CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 223 enrolled
Drug / intervention
Active Interventiondevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05462652
NCT05462652N/ACompleted

Project STAND (Self-guided Treatment for Adolescents Navigating Depression): a Randomized Controlled Trial

Limbix Health, Inc.·interventional·Posted Jul 18, 2022·Updated Jun 12, 2024

In Brief

A clinical study evaluating Active Intervention for Depressive Symptoms and 3 related conditions. Completed, enrolled 223 participants across 1 site.

Detailed Summary

The goal of this study is to test whether an investigational mobile app can be a helpful treatment option for adolescents with symptoms of depression. Adolescents aged 13 to 21 with depression symptoms can be part of this study if eligible. Eligible participants will be randomly assigned to one of two groups: one group will receive the mobile app intervention in addition to their usual care and the other group will simply continue their usual care for symptoms of depression. Both groups will have 5 weeks to use a study app, and will complete assessments during the intervention period, at post-intervention, and at one month follow-up.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedJul 18, 2022
Enrollment StartJul 28, 2022
Primary CompletionApr 21, 2023
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 4.0 years ago

Interventions

Active Interventiondevice

The active intervention is a 5-week program divided into 5 levels intended to be completed weekly. Each level is expected to take about 60 minutes to complete. Activities in each level may include reading text on the screen, answering multiple choice style questions, swiping or clicking a button to move through screens, dragging and dropping elements on screen, and completing tasks outside of the app. Certain on-demand resources can be accessed in the apps at any time, including crisis resources. Where appropriate, text entries in the app that match a database of concerning words/phrases will trigger an automated pop-up suggesting participants visit the in-app crisis resources if they need additional support. Text entries will also be monitored by study staff for safety, though not in real-time. Participants will be instructed to complete a weekly PHQ-8 assessment in the mobile app.