Clinical trial NCT01701609: Cognitive Remediation Therapy (CRT) in Adolescents With EOS
Official title: Efficacy of a Cognitive Remediation Treatment in Adolescents With Schizophrenia Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: early-onset schizophrenia
adolescents
cognition
cognitive remediation therapy
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Centro de Investigación Biomédica en Red de Salud Mental
First posted: 2012-10-05
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 criteria: 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

Primary outcomes:
measure: Cognitive performance
timeFrame: 20 weeks
Secondary outcomes:
measure: Functional outcome
timeFrame: 20 weeks
measure: Symptoms
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Department of Child and Adolescent Pyshicatry and Psychology
state: Catalunya
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Olga Puig, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic of Barcelona
name: Rafael Penadés, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Clinic of Barcelona
name: Josefina Castro-Fornieles, MD
role: STUDY_DIRECTOR
References:
citation: Puig O, Penades R, Baeza I, De la Serna E, Sanchez-Gistau V, Bernardo M, Castro-Fornieles J. Cognitive remediation therapy in adolescents with early-onset schizophrenia: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2014 Aug;53(8):859-68. doi: 10.1016/j.jaac.2014.05.012. Epub 2014 Jun 21.