Digitally Enhanced Cognitive-Behavioral Therapy (CBT+)
1 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
60
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Lauren B Shomaker, PhD
- Numéro de téléphone: 970-491-3217
- E-mail: lauren.shomaker@colostate.edu
Lieux d'étude
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Colorado
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Aurora, Colorado, États-Unis, 80045
- University of Colorado Anschutz Medical Campus
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Contact:
- Lauren Shomaker, PhD
- Numéro de téléphone: 1-855-395-9031
- E-mail: lauren.shomaker@cuanschutz.edu
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Non
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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
|
|
Expérimental: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Intervention Acceptability
Délai: 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
Délai: Six-week follow-up
|
≥80% of adolescents will receive 80% group dosage (≥5 of 6 sessions)
|
Six-week follow-up
|
|
App Acceptability
Délai: Six-week follow-up
|
Of those in CBT+, ≥80% of adolescents will use the app regularly (≥3 times per week)
|
Six-week follow-up
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Enrollment Feasibility
Délai: End-of-enrollment
|
10 teens in ≤12 weeks to form CBT+ vs. CBT-group only parallel cohorts
|
End-of-enrollment
|
|
Enrollment Feasibility
Délai: End-of-enrollment
|
≥75% of those determined to be eligible will enroll
|
End-of-enrollment
|
|
Protocol Feasibility
Délai: End-of-3-month follow-ups
|
<10% missing data
|
End-of-3-month follow-ups
|
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Protocol Feasibility
Délai: End-of-3-month follow-ups
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≥80% 3-month follow-up retention
|
End-of-3-month follow-ups
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Depression Symptoms
Délai: 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
Délai: 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
Délai: 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
Délai: Six-week follow-up
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Adolescent report on the Homework Rating Scale-Version 2
|
Six-week follow-up
|
|
Coping
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
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Six-week follow-up and 3-month follow-up
|
|
Insulin Resistance
Délai: 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
Délai: 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
Délai: 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
Délai: Six-week follow-up and 3-month follow-up
|
Adolescent triglycerides
|
Six-week follow-up and 3-month follow-up
|
|
Lipids
Délai: Six-week follow-up and 3-month follow-up
|
Adolescent HDL cholesterol
|
Six-week follow-up and 3-month follow-up
|
|
Lipids
Délai: Six-week follow-up and 3-month follow-up
|
Adolescent LDL cholesterol
|
Six-week follow-up and 3-month follow-up
|
|
Glycemic Variability
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 janvier 2027
Achèvement primaire (Estimé)
1 janvier 2028
Achèvement de l'étude (Estimé)
1 août 2028
Dates d'inscription aux études
Première soumission
29 avril 2026
Première soumission répondant aux critères de contrôle qualité
29 avril 2026
Première publication (Réel)
6 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
3 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Troubles nutritionnels
- Suralimentation
- Poids
- Symptômes comportementaux
- Conditions pathologiques, signes et symptômes
- Comportement
- Maladies nutritionnelles et métaboliques
- Signes et symptômes
- En surpoids
- Obésité
- La dépression
- Comportement de santé
- Thérapie comportementale
- Psychothérapie
- Disciplines et activités comportementales
- Thérapie cognitivo-comportementale
Autres numéros d'identification d'étude
- 25-0997
- R34HL180788 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime 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
Délai de partage IPD
Data will be made available no later than the time of an associated publication
Critères d'accès au partage 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
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .