Graduated Recovery Intervention Program for Enhancing Treatment for First-Episode Psychosis
Randomized Controlled Trial of the Graduated Recovery Intervention Program for First-Episode Psychosis
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27514
- UNC Hospitals OASIS Program for Early Psychosis
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 2
Los participantes recibirán el tratamiento habitual.
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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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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Role Functioning Scale
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Brief Evaluation of Medication Influences and Beliefs
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: Measured at post-test
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Measured at post-test
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Scales of Wellbeing
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: Measured at post-test
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Measured at post-test
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: David L. Penn, PhD, University of North Carolina, Chapel Hill
- Investigador principal: Diana O. Perkins, MD, University of North Carolina, Chapel Hill
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R34MH071252 (Subvención/contrato del NIH de EE. UU.)
- DATR A2-AISZ (World Health Organization ICTRP)
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