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Clinical Trials/NCT04603053
NCT04603053
Completed
Not Applicable

Acceptability and Effectiveness of an mHealth Intervention to Provide Cognitive Behavioral Therapy (CBT) for Adolescents With Depression/Anxiety

Washington University School of Medicine1 site in 1 country18 target enrollmentNovember 9, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adolescent Depression
Sponsor
Washington University School of Medicine
Enrollment
18
Locations
1
Primary Endpoint
Patient Health Questionnaire-9 (PHQ-9)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Washington University will evaluate the acceptability and effectiveness of a mobile health (mHealth) intervention to provide cognitive behavioral therapy for adolescents with depression.

Detailed Description

In this pilot project, Washington University will start to evaluate CBot-A, a promising mHealth therapeutic intervention designed to deliver cognitive behavioral therapy (CBT) through an app on a phone or other mobile device. The evaluation will include a randomized trial among 40 adolescents diagnosed with depression and/or anxiety and will assess if CBot-A is usable by teens and likely to provide benefit, and acceptable to adolescents. The primary outcome of depression and anxiety symptoms in adolescents will be assessed at 1 month and 3 months to check for any changes.

Registry
clinicaltrials.gov
Start Date
November 9, 2020
End Date
August 20, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jane Garbutt, MD

Professor of Medicine and Pediatrics

Washington University School of Medicine

Eligibility Criteria

Inclusion Criteria

  • Adolescents 12-17 years of age and diagnosed with a major depressive disorder (MDD) and/or generalized anxiety disorder by their primary care provider within the past 3 months.

Exclusion Criteria

  • Adolescents with the following conditions (identified by parental report) will be excluded:
  • Participated in formal CBT within the past 12-months
  • Diagnosed with severe depression
  • Diagnosed with the following anxiety disorders - obsessive-compulsive disorders, post-traumatic stress disorder, panic disorder, or specific phobias
  • A psychiatric hospitalization in the previous month
  • With significant comorbidities such that the PCP would refer to a mental health professional for treatment, including those with a substance use disorder or a psychotic illness.
  • Are not accompanied by a guardian to the diagnostic visit
  • Without access to a mobile device (cell phone or tablet) for regular use
  • Unable to read and write English
  • Participants may also be excluded at the discretion of the PI.

Outcomes

Primary Outcomes

Patient Health Questionnaire-9 (PHQ-9)

Time Frame: 1 month

The PHQ-9 Adolescent Version will be used.This 9-item instrument scores from 0 to 27, with higher scores indicating more depressive symptoms

Secondary Outcomes

  • General Anxiety Disorder-7 (GAD-7)(1 month)

Study Sites (1)

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