Cognitive Remediation Therapy (CRT) in Adolescents With EOS

NCT ID: NCT01701609

Last Updated: 2018-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2013-07-31

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive Remediation Therapy

Intervention Type: BEHAVIORAL

Interventions

Cognitive Remediation Therapy

Intervention Type: BEHAVIORAL

Other Intervention Names

Cognitive training; Cognitive enhancement

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Centro de Investigación Biomédica en Red de Salud Mental

NETWORK

Sponsor Role: collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Olga Puig

Olga Puig Navarro

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olga Puig, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Rafael Penadés, PhD

Role: STUDY_DIRECTOR

Hospital Clinic of Barcelona

Josefina Castro-Fornieles, MD

Role: STUDY_DIRECTOR

Hospital Clinic of Barcelona

Locations

Department of Child and Adolescent Pyshicatry and Psychology

Barcelona, Catalonia, Spain

Countries

Spain

References

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.

Reference Type: RESULT

PMID: 25062593 (View on PubMed)

Other Identifiers

ETES07/90054

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PI07/90054

Identifier Type: -

Identifier Source: org_study_id