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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)

2026년 11월 8일 업데이트: 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).

The investigators 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.

연구 개요

상세 설명

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:

The investigators 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:

The investigators 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.

연구 유형

중재적

등록 (추정된)

140

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

15년 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

활성 비교기: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Depression, Anxiety, and Stress as Assessed by DASS-21
기간: 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
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Subjective Well-Being as Assessed by the WEMWBS
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 연구 책임자: Mythily Subramaniam, Ph.D., Institute of Mental Health, Singapore

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 12월 1일

기본 완료 (추정된)

2029년 4월 1일

연구 완료 (추정된)

2030년 4월 1일

연구 등록 날짜

최초 제출

2026년 11월 2일

QC 기준을 충족하는 최초 제출

2026년 11월 2일

처음 게시됨 (실제)

2026년 11월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 8일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

IPD 공유 기간

Beginning 1 year after publication with no end date

IPD 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ANALYTIC_CODE

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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