- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01945333
Personalized and Scalable Cognitive Remediation Approaches
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
There are three phases of this study.
Phase 1: Development and Adaptation. The goal of this phase is to adapt currently used computer based CR approaches to make them more personalized and scalable. We will create two CR interventions which differ in choice and pacing of the cognitive exercises. This phase is complete.
Phase 2: Open Trial and Intervention Refinement. The goal of this phase is to obtain quantitative and qualitative feedback on the acceptability and usability of the interventions from participants to inform further refinement of the assessment and treatment packages. We will recruit ten subjects from an outpatient psychiatric rehabilitation program in New York City. After determining study eligibility, individuals will complete a standardized neuropsychological battery for schizophrenia assessment, and a 5-minute Tone Matching Test to assess basic auditory processing. Participants will be randomly assigned to receive one of two intervention packages, developed in Phase 1. Each session includes 60 minutes of computer-based learning activities and a 15 minute therapist-led discussion that links the computer activities to cognition as applied to daily tasks and recovery goals. Participants will complete a total of 10 sessions attending 2-3 times weekly for 5 weeks. During each session, participants will be asked to keep a log of software used. At the conclusion of this abbreviated trial, the participants will participate in focus groups in which they will be asked to provide verbal feedback on how enjoyable, engaging, and useful they perceived the computer and discussion based exercises to be. Participants will be asked to provide verbal feedback on the assessment procedures. CR clinicians will join the research team to discuss participants' engagement and their experience with administering the Tone Matching Test and interventions. Qualitative data summarized from participant logs and focus groups will be considered by the research team to refine the assessment battery, treatment parameters, and rubric of learning exercises. This phase is complete.
Phase 3: Pilot Feasibility Trial. People with a diagnosis of schizophrenia or schizoaffective disorder may be referred by their treating clinician or may respond to posted advertisements to inquire about study participation. After being informed of study procedures, interested individuals will be asked to sign a consent form that documents willingness to participate in this study. Following informed consent, participants will be asked questions about demographic characteristics (e.g. age, education, employment), medication and psychosocial treatment status, psychiatric symptoms and symptoms severity, and will complete a brief assessment of estimated Intelligence. Those with an Intelligence Quotient (IQ) estimate below 70 or meeting substance dependence criteria at the time of evaluation will be exited from the study. In the same or second assessment session, participants will complete assessments of neuropsychological ability, current functioning, and motivation for treatment. Participants will then be randomly assigned to one of two treatment conditions named "Brain Basics" or "Brain Exercises".
Each treatment condition is structured in a group format of up to 5 participants. Both treatments use commercially available computer-based training software to exercise cognitive skills such as speed of processing, attention, working memory, and verbal memory. Both conditions will entail 50 minutes on the computer and 10 minutes group discussion. In the discussion, participants review the cognitive activities they are working on and how they will help them achieve their recovery goals. The treatment phase will consist of 30 separate sessions each 60 minutes in duration, administered 3 times a week over the course of a 10-week period. Participants will be re-tested on outcome measures approximately 1 week following end of treatment, and again 3 months later.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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Bronx, New York, Estados Unidos, 10467
- FEGS Bronx Mental Health Clinic
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Brooklyn, New York, Estados Unidos, 11206
- Williamsburg Clinic
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Brooklyn, New York, Estados Unidos, 11207
- Institute for Community Living
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New York, New York, Estados Unidos, 10032
- Nyspi/ Cumc
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New York, New York, Estados Unidos, 10040
- The Bridge Inc
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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:
- Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis of schizophrenia or schizoaffective disorder
- Age 18 to 65
- English speaking
- Psychiatrically stable, verified by current living/treatment status
Exclusion Criteria:
- Indication of mental retardation, determined by estimated IQ of less than 70
- Hearing or visual impairment that precludes completing assessments
- Neurologic illness that may affect brain physiology (e.g. Parkinson's, seizure disorder, epilepsy)
- Current substance dependence symptoms in the past 6 weeks
- Participation in cognitive remediation in the 12 months prior to study entry.
