Cognitive Remediation Therapy (CRT) in Adolescents With EOS

Schizophrenia Clinical Trial

Official title:

Efficacy of a Cognitive Remediation Treatment in Adolescents With Schizophrenia Spectrum Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01701609
• Other study ID #: PI07/90054
• Secondary ID: ETES07/90054
• Status: Completed
• Phase: N/A
• Start date: January 2007
• Est. completion date: July 2013

Study information

• Verified date: August 2018
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• Cognitive Remediation Therapy

Locations

Country	Name	City	State
Spain	Department of Child and Adolescent Pyshicatry and Psychology	Barcelona	Catalunya

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Centro de Investigación Biomédica en Red de Salud Mental, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Puig O, Penadés R, Baeza I, De la Serna E, Sánchez-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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive performance	Change from baseline in neuropsychological test scores of memory, executive functions, working memory and processing speed at post-treatment evaluation	20 weeks
Secondary	Functional outcome	Change in real-world functioning scales, self-esteem and caregiver burden at post-treatment evaluation	20 weeks
Secondary	Symptoms	Change from baseline in measures of clinical symptoms at post-treatment evaluation	20 weeks