Determining Effectiveness of an mHealth Intervention to Provide Adolescent CBT

Not Applicable

Completed

• Conditions: Adolescent Depression; Anxiety Disorders

• Registration Number: NCT04603053
• Lead Sponsor: Washington University School of Medicine

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.

Study Timeline

• Study First Submitted: 2020-10-16
• Study First Submitted QC: 2020-10-22
• Study First Posted: 2020-10-26
• Study Start: 2020-11-09
• Primary Completion: 2021-08-20
• Study Completion: 2021-08-20
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire-9 (PHQ-9)	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 Outcome Measures

Name	Time	Method
General Anxiety Disorder-7 (GAD-7)	1 month	This 7 item instrument scores from 0 to 21 with higher scores indicating more anxiety symptoms

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States