Digitally Enhanced Cognitive-Behavioral Therapy (CBT+)
Digitally Enhanced Cognitive-Behavioral Therapy for Adolescents With Depression and Obesity
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Studientyp
Einschreibung (Geschätzt)
Einschreibung
Phase
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
Studienkontakt
- Name: Lauren B Shomaker, PhD
- Telefonnummer: 970-491-3217
- E-Mail: lauren.shomaker@colostate.edu
Studienorte
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-
Colorado
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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
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
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
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
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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
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Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually
|
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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
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Six-week, six-session group cognitive-behavioral therapy (CBT) delivered virtually
App tailored to support cognitive-behavioral therapy (CBT) skills and homework practices
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Was misst die Studie?
Primäre Ergebnismessungen
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)
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Six-week follow-up
|
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Intervention Feasibility
Zeitfenster: Six-week follow-up
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≥80% of adolescents will receive 80% group dosage (≥5 of 6 sessions)
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Six-week follow-up
|
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App Acceptability
Zeitfenster: Six-week follow-up
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Of those in CBT+, ≥80% of adolescents will use the app regularly (≥3 times per week)
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Six-week follow-up
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Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Enrollment Feasibility
Zeitfenster: End-of-enrollment
|
10 teens in ≤12 weeks to form CBT+ vs. CBT-group only parallel cohorts
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End-of-enrollment
|
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Enrollment Feasibility
Zeitfenster: End-of-enrollment
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≥75% of those determined to be eligible will enroll
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End-of-enrollment
|
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Protocol Feasibility
Zeitfenster: End-of-3-month follow-ups
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<10% missing data
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End-of-3-month follow-ups
|
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Protocol Feasibility
Zeitfenster: End-of-3-month follow-ups
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≥80% 3-month follow-up retention
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End-of-3-month follow-ups
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Andere Ergebnismessungen
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Depression Symptoms
Zeitfenster: Six-week follow-up and 3-month follow-up
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Adolescent report on the 20-item Center for Epidemiologic Studies-Depression Scale (CES-D), total score
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Six-week follow-up and 3-month follow-up
|
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Negative Automatic Thoughts
Zeitfenster: Six-week follow-up and 3-month follow-up
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Adolescent report on the Negative Automatic Thoughts subscale of the Children's Automatic Thoughts Scale-Negative/Positive
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Six-week follow-up and 3-month follow-up
|
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Pleasant Activities
Zeitfenster: Six-week follow-up and 3-month follow-up
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Adolescent report of frequency/pleasantness of pleasant activities on the Pleasant Events Schedule
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Six-week follow-up and 3-month follow-up
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Homework Completion
Zeitfenster: Six-week follow-up
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Adolescent report on the Homework Rating Scale-Version 2
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Six-week follow-up
|
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Coping
Zeitfenster: Six-week follow-up and 3-month follow-up
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Adolescent report on the Brief COPE inventory
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Six-week follow-up and 3-month follow-up
|
|
Self-efficacy
Zeitfenster: Six-week follow-up and 3-month follow-up
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Adolescent report on the Self-efficacy Questionnaire for Children
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Six-week follow-up and 3-month follow-up
|
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Loneliness
Zeitfenster: Six-week follow-up and 3-month follow-up
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Adolescent report on the UCLA Loneliness Scale
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Six-week follow-up and 3-month follow-up
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Physical Activity
Zeitfenster: Six-week follow-up and 3-month follow-up
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Time spent in moderate-to-vigorous physical activity measured from the adolescent-worn actigraphy
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Six-week follow-up and 3-month follow-up
|
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Sedentary Time
Zeitfenster: Six-week follow-up and 3-month follow-up
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Time spent sedentary measured from adolescent-worn actigraphy
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Six-week follow-up and 3-month follow-up
|
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Emotional Eating
Zeitfenster: Six-week follow-up and 3-month follow-up
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Adolescent report on the Emotional Eating Scale-Adapted for Children and Adolescents
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Six-week follow-up and 3-month follow-up
|
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Loss-of-control Eating
Zeitfenster: Six-week follow-up and 3-month follow-up
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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
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Insulin Resistance
Zeitfenster: Six-week follow-up and 3-month follow-up
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Homeostatic model assessment of insulin resistance derived from adolescent fasting insulin and fasting glucose
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Six-week follow-up and 3-month follow-up
|
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Blood pressure
Zeitfenster: Six-week follow-up and 3-month follow-up
|
Systolic blood pressure derived from adolescent ambulatory monitoring
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Six-week follow-up and 3-month follow-up
|
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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
|
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Lipids
Zeitfenster: Six-week follow-up and 3-month follow-up
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Adolescent triglycerides
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Six-week follow-up and 3-month follow-up
|
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Lipids
Zeitfenster: Six-week follow-up and 3-month follow-up
|
Adolescent HDL cholesterol
|
Six-week follow-up and 3-month follow-up
|
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Lipids
Zeitfenster: Six-week follow-up and 3-month follow-up
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Adolescent LDL cholesterol
|
Six-week follow-up and 3-month follow-up
|
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Glycemic Variability
Zeitfenster: Six-week follow-up and 3-month follow-up
|
Standard deviation of glucose derived from adolescent wear of continuous glucose monitor
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Six-week follow-up and 3-month follow-up
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Mitarbeiter und Ermittler
Sponsor
Sponsor
Mitarbeiter
Mitarbeiter
Publikationen und hilfreiche Links
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
Haupttermine studieren
Studienbeginn (Geschätzt)
Studienbeginn
Primärer Abschluss (Geschätzt)
Primärer Abschluss
Studienabschluss (Geschätzt)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
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
Andere Studien-ID-Nummern
- 25-0997
- R34HL180788 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
IPD-Sharing-Zeitrahmen
IPD-Sharing-Zugriffskriterien
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- ICF
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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