Brief Cognitive Behavioral Therapy (CBT) for Pediatric Anxiety and Depression in Primary Care (BCBT-PC)
12. april 2016 opdateret af: V. Robin Weersing, San Diego State University
Brief CBT for Pediatric Anxiety and Depression in Primary Care
The purpose of this study is to determine whether a brief (12 week) psychological treatment program, based in primary care, can help youths struggling with anxiety and/or depression.
This brief cognitive behavioral therapy program will be compared to enhanced referral to specialty mental health care.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Mood and anxiety disorders in childhood and adolescence are disabling, distressing, and prevalent and produce added costs to health systems.
This two-site randomized controlled trial will test the effects of a brief cognitive behavioral therapy (BCBT) protocol (8-12 sessions) in a large sample (N=210) of children and adolescents (age 8-16) presenting with anxiety and/or depression in primary care.
Clinical and cost-effectiveness of BCBT will be compared to a plausible public health alternative - enhanced referral to specialty mental health care (SMHC).
This investigation is noteworthy in adopting a deployment-focused model and testing this intervention early in its development within a real world context (primary care) and against a plausible public health comparison condition (SMHC) relevant for future treatment dissemination.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
185
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
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San Diego, California, Forenede Stater, 92120
- San Diego State University
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Western Psychiatric Institute and Clinics
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-
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
8 år til 16 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- meet full or probable diagnostic criteria for Separation Anxiety Disorder, Generalized Anxiety Disorder, Social Phobia, Major Depression, Dysthymic Disorder, or Minor Depression
- age 8.0 to 16.9
- live with legal, consenting guardian for at least 6 months
Exclusion Criteria:
- youths requiring alternate intervention (e.g., youths with bipolar disorder, psychosis, active suicidal ideation with plan, PTSD, substance dependence, current physical or sexual abuse, or mental retardation
- suffer from serious or unstable physical illness (e.g., uncontrolled diabetes)
- currently in active, alternate intervention for anxiety or depression (e.g., antidepressant use)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: specialty mental health care referral
|
SMHC: specialty mental health care referrals provided
Andre navne:
|
|
Eksperimentel: Kort kognitiv adfærdsterapi
|
BCBT: 8-12 sessions over 16 weeks of cognitive-behavioral therapy administered by Master's-level clinicians in primary care setting
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Clinical Global Impression
Tidsramme: measured at baseline (week 0)
|
measured at baseline (week 0)
|
|
Clinical Global Impression
Tidsramme: measured at post-treatment (week 16)
|
measured at post-treatment (week 16)
|
|
Clinical Global Impression
Tidsramme: measured at 8 month follow-up (week 32)
|
measured at 8 month follow-up (week 32)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pediatric Anxiety Rating Scale
Tidsramme: measured at baseline (week 0)
|
measured at baseline (week 0)
|
|
|
Children's Depression Rating Scale - Revised
Tidsramme: measured at baseline (week 0)
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measured at baseline (week 0)
|
|
|
Health Utilities Index
Tidsramme: measured at baseline (week 0)
|
This measure will aid in cost-effectiveness analyses.
|
measured at baseline (week 0)
|
|
Pediatric Anxiety Rating Scale
Tidsramme: measured at post-treatment (week 16)
|
measured at post-treatment (week 16)
|
|
|
Pediatric Anxiety Rating Scale
Tidsramme: measured at 8 month follow-up (week 32)
|
measured at 8 month follow-up (week 32)
|
|
|
Children's Depression Rating Scale - Revised
Tidsramme: measured at post-treatment (week 16)
|
measured at post-treatment (week 16)
|
|
|
Children's Depression Rating Scale - Revised
Tidsramme: measured at 8 month follow-up (week 32)
|
measured at 8 month follow-up (week 32)
|
|
|
Health Utilities Index
Tidsramme: measured at post-treatment (week 16)
|
This measure will aid in cost-effectiveness analyses.
|
measured at post-treatment (week 16)
|
|
Health Utilities Index
Tidsramme: measured at 8 month follow-up (week 32)
|
This measure will aid in cost-effectiveness analyses.
|
measured at 8 month follow-up (week 32)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: V. Robin Weersing, Ph.D., San Diego State University
- Ledende efterforsker: David A Brent, M.D., Western Psychiatric Institute and Clinics
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
- Weersing VR, Gonzalez A, Campo JV, Lucas AN. Brief behavioral therapy for pediatric anxiety and depression: Piloting an integrated treatment approach. Cognitive and Behavioral Practice 15: 126-139, 2008.
- Schwartz KTG, Kado-Walton M, Dickerson JF, Rozenman M, Brent DA, Porta G, Lynch FL, Gonzalez A, Weersing VR. Brief Behavioral Therapy for Anxiety and Depression in Pediatric Primary Care: Breadth of Intervention Impact. J Am Acad Child Adolesc Psychiatry. 2023 Feb;62(2):230-243. doi: 10.1016/j.jaac.2022.08.007. Epub 2022 Aug 24.
- Brent DA, Porta G, Rozenman MS, Gonzalez A, Schwartz KTG, Lynch FL, Dickerson JF, Iyengar S, Weersing VR. Brief Behavioral Therapy for Pediatric Anxiety and Depression in Primary Care: A Follow-up. J Am Acad Child Adolesc Psychiatry. 2020 Jul;59(7):856-867. doi: 10.1016/j.jaac.2019.06.009. Epub 2019 Jul 3.
- Weersing VR, Brent DA, Rozenman MS, Gonzalez A, Jeffreys M, Dickerson JF, Lynch FL, Porta G, Iyengar S. Brief Behavioral Therapy for Pediatric Anxiety and Depression in Primary Care: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Jun 1;74(6):571-578. doi: 10.1001/jamapsychiatry.2017.0429.
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
1. september 2010
Primær færdiggørelse (Faktiske)
1. april 2016
Studieafslutning (Faktiske)
1. april 2016
Datoer for studieregistrering
Først indsendt
17. juni 2010
Først indsendt, der opfyldte QC-kriterier
21. juni 2010
Først opslået (Skøn)
22. juni 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
14. april 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. april 2016
Sidst verificeret
1. april 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 7887933
- 5R01MH084935 (U.S. NIH-bevilling/kontrakt)
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 .