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Graduated Recovery Intervention Program for Enhancing Treatment for First-Episode Psychosis

28. marts 2013 opdateret af: David Penn, PhD, University of North Carolina, Chapel Hill

Randomized Controlled Trial of the Graduated Recovery Intervention Program for First-Episode Psychosis

This study will determine the effectiveness of the Graduated Recovery Intervention Program, a manual-based individual therapy program, in enhancing the clinical benefit of routine treatment for individuals recovering from their first episodes of psychosis.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Several mental disorders can be classified as psychotic disorders, such as schizophrenia and manic depression. Psychosis is a defining feature of psychotic disorders, and is characterized by delusions and hallucinations that result in extreme impairment of a person's ability to think clearly. First-episode psychosis refers to the first time someone experiences psychotic symptoms or a psychotic episode. The symptoms can be disturbing and unfamiliar to those who have not previously experienced them. The person experiencing first-episode psychosis may not understand what is happening, and may become confused and distressed. Psychosis is treatable, however, and most people recover. Standard treatment for psychosis entails a combination of behavioral therapy and drug therapy. GRIP is a comprehensive psychosocial intervention for people recovering from an initial episode of non-affective psychosis. The purpose of GRIP is to improve occupational functioning after first-episode psychosis and promote goal pursuit and effective illness self-management. This study will determine the effectiveness of GRIP in enhancing the clinical benefit of routine treatment for individuals recovering from their first episodes of psychosis.

Participants in this study will be randomly assigned to receive either treatment as usual (TAU) or TAU plus GRIP. Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis. Participants assigned to receive TAU plus GRIP will attend therapy sessions weekly for up to 36 weeks, in addition to routine appointments. GRIP includes four phases, each of which focuses on one of the following topics: engagement and wellness management; substance use; persistent symptoms; and functional recovery. Assessments of social functioning, psychotic symptoms, attitudes toward treatment, substance use, and hospital readmission rate will be assessed at baseline, mid-treatment, post-treatment, and at the follow-up visit 3 months post-treatment.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

46

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27514
        • UNC Hospitals OASIS Program for Early Psychosis

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Meets DSM-IV criteria for schizophrenia, schizophreniform disorder, or schizoaffective disorder
  • Has been in treatment for psychosis for less than 3 years
  • Clinically stable (based on clinician judgement)
  • IQ score greater than 70
  • Currently receiving keyworker services at UNC Hospital's OASIS program

Exclusion Criteria:

  • Organic brain disorder
  • Substance-induced psychotic disorder
  • Mental retardation

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: 2
Deltagerne vil modtage behandling som normalt
Adfærdsmæssigt: Treatment as usual (TAU)
Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis.
Eksperimentel: 1
Participants will receive Graduated Recovery Intervention Program plus treatment as usual
Adfærdsmæssigt: Graduated Recovery Intervention Program (GRIP)
GRIP is a manual-based comprehensive psychosocial intervention for people recovering from an initial episode of nonaffective psychosis. The purpose of GRIP is to improve occupational functioning after first-episode psychosis and promote goal pursuit and effective illness self-management. Participants assigned to receive TAU plus GRIP will attend therapy sessions weekly for up to 36 weeks, in addition to routine appointments. GRIP includes four phases, each of which focuses on one of the following topics: engagement and wellness management, substance use, persistent symptoms, and functional recovery.
Adfærdsmæssigt: Treatment as usual (TAU)
Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Role Functioning Scale
Tidsramme: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Heinrichs-Carpenter Quality of Life Scale (QLS)
Tidsramme: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Multidimensional Scale of Perceived Social Support (MSPSS)
Tidsramme: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Global Functioning Scale
Tidsramme: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up

Sekundære resultatmål

Resultatmål
Tidsramme
Brief Evaluation of Medication Influences and Beliefs
Tidsramme: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Positive and Negative Syndrome Scale (PANSS)
Tidsramme: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Calgary Depression Scale for Schizophrenia (CDSS)
Tidsramme: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Brief Trauma Questionnaire (BTQ)
Tidsramme: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
PTSD Checklist (PCL)
Tidsramme: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Alcohol Use Scale and Drug Use Scale (AUS/DUS)
Tidsramme: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Number of hospital admissions
Tidsramme: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Ambiguous Intentions Hostility Questionnaire (AIHQ)
Tidsramme: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Goal attainment ratings
Tidsramme: Measured at post-test
Measured at post-test
Scales of Wellbeing
Tidsramme: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Social Skills Performance Assessment (SSPA)
Tidsramme: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Treatment Compliance Scale (TCS)
Tidsramme: Measured at post-test
Measured at post-test

Samarbejdspartnere og efterforskere

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

Sponsor

University of North Carolina, Chapel Hill

Samarbejdspartnere

National Institute of Mental Health (NIMH)

Efterforskere

  • Ledende efterforsker: David L. Penn, PhD, University of North Carolina, Chapel Hill
  • Ledende efterforsker: Diana O. Perkins, MD, University of North Carolina, Chapel Hill

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. april 2006

Primær færdiggørelse (Faktiske)

1. december 2008

Studieafslutning (Faktiske)

1. december 2008

Datoer for studieregistrering

Først indsendt

23. marts 2006

Først indsendt, der opfyldte QC-kriterier

23. marts 2006

Først opslået (Skøn)

27. marts 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. marts 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. marts 2013

Sidst verificeret

1. marts 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R34MH071252 (U.S. NIH-bevilling/kontrakt)
  • DATR A2-AISZ (World Health Organization ICTRP)

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 .

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