search
Back to results

Effects of a Cognitive Rehabilitation Program: a Neurocognitive Study

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Computer-assisted cognitive training
Computerized active condition
Treatment as usual (TAU)
Sponsored by
Salvador Sarró, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Rehabilitation, Cognition

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • schizophrenia or schizoaffective disorder fulfilling the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria diagnosis
  • estimated premorbid intelligence quotient (IQ) in the normal range
  • chronic illness (i.e. duration ≥two years)
  • relative clinical stability (i.e. the patients had not experienced any recent exacerbation of symptoms).

Exclusion Criteria:

  • history of brain trauma
  • alcohol or substance abuse/dependence within the previous six months.

Sites / Locations

  • FIDMAG Germanes Hospitalàries Research Foundation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Computer-assisted cognitive training

Computerized active condition

Treatment as usual

Arm Description

Patients in this arm of the trial carried out computerized online training drawn from the Feskits program (www.feskits.com), chosen to have attention, memory and executive function components. Specifically the sessions included the following exercises: sustained attention (4 minutes), attention/perception (5 minutes), working memory (8 minutes), auditory and visual memory (8 minutes), executive function (10 minutes), language (6 minutes), and games (4 minutes).

Patients allocated to this condition completed the same number of sessions as the cognitive training group but followed a computerized typing program (www.rapidtyping.com). This had similar design characteristics to the CRT condition, in that it was hierarchically organized with exercise level of difficulty being adjusted to the individual's level of performance and feedback being given at the end of each exercise. Additionally, patients in this condition played computerized games requiring typing (crosswords, word puzzles, etc) and were taught basic internet navigation by a supervisor. Exposure to the computer was of equivalent duration to the CRT condition.

Patients in this condition participated in their (individually variable) daily rehabilitative activities. Patients allocated to the other two conditions also participated in these activities

Outcomes

Primary Outcome Measures

Memory test battery
memory test battery Rivermead Behavioural Memory Test (RBMT)(Wilson, 1985) a memory test battery and the executive test battery, the Behavioural Assessment of the Dysexecutive Syndrome (BADS)(Wilson, 1996)

Secondary Outcome Measures

Full Information

First Posted
July 24, 2014
Last Updated
July 25, 2014
Sponsor
Salvador Sarró, MD
Collaborators
Instituto de Salud Carlos III, Centro de Investigación Biomédica en Red de Salud Mental, Hermanas Hospitalarias del Sagrado Corazón de Jesús, Spain
search

1. Study Identification

Unique Protocol Identification Number
NCT02201888
Brief Title
Effects of a Cognitive Rehabilitation Program: a Neurocognitive Study
Official Title
Effects of a Cognitive Rehabilitation Program: a Neurocognitive Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Salvador Sarró, MD
Collaborators
Instituto de Salud Carlos III, Centro de Investigación Biomédica en Red de Salud Mental, Hermanas Hospitalarias del Sagrado Corazón de Jesús, Spain

