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通过Internet提供的情绪障碍的个性化的,基于响应的转诊干预的功效:适应性试验的协议

2026年5月21日 更新者:Universitat Jaume I
这项自适应随机对照试验评估了针对患者的早期临床反应量身定制的转诊,互联网延伸的心理干预的疗效。 366名具有临床意义抑郁症症状和/或焦虑症状的成年人将开始一个12模块自我应用程序。 基于前三个模块后的Sympron减少,参与者将被归类为早期或晚期响应者,并将其随机分为不同的实验组。 主要假设是混合格式(自我应用的模块以及与治疗师同步会议)将为晚期响应者带来更好的结果。 结果包括减轻症状,情绪调节和基于互联网的疗法联盟。

研究概览

详细说明

为了评估其有效性,将比较两种格式:原始格式由12个自我管理模块和一种混合格式组成,其中包括两个与训练有素的治疗师的同步课程。 早期的响应者将继续进行原始干预或停止治疗;虽然晚期响应者将获得混合格式或继续进行原始干预。 与自我应用格式相比,预期的主要结果是,混合形式将改善晚期响应者的治疗结果。 这些发现有望通过强调评估症状反应的重要性来为临床实践提供依据,尤其是在其早期阶段

研究类型

介入性

注册 (估计的)

366

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。

学习联系方式

  • 姓名:Fernanda Longo Elia, Psychologist
  • 电话号码:+541159643668
  • 邮箱:FERLONGO1@GMAIL.COM

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:

  • 西班牙语者
  • PHQ 9分数 + 5
  • GAD 7分数 + 5
  • 访问互联网
  • 电子邮件

排除标准:

  • 严重的精神障碍:精神分裂症/躁郁症
  • 活跃的药物滥用
  • 高自杀风险
  • 正在进行的心理/药理治疗
  • 干扰身体疾病

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:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:早期响应者自我应用完成
是通过互动多媒体平台提供的情绪障碍的手动治疗方法。 自动应用格式由12个自动应用模块(心理教育,情感处理,认知灵活性训练,暴露,应对策略,适应不良行为,避免等)组成)
实验性的:早期响应者自我应用中断
是通过互动多媒体平台提供的情绪障碍的手动治疗方法。 自动应用格式由12个自动应用模块(心理教育,情感处理,认知灵活性训练,暴露,应对策略,适应不良行为,避免等)组成)
实验性的:已故的响应者自我应用
是通过互动多媒体平台提供的情绪障碍的手动治疗方法。 自动应用格式由12个自动应用模块(心理教育,情感处理,认知灵活性训练,暴露,应对策略,适应不良行为,避免等)组成)
实验性的:已故响应者混合了
Hybrid format: 12 self applied modules with two synchronous videoconference sessions with a trained therapist

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
Clinical Outcomes in Routine Evaluation (CORE-34, Evans et al., 2002)
大体时间:Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1
Is a self report questionnaire designed to assess psychological distress and global functioning across four domains: subjective well being, problems/symptoms, functioning and risk. Items are rated on a 5 point Likert scale. The instrument has demostrated good psychometrics properties. Higher scores indicate greater psychological distress.
Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1
Clinical Outcomes in Routine Evaluation 10 (CORE 10, Barkham et al., 2013)
大体时间:Day 1 (BL) Week 1, 2, 4, 5, 7, 8, 10, 11
Is a Self-report 10-items questionnaire with 5 Likert response options. Assess general distress. Validated for Spanish speaking population with adequate internal consistency, convergent validity and sensitivity to change.
Day 1 (BL) Week 1, 2, 4, 5, 7, 8, 10, 11

次要结果测量

结果测量
措施说明
大体时间
Difficulties in Emotion Regulation Scale (DERS, Gratz & Roemer, 2004)
大体时间:Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1
Self- report 28-items questionnaire with 5 Likert response options. The scale assesses emotion regulation process and several difficulties associated. Adapted and validated in Spain with sound psychometric properties reported -internal consistency, test-retest reliability, convergent and incremental validity.
Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1
Inventory of Interpersonal Problems (IIP32, Horowitz, 2000)
大体时间:Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1
Is is a self-report questionnaire designed to assess interpersonal difficulties experienced over the past month. It covers eight dimensions of interpersonal functioning (e.g., being too controlling, socially inhibited, or self-sacrificing). Each item is rated on a 5-point Likert scale. The IIP-32 is a widely validated and efficient tool for identifying interpersonal patterns relevant to psychological distress and treatment planning.
Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1
Overall Anxiety Severity and Impairment Scale (OASIS; Norman et al., 2006)
大体时间:Day 1 (BL) Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 Week 25 Year 1
Self-report 5-item questionnaire that assesses frequency and severity of anxiety symptoms during the previous week. With 5 Likert response options (from 0 to 4). Adapted in Spain with good internal consistency (α = .86) and test-retest reliability (k= .84)
Day 1 (BL) Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 Week 25 Year 1
Overall Depression Severity and Impairment Scale (ODSIS; Bentley et al., 2014)
大体时间:Day 1 (BL) Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 Week 25 Year 1
Self-report 5-item questionnaire with 5 Likert response options (from 0 to 4). Assesses frequency and severity of depression symptoms during the previous week. Adapted in Spain with excellent psychometrics properties, internal consistency (α = .93) and convergent and discriminant validity
Day 1 (BL) Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 Week 25 Year 1
Working Alliance Inventory for Internet Interventions (WAI-I; Gómez Penedo et al., 2020).
大体时间:Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
12-items self-report questionnaire with 5 Likert response options. Assesses working alliance in internet-based interventions. Validated in German sample of adults with depressive symptoms receiving guided online intervention
Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Emotional Processing Self Report (EP-SR; Fisher et al., 2025)
大体时间:Week 3, 6, 9, 12 Week 25 Year 1
Self-report 7-items questionnaire with 5 Likert response options. Assesses emotional processing during therapeutic sessions in three independent dimensions: emotional expression, regulation and understanding emotional meaning. The instrument demonstrates adequate psychometrics properties, with internal consistency, convergent, incremental and predictive validity in clinical sample. It has not yet been validated in Spanish speaking population.
Week 3, 6, 9, 12 Week 25 Year 1
Unified Protocol Skill Use Scale (UPSUS; Southward, & Sauer-Zavala, 2022)
大体时间:Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Self-report 7-items questionnaire with 7 Likert response options. Assesses the use of emotional regulation skills from Barlow's Unified Protocol (UP). Adapted for Spanish speaking population
Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Brief Positive and Negative Affect Schedule (Brief PANAS; Watson et al., 1988
大体时间:Day 1 (BL) Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Self-report 10-items questionnaire with 5 Likert response options (1 to 5). Assesses positive and negative affectivity (trait/state) during the past few weeks. Adapted for Spanish speaking population
Day 1 (BL) Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Quality of Life Index Spanish (QLI-Sp; Mezzich et al., 2000)
大体时间:Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1
Self-report questionnaire containing 10 ítems with 10 Likert response options. Assess physical and emotional wellbeing, social support, interpersonal functioning, personal satisfaction and overall assessment of quality of life. Validated in Spanish speaking population with adequate psychometric properties in clinical sample (α = .87).
Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1
Generalized Self-Efficacy Scale (GSES; Jerusalem & Schwarzer, 1992).
大体时间:Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1
Self-report 10-items questionnaire with 4-point Likert scale. Assesses general sense of perceived self-efficacy. Validated in Spanish speaking population with sound psychometric properties
Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1

其他结果措施

结果测量
措施说明
大体时间
Personality Inventory for DSM-5 (PID-5; Krueger et al., 2012).
大体时间:Day 1 (BL) Week 3, 12
Self-report 31-items questionnaire with 5-point Likert scale which assesses maladaptive personality traits proposed in the DSM-5. Validated in Spanish speaking population with adequate psychometric properties
Day 1 (BL) Week 3, 12
Level of Personal Functioning Scale - Brief Form 2.0 (LPFS-BF 2.0; Weekers et al., 2019).
大体时间:Day 1 (BL) Week 3, 12
Self-report 12-items questionnaire with 4-point Likert response options. Asseses levels of personality functioning according to the alternative model of personality disorders of DSM-5. There is Spanish version available
Day 1 (BL) Week 3, 12
Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000).
大体时间:Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1
Self-report questionnaire with Likert scale responses from 0 to 100%. Assesses treatment outcome expectations (patient subscale). High internal consistency (α =.79 -.90). Test-retest reliability: r = .82 for expectancy, r = .75 for credibility. Used in Spanish clinical trials with good results
Day 1 (BL) Week 3, 6, 9, 12 Week 25 Year 1
System Usability Scale (SUS; Brooke, 1996).
大体时间:Week 3
Self-report 10-items questionnaire with 5-point Likert scale (1 to 5). Good psychometric properties (α = .91, Lewis, 2018). Validated in Spain with adequate psychometric properties (Castilla et al., 2023). Assesses usability of a digital program or tool.
Week 3

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 (估计的)

2027年5月1日

初级完成 (估计的)

2029年12月1日

研究完成 (估计的)

2030年7月1日

研究注册日期

首次提交

2025年5月26日

首先提交符合 QC 标准的

2025年6月26日

首次发布 (实际的)

2025年7月3日

研究记录更新

最后更新发布 (实际的)

2026年5月27日

上次提交的符合 QC 标准的更新

2026年5月21日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

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.

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