Interventions to Improve Functional Outcome and Persistent Symptoms in Schizophrenia (Mcog)
1 de agosto de 2013 actualizado por: Dawn Velligan, The University of Texas Health Science Center at San Antonio
Many individuals with schizophrenia continue to hear voices, have false beliefs, and problems with attention, memory planning and everyday functioning even with medication treatment.
The process of recovery in schizophrenia involves treating the whole person.
This study will test a new Multimodal Cognitive Treatment (Mcog).
Mcog works around problems in attention, memory and planning by using supports in the home such as signs, checklists, and alarms to improve everyday functioning.
Mcog also helps the individual to examine the evidence for their beliefs and to deal with symptoms like voices that are not completely resolved with medications.
We will compare 4 treatments to determine if this combined approach improves both symptoms and functioning for individuals with schizophrenia.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
The process of recovery in schizophrenia involves resolving persistent symptoms and improving functional outcomes.
Our research groups have demonstrated that using environmental supports in the patient's home to bypass deficits in cognitive functioning in a treatment called Cognitive Adaptation Training (CAT) improves adherence to medications and functional outcomes in schizophrenia and that Cognitive Behavior Therapy (CBT) decreases symptomatology and the negative effect of persisting symptoms upon individuals with this disorder.
Data suggest these treatments have modality specific effects.
Targeting both functional outcomes and persistent positive symptoms in a multimodal cognitive treatment provided in the patient's home is likely to have the most robust effects on functional outcomes, persistent symptoms and the distress caused by these symptoms for individuals with schizophrenia.
We propose to randomize 200 individuals with schizophrenia taking antipsychotic medications to one of four psychosocial treatments for a period of 9 months: 1) CAT, 2) CBT, 3) Multimodal Cognitive Treatment (Mcog; an integrated treatment featuring aspects of both CAT and CBT), and 4) standard treatment as usual (TAU).
Patients will be followed for 6 months after treatment is completed.
Outcomes will be assessed at baseline and every 3 months.
Primary outcome variables with include measures of symptomatology and functional outcome.
We hypothesize that patients in treatments with CBT as a component (CBT and Mcog) will improve to a greater extent on measures of symptomatology than those randomized to non-CBT treatments (CAT or TAU)and that patients in Mcog will improve to a greater extent than those in single modality CAT.
Moreover, we hypothesize that patients in treatments with CAT as a component (CAT and Mcog) will improve to a greater extent on measures of symptomatology than those randomized to non-CAT treatments (CBT or TAU) and that patients in Mcog will improve to a greater extent than those in single modality CAT.
The potential public health implications of promoting recovery in schizophrenia through multi-modal treatments are profound.
By integrating effective treatments the potential for synergistic improvement scan be assessed.
Home visits can be costly.
Maximizing the benefits to patients by providing multi-modal treatment on the same home visit is likely to improve a broader range of outcomes with minimal additional cost.
Tipo de estudio
Intervencionista
Inscripción (Actual)
178
Fase
- No aplica
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 60 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Males and females who have given informed consent.
- Between the ages of 18 and 60.
- Diagnosis of schizophrenia or schizoaffective disorder according to DSM-IV criteria as determined on the basis of the Structured Clinical Interview for Diagnosis Checklist (SCID-P) Checklist.
- Receiving treatment with an oral atypical antipsychotic medication other than clozapine
- Able to provide evidence of a stable living environment (individual apartment, family home, board and care facility) with no plans to move in the next year.
- Intact visual and auditory ability as determined by a computerized screening battery.
- Ability to read at the 5th grade level or higher based upon WRAT score.
- Able to understand and complete rating scales and neuropsychological testing.
- Delusions or hallucinations at a level of Moderate according to the BPRS. (Score of 4 or higher on items assessing hallucinations, unusual thought content, or suspiciousness.
Exclusion Criteria:
- History of significant head trauma, seizure disorder, or mental retardation.
- SOFAS scores >70 indicating a high level of social and occupational functioning.
