Cognitive Remediation Therapy (CRT) in Adolescents With EOS
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy of a Cognitive Remediation Treatment in Adolescents With Schizophrenia Spectrum Disorders|
- Cognitive performance [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]Change from baseline in neuropsychological test scores of memory, executive functions, working memory and processing speed at post-treatment evaluation
- Functional outcome [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]Change in real-world functioning scales, self-esteem and caregiver burden at post-treatment evaluation
- Symptoms [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]Change from baseline in measures of clinical symptoms at post-treatment evaluation
|Study Start Date:||January 2007|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Cognitive Remediation Therapy
CRT: Frontal/Executive Program. The program has a duration of 40 sessions, with two session for week. Is is carried out individually and utilizes paper and pencil tasks. The main technique utilized is the scaffolding in a context of learning without errors.
Behavioral: Cognitive Remediation Therapy
Early-onset schizophrenia (EOS) is associated with worse course and poor outcome than adulthood schizophrenia. Cognitive deficits are known to be a core feature in EOS, with large deficits on almost all cognitive domains. Importantly, cognitive deficits are known to be strong predictors of psychosocial and functional outcomes in schizophrenia and also in the early-onset form of the illness. Cognitive Remediation Therapy (CRT) is a behavioral training based intervention that aims to improve cognitive processes (attention, memory, executive function, social cognition or metacognition) with the goal of durability and generalization. It has been demonstrated that CRT improve cognitive deficits and functional outcome in adult patients but there are very few studies with adolescent samples.
A controlled randomized study will be carry out with two groups: patients receiving treatment as usual plus CRT, and patients receiving treatment as usual (TAU). The independent variable is the cognitive remediation treatment. The CRT will be applied according to the manual of Wykes and Reeder (2005). The program has a duration of 40 sessions, with two session for week. It is carried out individually and utilizes paper and pencil tasks. The main technique utilized is the scaffolding in a context of learning without errors.
The main dependent variable is the cognitive performance measured through neuropsychological tests. Other secondary dependent variables are functional outcome and clinical symptoms obtained from the psychometric evaluation.
All participants will be evaluated before and after the experimental intervention in several neurocognitive domains, clinical symptoms and functional outcome. The evaluations will be carried out by expert evaluators. Intention-to-treat analysis will be carry out using the statistical package SPSS v 18.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01701609
|Department of Child and Adolescent Pyshicatry and Psychology|
|Barcelona, Catalunya, Spain, 08036|
|Principal Investigator:||Olga Puig, PhD||Hospital Clinic of Barcelona|
|Study Director:||Rafael Penadés, PhD||Hospital Clínic de Barcelona|
|Study Director:||Josefina Castro-Fornieles, MD||Hospital Clínic de Barcelona|