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| ID | Type | Description | Link |
|---|---|---|---|
| R34HL180788 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive-behavioral therapy (CBT) | Active Comparator | Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually; CBT focuses on changing thoughts and changing behaviors to improve mood |
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| Cognitive-behavioral therapy-Plus (CBT+) | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-behavioral therapy (CBT) | Behavioral | Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually |
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| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauren B Shomaker, PhD | Contact | 970-491-3217 | lauren.shomaker@colostate.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27333897 | Background | 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. | |
| 40795045 | Background |
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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
Data will be made available no later than the time of an associated publication
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
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D015438 | Health Behavior |
| D003863 | Depression |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Digital app | Behavioral | App tailored to support cognitive-behavioral therapy (CBT) skills and homework practices |
|
| 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 |
| 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 |
| 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. |
| 28370947 | Background | 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. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |