岁的抑郁症青少年。
课程和练习作业是建立在关于青少年抑郁症的认知和行为特征以及有益治疗的发现之上的(例如,Lewinsohn 等人,1990 年;Stark 等人,1987 年),以及感知控制的双过程模型和应对 (Rothbaum, Weisz, & Snyder, 1982; Weisz et al., 1984a,b)。
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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 |
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临床整体印象严重程度 (CGIS) 量表的变化:独立评估员
大体时间:从治疗前到治疗后的变化(基线到 14 周)
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CGI-S 评分提供了从 1(完全没有生病)到 7(极度生病)的基线严重程度的全球评分,而 CGI-I 提供了从 1(非常好改善)到 7 的临床改善的全球评分(非常糟糕)。
IE 将在治疗前和治疗后为每位患者提供基线 CGI 评级。
在治疗后结束时接受 IE 的 CGI-I 评级为 1(非常大改善)或 2(大大改善)的受试者将被视为治疗反应者。
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从治疗前到治疗后的变化(基线到 14 周)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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行为激活的变化
大体时间:从治疗前到治疗后的变化(基线到 14 周)
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BADS-Y 是成人 BADS(Kanter 等人,1997 年;Kanter 等人,1999 年)的 26 项改编版,评级为“0”(完全没有)到“6”(完全),旨在评估行为激活和回避的水平。
成人版的因子分析检测到四个因子:激活、回避/反刍、工作/学业障碍和社会障碍),具有良好的因子结构、内部一致性和重测信度。
规范性数据也在成人社区样本中收集。
BADS-A 适用于当前的研究,以反映适合发展的阅读水平和概念。
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从治疗前到治疗后的变化(基线到 14 周)
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儿童自动思维量表-消极/积极
大体时间:从治疗前到治疗后的变化(基线到 14 周)
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CATS 是一个包含 50 个项目的儿童报告测量,旨在评估儿童和青少年的消极和积极的自我陈述。
CATS 是在广泛年龄段的青年(7 - 16 岁)中开发和验证的,发现它可以有效地区分非临床青年和临床焦虑、抑郁和行为障碍的青年。
验证性因素分析支持四个不同但密切相关的因素,这些因素与对身体威胁、社会威胁、个人失败和敌意的自动思考有关。
总分和子量表的内部一致性很高 (α > .85)
1 个月和 3 个月的重测信度是可以接受的 (r = .91)。
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从治疗前到治疗后的变化(基线到 14 周)
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合作者和调查者
调查人员
- 首席研究员:Brian C Chu, Ph.D.、Rutgers University (Youth Anxiety and Depression Clinic)
出版物和有用的链接
一般刊物
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- Kazdin, A. E. (1992). Research Design in Clinical Psychology, 2nd Ed. Needham Heights, MA: Allyn & Bacon.
- March, J. S. (1997). Multidimensional Anxiety Scale for Children: Technical Manual. North Tonawanda, NY: Multi-Health Systems, Inc.
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