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Schizophrenia is known to be associated with cognitive dysfunction which increasing evidence suggests has consequences for functional adaptation and which cause difficulties in social re-integration after hospitalization. The investigators propose a large scale, multicentric study (7 centres from the Hermanas Hospitalarias del Sagrado Corazón de Jesús network) aimed at answering outstanding questions concerning the effectiveness of cognitive estimulation therapy for schizophrenic cognitive impairment. Specifically, the study will examine a) issues related to the size of the effect compared to treatment as usual and compared to a control intervention; b) generalizability of improvement to cognitive function and social cognition in daily life; and c) the durability of therapeutic gains after the end of treatment. 192 patients with chronic schizophrenia will be randomly assigned to one of three treatment conditions: a computer- assisted cognitive estimulation program (n=64), non-structured time on computer (n=64) and treatment as usual (n=64). A battery of neurocognitive tests of memory and executive function, including 'ecologically valid' measures, will be administered by blind evaluators at baseline, after 6 months of cognitive estimulation, and after 6 months follow-up. Symptoms, social functioning and self-esteem will be also be assessed at baseline, after the treatment and at follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Rehabilitation, Cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Computer-assisted cognitive training
Arm Type
Experimental
Arm Description
Patients in this arm of the trial carried out computerized online training drawn from the Feskits program (www.feskits.com), chosen to have attention, memory and executive function components. Specifically the sessions included the following exercises: sustained attention (4 minutes), attention/perception (5 minutes), working memory (8 minutes), auditory and visual memory (8 minutes), executive function (10 minutes), language (6 minutes), and games (4 minutes).
Arm Title
Computerized active condition
Arm Type
Active Comparator
Arm Description
Patients allocated to this condition completed the same number of sessions as the cognitive training group but followed a computerized typing program (www.rapidtyping.com). This had similar design characteristics to the CRT condition, in that it was hierarchically organized with exercise level of difficulty being adjusted to the individual's level of performance and feedback being given at the end of each exercise. Additionally, patients in this condition played computerized games requiring typing (crosswords, word puzzles, etc) and were taught basic internet navigation by a supervisor. Exposure to the computer was of equivalent duration to the CRT condition.
Arm Title
Treatment as usual
Arm Type
Placebo Comparator
Arm Description
Patients in this condition participated in their (individually variable) daily rehabilitative activities. Patients allocated to the other two conditions also participated in these activities
Intervention Type
Behavioral
Intervention Name(s)
Computer-assisted cognitive training
Other Intervention Name(s)
Computer-assisted cognitive training (CRT)
Intervention Description
Treatment lasted six months. The CRT and CC conditions consisted of biweekly sessions of 45 minutes. Patients in both conditions trained in groups of up to 8, supervised by a single person. The CRT and CC groups were scheduled at different times. The same personnel supervised both treatment conditions. All supervisors were trained by the coordinator of the study in the technical management of the two conditions.
Intervention Type
Other
Intervention Name(s)
Computerized active condition
Other Intervention Name(s)
Computerized active condition (CC)
Intervention Description
Treatment lasted six months. The CRT and CC conditions consisted of biweekly sessions of 45 minutes. Patients in both conditions trained in groups of up to 8, supervised by a single person. The CRT and CC groups were scheduled at different times. The same personnel supervised both treatment conditions. All supervisors were trained by the coordinator of the study in the technical management of the two conditions.
Intervention Type
Other
Intervention Name(s)
Treatment as usual (TAU)
Intervention Description
TAU: Patients in this condition participated in their (individually variable) daily rehabilitative activities. Patients allocated to the other two conditions also participated in these activities.
Primary Outcome Measure Information:
Title
Memory test battery
Description
memory test battery Rivermead Behavioural Memory Test (RBMT)(Wilson, 1985) a memory test battery and the executive test battery, the Behavioural Assessment of the Dysexecutive Syndrome (BADS)(Wilson, 1996)
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: schizophrenia or schizoaffective disorder fulfilling the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria diagnosis estimated premorbid intelligence quotient (IQ) in the normal range chronic illness (i.e. duration ≥two years) relative clinical stability (i.e. the patients had not experienced any recent exacerbation of symptoms). Exclusion Criteria: history of brain trauma alcohol or substance abuse/dependence within the previous six months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J McKenna, MD
Organizational Affiliation
FIDMAG Germanes Hospitalàries Research Foundation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jesus J Gomar, PhD
Organizational Affiliation
FIDMAG Germanes Hospitalàries Research Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edith Pomarol-Clotet, MD, PhD
Organizational Affiliation
FIDMAG Germanes Hospitalàries Research Foundation
Official's Role
Study Chair
Facility Information:
Facility Name
FIDMAG Germanes Hospitalàries Research Foundation
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Effects of a Cognitive Rehabilitation Program: a Neurocognitive Study

We'll reach out to this number within 24 hrs