Last reviewed · How we verify
NCT04806321
Project SOLVE: Trial of a Brief Digital Problem-solving Intervention
NA trial testing Project SOLVE in Anxiety in 522 participants. Completed in 15 May 2022.
15 May 2022
Quick facts
| Lead sponsor | Harvard University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 522 |
| Start date | 15 March 2021 |
| Primary completion | 15 May 2022 |
| Estimated completion | 15 May 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Project SOLVE
- Project SUCCESS
Conditions studied
- Anxiety — all drugs for Anxiety →
- Depression — all drugs for Depression →
- Stress — all drugs for Stress →
Sponsor
Harvard University
Who can join
Adults 10 to 14, any sex, with Anxiety or Depression. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this trial is to examine the effectiveness of a universal, self-guided, digital single-session intervention focusing on problem-solving skills in improving adolescent mental health and well-being, relative to an active control intervention focusing on study skills, within the context of school settings during the coronavirus disease pandemic.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Is There a Place for Cognitive Restructuring in Brief, Self-Guided Interventions? Randomized Controlled Trial of a Single-Session, Digital Program for Adolescents.
Steinberg JS, Fitzpatrick OM, Khurana S, Kim MY, et al · · 2024 · cited 4× · PMID 39120779 · DOI 10.1080/15374416.2024.2384026
Verify or expand the search:
- PubMed search for NCT04806321
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Project SOLVE
Trials testing the same drug.
- NCT06896071 — Evaluating a Digital Single-session Intervention for Adolescent Mental Health in New Zealand · NA · recruiting
- NCT06064578 — The Ukrainian Student Problem Solving Project · NA · completed
Other recruiting trials for Anxiety
Currently open trials in the same condition.
- NCT07336238 — Group Retreat Psilocybin Therapy for the Treatment of Anxiety and Depression in Patients With Metastatic Solid Tumors or · Phase 2 · recruiting
- NCT07522944 — AI-Guided Relaxation for Hemodialysis Anxiety · NA · recruiting
- NCT07466875 — Auricular Stimulation for Nicotine Withdrawal in Psychiatric Inpatients · NA · recruiting
- NCT07425951 — Building Cognitive Behavioural Skills With StoryBooks to Reduce Emotional Difficulties in Kindergarten Years · NA · recruiting
- NCT07473505 — Integrative Bilateral Cervical Sympathetic Blocks for Trauma-Related Symptoms in Special Operations Veterans: A Prospect · recruiting
Other Harvard University trials
Trials by the same sponsor.
- NCT07316647 — Using Conversational AI to Teach Growth Mindset Skills to Youths in India · NA · completed
- NCT06114862 — Brief Interventions on Social Media to Reduce Suicide Risk (Intervention 2) · NA · withdrawn
- NCT07394465 — First Tones: Artistic Communal Practices for 4 and 5 Year Old Children · NA · completed
- NCT06217705 — Testing the Effects of Project Calm in Ukrainian Schools · NA · completed
- NCT06114875 — Brief Interventions on Social Media to Reduce Suicide Risk (Intervention 1) · NA · terminated
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 NCT04806321 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Harvard University
- Last refreshed: 11 July 2022
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/NCT04806321.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing