Enhancing Cognitive Training Through Exercise After a First Schizophrenia Episode (CT&E)
5 de diciembre de 2017 actualizado por: Keith Nuechterlein, Ph.D., University of California, Los Angeles
This is a randomized controlled 6-month trial of the efficacy of a novel intervention combining neuroplasticity-based cognitive training with aerobic exercise, compared to the same systematic cognitive training alone.
The primary treatment targets are overall cognitive deficit level and independent living skills.
The investigators hypothesize that combining neuroplasticity-based computerized cognitive training and neurotrophin-enhancing physical exercise will produce large cognitive and functional improvements, even relative to cognitive training alone.
Adding aerobic exercise to a cognitive training program will have the additional benefit of helping to ameliorate medication side effects, reduce the risk for developing metabolic syndrome, and help to prevent the deterioration in physical health that usually follows the onset of schizophrenia and its pharmacologic treatment.
The investigators target the period shortly after a first episode of schizophrenia to maximize the generalization of cognitive improvement to functional outcome, before chronic disability is established.
Descripción general del estudio
Estado
Terminado
Descripción detallada
The Cognitive Training and Exercise intervention involves 24 weeks of systematic computerized cognitive training, 4 hours per week, plus aerobic exercise, four 30 minute sessions per week.
The first 12 weeks involves neurocognitive training, using auditory training exercises from Posit Science Brain HQ.
The second 12 weeks involves social cognitive training, using the Posit Science SocialVille modules.
Aerobic exercise occurs as two 30-minute sessions at the clinic and two at home weekly.
Intensity of aerobic exercise is tailored to maintain an individualized target heart rate zone and is monitored by a heart rate recorder.
A weekly one-hour Bridging Skills Group with other members of the treatment condition is designed to aid generalization of training to everyday life situations.
Tipo de estudio
Intervencionista
Inscripción (Actual)
48
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90095-6968
- University of California, Los Angeles
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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 45 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- a first episode of a psychotic illness that began within the past two years;
- a diagnosis by Diagnostic and Statistical Manual of Mental Disorders of schizophrenia, schizoaffective disorder, mainly depressed type, or schizophreniform disorder;
- between 18 and 45 years of age;
- sufficient acculturation and fluency in the English language to avoid invalidating research measures of thought, language, and speech disorder or of verbal cognitive abilities; and
- residence within commuting distance of the Aftercare Research Program at the University of California, Los Angeles.
Exclusion Criteria:
- evidence of a known neurological disorder (e.g., epilepsy) or significant head injury;
- evidence of alcohol or substance use disorder within the six months prior to the first episode and evidence that substance abuse triggered the psychotic episode or makes the schizophrenia diagnosis ambiguous;
- mental retardation, i.e. premorbid intelligence quotient less than 70.
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 paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Cognitive Training and Exercise
24 weeks of systematic computerized cognitive training, 4 hours per week, plus aerobic exercise, four 30 minute sessions per week.
The first 12 weeks involves neurocognitive training, using auditory training exercises from Posit Science Brain HQ.
The 2nd 12 weeks involves social cognitive training, using the Posit Science SocialVille modules.
Aerobic exercise occurs as two 30-minute sessions at the clinic and two at home weekly.
Intensity of aerobic exercise is tailored to maintain an individualized target heart rate zone and is monitored by a heart rate recorder.
A weekly one-hour Bridging Skills Group is designed to aid generalization of training to everyday life situations.
All members receive individual case management and supportive psychotherapy, and family psychoeducation.
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Un terapeuta individual proporcionará administración de casos semanales y terapia dirigida a los problemas psicológicos individuales y las necesidades de funcionamiento diario del paciente.
All immediate family members will be invited to family psychoeducation sessions.
The Cognitive Training and Exercise intervention involves 24 weeks of systematic computerized cognitive training, 4 hours per week, plus aerobic exercise, four 30 minute sessions per week.
The first 12 weeks involves neurocognitive training, using auditory training exercises from Posit Science Brain HQ.
The second 12 weeks involves social cognitive training, using the Posit Science SocialVille modules.
A weekly one-hour Bridging Skills Group with other members of the treatment condition is designed to aid generalization of training to everyday life situations.
Otros nombres:
Aerobic exercise occurs as two 30-minute sessions at the clinic and two at home weekly.
Intensity of aerobic exercise is tailored to maintain an individualized target heart rate zone and is monitored by a heart rate recorder.
Otros nombres:
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Comparador activo: Cognitive Training
24 weeks of systematic computerized cognitive training, 4 hours per week, plus aerobic exercise, four 30 minute sessions per week.
The first 12 weeks involves neurocognitive training, using auditory training exercises from Posit Science Brain HQ.
The 2nd 12 weeks involves social cognitive training, using the Posit Science SocialVille modules.
A weekly one-hour Bridging Skills Group is designed to aid generalization of training to everyday life situations.
All members receive individual case management and supportive psychotherapy, and family psychoeducation.
|
Un terapeuta individual proporcionará administración de casos semanales y terapia dirigida a los problemas psicológicos individuales y las necesidades de funcionamiento diario del paciente.
All immediate family members will be invited to family psychoeducation sessions.
The Cognitive Training and Exercise intervention involves 24 weeks of systematic computerized cognitive training, 4 hours per week, plus aerobic exercise, four 30 minute sessions per week.
The first 12 weeks involves neurocognitive training, using auditory training exercises from Posit Science Brain HQ.
The second 12 weeks involves social cognitive training, using the Posit Science SocialVille modules.
A weekly one-hour Bridging Skills Group with other members of the treatment condition is designed to aid generalization of training to everyday life situations.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score
Periodo de tiempo: 6 months
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The overall composite score from the MCCB is a summary of cognitive performance across seven domains.
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Brain-derived neurotrophic factor (BDNF)
Periodo de tiempo: 6 months
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BDNF is a principal growth factor known to mediate the effects of exercise in the brain.
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6 months
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Cardiorespiratory fitness
Periodo de tiempo: 6 months
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Cardiorespiratory fitness, a secondary physical health outcome variable, will be measured using a ramped version of the traditional Bruce treadmill protocol.
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6 months
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University of California, San Diego (UCSD) Performance-Based Skills Assessment (UPSA)
Periodo de tiempo: 6 months
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The UCSD Performance-Based Skills Assessment (UPSA)assesses five all-purpose skills that are important for functioning in the community: general organization, finance, social/communications, transportation, and household chores.
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6 months
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Facial Emotion Identification Test
Periodo de tiempo: 6 months
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The Facial Emotion Identification Test involves choice of emotions in facial expressions of 6 different emotions (happy, sad, angry, afraid, surprised, disgusted) plus neutral expressions.
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6 months
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Prosody Task
Periodo de tiempo: 6 months
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The Prosody Task involves identifying emotions in audio recordings of male and female actors portraying 5 emotions.
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6 months
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Global Functioning Scale
Periodo de tiempo: 6 months
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A 10-point rating scale to evaluate role and social functioning
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6 months
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Modified Social Adjustment Scale - Work Outcome
Periodo de tiempo: 6 months
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A measure of the quantity and type of work at a job, school, or in the home
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6 months
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Independent Living Skills Survey
Periodo de tiempo: 6 months
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The Independent Living Skills Survey is a 76-item measure based on patient interview, which provides a more detailed assessment of 11 daily living skill domains
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6 months
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Quality of Life Scale
Periodo de tiempo: 6 months
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The Quality of Life scale135, a 53-item interview-based inventory, assesses a patient's subjective satisfaction in several key domains
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6 months
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Role Functioning Scale: Work Productivity, Social Relationships, Family Relationships
Periodo de tiempo: 6 months
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The Role Functioning Scale is a global clinician-rated measure of everyday functioning in several domains.
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6 months
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Independent Living rating from Role Functioning Scale
Periodo de tiempo: 6 months
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The Independent Living rating assesses daily living skills and extent of living independently based on a clinician interview.
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6 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Keith H Nuechterlein, Ph.D., University of California, Los Angeles
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 (Actual)
1 de noviembre de 2013
Finalización primaria (Actual)
1 de noviembre de 2016
Finalización del estudio (Actual)
1 de julio de 2017
Fechas de registro del estudio
Enviado por primera vez
19 de noviembre de 2013
Primero enviado que cumplió con los criterios de control de calidad
16 de octubre de 2014
Publicado por primera vez (Estimar)
17 de octubre de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
7 de diciembre de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
5 de diciembre de 2017
Última verificación
1 de diciembre de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1R34MH102529-01 (Subvención/contrato del NIH de EE. UU.)
- R34MH102529 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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