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NCT Number: NCT07569991

Digitally Enhanced Cognitive-Behavioral Therapy

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.

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Key information

Conditions

Depression in Adolescence Behavior Behavioral Symptoms Body Weight Cognitive-behavioral Therapy Depression Health Behavior Mobile Health Technology (mHealth) Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity & Overweight Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

About this study

Adolescent depression is a major public health problem that has serious consequences for cardiometabolic disease, predicting heightened risk for glucose dysregulation, type 2 diabetes onset, and cardiovascular events. Evidence-based interventions such as cognitive-behavioral therapy (CBT) to decrease depression in adolescents with elevated body mass index (BMI ≥85th percentile for age and sex) are anticipated to improve cardiometabolic health, in part by ameliorating the negative impacts of depression on health behavior (e.g., physical activity, eating, and sleep). Our preliminary studies provide support for this overarching hypothesis. However, effect sizes for CBT were small-to-moderate, possibly due to less-than-optimal home practice in between sessions. Homework completion tracks with treatment effects in our team's and others' studies, likely because homework facilitates skills acquisition in daily life. Our overarching study rationale is that enhancement of CBT-group with a digital app is likely to strengthen homework completion and translation of CBT skills to healthier coping and behavior, leading to stronger improvements in cardiometabolic health than CBT-group alone. We will leverage mobile health (mHealth) to adapt a CBT-digital app for the distinct needs and preferences of adolescents with depression and elevated BMI. After we optimize the app's integration with CBT-group virtual sessions through focus groups and iterative pilot testing with adolescents, we will conduct a two-arm, single-site pilot and feasibility randomized controlled trial to compare a digitally-enhanced CBT-group (CBT+) with a virtual CBT-group only in 60 adolescents with depression and overweight/obesity to assess feasibility, acceptability, proof-of-concept, and implementation outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Intervention Acceptability

    Time frame: Six-week follow-up

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

  2. Intervention Feasibility

    Time frame: Six-week follow-up

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

  3. App Acceptability

    Time frame: Six-week follow-up

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

Secondary outcomes

  1. Enrollment Feasibility

    Time frame: End-of-enrollment

    10 teens in ≤12 weeks to form CBT+ vs. CBT-group only parallel cohorts

  2. Enrollment Feasibility

    Time frame: End-of-enrollment

    ≥75% of those determined to be eligible will enroll

  3. Protocol Feasibility

    Time frame: End-of-3-month follow-ups

    <10% missing data

  4. Protocol Feasibility

    Time frame: End-of-3-month follow-ups

    ≥80% 3-month follow-up retention

Other outcomes

  1. Depression Symptoms

    Time frame: Six-week follow-up and 3-month follow-up

    Adolescent report on the 20-item Center for Epidemiologic Studies-Depression Scale (CES-D), total score

  2. Negative Automatic Thoughts

    Time frame: Six-week follow-up and 3-month follow-up

    Adolescent report on the Negative Automatic Thoughts subscale of the Children's Automatic Thoughts Scale-Negative/Positive

  3. Pleasant Activities

    Time frame: Six-week follow-up and 3-month follow-up

    Adolescent report of frequency/pleasantness of pleasant activities on the Pleasant Events Schedule

  4. Homework Completion

    Time frame: Six-week follow-up

    Adolescent report on the Homework Rating Scale-Version 2

  5. Coping

    Time frame: Six-week follow-up and 3-month follow-up

    Adolescent report on the Brief COPE inventory

  6. Self-efficacy

    Time frame: Six-week follow-up and 3-month follow-up

    Adolescent report on the Self-efficacy Questionnaire for Children

  7. Loneliness

    Time frame: Six-week follow-up and 3-month follow-up

    Adolescent report on the UCLA Loneliness Scale

  8. Physical Activity

    Time frame: Six-week follow-up and 3-month follow-up

    Time spent in moderate-to-vigorous physical activity measured from the adolescent-worn actigraphy

  9. Sedentary Time

    Time frame: Six-week follow-up and 3-month follow-up

    Time spent sedentary measured from adolescent-worn actigraphy

  10. Emotional Eating

    Time frame: Six-week follow-up and 3-month follow-up

    Adolescent report on the Emotional Eating Scale-Adapted for Children and Adolescents

  11. Loss-of-control Eating

    Time frame: Six-week follow-up and 3-month follow-up

    Adolescent report of loss-of-control episodes on the Loss-of-Control Eating Disorder Questionnaire for Children

  12. Insulin Resistance

    Time frame: Six-week follow-up and 3-month follow-up

    Homeostatic model assessment of insulin resistance derived from adolescent fasting insulin and fasting glucose

  13. Blood pressure

    Time frame: Six-week follow-up and 3-month follow-up

    Systolic blood pressure derived from adolescent ambulatory monitoring

  14. Blood Pressure

    Time frame: Six-week follow-up and 3-month follow-up

    Diastolic blood pressure derived from adolescent ambulatory monitoring

  15. Lipids

    Time frame: Six-week follow-up and 3-month follow-up

    Adolescent triglycerides

  16. Lipids

    Time frame: Six-week follow-up and 3-month follow-up

    Adolescent HDL cholesterol

  17. Lipids

    Time frame: Six-week follow-up and 3-month follow-up

    Adolescent LDL cholesterol

  18. Glycemic Variability

    Time frame: Six-week follow-up and 3-month follow-up

    Standard deviation of glucose derived from adolescent wear of continuous glucose monitor

Study contacts

Contact information is provided by the study sponsor or research team.

Lauren B Shomaker, PhD

CONTACT

[email protected]

970-491-3217

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: CBT+

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
May 6, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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