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青少年复发的数字干预预防 (DigiTIFF)

2026年11月2日 更新者：Ragnhild Bø、University of Oslo

预防青少年复发的数字干预措施

Some adolescents experience periods of anxiety and/or depression, and some find that these periods return over time. The purpose of this study is to examine whether digital interventions-where individuals work systematically with their own thoughts and feelings during periods when they feel well-can help them maintain well-being for longer.

The study includes adolescents aged 16-19 who have previously experienced episodes of depression and/or anxiety to a degree that led them to seek help (e.g., from a school nurse, general practitioner, health clinic, or child and adolescent mental health service). Through a research app on their smartphones, participants complete tasks and answer questionnaires. The study is fully digital. Some participants meet with a therapist in digital group sessions, while others work independently with the digital content.

We will also examine the cost-benefit aspects of offering such interventions. If the study achieves its goals, digital interventions may eventually become a service offered to adolescents recovering from depression and anxiety.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

495

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

学习地点

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

16年 至 19年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Currently in full or partial remission for a minimum of 2 months from a depressive disorder or an anxiety disorder as defined by self-reported scores on RCADS-47: previous episode(s) of t-score > 65 and current t-score =<65.
  • Native or fluent Scandinavian language skills.
  • Willingness to take part even when allocated to the non-preferred arm of the trial.

Exclusion Criteria:

  • Ongoing depressive disorder, ongoing anxiety disorder as defined by current t-score =<65 on RCADS-47.
  • Recent completion of one of the interventions in the two interventional arms.
  • no available smartphone.

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：预防
  • 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：App intervention

A transdiagnostic, self-guided CBT app:

  1. Standardized self-assessment for mental health: 'Test your psychological immune system'.
  2. Educational mini-series: A 30-minute, entertaining video series that teaches users to build resilience by addressing essential needs like sleep (psychological immune system), recognizing negative thought patterns (thought viruses), and developing healthier coping mechanisms (psychological vitamins).
  3. Daily practice: Over 20 days, users receive a short, 1-2-minute video each morning. These videos provide practical tips, small experiments, or simple tasks designed to help users integrate healthier coping strategies into their daily lives.
行为的：Transdiagnostic app intervention

A transdiagnostic, self-guided CBT app, called TankeVirus (literally translated Thought Viruses), consisting of three components:

  1. Standardized self-assessment for mental health: 'Test your psychological immune system'.
  2. Educational mini-series: A 30-minute, entertaining video series that teaches users to build resilience by addressing essential needs like sleep (psychological immune system), recognizing negative thought patterns (thought viruses), and developing healthier coping mechanisms (psychological vitamins).
  3. Daily practice: Over 20 days, users receive a short, 1-2-minute video each morning. These videos provide practical tips, small experiments, or simple tasks designed to help users integrate healthier coping strategies into their daily lives.
实验性的：Group intervention

A transdiagnostic, mastery course for groups, delivered weekly in webinar format over three sessions. It includes videos and group discussions.
行为的：Transdiagnostic mastery course

Group-based webinar offering psychoeducation based on principles of CBT.
无干预：Assessment only

Only assessment will be conducted.

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
Relapse: Number of participants scoring above the diagnostic cut-off on the PHQ-9 modified for teens during the 12-month follow-up.
大体时间：From enrollment to the end of follow-up at 12-months.

To use the PHQ-9 as a diagnostic aid for Major Depressive Disorder:

  • Questions 1 and/or 2 need to be endorsed as a "2" or "3"
  • Need five or more positive symptoms (positive is defined by a "2" or "3" in questions 1-8 and "1", "2", or "3" in question 9).
  • The functional impairment question (How difficult….) needs to be rated at least as "somewhat difficult."
From enrollment to the end of follow-up at 12-months.
Time until relapse; reaching the diagnostic criteria of MDD according to PHQ-9 modified for teens
大体时间：From enrollment to 12-months follow-up

Number of days until the diagnostic criteria of MDD as assessed PHQ-9 modified for teens has been reached.

- Questions 1 and/or 2 need to be endorsed as a "2" or "3"

  • Need five or more positive symptoms (positive is defined by a "2" or "3" in questions 1-8 and by a "1", "2", or "3" in question 9).
  • The functional impairment question (How difficult….) needs to be rated at least as "somewhat difficult."
From enrollment to 12-months follow-up

次要结果测量

结果测量
措施说明
大体时间
Repetitive negative thinking (RNT-10)
大体时间：At enrollment, and at 3, 6 and 12 months follow-up

Assess transdiagnostic repetitive negative thinking
At enrollment, and at 3, 6 and 12 months follow-up
Somatic complaints (SSS8)
大体时间：At enrollment, and at 3, 6, and 12-months follow-up.

Somatic complaints based on sum score of all items
At enrollment, and at 3, 6, and 12-months follow-up.
EPOCH Measure of Adolescent Well-Being
大体时间：At baseline, 3, 6 and 12-months follow-up.

A 20-item validated questionnaire (4 items per domain; Engagement, Perseverance, Optimism, Connectedness, Happiness) on a 1-5 Likert scale (1=Almost Never, 5=Almost Always) resulting in domain scores, reflecting strengths in these positive psychological areas crucial for youth well-being.
At baseline, 3, 6 and 12-months follow-up.
Health related quality of life
大体时间：At baseline, 3, 6 and 12-months follow-up.

EQ-5D-5L will be used to assess five domains of patient reported outcomes and for economic evaluation of the interventions.
At baseline, 3, 6 and 12-months follow-up.
Health related quality of life - Visual Analog Scale
大体时间：At baseline, 3, 6 and 12-months follow-up.

EQ VAS will be used to assess patient reported outcomes for self-rated health and for economic evaluation of the interventions.
At baseline, 3, 6 and 12-months follow-up.

其他结果措施

结果测量
措施说明
大体时间
Client satisfaction questionnaires (CSQ-I)
大体时间：At 3 months follow-up.

The 8-item questionnaire assesses how satisfied the participants are with the interventions, only administrated to those who are in the interventional arms.
At 3 months 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。

赞助

University of Oslo

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。

有用的网址

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)

2026年8月10日

初级完成 (估计的)

2028年2月1日

研究完成 (估计的)

2028年2月1日

研究注册日期

首次提交

2025年12月22日

首先提交符合 QC 标准的

2026年1月7日

首次发布 (实际的)

2026年1月16日

研究记录更新

最后更新发布 (实际的)

2026年11月5日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 870757

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

The dataset underlying the results will be shared together with publications.

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

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