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Digitally Enhanced Cognitive-Behavioral Therapy

Digitally Enhanced Cognitive-Behavioral Therapy for Adolescents With Depression and Obesity

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests group cognitive-behavioral therapy (CBT), with or without an app to practice skills between sessions. CBT teaches skills to manage thoughts, feelings, and actions. The study is for teens ages 12–17 with depression symptoms and overweight or obesity, and will check whether the program is practical and well-liked.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 12–17 years old.
  • Your body mass index (BMI), a measure of weight compared with height, is at or above the 85th percentile for your age and sex.
  • You have higher depression symptoms, with a score of 21 or more on the CES-D depression survey.

Who can't join

  • You have type 2 diabetes, fasting blood sugar of 126 mg/dL or higher, or HbA1c (a measure of average blood sugar) of 6.5 or higher.
  • You have a major developmental, medical, or genetic condition, such as an intellectual disability, cancer, or Bardet-Biedhl syndrome.
  • You are pregnant or breastfeeding.
  • You have had weight-loss surgery, use weight-loss medicine, or lost more than 3% of your weight in the past 3 months.
  • You currently have suicidal thoughts or behavior, or harm yourself.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

CO