Determining Effectiveness of an mHealth Intervention to Provide Adolescent CBT

The Washington University

Status: Completed

Conditions: Anxiety Disorders; Adolescent Depression

Treatments: Behavioral: mHealth app

Study type: Interventional

Funder types: Other

Identifiers

NCT04603053

202005103

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 2 patient groups

CBot-A Group

Experimental group

Description:

Participants randomly assigned to this arm will receive access to CBot-A app.

Treatment:

Behavioral: mHealth app

Wait List Group

No Intervention group

Description:

Participants randomly assigned to this arm will be offered the intervention after the completion of the trial.