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NCT07399314: SMART-STEP
Evaluating the Effectiveness of a School-based Stepped Care Treatment Model for Adolescent Depression in Pakistan
NA trial testing Universal Intervention & CBT-based Guided Self-Help Application in Depression Anxiety Disorder in 600 participants. Completed in 1 December 2025.
1 December 2025
Quick facts
| Lead sponsor | Global Institute of Human Development |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 600 |
| Start date | 13 November 2025 |
| Primary completion | 1 December 2025 |
| Estimated completion | 1 December 2025 |
| Sites | 1 location across Pakistan |
Drugs / interventions tested
- Universal Intervention & CBT-based Guided Self-Help Application
Conditions studied
- Depression Anxiety Disorder — all drugs for Depression Anxiety Disorder →
- Psychological Distress — all drugs for Psychological Distress →
- Well-Being, Psychological — all drugs for Well-Being, Psychological →
Sponsor
Global Institute of Human Development
Who can join
Adults 13 to 15, any sex, with Depression Anxiety Disorder or Psychological Distress. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aims to test the effectiveness of a stepped-care model to reduce depressive symptoms in adolescents in school settings in Pakistan. The study will examine whether the universal intervention, delivered by non-specialists, can reduce depressive symptoms in adolescents after 3 months. For adolescents who do not improve with universal intervention, the study will assess whether a Cognitive Behavioural Therapy (CBT)-based guided self-help app can provide additional support as a second-step intervention. Six hundred adolescents aged 13-15 from 40 schools in Rawalpindi, Pakistan, will take part. The study will determine which interventions work best and for which students to reduce depressive symptoms in school settings in Pakistan.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07399314
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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- Google Scholar
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Other Global Institute of Human Development trials
Trials by the same sponsor.
- NCT06881342 — Evaluating the Feasibility of a School-based Stepped Care Program for Internalizing Symptoms in Adolescents in Pakistan · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07399314 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Global Institute of Human Development
- Last refreshed: 10 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07399314.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing