Personalized and Scalable Cognitive Remediation Approaches
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
New York
-
Brooklyn, New York, Estados Unidos, 11206
- Williamsburg Clinic
-
Brooklyn, New York, Estados Unidos, 11207
- Institute for Community Living
-
New York, New York, Estados Unidos, 10032
- Nyspi/ Cumc
-
New York, New York, Estados Unidos, 10040
- The Bridge Inc
-
The Bronx, New York, Estados Unidos, 10467
- FEGS Bronx Mental Health Clinic
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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 Ativo: 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 Ativo: 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 Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Feasibility of Enrollment, Randomization and Retention
Prazo: Two years
|
Feasibility is measured by enrollment, acceptability of randomization defined as number initiated allocated treatment, retention of subjects defined as number completed allocated treatment
|
Two years
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Neurocognition From Baseline to Treatment End-point
Prazo: 10 weeks
|
Change in neurocognition is calculated as the difference in the MATRICS Consensus Cognitive Battery Neurocognitive Composite Score between baseline and treatment end-point (10 weeks).
The MATRICS Consensus Cognitive Battery Neurocognitive Composite T-Score is a scaled score calculated from the following component subscales: a) working memory; b) attention/vigilance; c) verbal learning; d) visual learning; e) processing speed; f) reasoning and problem solving.
The mean T-score is 50 with a standard deviation of 10.
Higher scores on the scale mean better outcomes.
Higher change scores mean better outcomes.
|
10 weeks
|
|
Change in Neurocognition From Baseline to 3-month Follow-up
Prazo: 5.5 to 6 months
|
Change in neurocognition is calculated as the difference in the MATRICS Consensus Cognitive Battery Neurocognitive Composite Score between baseline and 3-month follow-up (5.5 to 6 months).
The MATRICS Consensus Cognitive Battery Neurocognitive Composite T-Score is a scaled score calculated from the following component subscales: a) working memory; b) attention/vigilance; c) verbal learning; d) visual learning; e) processing speed; f) reasoning and problem solving.
The mean T-score is 50 with a standard deviation of 10.
Higher scores on the scale mean better outcomes.
Higher change scores mean better outcomes.
|
5.5 to 6 months
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR)
Prazo: 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)
Prazo: 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
|
|
Change in Tone Matching Ability From Baseline to Treatment End-point
Prazo: 10 weeks
|
Change in Tone Matching (percent correct) will be calculated as the difference between scores measured at baseline and treatment end-point (10 weeks), using pairs of 100-ms tones in series, with 500-ms inter-tone interval.
The values on this scale range from 0% to 100% where higher scores mean better outcomes.
Higher change scores mean better outcomes.
|
10 weeks
|
|
Change in UCSD Performance-Based Skills Assessment (UPSA)-Brief From Baseline to Treatment End-point
Prazo: 10 weeks
|
The UPSA - Brief is a proxy measure of daily functioning skills.
Change from baseline to treatment end-point (10 weeks) will be assessed as the difference between the two scores.
The scale score can range from 0 to 100.
Higher scores mean better outcomes.
Higher change scores mean better outcomes.
|
10 weeks
|
|
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) - Treatment End-point
Prazo: 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 (10 weeks) will be assessed.
Higher scores mean higher symptom severity.
Change is calculated as the difference between the two scores.
Greater change scores mean greater symptom improvement.
|
10 weeks
|
|
Change in Tone Matching Ability From Baseline to 3-month Follow up
Prazo: 5.5 to 6 months
|
Change in Tone Matching (percent correct) will be calculated as the difference in scores assessed at baseline and 3-month follow-up (5.5 to 6 months), using pairs of 100-ms tones in series, with 500-ms inter-tone interval.
The values on this scale range from 0% to 100% where higher scores mean better outcomes.
Greater change scores mean greater improvement.
|
5.5 to 6 months
|
|
Change in UCSD Performance-Based Skills Assessment (UPSA)-Brief From Baseline to 3-month Follow-up
Prazo: 5.5 to 6 months
|
The UPSA-Brief is a proxy measure for daily functioning skills.
The scale score ranges from 0-100.
Change from baseline to 3-month follow-up (5.5-6 months) will be assessed as the difference between the two scores.
Higher scores mean better outcomes.
Higher change scores mean better outcomes.
|
5.5 to 6 months
|
|
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) - 3-month Follow-up
Prazo: 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
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimado)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- #6721
- 1R34MH100317-01 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .