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Cognitive Behavioral Treatment for Post-Traumatic Stress Disorder in People With Additional Serious Mental Illnesses

7. august 2012 oppdatert av: Dartmouth-Hitchcock Medical Center

Cognitive Behavioral Treatment of Post-Traumatic Stress Disorder in Clients With Severe Mental Illness (in New Jersey)

This study will evaluate the effectiveness of tailored cognitive behavioral therapy in treating post-traumatic stress disorder in people with additional mental illnesses.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Post-traumatic stress disorder (PTSD) is an anxiety disorder that can develop after experiencing a terrifying event or ordeal in which grave physical harm occurred or was threatened. People with PTSD have persistent frightening thoughts and memories about the traumatic event and may experience sleep problems, feel detached or numb, or be easily startled. Studies have shown that PTSD occurs at high rates among people with serious mental illnesses (SMI), such as bipolar disorder, schizophrenia, and major depression. Research has also proven that cognitive behavioral therapy (CBT) is an effective PTSD treatment for caucasians living in rural areas when it is administered by a PhD-level clinician. It is not clear, however, how successful this treatment will be when it is delivered to a minority population by frontline mental health clinicians in an urban setting. This study will evaluate the effectiveness of tailored CBT in treating PTSD in people with additional mental illnesses who live in urban areas of New Jersey.

Participants in this 4- to 5-month open-label study will be randomly assigned to receive either brief PTSD treatment or CBT. Participants assigned to brief PTSD treatment will have three meetings with a therapist per week. Participants will learn about PTSD, how symptoms may be affecting their lives, and a technique for reducing anxiety associated with PTSD. Participants assigned to CBT will attend 12 to 16 counseling sessions per week or every other week. Participants will learn about PTSD and ways to decrease anxiety associated with PTSD by completing homework assignments and practicing skills learned in counseling sessions. Outcomes will be assessed for all participants through interviews that will occur immediately post-treatment, 6 months post-treatment, and 1 year post-treatment.

For information on a related study, please follow this link:

http://clinicaltrials.gov/show/NCT00053690

Studietype

Intervensjonell

Registrering (Faktiske)

200

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • New Jersey
      • Monmouth Junction, New Jersey, Forente stater, 08852
        • United Behavioral HealthCare (UBHC): Partial Hospital Program
      • New Brunswick, New Jersey, Forente stater, 08901
        • University Behavioral HealthCare (UBHC) Adult Outpatient Psychiatric Services
      • New Brunswick, New Jersey, Forente stater, 08901
        • University Behavioral HealthCare (UBHC) Extended Treatment
      • Newark, New Jersey, Forente stater, 07101
        • University Behavioral HealthCare (UBHC) Extended Treatment Division - Adult Outpatient Psychiatric Services
      • Newark, New Jersey, Forente stater, 07101
        • University Behavioral HealthCare (UBHC) Extended Treatment Division - Partial Hospital Program

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Meets New Jersey definition of severe mental illness (SMI), which includes a DSM-IV diagnosis of an SMI; within the 3 to 6 months prior to study entry, functional limitations in major life activities that would be appropriate for the client's developmental stage; and within 2 years prior to study entry, two or more treatment episodes of greater intensity than outpatient services (such as inpatient, emergency, or partial hospitalization care, or a single episode lasting 3 months or more) OR a normal living situation disrupted to the point that supportive services were required to maintain the patient in their home or residence, or law enforcement officials were required to intervene
  • DSM-IV Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depression (as determined by Structured Clinical Interview)
  • Diagnosis of current severe PTSD at baseline assessment (as determined by a score greater than 65 on a Clinician Administered PTSD Scale)
  • Speaks English

Exclusion Criteria:

  • Current diagnosis of alcohol or drug dependence
  • Hospitalization or suicide attempt in the past 2 months

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 1
Participants will receive cognitive behavioral therapy.
Atferdsmessig: Cognitive behavioral therapy (CBT)
CBT will include 12 to 16 counseling sessions, occurring weekly or every other week. Participants will learn about PTSD and ways to decrease anxiety associated with PTSD by completing homework assignments and practicing skills learned in counseling sessions.
Aktiv komparator: 2
Participants will receive brief PTSD treatment.
Atferdsmessig: Brief PTSD treatment
Brief PTSD treatment will include three weekly meetings with a therapist. Participants will learn about PTSD, how symptoms may be affecting their lives, and a technique for reducing anxiety associated with PTSD.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Knowledge of PTSD and effectiveness in correcting faulty, trauma-related beliefs
Tidsramme: Measured post-treatment and at 6- and 12-month follow-ups
Measured post-treatment and at 6- and 12-month follow-ups
Depression, anxiety, and other psychiatric symptoms
Tidsramme: Measured post-treatment and at 6- and 12-month follow-ups
Measured post-treatment and at 6- and 12-month follow-ups
PTSD diagnoses and symptom severity
Tidsramme: Measured post-treatment and at 6- and 12-month follow-ups
Measured post-treatment and at 6- and 12-month follow-ups

Sekundære resultatmål

Resultatmål
Tidsramme
Total cost for mental health and substance abuse treatment services utilization within the University Behavioral Health Care system
Tidsramme: Measured post-treatment and at 6- and 12-month follow-ups
Measured post-treatment and at 6- and 12-month follow-ups
Quality of life and community functioning
Tidsramme: Measured post-treatment and at 6- and 12-month follow-ups
Measured post-treatment and at 6- and 12-month follow-ups

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Dartmouth-Hitchcock Medical Center

Samarbeidspartnere

National Institute of Mental Health (NIMH)

Etterforskere

  • Hovedetterforsker: Kim T. Mueser, PhD, Dartmouth-Hitchcock Medical Center

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2008

Primær fullføring (Faktiske)

1. juli 2012

Datoer for studieregistrering

Først innsendt

28. juni 2007

Først innsendt som oppfylte QC-kriteriene

28. juni 2007

Først lagt ut (Anslag)

2. juli 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

8. august 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. august 2012

Sist bekreftet

1. august 2012

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • R01MH064662-02 (U.S. NIH-stipend/kontrakt)
  • DSIR 83-ATIT

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Posttraumatisk stresslidelse

Kliniske studier på Cognitive behavioral therapy (CBT)

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