Clinical trial

Digitally Enhanced Cognitive-Behavioral Therapy

Opening soon · Not applicable · 1 countries · Registry ID NCT07569991

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age12 Years to 17 Years

SexAll

Healthy volunteersNot accepted

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

Full registry criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Active suicidality or self-harm

Treatments and study arms

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

Primary outcomes

Intervention AcceptabilitySix-week follow-up

≥80% of adolescents will report likeability/benefit (≥4 on 1-5 scale where 5=Extremely)

Intervention FeasibilitySix-week follow-up

≥80% of adolescents will receive 80% group dosage (≥5 of 6 sessions)

App AcceptabilitySix-week follow-up

Of those in CBT+, ≥80% of adolescents will use the app regularly (≥3 times per week)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Colorado Anschutz Medical Campus🇺🇸 Aurora, Colorado, United States

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Lauren Shomaker, PhDContact

Email · Call 1-855-395-9031