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 |
---|---|
Comparador activo: Brain Basics for Impaired Tone Matchers
Cognitive remediation includes sensory processing training
|
Cognitive remediation sessions include working on computer based cognitive exercises and participating in a verbal discussion.
|
Comparador activo: Brain Basics for Intact Tone Matchers
Cognitive remediation includes sensory processing training
|
Cognitive remediation sessions include working on computer based cognitive exercises and participating in a verbal discussion.
|
Comparador activo: Brain Training for Impaired Tone Matcher
Cognitive remediation does not include sensory processing training
|
Cognitive remediation sessions include working on computer based cognitive exercises and participating in a verbal discussion.
|
Comparador activo: Brain Training for Intact Tone Matchers
Cognitive remediation does not include sensory processing training
|
Cognitive remediation sessions include working on computer based cognitive exercises and participating in a verbal discussion.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Feasibility
Periodo de tiempo: Two years
|
Feasibility of conducting a larger trial will be measured by recruitment, feasibility of enrollment, stratification, blinding and assessment, acceptability of randomization, retention of subjects
|
Two years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in neurocognition from baseline to treatment end-point
Periodo de tiempo: 10 weeks
|
Change in neurocognition will be measured with the MATRICS Consensus Cognitive Battery, including measures of: a) working memory; b) attention/vigilance; c) verbal learning; d) visual learning; e) processing speed; f) reasoning and problem solving.
|
10 weeks
|
Change in neurocognition from baseline to 3-month follow-up
Periodo de tiempo: 5.5 to 6 months
|
Change in neurocognition will be measured with the MATRICS Consensus Cognitive Battery (see above).
|
5.5 to 6 months
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Tone Matching Ability - Treatment end-point
Periodo de tiempo: 10 weeks
|
Tone matching (percent correct) will be assessed at baseline and at treatment end-point, using pairs of 100-ms tones in series, with 500-ms inter-tone interval.
|
10 weeks
|
UCSD Performance-Based Skills Assessment (UPSA)-Brief - treatment end-point
Periodo de tiempo: 10 weeks
|
The UPSA - Brief is a proxy measure of daily functioning skills.
Change from baseline to treatment end-point will be assessed.
|
10 weeks
|
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) - Treatment end-point
Periodo de tiempo: 10 weeks
|
The SCI-PANSS is a semi-structured interview containing 30 items that assess symptoms of psychotic disorders including positive, negative and general psychopathology.
Change from baseline to treatment end-point will be assessed.
|
10 weeks
|
Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR)
Periodo de tiempo: 10 weeks
|
Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR), a 21 item 7-point Likert type scale designed to assess a participant's subjective experience of an activity, specifically in an experimental setting (e.g.
"I enjoyed doing this activity very much").
The IMI-SR will be administered at the first and last treatment sessions.
|
10 weeks
|
Perceived Competency Scale (PCS)
Periodo de tiempo: 10 weeks
|
The PCS consists of 4 items on a 7-point Likert-type scale that assess feelings of competency when performing computer-based learning activities, with higher scores indicating greater perceived competency.
The PCS will be administered at the first and last treatment sessions.
|
10 weeks
|
Tone Matching ability - 3-month follow up
Periodo de tiempo: 5.5 to 6 months
|
Tone Matching (percent correct) will be assessed at baseline and 3-month follow-up, using pairs of 100-ms tones in series, with 500-ms inter-tone interval.
|
5.5 to 6 months
|
UCSD Performance-Based Skills Assessment (UPSA)-Brief - 3-month follow-up
Periodo de tiempo: 5.5 to 6 months
|
The UPSA-Brief is a proxy measure for daily functioning skills.
Change from baseline to 3-month follow-up will be assessed.
|
5.5 to 6 months
|
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) - 3-month follow-up
Periodo de tiempo: 5.5 to 6 months
|
The SCI-PANSS is a semi-structured interview containing 30 items that assess symptoms of psychotic disorders including positive, negative and general psychopathology.
Change from baseline to 3-month follow-up will be assessed.
|
5.5 to 6 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Alice Medalia, PhD, NYSPI
Publicaciones y enlaces útiles
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 (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- #6721
- 1R34MH100317-01 (Subvención/contrato del NIH de EE. UU.)
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