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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)

2. november 2026 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

140

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

15 år til 35 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

Aktiv komparator: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Depression, Anxiety, and Stress as Assessed by DASS-21
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Subjective Well-Being as Assessed by the WEMWBS
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. desember 2026

Primær fullføring (Antatt)

1. april 2029

Studiet fullført (Antatt)

1. april 2030

Datoer for studieregistrering

Først innsendt

2. november 2026

Først innsendt som oppfylte QC-kriteriene

2. november 2026

Først lagt ut (Faktiske)

6. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

Beginning 1 year after publication with no end date

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ANALYTIC_CODE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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