Digitally Enhanced Cognitive-Behavioral Therapy (CBT+)
1 de setembro de 2026 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
60
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Lauren B Shomaker, PhD
- Número de telefone: 970-491-3217
- E-mail: lauren.shomaker@colostate.edu
Locais de estudo
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-
Colorado
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Aurora, Colorado, Estados Unidos, 80045
- University of Colorado Anschutz Medical Campus
-
Contato:
- Lauren Shomaker, PhD
- Número de telefone: 1-855-395-9031
- E-mail: lauren.shomaker@cuanschutz.edu
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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
|
Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually
App tailored to support cognitive-behavioral therapy (CBT) skills and homework practices
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Intervention Acceptability
Prazo: Six-week follow-up
|
≥80% of adolescents will report likeability/benefit (≥4 on 1-5 scale where 5=Extremely)
|
Six-week follow-up
|
|
Intervention Feasibility
Prazo: Six-week follow-up
|
≥80% of adolescents will receive 80% group dosage (≥5 of 6 sessions)
|
Six-week follow-up
|
|
App Acceptability
Prazo: Six-week follow-up
|
Of those in CBT+, ≥80% of adolescents will use the app regularly (≥3 times per week)
|
Six-week follow-up
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Enrollment Feasibility
Prazo: End-of-enrollment
|
10 teens in ≤12 weeks to form CBT+ vs. CBT-group only parallel cohorts
|
End-of-enrollment
|
|
Enrollment Feasibility
Prazo: End-of-enrollment
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≥75% of those determined to be eligible will enroll
|
End-of-enrollment
|
|
Protocol Feasibility
Prazo: End-of-3-month follow-ups
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<10% missing data
|
End-of-3-month follow-ups
|
|
Protocol Feasibility
Prazo: End-of-3-month follow-ups
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≥80% 3-month follow-up retention
|
End-of-3-month follow-ups
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Depression Symptoms
Prazo: Six-week follow-up and 3-month follow-up
|
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
Prazo: 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
Prazo: Six-week follow-up and 3-month follow-up
|
Adolescent report of frequency/pleasantness of pleasant activities on the Pleasant Events Schedule
|
Six-week follow-up and 3-month follow-up
|
|
Homework Completion
Prazo: Six-week follow-up
|
Adolescent report on the Homework Rating Scale-Version 2
|
Six-week follow-up
|
|
Coping
Prazo: Six-week follow-up and 3-month follow-up
|
Adolescent report on the Brief COPE inventory
|
Six-week follow-up and 3-month follow-up
|
|
Self-efficacy
Prazo: Six-week follow-up and 3-month follow-up
|
Adolescent report on the Self-efficacy Questionnaire for Children
|
Six-week follow-up and 3-month follow-up
|
|
Loneliness
Prazo: Six-week follow-up and 3-month follow-up
|
Adolescent report on the UCLA Loneliness Scale
|
Six-week follow-up and 3-month follow-up
|
|
Physical Activity
Prazo: Six-week follow-up and 3-month follow-up
|
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
Prazo: Six-week follow-up and 3-month follow-up
|
Time spent sedentary measured from adolescent-worn actigraphy
|
Six-week follow-up and 3-month follow-up
|
|
Emotional Eating
Prazo: Six-week follow-up and 3-month follow-up
|
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
Prazo: Six-week follow-up and 3-month follow-up
|
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
Prazo: Six-week follow-up and 3-month follow-up
|
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
Prazo: Six-week follow-up and 3-month follow-up
|
Systolic blood pressure derived from adolescent ambulatory monitoring
|
Six-week follow-up and 3-month follow-up
|
|
Blood Pressure
Prazo: 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
|
|
Lipids
Prazo: Six-week follow-up and 3-month follow-up
|
Adolescent triglycerides
|
Six-week follow-up and 3-month follow-up
|
|
Lipids
Prazo: Six-week follow-up and 3-month follow-up
|
Adolescent HDL cholesterol
|
Six-week follow-up and 3-month follow-up
|
|
Lipids
Prazo: Six-week follow-up and 3-month follow-up
|
Adolescent LDL cholesterol
|
Six-week follow-up and 3-month follow-up
|
|
Glycemic Variability
Prazo: Six-week follow-up and 3-month follow-up
|
Standard deviation of glucose derived from adolescent wear of continuous glucose monitor
|
Six-week follow-up and 3-month follow-up
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de janeiro de 2027
Conclusão Primária (Estimado)
1 de janeiro de 2028
Conclusão do estudo (Estimado)
1 de agosto de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
29 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de abril de 2026
Primeira postagem (Real)
6 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
3 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
1 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Distúrbios Nutricionais
- Supernutrição
- Peso corporal
- Sintomas Comportamentais
- Condições Patológicas, Sinais e Sintomas
- Comportamento
- Doenças Nutricionais e Metabólicas
- Sinais e sintomas
- Excesso de peso
- Obesidade
- Depressão
- Comportamento de saúde
- Terapia comportamental
- Psicoterapia
- Disciplinas e atividades comportamentais
- Terapia cognitivo -comportamental
Outros números de identificação do estudo
- 25-0997
- R34HL180788 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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
Prazo de Compartilhamento de IPD
Data will be made available no later than the time of an associated publication
Critérios de acesso de compartilhamento 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 informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- CIF
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .