About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 12-17 years
Body mass index (BMI) ≥85th percentile for age and sex
Elevated depression symptoms, Center for Epidemiologic Studies-Depression Scale (CES-D) ≥21
Disqualifiers
Type 2 diabetes; Fasting glucose ≥126 mg/dL or HbA1c ≥6.5
Major developmental (e.g., intellectual developmental disability) or medical or genetic condition (e.g. cancer, Bardet-Biedhl)
Pregnancy/breastfeeding (females)
Bariatric surgery, weight loss medication, or weight loss >3% in the past 3 months
Trial design
Parallel
Treatments tested in this trial
Cognitive-behavioral therapy (CBT)
BehavioralSix-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually
Digital app
BehavioralApp tailored to support cognitive-behavioral therapy (CBT) skills and homework practices
Treatment groups
Trial outcomes
Primary outcomes
Intervention Acceptability
≥80% of adolescents will report likeability/benefit (≥4 on 1-5 scale where 5=Extremely)
Intervention Feasibility
≥80% of adolescents will receive 80% group dosage (≥5 of 6 sessions)
App Acceptability
Of those in CBT+, ≥80% of adolescents will use the app regularly (≥3 times per week)
Secondary outcomes
Enrollment Feasibility
10 teens in ≤12 weeks to form CBT+ vs. CBT-group only parallel cohorts
Enrollment Feasibility
≥75% of those determined to be eligible will enroll
Protocol Feasibility
\<10% missing data
Protocol Feasibility
≥80% 3-month follow-up retention
Other outcomes
Depression Symptoms
Adolescent report on the 20-item Center for Epidemiologic Studies-Depression Scale (CES-D), total score
Negative Automatic Thoughts
Adolescent report on the Negative Automatic Thoughts subscale of the Children's Automatic Thoughts Scale-Negative/Positive
Pleasant Activities
Adolescent report of frequency/pleasantness of pleasant activities on the Pleasant Events Schedule
Homework Completion
Adolescent report on the Homework Rating Scale-Version 2
Sponsors and contacts
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Colorado State University
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
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