Cognitive Remediation Therapy (CRT) in Adolescents With EOS
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Purpose
Cognitive Remediation Therapy (CRT) can enhance cognitive performance in schizophrenia improving functional outcome. But most of the studies have involved participants who are in average in their mid 30s, and little is known about the efficacy of CRT in adolescents with early-onset schizophrenia (EOS). The aim of this study is to investigate efficacy of CRT in improving cognitive performance and functional outcome in adolescents with EOS. We expect to find that CRT improves cognitive and functional outcomes in adolescents with schizophrenia.
| Condition | Intervention |
|---|---|
|
Schizophrenia |
Behavioral: Cognitive Remediation Therapy |
| Study Type: | Interventional |
| 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
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
Other Names:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 12 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age between 12 and 18 years
- a DSM-IV-TR schizophrenia-type disorder (schizophrenia or schizoaffective disorder), with onset before the age of 17
- being clinically and pharmacologically stabilized during the last 6 weeks before the baseline assessment
- the estimation of not modifying pharmacological antipsychotic treatment
- presence of cognitive deficit confirmed by the neuropsychological battery
Exclusion Criteria:
- IQ below 70
- presence of an active misuse disorder
- presence of organic brain syndromes or neurological disorders
- having received electroconvulsive therapy in the previous 6 months
Contacts and Locations| Contact: Olga Puig, PhD | + 34 93 227 99 74 | opuig@clinic.ub.es |
| Contact: Rafael Penadés, PhD | rpenades@clinic.ub.es |
| Spain | |
| Department of Child and Adolescent Pyshicatry and Psychology | Recruiting |
| Barcelona, Catalunya, Spain, 08036 | |
| Contact: Olga Puig, PhD + 34 227 99 74 opuig@clinic.ub.es | |
| Principal Investigator: Olga Puig, PhD | |
| Principal Investigator: | Olga Puig, PhD | Hospital Clinic de Barcelona |
| Study Director: | Rafael Penadés, PhD | Hospital Clínic de Barcelona |
| Study Director: | Josefina Castro-Fornieles, MD | Hospital Clínic de Barcelona |
More Information
No publications provided
| Responsible Party: | Olga Puig, Olga Puig Navarro, Hospital Clinic of Barcelona |
| ClinicalTrials.gov Identifier: | NCT01701609 History of Changes |
| Other Study ID Numbers: | PI07/90054, ETES07/90054 |
| Study First Received: | October 3, 2012 |
| Last Updated: | October 3, 2012 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by Hospital Clinic of Barcelona:
|
early-onset schizophrenia adolescents cognition cognitive remediation therapy |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013