Graduated Recovery Intervention Program for Enhancing Treatment for First-Episode Psychosis
Randomized Controlled Trial of the Graduated Recovery Intervention Program for First-Episode Psychosis
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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North Carolina
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Chapel Hill, North Carolina, Spojené státy, 27514
- UNC Hospitals OASIS Program for Early Psychosis
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: 2
Účastníci budou ošetřeni jako obvykle
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Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis.
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Experimentální: 1
Participants will receive Graduated Recovery Intervention Program plus treatment as usual
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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.
Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Role Functioning Scale
Časové okno: Measured at baseline, post-test, and Month 3 follow-up
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Measured at baseline, post-test, and Month 3 follow-up
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Heinrichs-Carpenter Quality of Life Scale (QLS)
Časové okno: Measured at baseline, post-test, and Month 3 follow-up
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Measured at baseline, post-test, and Month 3 follow-up
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Multidimensional Scale of Perceived Social Support (MSPSS)
Časové okno: Measured at baseline, post-test, and Month 3 follow-up
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Measured at baseline, post-test, and Month 3 follow-up
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Global Functioning Scale
Časové okno: Measured at baseline, post-test, and Month 3 follow-up
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Measured at baseline, post-test, and Month 3 follow-up
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Brief Evaluation of Medication Influences and Beliefs
Časové okno: Measured at baseline, post-test, and Month 3 follow-up
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Measured at baseline, post-test, and Month 3 follow-up
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Positive and Negative Syndrome Scale (PANSS)
Časové okno: Measured at baseline, post-test, and Month 3 follow-up
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Measured at baseline, post-test, and Month 3 follow-up
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Calgary Depression Scale for Schizophrenia (CDSS)
Časové okno: Measured at baseline, post-test, and Month 3 follow-up
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Measured at baseline, post-test, and Month 3 follow-up
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Brief Trauma Questionnaire (BTQ)
Časové okno: Measured at baseline, post-test, and Month 3 follow-up
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Measured at baseline, post-test, and Month 3 follow-up
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PTSD Checklist (PCL)
Časové okno: Measured at baseline, post-test, and Month 3 follow-up
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Measured at baseline, post-test, and Month 3 follow-up
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Alcohol Use Scale and Drug Use Scale (AUS/DUS)
Časové okno: Measured at baseline, post-test, and Month 3 follow-up
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Measured at baseline, post-test, and Month 3 follow-up
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Number of hospital admissions
Časové okno: Measured at baseline, post-test, and Month 3 follow-up
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Measured at baseline, post-test, and Month 3 follow-up
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Ambiguous Intentions Hostility Questionnaire (AIHQ)
Časové okno: Measured at baseline, post-test, and Month 3 follow-up
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Measured at baseline, post-test, and Month 3 follow-up
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Goal attainment ratings
Časové okno: Measured at post-test
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Measured at post-test
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Scales of Wellbeing
Časové okno: Measured at baseline, post-test, and Month 3 follow-up
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Measured at baseline, post-test, and Month 3 follow-up
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Social Skills Performance Assessment (SSPA)
Časové okno: Measured at baseline, post-test, and Month 3 follow-up
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Measured at baseline, post-test, and Month 3 follow-up
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Treatment Compliance Scale (TCS)
Časové okno: Measured at post-test
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Measured at post-test
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: David L. Penn, PhD, University of North Carolina, Chapel Hill
- Vrchní vyšetřovatel: Diana O. Perkins, MD, University of North Carolina, Chapel Hill
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- R34MH071252 (Grant/smlouva NIH USA)
- DATR A2-AISZ (World Health Organization ICTRP)
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