Determining Effectiveness of an mHealth Intervention to Provide Adolescent CBT

Study 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.

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

Conditions
-----------------
Adolescent Depression, Anxiety Disorders

Intervention / Treatment
-----------------
* Behavioral: mHealth app


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBot-A Group<br>Participants randomly assigned to this arm will receive access to CBot-A app. | Behavioral: mHealth app<br>* Participants will receive access to CBot-A app for 12 weeks.<br>|
| No Intervention: Wait List Group<br>Participants randomly assigned to this arm will be offered the intervention after the completion of the trial. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General Anxiety Disorder-7 (GAD-7) | This 7 item instrument scores from 0 to 21 with higher scores indicating more anxiety symptoms | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognitive Behavioral Therapy, mHealth