Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
NCT07921446, Not applicable, Not yet recruiting, Institute of Mental Health, Singapore
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences | ClinicalTrials.gov |
| NCT number | NCT07921446 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 140 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Institute of Mental Health, Singapore | ClinicalTrials.gov |
| Conditions | Adverse Childhood Experience, Depression / Major Depressive Disorder, Anxiety Depression, Anxiety | ClinicalTrials.gov |
| Interventions | Lifestyle psychoeducation intervention, Personalized digital psychoeducation intervention on emotion regulation | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Depression, Anxiety, and Stress as Assessed by DASS-21 | 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. | ClinicalTrials.gov |
| Primary | Global Emotion Dysregulation as Assessed by the DERS-SF | 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). | ClinicalTrials.gov |
| Primary | Ecological Assessment of Momentary Emotion Dysregulation | 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). | ClinicalTrials.gov |
| Primary | Rumination as Assessed by the RRS | 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). | ClinicalTrials.gov |
| Secondary | Subjective Well-Being as Assessed by the WEMWBS | 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. | ClinicalTrials.gov |
| Secondary | Multi-Dimensional Impulsivity as Assessed by the UPPS-P | 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). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 10
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)