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

NCT04524598 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 227

Last updated 2023-05-18

Study results available
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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).

Conditions

Interventions

DEVICE

Limbix Spark

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

OTHER

Psychoeducation

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

Sponsors & Collaborators

  • Limbix Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Jessica Lake, PhD · Director of Research

  • Aarthi Padmanabhan, Phd · Research Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-20
Primary Completion
2021-09-03
Completion
2022-01-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT04524598 on ClinicalTrials.gov