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Determining Effectiveness of an mHealth Intervention to Provide Adolescent CBT

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04603053
Enrollment
18
Registered
2020-10-26
Start date
2020-11-09
Completion date
2021-08-20
Last updated
2022-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Depression, Anxiety Disorders

Keywords

Cognitive Behavioral Therapy, mHealth

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.

Interventions

BEHAVIORALmHealth app

Participants will receive access to CBot-A app for 12 weeks.

Sponsors

Washington University Institute of Clinical and Translational Sciences
CollaboratorUNKNOWN
Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Patient Health Questionnaire-9 (PHQ-9)1 monthThe PHQ-9 Adolescent Version will be used.This 9-item instrument scores from 0 to 27, with higher scores indicating more depressive symptoms

Secondary

MeasureTime frameDescription
General Anxiety Disorder-7 (GAD-7)1 monthThis 7 item instrument scores from 0 to 21 with higher scores indicating more anxiety symptoms

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026