Digitally Enhanced Cognitive-Behavioral Therapy (CBT+)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Health Behavior; Depression in Adolescence; Cognitive-behavioral Therapy; Obesity & Overweight; Mobile Health Technology (mHealth)
• Intervention / Treatment: Behavioral: Cognitive-behavioral therapy (CBT); Behavioral: Digital app

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren B Shomaker, PhD; Phone Number: 970-491-3217; Email: lauren.shomaker@colostate.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Behavioral: Cognitive-behavioral therapy (CBT); Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually
Experimental: Cognitive-behavioral therapy-Plus (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); Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually; Behavioral: Digital app; App tailored to support cognitive-behavioral therapy (CBT) skills and homework practices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment Feasibility	10 teens in ≤12 weeks to form CBT+ vs. CBT-group only parallel cohorts	End-of-enrollment
Enrollment Feasibility	≥75% of those determined to be eligible will enroll	End-of-enrollment
Protocol Feasibility	<10% missing data	End-of-3-month follow-ups
Protocol Feasibility	≥80% 3-month follow-up retention	End-of-3-month follow-ups

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression Symptoms	Adolescent report on the 20-item Center for Epidemiologic Studies-Depression Scale (CES-D), total score	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	Six-week follow-up and 3-month follow-up
Pleasant Activities	Adolescent report of frequency/pleasantness of pleasant activities on the Pleasant Events Schedule	Six-week follow-up and 3-month follow-up
Homework Completion	Adolescent report on the Homework Rating Scale-Version 2	Six-week follow-up
Coping	Adolescent report on the Brief COPE inventory	Six-week follow-up and 3-month follow-up
Self-efficacy	Adolescent report on the Self-efficacy Questionnaire for Children	Six-week follow-up and 3-month follow-up
Loneliness	Adolescent report on the UCLA Loneliness Scale	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	Six-week follow-up and 3-month follow-up
Sedentary Time	Time spent sedentary measured from adolescent-worn actigraphy	Six-week follow-up and 3-month follow-up
Emotional Eating	Adolescent report on the Emotional Eating Scale-Adapted for Children and Adolescents	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	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	Six-week follow-up and 3-month follow-up
Blood pressure	Systolic blood pressure derived from adolescent ambulatory monitoring	Six-week follow-up and 3-month follow-up
Blood Pressure	Diastolic blood pressure derived from adolescent ambulatory monitoring	Six-week follow-up and 3-month follow-up
Lipids	Adolescent triglycerides	Six-week follow-up and 3-month follow-up
Lipids	Adolescent HDL cholesterol	Six-week follow-up and 3-month follow-up
Lipids	Adolescent LDL cholesterol	Six-week follow-up and 3-month follow-up
Glycemic Variability	Standard deviation of glucose derived from adolescent wear of continuous glucose monitor	Six-week follow-up and 3-month follow-up

Collaborators and Investigators

• Sponsor: Colorado State University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

General Publications

• Shomaker 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.
• 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.
• Perzow 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: depression; mHealth; adolescents; cognitive-behavioral therapy; cardiometabolic health
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Behavioral Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Depression; Health Behavior; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy
• Other Study ID Numbers: 25-0997; R34HL180788 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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
• IPD Sharing Time Frame: Data will be made available no later than the time of an associated publication
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No