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Self-guided Treatment for Depression

NCT06028984 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2024-04-05

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Intervention app

An app-based intervention for depression

OTHER

Control app

An app with non-therapeutic content

Sponsors & Collaborators

  • Duke University

    collaborator OTHER

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Big Health Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-12
Primary Completion
2025-03-31
Completion
2025-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06028984 on ClinicalTrials.gov