An interventional study of Cognitive-behavioral therapy (CBT) and Digital app in Depression in Adolescence, Obesity & Overweight and Cognitive-behavioral Therapy, sponsored by Colorado State University. Not yet recruiting at 1 site in United States. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Colorado State University · Not applicable, Interventional, and Prevention
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.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 60 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Colorado State University is the lead sponsor of 117 studies on the registry; 19 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually; CBT focuses on changing thoughts and changing behaviors to improve mood
Behavioral: 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 PLUS access to a digital app to use throughout the CBT group program
Behavioral: Cognitive-behavioral therapy (CBT) · Behavioral: Digital app
Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually
App tailored to support cognitive-behavioral therapy (CBT) skills and homework practices
Intervention Acceptability
≥80% of adolescents will report likeability/benefit (≥4 on 1-5 scale where 5=Extremely)
Time frame: Six-week follow-up
Intervention Feasibility
≥80% of adolescents will receive 80% group dosage (≥5 of 6 sessions)
Time frame: Six-week follow-up
App Acceptability
Of those in CBT+, ≥80% of adolescents will use the app regularly (≥3 times per week)
Time frame: Six-week follow-up
Enrollment Feasibility
10 teens in ≤12 weeks to form CBT+ vs. CBT-group only parallel cohorts
Time frame: End-of-enrollment
Enrollment Feasibility
≥75% of those determined to be eligible will enroll
Time frame: End-of-enrollment
Protocol Feasibility
\<10% missing data
Time frame: End-of-3-month follow-ups
Protocol Feasibility
≥80% 3-month follow-up retention
Time frame: End-of-3-month follow-ups
Depression Symptoms
Adolescent report on the 20-item Center for Epidemiologic Studies-Depression Scale (CES-D), total score
Time frame: Six-week follow-up and 3-month follow-up
Negative Automatic Thoughts
Adolescent report on the Negative Automatic Thoughts subscale of the Children's Automatic Thoughts Scale-Negative/Positive
Time frame: Six-week follow-up and 3-month follow-up
Pleasant Activities
Adolescent report of frequency/pleasantness of pleasant activities on the Pleasant Events Schedule
Time frame: Six-week follow-up and 3-month follow-up
Homework Completion
Adolescent report on the Homework Rating Scale-Version 2
Time frame: Six-week follow-up
Coping
Adolescent report on the Brief COPE inventory
Time frame: Six-week follow-up and 3-month follow-up
Self-efficacy
Adolescent report on the Self-efficacy Questionnaire for Children
Time frame: Six-week follow-up and 3-month follow-up
Loneliness
Adolescent report on the UCLA Loneliness Scale
Time frame: Six-week follow-up and 3-month follow-up
Physical Activity
Time spent in moderate-to-vigorous physical activity measured from the adolescent-worn actigraphy
Time frame: Six-week follow-up and 3-month follow-up
Sedentary Time
Time spent sedentary measured from adolescent-worn actigraphy
Time frame: Six-week follow-up and 3-month follow-up
Emotional Eating
Adolescent report on the Emotional Eating Scale-Adapted for Children and Adolescents
Time frame: Six-week follow-up and 3-month follow-up
Loss-of-control Eating
Adolescent report of loss-of-control episodes on the Loss-of-Control Eating Disorder Questionnaire for Children
Time frame: Six-week follow-up and 3-month follow-up
Insulin Resistance
Homeostatic model assessment of insulin resistance derived from adolescent fasting insulin and fasting glucose
Time frame: Six-week follow-up and 3-month follow-up
Blood pressure
Systolic blood pressure derived from adolescent ambulatory monitoring
Time frame: Six-week follow-up and 3-month follow-up
Blood Pressure
Diastolic blood pressure derived from adolescent ambulatory monitoring
Time frame: Six-week follow-up and 3-month follow-up
Lipids
Adolescent triglycerides
Time frame: Six-week follow-up and 3-month follow-up
Lipids
Adolescent HDL cholesterol
Time frame: Six-week follow-up and 3-month follow-up
Lipids
Adolescent LDL cholesterol
Time frame: Six-week follow-up and 3-month follow-up
Glycemic Variability
Standard deviation of glucose derived from adolescent wear of continuous glucose monitor
Time frame: Six-week follow-up and 3-month follow-up
Plan to share: Yes — CBT-app usage and CBT group attendance; adolescent depression questionnaire data; CBT and CBT-app adolescent questionnaires assessing CBT-group and CBT-app therapeutic targets (thoughts, pleasant activities, coping, self-efficacy, loneliness); health behavior measured by actigraphy (physical activity/sleep) and adolescent questionnaire (eating); adolescent cardiometabolic health indicators by fasting blood draw to assess lipids (triglycerides, cholesterol) and glucose/insulin to calculate insulin resistance, continuous glucose monitoring data, and heart rate/blood pressure
Supporting information: Study protocol, Informed consent form
Time frame: Data will be made available no later than the time of an associated publication
Access criteria: We will use the openICPSR data repository, an NIH-approved self-publishing repository for social, behavioral, and health sciences research data; to request access of the data, researchers will follow the standard process at openICPSR
Data sharing details ↗ · www.openicpsr.org
Start is estimated for Jan 2027; primary completion for Jan 2028, 12 months later.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 12 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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