Digitally Enhanced Cognitive-Behavioral Therapy (CBT+)
1. September 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
60
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Lauren B Shomaker, PhD
- Telefonnummer: 970-491-3217
- E-Mail: lauren.shomaker@colostate.edu
Studienorte
-
-
Colorado
-
Aurora, Colorado, Vereinigte Staaten, 80045
- University of Colorado Anschutz Medical Campus
-
Kontakt:
- Lauren Shomaker, PhD
- Telefonnummer: 1-855-395-9031
- E-Mail: lauren.shomaker@cuanschutz.edu
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver 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
|
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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Intervention Acceptability
Zeitfenster: 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
Zeitfenster: Six-week follow-up
|
≥80% of adolescents will receive 80% group dosage (≥5 of 6 sessions)
|
Six-week follow-up
|
|
App Acceptability
Zeitfenster: Six-week follow-up
|
Of those in CBT+, ≥80% of adolescents will use the app regularly (≥3 times per week)
|
Six-week follow-up
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Enrollment Feasibility
Zeitfenster: End-of-enrollment
|
10 teens in ≤12 weeks to form CBT+ vs. CBT-group only parallel cohorts
|
End-of-enrollment
|
|
Enrollment Feasibility
Zeitfenster: End-of-enrollment
|
≥75% of those determined to be eligible will enroll
|
End-of-enrollment
|
|
Protocol Feasibility
Zeitfenster: End-of-3-month follow-ups
|
<10% missing data
|
End-of-3-month follow-ups
|
|
Protocol Feasibility
Zeitfenster: End-of-3-month follow-ups
|
≥80% 3-month follow-up retention
|
End-of-3-month follow-ups
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Depression Symptoms
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Six-week follow-up
|
Adolescent report on the Homework Rating Scale-Version 2
|
Six-week follow-up
|
|
Coping
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Six-week follow-up and 3-month follow-up
|
Adolescent triglycerides
|
Six-week follow-up and 3-month follow-up
|
|
Lipids
Zeitfenster: Six-week follow-up and 3-month follow-up
|
Adolescent HDL cholesterol
|
Six-week follow-up and 3-month follow-up
|
|
Lipids
Zeitfenster: Six-week follow-up and 3-month follow-up
|
Adolescent LDL cholesterol
|
Six-week follow-up and 3-month follow-up
|
|
Glycemic Variability
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Januar 2027
Primärer Abschluss (Geschätzt)
1. Januar 2028
Studienabschluss (Geschätzt)
1. August 2028
Studienanmeldedaten
Zuerst eingereicht
29. April 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
29. April 2026
Zuerst gepostet (Tatsächlich)
6. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
3. September 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
1. September 2026
Zuletzt verifiziert
1. September 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Ernährungsstörungen
- Überernährung
- Körpergewicht
- Verhaltenssymptome
- Pathologische Zustände, Anzeichen und Symptome
- Verhalten
- Ernährungs- und Stoffwechselerkrankungen
- Anzeichen und Symptome
- Übergewicht
- Fettleibigkeit
- Depression
- Gesundheitsverhalten
- Verhaltenstherapie
- Psychotherapie
- Verhaltensdisziplinen und Aktivitäten
- Kognitive Verhaltenstherapie
Andere Studien-ID-Nummern
- 25-0997
- R34HL180788 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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-Sharing-Zeitrahmen
Data will be made available no later than the time of an associated publication
IPD-Sharing-Zugriffskriterien
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
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- ICF
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .