Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Digitally Enhanced Cognitive-Behavioral Therapy (CBT+)

3. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • University of Colorado Anschutz Medical Campus

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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
Adfærdsmæssigt: Cognitive-behavioral therapy (CBT)
Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually
Eksperimentel: 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
Adfærdsmæssigt: Cognitive-behavioral therapy (CBT)
Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually
Adfærdsmæssigt: Digital app
App tailored to support cognitive-behavioral therapy (CBT) skills and homework practices

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Intervention Acceptability
Tidsramme: 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
Tidsramme: Six-week follow-up
≥80% of adolescents will receive 80% group dosage (≥5 of 6 sessions)
Six-week follow-up
App Acceptability
Tidsramme: Six-week follow-up
Of those in CBT+, ≥80% of adolescents will use the app regularly (≥3 times per week)
Six-week follow-up

Sekundære resultatmål

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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Depression Symptoms
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Six-week follow-up
Adolescent report on the Homework Rating Scale-Version 2
Six-week follow-up
Coping
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Six-week follow-up and 3-month follow-up
Adolescent triglycerides
Six-week follow-up and 3-month follow-up
Lipids
Tidsramme: Six-week follow-up and 3-month follow-up
Adolescent HDL cholesterol
Six-week follow-up and 3-month follow-up
Lipids
Tidsramme: Six-week follow-up and 3-month follow-up
Adolescent LDL cholesterol
Six-week follow-up and 3-month follow-up
Glycemic Variability
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Colorado State University

Samarbejdspartnere

National Heart, Lung, and Blood Institute (NHLBI)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. januar 2027

Primær færdiggørelse (Anslået)

1. januar 2028

Studieafslutning (Anslået)

1. august 2028

Datoer for studieregistrering

Først indsendt

29. april 2026

Først indsendt, der opfyldte QC-kriterier

29. april 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 25-0997
  • R34HL180788 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Sundhedsadfærd

Kliniske forsøg med Cognitive-behavioral therapy (CBT)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Bahrain

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner