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

28 marzo 2013 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

46

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • North Carolina
      • Chapel Hill, North Carolina, Stati Uniti, 27514
        • UNC Hospitals OASIS Program for Early Psychosis

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 2
I partecipanti riceveranno il trattamento come di consueto
Comportamentale: Treatment as usual (TAU)
Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis.
Sperimentale: 1
Participants will receive Graduated Recovery Intervention Program plus treatment as usual
Comportamentale: 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.
Comportamentale: Treatment as usual (TAU)
Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Role Functioning Scale
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up
Global Functioning Scale
Lasso di tempo: Measured at baseline, post-test, and Month 3 follow-up
Measured at baseline, post-test, and Month 3 follow-up

Misure di risultato secondarie

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of North Carolina, Chapel Hill

Collaboratori

National Institute of Mental Health (NIMH)

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2006

Completamento primario (Effettivo)

1 dicembre 2008

Completamento dello studio (Effettivo)

1 dicembre 2008

Date di iscrizione allo studio

Primo inviato

23 marzo 2006

Primo inviato che soddisfa i criteri di controllo qualità

23 marzo 2006

Primo Inserito (Stima)

27 marzo 2006

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

29 marzo 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 marzo 2013

Ultimo verificato

1 marzo 2013

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • R34MH071252 (Sovvenzione/contratto NIH degli Stati Uniti)
  • DATR A2-AISZ (World Health Organization ICTRP)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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