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Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences (PREVENT-DERS)

2026年11月2日 更新者:Liu Jianlin、Institute of Mental Health, Singapore

Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences: The PREVENT-DERS Randomized Controlled Trial

The present study aims to determine whether a personalized digital psychoeducation intervention (active intervention group) is more effective than self-monitoring of one's mood (control group) in reducing emotion regulation difficulties, depression, anxiety, and stress symptoms in at-risk youths exposed to adverse childhood experiences (ACEs).

We hypothesized that the active intervention group will be associated with less severe emotion regulation difficulties, depression, anxiety, and stress symptoms than the control group at post-intervention and 3-month follow-up. This study will recruit a total of N = 140 youths (age 15 to 35 years) with ACEs and randomized into either the active intervention group (n = 70) or the control group (n = 70). Participants will complete study measures at baseline, post-intervention, and at 3-month follow-up. The study team has expertise in youth mental health. This study is feasible and will be completed within 4 years. Our findings will support the development and implementation of an efficacious, cost-effective, personalized and scalable intervention to reduce poor mental health and prevent the onset of mental disorders among at-risk youths. Our intervention has significant potential to improve population health, quality of life, functioning, morbidity, and mortality, as well as alleviate the healthcare burden associated with ACEs.

研究概览

详细说明

Specific aims:

This study aims to examine the efficacy of personalized digital psychoeducation to self-monitoring control (1) to reduce poor mental health as indexed by self-reported depression, anxiety, and stress symptoms at post-intervention and at 3-month follow-up; and (2) to reduce emotion dysregulation as indexed by momentary emotion regulation ability deficits and rumination severity at post-intervention in youths with elevated hypothesized risk (exposure to adverse childhood experiences (ACEs) and elevated levels of emotion dysregulation, or mild to moderate depression, anxiety or stress symptoms).

Hypotheses:

We hypothesized that (1) the active intervention group will be associated with less depression, anxiety, and stress symptoms than the control group at post-intervention and 3-month follow-up; (2) the active intervention group will be associated with less severe emotion dysregulation than the control group at post-intervention.

Methodology and approach:

This study will involve a two-arm, single-blinded, prospective (i.e., three time-points; baseline, post-intervention, 3-month follow-up), pilot randomized controlled trial. A total of N = 140 youths (age 15 to 35 years) with ACEs will be recruited and randomized into either the active intervention group (Personalized Psychoeducation + Self-Monitoring; n = 70) or the control group (Self-Monitoring; n = 70).

Feasibility:

The study team has clinical and research expertise in youth mental health. This study is supported by a multidisciplinary team of established clinician-scientists and researchers. It is expected that this study will be completed within four years.

Importance to science or medicine:

We aim to develop an efficacious, cost-effective, personalized, scalable, and accessible transdiagnostic intervention to reduce poor mental health and prevent the onset of mental disorders among youths exposed to ACEs. Our intervention has a significant public health impact due to positive downstream effects on improving population health, quality of life, functioning, morbidity, and mortality, as well as alleviating the healthcare burden due to ACEs.

研究类型

介入性

注册 (估计的)

140

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

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

15年 至 35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:

  • Exposed to at least one Adverse Childhood Experience (ACE)
  • Screened positive for elevated scores on the Difficulty with Emotion Regulation Scale (DERS) OR Ruminative Response Scale (RRS) OR mild to moderate scores on the Depression Anxiety and Stress Scales (DASS)
  • Aged 15 years to 35 years
  • Singapore citizens or permanent residents
  • Able to speak or understand English
  • Regular access to a smart phone or tablet with internet connection

Exclusion Criteria:

  • Self-reported diagnosis of any mental disorder
  • Currently seeking mental health support from any mental health professional (i.e., psychiatrist, clinical psychologist, counsellor, etc.) for any mental health difficulties
  • Self-reported active suicidal behavior
  • Miss 2 consecutive intervention sessions

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:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Personalized digital psychoeducation intervention on emotion regulation

In this active intervention arm, participants will undergo a 4-week (1 hour per session) online psychoeducation and skills training intervention focused on improving emotion regulation skills. We will tailor and personalize the 4-week intervention to each participant based on the Ecological Momentary Assessment-generated emotion regulation profiles at baseline. Emotion regulation profiles are mapped to 6 core areas (poor emotional awareness, poor emotional clarity, non-acceptance of emotional responses, difficulty in engaging in goal-directed behavior, impulsivity, and limited access to adaptive emotion regulation strategies) as outlined by the validated Difficulty in Emotion Regulation Scale (DERS) or DERS model.

The Active Intervention is a 4-week (1 hour per session) online psychoeducation and skills training intervention focused on improving emotion regulation skills. The Active Intervention includes personalized and non-personalized syllabus. The non-personalized intervention syllabus includes the following content: Session 1 (Enhancing emotional awareness and clarity), Session 2 (Accepting emotional responses), Session 3 (Reducing impulsivity and engaging in goal-directed behavior), and Session 4 (Accessing emotion regulation strategies). The personalized syllabus is based on each participant's Ecological Momentary Assessment (EMA)-generated emotion regulation profiles at baseline. In general, for weaker areas, we will reduce the difficulty in the type of skills taught and provide more skills practice. For stronger areas, we will teach more advanced skills for the participant to explore. Participants will undergo EMA self-monitoring of their emotions between each intervention session.

有源比较器:Lifestyle psychoeducation intervention

In this Active Comparator arm, participants will undergo a 4-week (1 hour per session) online psychoeducation intervention focused on learning healthy lifestyle strategies. The purpose of this arm is to support the blinding process, where both arms appear to receive similar interventions. Further, the lifestyle psychoeducation intervention is an evidence-based prevention intervention for depression and anxiety.

