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CompletedNCT02201888Updated Jul 28, 2014

Effects of a Cognitive Rehabilitation Program: a Neurocognitive Study

An interventional study of Computer-assisted cognitive training and Computerized active condition in Schizophrenia, sponsored by Salvador Sarró, MD. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-07-28.

Sponsored by Salvador Sarró, MD · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Schizophrenia

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Keywords

  • Schizophrenia
  • Rehabilitation
  • Cognition
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 130 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

This is the only study on the registry with Salvador Sarró, MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • history of brain trauma
  • alcohol or substance abuse/dependence within the previous six months.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
130 participants (actual)

Study arms

  • Experimental
    Computer-assisted cognitive training

    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).

    Behavioral: Computer-assisted cognitive training

  • Active comparator
    Computerized active condition

    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.

    Other: Computerized active condition

  • Placebo comparator
    Treatment as usual

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

    Other: Treatment as usual (TAU)

Interventions

  • BehavioralComputer-assisted cognitive training

    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.

    Also known as: Computer-assisted cognitive training (CRT)

  • OtherComputerized active condition

    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.

    Also known as: Computerized active condition (CC)

  • OtherTreatment as usual (TAU)

    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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Six months

07

Study locations

1 site
  • FIDMAG Germanes Hospitalàries Research Foundation
    Barcelona, 08035, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02201888
Lead 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
Responsible party
Salvador Sarró, MD (Chief administrator, FIDMAG Germanes Hospitalàries) — Sponsor-investigator
First posted
Jul 28, 2014
Start date
Jan 2010
Primary completion
Dec 2013
Completion
Feb 2014
Last update
Jul 28, 2014

Study contacts

Peter J McKenna, MD
study director · FIDMAG Germanes Hospitalàries Research Foundation
Jesus J Gomar, PhD
principal investigator · FIDMAG Germanes Hospitalàries Research Foundation
Edith Pomarol-Clotet, MD, PhD
study chair · FIDMAG Germanes Hospitalàries Research Foundation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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