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Digitally Enhanced Cognitive-Behavioral Therapy (CBT+)

3 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80045
        • University of Colorado Anschutz Medical Campus

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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
Comportamentale: Cognitive-behavioral therapy (CBT)
Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually
Sperimentale: 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
Comportamentale: Cognitive-behavioral therapy (CBT)
Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually
Comportamentale: Digital app
App tailored to support cognitive-behavioral therapy (CBT) skills and homework practices

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Intervention Acceptability
Lasso di tempo: 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
Lasso di tempo: Six-week follow-up
≥80% of adolescents will receive 80% group dosage (≥5 of 6 sessions)
Six-week follow-up
App Acceptability
Lasso di tempo: Six-week follow-up
Of those in CBT+, ≥80% of adolescents will use the app regularly (≥3 times per week)
Six-week follow-up

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Enrollment Feasibility
Lasso di tempo: End-of-enrollment
10 teens in ≤12 weeks to form CBT+ vs. CBT-group only parallel cohorts
End-of-enrollment
Enrollment Feasibility
Lasso di tempo: End-of-enrollment
≥75% of those determined to be eligible will enroll
End-of-enrollment
Protocol Feasibility
Lasso di tempo: End-of-3-month follow-ups
<10% missing data
End-of-3-month follow-ups
Protocol Feasibility
Lasso di tempo: End-of-3-month follow-ups
≥80% 3-month follow-up retention
End-of-3-month follow-ups

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Depression Symptoms
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Six-week follow-up
Adolescent report on the Homework Rating Scale-Version 2
Six-week follow-up
Coping
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Six-week follow-up and 3-month follow-up
Adolescent triglycerides
Six-week follow-up and 3-month follow-up
Lipids
Lasso di tempo: Six-week follow-up and 3-month follow-up
Adolescent HDL cholesterol
Six-week follow-up and 3-month follow-up
Lipids
Lasso di tempo: Six-week follow-up and 3-month follow-up
Adolescent LDL cholesterol
Six-week follow-up and 3-month follow-up
Glycemic Variability
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Colorado State University

Collaboratori

National Heart, Lung, and Blood Institute (NHLBI)

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 gennaio 2027

Completamento primario (Stimato)

1 gennaio 2028

Completamento dello studio (Stimato)

1 agosto 2028

Date di iscrizione allo studio

Primo inviato

29 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 aprile 2026

Primo Inserito (Effettivo)

6 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 25-0997
  • R34HL180788 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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

Periodo di condivisione IPD

Data will be made available no later than the time of an associated publication

Criteri di accesso alla condivisione 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 di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Sponsor e collaboratori

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Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

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