Digitally Enhanced Cognitive-Behavioral Therapy (CBT+)
1 de septiembre de 2026 actualizado por: Colorado State University
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
60
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Lauren B Shomaker, PhD
- Número de teléfono: 970-491-3217
- Correo electrónico: lauren.shomaker@colostate.edu
Ubicaciones de estudio
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- University of Colorado Anschutz Medical Campus
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Contacto:
- Lauren Shomaker, PhD
- Número de teléfono: 1-855-395-9031
- Correo electrónico: lauren.shomaker@cuanschutz.edu
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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
|
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
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Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually
App tailored to support cognitive-behavioral therapy (CBT) skills and homework practices
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Intervention Acceptability
Periodo de tiempo: Six-week follow-up
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≥80% of adolescents will report likeability/benefit (≥4 on 1-5 scale where 5=Extremely)
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Six-week follow-up
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Intervention Feasibility
Periodo de tiempo: Six-week follow-up
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≥80% of adolescents will receive 80% group dosage (≥5 of 6 sessions)
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Six-week follow-up
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App Acceptability
Periodo de tiempo: Six-week follow-up
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Of those in CBT+, ≥80% of adolescents will use the app regularly (≥3 times per week)
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Six-week follow-up
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Enrollment Feasibility
Periodo de tiempo: End-of-enrollment
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10 teens in ≤12 weeks to form CBT+ vs. CBT-group only parallel cohorts
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End-of-enrollment
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Enrollment Feasibility
Periodo de tiempo: End-of-enrollment
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≥75% of those determined to be eligible will enroll
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End-of-enrollment
|
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Protocol Feasibility
Periodo de tiempo: End-of-3-month follow-ups
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<10% missing data
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End-of-3-month follow-ups
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Protocol Feasibility
Periodo de tiempo: End-of-3-month follow-ups
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≥80% 3-month follow-up retention
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End-of-3-month follow-ups
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Depression Symptoms
Periodo de tiempo: Six-week follow-up and 3-month follow-up
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Adolescent report on the 20-item Center for Epidemiologic Studies-Depression Scale (CES-D), total score
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Six-week follow-up and 3-month follow-up
|
|
Negative Automatic Thoughts
Periodo de tiempo: 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
|
Six-week follow-up and 3-month follow-up
|
|
Pleasant Activities
Periodo de tiempo: Six-week follow-up and 3-month follow-up
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Adolescent report of frequency/pleasantness of pleasant activities on the Pleasant Events Schedule
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Six-week follow-up and 3-month follow-up
|
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Homework Completion
Periodo de tiempo: Six-week follow-up
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Adolescent report on the Homework Rating Scale-Version 2
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Six-week follow-up
|
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Coping
Periodo de tiempo: Six-week follow-up and 3-month follow-up
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Adolescent report on the Brief COPE inventory
|
Six-week follow-up and 3-month follow-up
|
|
Self-efficacy
Periodo de tiempo: Six-week follow-up and 3-month follow-up
|
Adolescent report on the Self-efficacy Questionnaire for Children
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Six-week follow-up and 3-month follow-up
|
|
Loneliness
Periodo de tiempo: Six-week follow-up and 3-month follow-up
|
Adolescent report on the UCLA Loneliness Scale
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Six-week follow-up and 3-month follow-up
|
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Physical Activity
Periodo de tiempo: Six-week follow-up and 3-month follow-up
|
Time spent in moderate-to-vigorous physical activity measured from the adolescent-worn actigraphy
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Six-week follow-up and 3-month follow-up
|
|
Sedentary Time
Periodo de tiempo: Six-week follow-up and 3-month follow-up
|
Time spent sedentary measured from adolescent-worn actigraphy
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Six-week follow-up and 3-month follow-up
|
|
Emotional Eating
Periodo de tiempo: Six-week follow-up and 3-month follow-up
|
Adolescent report on the Emotional Eating Scale-Adapted for Children and Adolescents
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Six-week follow-up and 3-month follow-up
|
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Loss-of-control Eating
Periodo de tiempo: Six-week follow-up and 3-month follow-up
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Adolescent report of loss-of-control episodes on the Loss-of-Control Eating Disorder Questionnaire for Children
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Six-week follow-up and 3-month follow-up
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Insulin Resistance
Periodo de tiempo: Six-week follow-up and 3-month follow-up
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Homeostatic model assessment of insulin resistance derived from adolescent fasting insulin and fasting glucose
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Six-week follow-up and 3-month follow-up
|
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Blood pressure
Periodo de tiempo: Six-week follow-up and 3-month follow-up
|
Systolic blood pressure derived from adolescent ambulatory monitoring
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Six-week follow-up and 3-month follow-up
|
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Blood Pressure
Periodo de tiempo: Six-week follow-up and 3-month follow-up
|
Diastolic blood pressure derived from adolescent ambulatory monitoring
|
Six-week follow-up and 3-month follow-up
|
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Lipids
Periodo de tiempo: Six-week follow-up and 3-month follow-up
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Adolescent triglycerides
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Six-week follow-up and 3-month follow-up
|
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Lipids
Periodo de tiempo: Six-week follow-up and 3-month follow-up
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Adolescent HDL cholesterol
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Six-week follow-up and 3-month follow-up
|
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Lipids
Periodo de tiempo: Six-week follow-up and 3-month follow-up
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Adolescent LDL cholesterol
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Six-week follow-up and 3-month follow-up
|
|
Glycemic Variability
Periodo de tiempo: Six-week follow-up and 3-month follow-up
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Standard deviation of glucose derived from adolescent wear of continuous glucose monitor
|
Six-week follow-up and 3-month follow-up
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de enero de 2027
Finalización primaria (Estimado)
1 de enero de 2028
Finalización del estudio (Estimado)
1 de agosto de 2028
Fechas de registro del estudio
Enviado por primera vez
29 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
29 de abril de 2026
Publicado por primera vez (Actual)
6 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
1 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Trastornos Nutricionales
- Sobrenutrición
- Peso corporal
- Síntomas de comportamiento
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Exceso de peso
- Obesidad
- Depresión
- Comportamiento de salud
- Terapia conductual
- Psicoterapia
- Disciplinas y actividades de comportamiento
- Terapia cognitiva conductual
Otros números de identificación del estudio
- 25-0997
- R34HL180788 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
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
Marco de tiempo para compartir IPD
Data will be made available no later than the time of an associated publication
Criterios de acceso compartido de IPD
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
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .