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

November 2, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Personalized digital psychoeducation intervention on emotion regulation

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.
Active Comparator: 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.
Behavioral: Lifestyle psychoeducation intervention

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression, Anxiety, and Stress as Assessed by DASS-21
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Well-Being as Assessed by the WEMWBS
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Mental Health, Singapore

Investigators

  • Study Director: Mythily Subramaniam, Ph.D., Institute of Mental Health, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2030

Study Registration Dates

First Submitted

November 2, 2026

First Submitted That Met QC Criteria

November 2, 2026

First Posted (Actual)

November 6, 2026

Study Record Updates

Last Update Posted (Actual)

November 6, 2026

Last Update Submitted That Met QC Criteria

November 2, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-0592
  • MOH-TA25jul-0002 (Other Grant/Funding Number: National Medical Research Council)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

Beginning 1 year after publication with no end date

IPD Sharing Access Criteria

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 Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe