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Digitally Enhanced Cognitive-Behavioral Therapy

NCT07569991 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

  • Depression in Adolescence
  • Obesity & Overweight
  • Cognitive-behavioral Therapy
  • Mobile Health Technology (mHealth)
  • Health Behavior

Interventions

BEHAVIORAL

Cognitive-behavioral therapy (CBT)

Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually

BEHAVIORAL

Digital app

App tailored to support cognitive-behavioral therapy (CBT) skills and homework practices

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Colorado State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-31
Primary Completion
2028-01-31
Completion
2028-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07569991 on ClinicalTrials.gov