Graduated Recovery Intervention Program for Enhancing Treatment for First-Episode Psychosis
Randomized Controlled Trial of the Graduated Recovery Intervention Program for First-Episode Psychosis
Przegląd badań
Status
Warunki
Szczegółowy opis
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 studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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North Carolina
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Chapel Hill, North Carolina, Stany Zjednoczone, 27514
- UNC Hospitals OASIS Program for Early Psychosis
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny komparator: 2
Uczestnicy będą traktowani jak zwykle
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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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Eksperymentalny: 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
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Role Functioning Scale
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
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Brief Evaluation of Medication Influences and Beliefs
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: Measured at post-test
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Measured at post-test
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Scales of Wellbeing
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: Measured at post-test
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Measured at post-test
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Współpracownicy i badacze
Współpracownicy
Śledczy
- Główny śledczy: David L. Penn, PhD, University of North Carolina, Chapel Hill
- Główny śledczy: Diana O. Perkins, MD, University of North Carolina, Chapel Hill
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- R34MH071252 (Grant/umowa NIH USA)
- DATR A2-AISZ (World Health Organization ICTRP)
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