The Control Intervention is a 4-week (1 hour per session) online psychoeducation intervention focused on learning healthy lifestyle strategies. The first online session (Week 1) involves providing participants with a background of psychoeducation, adverse childhood experiences (ACEs), and mental health. The second online session (Week 2) involves teaching participants the importance of sleep hygiene. The third online session (Week 3) involves teaching participants the importance of a healthy diet. The fourth online session (Week 4) involves teaching participants the importance of exercise and providing an overview of outdoor activities in Singapore. Participants will undergo Ecological Momentary Assessment (EMA) self-monitoring of their emotions between each intervention session.

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
Depression, Anxiety, and Stress as Assessed by DASS-21
大体时间:From enrollment to 3-month (post-intervention) follow-up

The 21-item Depression Anxiety and Stress Scales (DASS; Lovibond & Lovibond, 1995) will be used to screen for mild to moderate depression, anxiety, and stress symptoms. The DASS will also be administered at post-intervention and at the 3-month follow-up. Each item is rated on a 4-point Likert scale ranging from 0 (Did not apply to me) to 3 (Applied to me very much); higher scores indicate more severe depression, anxiety, and stress symptoms. Each subscale comprises 7 items and the subscale scores will be summed and multiplied by 2 as per scoring guidelines. Hence, each subscale score will range from 0 to 42.

From enrollment to 3-month (post-intervention) follow-up
Global Emotion Dysregulation as Assessed by the DERS-SF
大体时间:From enrollment to 3-month (post-intervention) follow-up

The 18-item Difficulties with Emotion Regulation Scale Short-Form (DERS-SF; Kaufman et al., 2016) will be used to screen for elevated levels of global emotion dysregulation. Global emotion dysregulation has 6 subscales: poor emotional awareness, poor emotional clarity, non-acceptance of emotional responses, difficulty in engaging in goal-directed behavior, impulsivity, and limited access to adaptive emotion regulation strategies. These subscales correspond to the 6 dimensions of the DERS model. Each item is rated a 5-point Likert scale ranging from 1 (Almost never) to 5 (Almost always); higher scores will indicate more severe global emotion dysregulation (scores range from 18 to 90).

From enrollment to 3-month (post-intervention) follow-up
Ecological Assessment of Momentary Emotion Dysregulation
大体时间:From baseline to the end of intervention at 4 weeks

Ecological momentary assessment (EMA) of emotion dysregulation in the following two areas: Rumination and emotion regulation abilities. Two EMA items to assess rumination in response to recent stressors since the previous beep (How much were you focusing on the stressors? How much were you focusing on your emotions due to the stressors?). Both items are rated on a 100-point visual slider scale from 0 (not at all) to 100 (extremely). 21 EMA items to assess for emotion regulation abilities. Each item is rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely).

From baseline to the end of intervention at 4 weeks
Rumination as Assessed by the RRS
大体时间:From enrollment to 3-month (post-intervention) follow-up

The 10-item Ruminative Response Scale short-form (RRS; Treynor et al., 2003) will be used to screen for elevated levels of rumination. Each item is rated on a 4-point Likert scale ranging from 1 (Almost never) to 4 (Almost always); higher scores indicate more severe rumination (scores range from 10 to 40).

From enrollment to 3-month (post-intervention) follow-up

次要结果测量

结果测量
措施说明
大体时间
Subjective Well-Being as Assessed by the WEMWBS
大体时间:From enrollment to the 3-month (post-intervention) follow-up

The 14-item Warwick Edinburgh Mental Wellbeing Scale (WEMWBS; Tennant et al., 2007) will be used to assess for subjective well-being. Each item is rated on a 5-point Likert scale ranging from 1 (None of the time) to 5 (All of the time); higher scores indicate better positive well-being.

From enrollment to the 3-month (post-intervention) follow-up
Multi-Dimensional Impulsivity as Assessed by the UPPS-P
大体时间:From enrollment to three-month (post-intervention) follow-up

The 20-item Urgency-Premeditation-Perseverance-Sensation Seeking-Positive Urgency scale (UPPS-P; Cyders et al., 2014) will be used to assess for multi-dimensional impulsivity and the subdomains include negative and positive urgency, lack of perseverance, lack of premeditation, and sensation-seeking. Each item is rated on a 4-point Likert scale ranging from 1 (Strongly Agree) to 4 (Strongly Disagree).

From enrollment to three-month (post-intervention) 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。

调查人员

  • 研究主任:Mythily Subramaniam, Ph.D.、Institute of Mental Health, Singapore

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。

一般刊物

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)

2026年12月1日

初级完成 (估计的)

2029年4月1日

研究完成 (估计的)

2030年4月1日

研究注册日期

首次提交

2026年11月2日

首先提交符合 QC 标准的

2026年11月2日

首次发布 (实际的)

2026年11月6日

研究记录更新

最后更新发布 (实际的)

2026年11月6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8月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2026-0592
  • MOH-TA25jul-0002 (其他赠款/资助编号:National Medical Research Council)

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

All de-identified IPD used in the results publication and subjected to formal approval by our governing ethics board.

IPD 共享时间框架

Beginning 1 year after publication with no end date

IPD 共享访问标准

Researchers who contact the Principal Investigator and (1) submit a proposal that describes planned analyses (including but not limited to IPD meta-analysis, Intention-to-Treat (ITT) analyses based on pooled RCT data); and (2) sign a data sharing agreement; and (3) receive formal approval from our governing ethics board may be granted access to the de-identified IPD. Access to the de-identified IPD will be provided by the Principal Investigator and/or other methods (e.g., Trust Platform) as approved by our ethics boards and stated in the signed data sharing agreement.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 分析代码

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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