NCT06028984

Self-guided Treatment for Depression

Self-guided Treatment for Adolescents/Adults Navigating Depression (STAND-MDD): A Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 248 (estimated)
• Sponsor: Big Health Inc. · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

This study will examine the efficacy and safety of a self-guided digital therapeutic app for the adjunct treatment of Major Depressive Disorder compared to a control app in adolescents and adults.

Detailed description

This study aims to examine the efficacy of a self-guided digital therapeutic app for depression compared to a control app in individuals aged 13 and older with a diagnosis of Major Depressive Disorder. The primary outcomes are patient- and clinician-reported depression symptom severity after 5 weeks.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	Intervention app	An app-based intervention for depression
OTHER	Control app	An app with non-therapeutic content

Timeline

• Start date: 2023-10-12
• Primary completion: 2025-03-01
• Completion: 2025-09-01
• First posted: 2023-09-08
• Last updated: 2024-04-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study