Clinical Trial

Digitally Enhanced Cognitive-Behavioral Therapy

Study acronym: CBT+
Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
Adolescent depression is a major public health problem. Depression affects adolescents' emotional well-being now and in the future, and it also affects their physical health, especially the risk for heart disease and other cardiovascular and metabolic health problems. In adolescents with depression and obesity, evidence-based programs for depression, like cognitive-behavioral therapy (CBT), might improve physical health, in part by supporting healthy behaviors such as physical activity, nutritious eating, and getting enough sleep. Our preliminary studies provide support for this overarching hypothesis. If adolescents have access to a digital app to support practicing CBT skills in between program sessions, it might especially help them to learn skills that help to feel better and be healthier in their day-to-day lives. We are tailoring a digital app for this purpose and we will make changes to the app based on feedback from adolescents, their parents, and their doctors. Once the app is well-liked and helpful, and works well as a support for taking part in CBT, we will randomly assign 60 adolescents with depression and overweight/obesity to either "CBT+" - a CBT group program plus the app, or "CBT-only" - the CBT group program only. We will pilot test whether this research is feasible, likeable, and credible, learning information that will inform a larger study to test of CBT+ can support emotional well-being, health behavior, and cardiovascular and metabolic health in adolescents.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-04-29.
Trial Details
NCT Number NCT07569991
Lead Sponsor Colorado State University
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions Depression in Adolescence, Obesity & Overweight, Cognitive-behavioral Therapy, Mobile Health Technology (mHealth), Health Behavior
Enrollment 60 participants
Start Date 2027-01-01
Primary Completion 2028-01-01 (estimated)
Study Completion 2028-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-05