An interventional study of mHealth Toolkit for Wellness & Empowering Lives of School Community (mWEL) in Mental Health Literacy and Depression, Anxiety, sponsored by NYU Langone Health. Recruiting at 2 sites in Uganda. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Prevention
Among 25 studies in Depression by NYU Langone Health — 8 open to participants now, 10 under way, none of them phase 3. Depression · NYU Langone Health.
Among the 25 studies in Depression by NYU Langone Health, this one has the largest planned enrollment of the 22 interventional ones, is one of 3 that started in 2026, is one of 12 with no phase, and was the 19th registered.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 1,180 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →8 of the 25 studies in Depression by NYU Langone Health are open now, in 2 countries. Each count lists the studies.
Of the 1,088 Depression studies recruiting now, 469 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 310 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →25 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 3 started in 2026.
Median enrollment 33 across the 22 interventional studies, 30 across the 3 observational. Of the 11 that completed or were terminated, 7 (64%) have results posted.
NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
6 of the studies in Depression by NYU Langone Health that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06004414NYU Langone HealthSilverCloud as a School-Based Intervention for Vulnerable Youth | 2026-12-31 |
| NCT07111390NYU Langone HealthFeasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD) | 2027-01-01 |
| NCT06087159NYU Langone HealthPromoting Mental Health of Teachers and Caregiver Using a Personalized mHealth Toolkit in Uganda | 2027-08-01 |
| NCT05082181NYU Langone HealthTelephone-Based Support Programs for People With Epilepsy | 2027-08-31 |
| NCT06455527NYU Langone HealthHeart Rate Variability (HRV)-Guided Transcranial Direct Current Stimulation (tDCS) | 2027-11-01 |
Among the 25 studies in Depression by NYU Langone Health, from their registry updates:
This study record describes a two-phase of clinical trial study. The first phase is a pilot study phase (to study feasibility and efficacy of the intervention), and the second phase is an effectiveness study phase (a fully powered evaluation study to test the intervention effectiveness). This proposal seeks to develop and test a new mHealth intervention, the mHealth Toolkit for Wellness \& Empowering Lives of School Community (mWEL) in Uganda. The mWEL-digial toolkit is a preventive intervention tool for teachers and parents as a self-help support modality. Caregivers who need support in navigating the toolkit will be supported by peer-community health workers (P-CHWs).
During the first phase (from 11-01-2024 to 8-15-2025), a cluster randomized controlled trial (cRCT) with 8 schools (4 intervention and 4 wait-list control schools) including 160 caregivers (80 teachers and 80 parents) is conducted. The aim of the pilot RCT is to pilot test the implementation process, feasibility, acceptability, usage patterns, and efficacy of the mWEL. The investigators hypothesize that: 1) relative to the control, caregivers receiving the mWEL will have better efficacy outcomes (mental health literacy, and mental health outcomes); and 2) mWEL implementation will have high acceptability, appropriateness, and feasibility.
During the second phase (from 10-01-2025 to 08-31-2028), the optimized version of mWEL toolkit will be further tested for effectiveness using a cRCT and a matched-pair randomization method. The sample will be recruited from urban and rural schools. In intervention schools, participants will engage with the mWEL toolkit through group sessions or one-on-one support with Peer-Community Health Workers (P-CHWs). Control schools will receive general and non-mental health related health literacy information, and without any tailored support. Impacts on caregivers' health literacy and their mental health (anxiety, depression) will be evaluated (n=1000, 500 parents and 500 teachers in 24 schools, with 12 intervention and 12 wait-list control). The investigators hypothesize that: 1) relative to control, teachers and parents receiving mWEL will have better effectiveness outcomes (i.e., mental health literacy, and mental health outcomes; and 2) similar effectiveness findings for urban/rural schools and for male/female.
Teachers Inclusion Criteria:
Parents Inclusion Criteria:
Exclusion Criteria:
Teachers or parents of children in participating schools who are randomly assigned to receive the mWEL intervention.
Behavioral: mHealth Toolkit for Wellness & Empowering Lives of School Community (mWEL)
Teachers or parents of children in participating schools who are randomly assigned to the control arm.
mWEL-App is a preventive intervention tool for teachers and parents as a self-help support. It integrates three key mental health presentive service functions: i) comprehensive screen to assess mental health (anxiety, depression), stress, and related contextual risks; ii) a tailored strength and weakness profile/report with recommendations to promote self-awareness and mental health knowledge; and iii) tailored evidence-based strategies and additional support and clinical resources to improve skills in stress management, emotion regulation, and maintain mental wellness. mWEL will be designed as a self-administered tool. Participating parents and teachers can access to mWEL app after they sign up for an account. Intervention participants will have access to the App anytime within a 3-5 month study period.
Change in Universal Mental Health Literacy Scale Score
The Universal Mental Health Literacy Scale comprises 21 items asking respondents to indicate their knowledge of various aspects regarding mental health. Items are rated on Yes/No or 5-point Likert scales. The total score is produced by mean of all item scores and ranges from 1-5 or % correct knowledge; higher scores indicate greater mental health literacy
Time frame: Baseline, Month 5
Change in PHQ-9 Score
The Patient Health Questionnaire-9 (PHQ-9) is a widely used self-administered tool designed to screen, diagnose, and monitor the severity of depression in individuals. It consists of nine questions that align directly with the diagnostic criteria for major depressive disorder in the DSM-5. Each item asks about the frequency of specific depressive symptoms experienced over the past two weeks (on a 0 to 3 point Likert scales), such as low mood, loss of interest, sleep problems, fatigue, appetite changes, feelings of worthlessness, trouble concentrating, psychomotor changes, and thoughts of self-harm or suicide. The total score ranges from 0 to 27, with higher scores indicating more severe depression. Severity is typically interpreted as follows: 0-4: None to minimal depression 5-9: Mild depression 10-14: Moderate depression 15-19: Moderately severe depression 20-27: Severe depression
Time frame: Baseline, Month 5
Change in GAD-7 Anxiety Score
The Generalized Anxiety Disorder 7-item scale (GAD-7) is a brief, self-administered questionnaire designed to screen for and assess the severity of generalized anxiety disorder (GAD) symptoms over the past two weeks. The scale is rated on a 0 to 3 point Likert scales). The total GAD-7 score ranges from 0 to 21, with higher scores indicating greater anxiety severity. Severity is commonly interpreted as: 0-4: Minimal anxiety 5-9: Mild anxiety 10-14: Moderate anxiety 15-21: Severe anxiety Less than 55 = None to slight depression 55.0-59.9 = Mild depression 60.0-69.9 = Moderate depression 70 and over = Severe depression
Time frame: Baseline, Month 5
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Keng-Yen.Huang@nyulangone.org The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Keng-Yen.Huang@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Started Apr 2026 (actual). Primary completion is estimated for Aug 2027, 15 months after the start.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 15 months is below that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.