Cognitive Remediation Therapy (CRT) in Adolescents With EOS
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Cognitive Remediation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring early-onset schizophrenia, adolescents, cognition, cognitive remediation therapy
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
Sites / Locations
- Department of Child and Adolescent Pyshicatry and Psychology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cognitive Remediation Therapy
Arm Description
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.
Outcomes
Primary Outcome Measures
Cognitive performance
Change from baseline in neuropsychological test scores of memory, executive functions, working memory and processing speed at post-treatment evaluation
Secondary Outcome Measures
Functional outcome
Change in real-world functioning scales, self-esteem and caregiver burden at post-treatment evaluation
Symptoms
Change from baseline in measures of clinical symptoms at post-treatment evaluation
Full Information
NCT ID
NCT01701609
First Posted
October 3, 2012
Last Updated
August 9, 2018
Sponsor
Hospital Clinic of Barcelona
Collaborators
Instituto de Salud Carlos III, Centro de Investigación Biomédica en Red de Salud Mental
1. Study Identification
Unique Protocol Identification Number
NCT01701609
Brief Title
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
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 2007 (Actual)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
Instituto de Salud Carlos III, Centro de Investigación Biomédica en Red de Salud Mental
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
early-onset schizophrenia, adolescents, cognition, cognitive remediation therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Remediation Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Remediation Therapy
Other Intervention Name(s)
Cognitive training, Cognitive enhancement
Primary Outcome Measure Information:
Title
Cognitive performance
Description
Change from baseline in neuropsychological test scores of memory, executive functions, working memory and processing speed at post-treatment evaluation
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Functional outcome
Description
Change in real-world functioning scales, self-esteem and caregiver burden at post-treatment evaluation
Time Frame
20 weeks
Title
Symptoms
Description
Change from baseline in measures of clinical symptoms at post-treatment evaluation
Time Frame
20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olga Puig, PhD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rafael Penadés, PhD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Josefina Castro-Fornieles, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Study Director
Facility Information:
Facility Name
Department of Child and Adolescent Pyshicatry and Psychology
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
25062593
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.
Results Reference
result
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Cognitive Remediation Therapy (CRT) in Adolescents With EOS
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