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

28. März 2013 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

46

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • North Carolina
      • Chapel Hill, North Carolina, Vereinigte Staaten, 27514
        • UNC Hospitals OASIS Program for Early Psychosis

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

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: 2
Die Teilnehmer werden wie gewohnt behandelt
Verhalten: Treatment as usual (TAU)
Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis.
Experimental: 1
Participants will receive Graduated Recovery Intervention Program plus treatment as usual
Verhalten: 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.
Verhalten: Treatment as usual (TAU)
Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Role Functioning Scale
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Global Functioning Scale
Zeitfenster: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Brief Evaluation of Medication Influences and Beliefs
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Brief Trauma Questionnaire (BTQ)
Zeitfenster: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
PTSD Checklist (PCL)
Zeitfenster: 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)
Zeitfenster: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Number of hospital admissions
Zeitfenster: 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)
Zeitfenster: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Goal attainment ratings
Zeitfenster: Measured at post-test
Measured at post-test
Scales of Wellbeing
Zeitfenster: 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)
Zeitfenster: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Treatment Compliance Scale (TCS)
Zeitfenster: Measured at post-test
Measured at post-test

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of North Carolina, Chapel Hill

Mitarbeiter

National Institute of Mental Health (NIMH)

Ermittler

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

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

1. April 2006

Primärer Abschluss (Tatsächlich)

1. Dezember 2008

Studienabschluss (Tatsächlich)

1. Dezember 2008

Studienanmeldedaten

Zuerst eingereicht

23. März 2006

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. März 2006

Zuerst gepostet (Schätzen)

27. März 2006

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

29. März 2013

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. März 2013

Zuletzt verifiziert

1. März 2013

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • R34MH071252 (US NIH Stipendium/Vertrag)
  • DATR A2-AISZ (World Health Organization ICTRP)

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 .

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