Determining Effectiveness of an mHealth Intervention to Provide Adolescent CBT

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04603053
• Other study ID #: 202005103
• Status: Completed
• Phase: N/A
• Start date: November 9, 2020
• Est. completion date: August 20, 2021

Study information

• Verified date: July 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 20, 2021
• Est. primary completion date: August 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Depression
• Anxiety Disorders
• Depression

Intervention

Behavioral:
• mHealth app
Participants will receive access to CBot-A app for 12 weeks.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Washington University Institute of Clinical and Translational Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Health Questionnaire-9 (PHQ-9)	The PHQ-9 Adolescent Version will be used.This 9-item instrument scores from 0 to 27, with higher scores indicating more depressive symptoms	1 month
Secondary	General Anxiety Disorder-7 (GAD-7)	This 7 item instrument scores from 0 to 21 with higher scores indicating more anxiety symptoms	1 month