- Alcohol or drug abuse or dependence within the past 3 months.
- Currently being treated by an ACT team.
- History of violence in the past one year period.
- Exposure to CAT treatment in that past 2 years.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Cognitive Behavior Therapy for Psychosis
Cognitive behavior therapy for psychosis is a manual-driven collaborative talk-therapy designed to help the individual identify appraisal biases and cognitive distortion, identify alternative explanations for events, and find ways to cope with the distress caused by persistent psychotic symptoms.
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The CBT manual to be used for the present study was based upon the work of Kingdon and Turkington (2005) and Granholm et al., (2005) a group-delivered CBT skills training).
Available manuals were modified to improve ease of training and to better accommodate the delivery of the full CBT treatment in the home environment.
Supervision will be provided throughout the study by D. Turkington and S. Tai world renowned experts in CBT for psychosis.
Training will be held for 1-2 weeks annually and supervision will proceed weekly via SKYPE.
All therapists will be certified prior to providing treatment for the trial.
Sessions are conducted weekly by master's and doctoral level therapists.
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Experimental: Cognitive Adaptation Training
CAT is a manual driven treatment using environmental supports such as signs, alarms, checklists, electronic devices, and the organization of belongings to bypass cognitive and motivational impairments and to cue and sequence adaptive behavior.
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CAT supports are established and maintained on weekly home visits by bachelor's and master's level staff.
Regular supervision will be provided by the PI who developed CAT.
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Experimental: Multi-modal Cognitive Therapy
Combines Cognitive Behavior Therapy for Psychosis and Cognitive Adaptation Training into one home-delivered intervention
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A manual driven intervention combining CBT and CAT.
Weekly sessions delivered in the home focus on altering cognitive biases using CBT and bypassing cognitive deficits using environmental supports
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Comparador activo: Treatment as Usual
Medication follow up and limited case management provided by the local community mental health center
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Standard medication follow up and limited case management
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Brief Psychiatric Rating Scale Psychosis Factor Score
Periodo de tiempo: baseline to 9 months
|
Combines scores on BPRS for hallucinations, unusual thought content, suspiciousness and conceptual disorganization.
Mean score varies from 1-7 with higher scores indicating more severe symptomatology
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baseline to 9 months
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Change in Multnomah Community Ability Scale
Periodo de tiempo: Baseline to 9 months
|
17-item scale assessing a variety of domains of community adjustment including Interference with functioning, Adjustment to living, Social competence, and Behavioral Problems.
Higher scores reflect better community functioning.
|
Baseline to 9 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Auditory Hallucination Rating Scale
Periodo de tiempo: Baseline to 9 months
|
Examines the degree to which hallucinatory experiences are negative, distressing and disrupt the activities of the individual.
The scale above separates how frequently the voices are distressing vs. non-distressing, the intensity of distress when the voices are distressing, the loudness of the voices and the degree of disruption in daily activities in separate items.
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Baseline to 9 months
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Change in Delusion Rating Scale
Periodo de tiempo: Baseline to 9 months
|
Delusional ideas are rated with respect to the degree of conviction, the amount and duration of preoccupation, the amount and the level of distress experienced and the level of interference with activities.
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Baseline to 9 months
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Scale to Assess Unawareness of Mental Disorders
Periodo de tiempo: Baseline to 9 months
|
Assesses insight into the illness, specific symptoms and the need for treatment.
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Baseline to 9 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de abril de 2008
Finalización primaria (Actual)
1 de julio de 2013
Finalización del estudio (Actual)
1 de julio de 2013
Fechas de registro del estudio
Enviado por primera vez
26 de julio de 2013
Primero enviado que cumplió con los criterios de control de calidad
1 de agosto de 2013
Publicado por primera vez (Estimar)
2 de agosto de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
2 de agosto de 2013
Última actualización enviada que cumplió con los criterios de control de calidad
1 de agosto de 2013
Última verificación
1 de julio de 2013
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R01MH082793-03 (Subvención/contrato del NIH de EE. UU.)
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