Digitally Enhanced Cognitive-Behavioral Therapy

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Colorado State University
Study ID
NCT07569991
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Cognitive-behavioral therapy (CBT) — BEHAVIORAL
    Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually
  • Digital app — BEHAVIORAL
    App tailored to support cognitive-behavioral therapy (CBT) skills and homework practices

Study Details

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.

Key Dates

Start date
Jan 1, 2027
Status verified
Jun 2026
Primary completion
Jan 1, 2028
Completion
Aug 1, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Cognitive-behavioral therapy (CBT)
    Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually; CBT focuses on changing thoughts and changing behaviors to improve mood
  • Experimental: Cognitive-behavioral therapy-Plus (CBT+)
    Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually; CBT focuses on changing thoughts and changing behaviors to improve mood PLUS access to a digital app to use throughout the CBT group program

Primary Outcome Measure

Intervention Acceptability [ Time Frame: Six-week follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical CampusAuroraColorado80045-

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University of Colorado Anschutz Medical Campus· Aurora, CO

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