- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02582528
Cognitive Remediation in Youth at Risk of Serious Mental Illness
30 de marzo de 2017 actualizado por: Danijela Piskulic, University of Calgary
Pilot Study of Cognitive Remediation and Motivational Interviewing on Cognition and Functioning in Young People at Risk of Serious Mental Illness
The primary aim of the project is to test the effectiveness of a cognitive remediation treatment (CRT) program, My Brain Solutions (MBS), in addition to motivational interviewing (MI) in improving cognition and functional outcome of individuals at risk of SMI.
An active control treatment consisting of CRT alone will be used.
Hypotheses: 1.
Both study groups will have improvement in cognition at the end of treatment; 2. CRT+MI group will have increased treatment adherence and superior improvements in cognition at the end of treatment and 12 months post baseline compared to the CRT only group; Secondary Hypothesis: 3. Improved cognition will be associated with improved functional outcome.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Individuals identified to be at clinical high risk of psychosis (CHR) of psychosis already evidence cognitive deficits, which increase around the time of conversion.
Much less is known about individuals that may be at risk of other serious mental disorders (SMI).
However, early reports are suggesting that young people at risk of SMI who are deemed to have "attenuated syndromes" according to the clinical staging model of mental health disorders already evidence cognitive deficits.
Therefore, cognition is an excellent treatment target.
Furthermore, there is clear evidence, in both established psychiatric disorders such as schizophrenia, depression and bipolar disorder, and in CHR samples, that deficits in cognition are associated to poor functional outcome.
Thus, treatments targeting cognition may consequently improve functional outcome.
This is a pilot project to determine feasibility and sample size for a large randomized controlled trial of cognitive remediation therapy (CRT) in people at risk of SMI with CIHR and AIHS funding targets.
The primary aim of the project is to test the effectiveness of a novel computerized CRT program in improving cognition in youth at risk of SMI following the addition of a counseling intervention, MI, to improve adherence to CRT.
One group will receive CRT and the other CRT plus MI.
Hypotheses: 1.
Both study groups will have improvement in cognition at the end of treatment; 2. CRT+MI group will have increased treatment adherence and superior improvements in cognition at the end of treatment and 12 months post baseline compared to the CRT only group; Secondary Hypothesis: 3. Improved cognition will be associated with improved functional outcome.
This is a longitudinal, single blind, controlled pilot trial of CRT in persons at risk of SMI.
Twenty-eight participants will be recruited from the Adolescent Mental Health: Canadian Psychiatric Risk and Outcome Study (PROCAN) study at the Calgary site led by Dr. J. Addington.
Participants in the PROCAN project who meet operationally defined criteria as being at risk of SMI by meeting attenuated syndromes criteria will be included.
Participants will be randomized to either the CRT condition consisting of a novel program called My Brain Fitness (MBS) and motivational interviewing (MI) or a control condition consisting of CRT alone, and will receive training that will be administered over a period of 10 weeks.
Assessments will occur at baseline, post treatment (3 months) and at 12 months after baseline.
Half of all participants will receive individual 1 hr MI once every 2 weeks for the duration of the cognitive remediation component of the study.
The study clinicians who are master level psychologists, will deliver MI ensuring engagement of study participants.
Time spent in therapy will be monitored and recorded.
All of the data necessary for this study will be collected as part of the PROCAN assessment at baseline and 12 months.
The one exception is that we will do an assessment of cognitive function, clinical symptoms and functional outcome at 10 weeks or immediately post treatment, which will take approximately 2.5 hours.
Tipo de estudio
Intervencionista
Inscripción (Actual)
12
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
-
-
Alberta
-
Calgary, Alberta, Canadá, T2N 4Z6
- University Of Calgary
-
-
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
14 años a 25 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Male and female participants aged 14-25 years with subthreshold mood and psychotic symptoms.
Exclusion Criteria:
- (i) meet criteria for current or lifetime Axis I bipolar or psychotic disorder (other Axis I disorders will not be exclusionary as they may be precursors to mood or psychotic disorders);
- (ii) IQ < 70;
- (iii) past or current history of a significant central nervous system disorder or serious medical disorder; and
- (iv) current pharmacological treatment that would be considered as an adequate trial of treatment for a SMI.
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 |
|---|---|
|
Experimental: cognitive remediation treatment and MI
Cognitive remediation treatment consisting of a novel computerized training called My Brain Solutions (MBS) and motivational interviewing, a client-centered, directive method for enhancing intrinsic motivation to change.
|
Cognitive remediation treatment consisting of a novel computerized training called My Brain Solutions (MBS)
Otros nombres:
A client-centered, directive method for enhancing intrinsic motivation to change.
Otros nombres:
|
|
Comparador activo: cognitive remediation treatment
Cognitive remediation treatment consisting of a novel computerized training called My Brain Solutions (MBS)
|
Cognitive remediation treatment consisting of a novel computerized training called My Brain Solutions (MBS)
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cognitive function assessment pre- and post-CRT in youth at risk of SMI using WebNeuro computerized cognitive battery
Periodo de tiempo: one year
|
A web-based battery for assessing general and emotional cognition, completed at any computer using mouse and keyboard.
The assessment has been validated against traditional paper-and-pencil tests and with established reliability, cross-cultural consistency and norms.
|
one year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Social functioning assessment pre- and post-CRT in youth at risk of SMI using Global Functioning: Social (GFS) scale.
Periodo de tiempo: one year
|
GFS consists of 10 items that are used to provide a rating of current social functioning.
Scores range between 1 and 10, with 10 indicating superior functioning and 1 representing severe dysfunction.
|
one year
|
|
Social functioning assessment pre- and post-CRT in youth at risk of SMI using Global Functioning: Role (GFR) scale.
Periodo de tiempo: one year
|
GFR consists of 10 items that are used to provide a rating of current role or occupational functioning.
Scores range between 1 and 10, with 10 indicating superior functioning and 1 representing severe dysfunction.
|
one year
|
|
Functional capacity assessment pre- and post-CRT in youth at risk of SMI using Social Skills Performance Assessment (SSPA).
Periodo de tiempo: one year
|
The SSPA is focused on both verbal and nonverbal social skills that are needed to succeed in two different social interaction tasks.
Higher scores on the SSPA indicate better social skills.
|
one year
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Danijela Piskulic, PhD, University Of Calgary
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 febrero de 2016
Finalización primaria (Actual)
1 de marzo de 2017
Finalización del estudio (Actual)
1 de marzo de 2017
Fechas de registro del estudio
Enviado por primera vez
16 de octubre de 2015
Primero enviado que cumplió con los criterios de control de calidad
19 de octubre de 2015
Publicado por primera vez (Estimar)
21 de octubre de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de abril de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
30 de marzo de 2017
Última verificación
1 de marzo de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UCalgary-MAT
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
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