Digitally Enhanced Cognitive-Behavioral Therapy
CBT+
2 other identifiers
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2027
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2026
CompletedFirst Posted
Study publicly available on registry
May 6, 2026
CompletedStudy Start
First participant enrolled
January 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
Study Completion
Last participant's last visit for all outcomes
August 1, 2028
May 6, 2026
April 1, 2026
1 year
April 29, 2026
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Intervention Acceptability
≥80% of adolescents will report likeability/benefit (≥4 on 1-5 scale where 5=Extremely)
Six-week follow-up
Intervention Feasibility
≥80% of adolescents will receive 80% group dosage (≥5 of 6 sessions)
Six-week follow-up
App Acceptability
Of those in CBT+, ≥80% of adolescents will use the app regularly (≥3 times per week)
Six-week follow-up
Secondary Outcomes (4)
Enrollment Feasibility
End-of-enrollment
Enrollment Feasibility
End-of-enrollment
Protocol Feasibility
End-of-3-month follow-ups
Protocol Feasibility
End-of-3-month follow-ups
Other Outcomes (18)
Depression Symptoms
Six-week follow-up and 3-month follow-up
Negative Automatic Thoughts
Six-week follow-up and 3-month follow-up
Pleasant Activities
Six-week follow-up and 3-month follow-up
- +15 more other outcomes
Study Arms (2)
Cognitive-behavioral therapy (CBT)
ACTIVE COMPARATORSix-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually; CBT focuses on changing thoughts and changing behaviors to improve mood
Cognitive-behavioral therapy-Plus (CBT+)
EXPERIMENTALSix-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
Interventions
Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually
App tailored to support cognitive-behavioral therapy (CBT) skills and homework practices
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Related Publications (3)
Shomaker LB, Kelly NR, Pickworth CK, Cassidy OL, Radin RM, Shank LM, Vannucci A, Thompson KA, Armaiz-Flores SA, Brady SM, Demidowich AP, Galescu OA, Courville AB, Olsen C, Chen KY, Stice E, Tanofsky-Kraff M, Yanovski JA. A Randomized Controlled Trial to Prevent Depression and Ameliorate Insulin Resistance in Adolescent Girls at Risk for Type 2 Diabetes. Ann Behav Med. 2016 Oct;50(5):762-774. doi: 10.1007/s12160-016-9801-0.
PMID: 27333897BACKGROUNDPerzow SED, Hu J, Bristol M, Ruzicka EB, Clementi MA, Handing EP, Vargas E, Gutierrez-Colina AM, Gulley LD, Shomaker LB. Systematic review and meta-analysis of psychological interventions for depression symptoms in young people with long-term physical health conditions. J Pediatr Psychol. 2025 Jul 1;50(7):699-714. doi: 10.1093/jpepsy/jsaf049.
PMID: 40795045BACKGROUNDShomaker LB, Kelly NR, Radin RM, Cassidy OL, Shank LM, Brady SM, Demidowich AP, Olsen CH, Chen KY, Stice E, Tanofsky-Kraff M, Yanovski JA. Prevention of insulin resistance in adolescents at risk for type 2 diabetes with depressive symptoms: 1-year follow-up of a randomized trial. Depress Anxiety. 2017 Oct;34(10):866-876. doi: 10.1002/da.22617. Epub 2017 Mar 31.
PMID: 28370947BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2026
First Posted
May 6, 2026
Study Start (Estimated)
January 1, 2027
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
August 1, 2028
Last Updated
May 6, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- 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
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