CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 227 enrolled
Drug / intervention
Limbix Spark +1 moredevice
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/NCT04524598
NCT04524598N/ACompleted

Limbix Spark: A CBT-based Mobile Intervention as First Line Treatment for Adolescent Depression During COVID-19

Limbix Health, Inc.·interventional·Posted Aug 24, 2020·Updated May 18, 2023

In Brief

A clinical study evaluating Limbix Spark and Psychoeducation for Depression. Completed, enrolled 227 participants across 1 site.

Detailed Summary

Over 3 million teenagers in the USA have depression, and rates of depression and suicide are sharply increasing. Teenage depression has far-reaching consequences including impairments in academic and work performance and social and family relationships, substance abuse, and worsening of other health conditions, which can persist into adulthood. Access to mental health care for teenagers is limited due to a shortage of mental health providers and many teenagers and parents are reluctant to take antidepressants. COVID-19 and mandated physical and social distancing is expected to increase rates of teenage depression, and further limit access to traditional methods of care (e.g. psychotherapy). This highlights an urgent need to develop accessible, digital treatments for teenage depression to address the serious mental health impacts of the COVID-19 pandemic. This fully virtual study (https://www.limbix.com/spark) will compare the relative safety, effectiveness, and engagement of a mobile application based on cognitive behavioral therapy and behavioral activation (Limbix Spark), focusing on the idea that engaging in behaviors that are rewarding or provide a sense of mastery can be effective in reducing symptoms of depression. Limbix Spark will be compared to a mobile app containing educational material about depression (Psychoeducation).

Study Details

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

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedAug 24, 2020
Enrollment StartJul 20, 2020
Primary CompletionSep 3, 2021
Study CompletionJan 16, 2022
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.9 years ago

Interventions

Limbix Sparkdevice

The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.

Psychoeducationother

The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.