Effects of a Cognitive Rehabilitation Program: a Neurocognitive Study

Salvador Sarró, MD

Status: Completed

Conditions: Schizophrenia

Treatments: Other: Treatment as usual (TAU); Behavioral: Computer-assisted cognitive training; Other: Computerized active condition

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT02201888

PI09/90483 (Other Identifier)

PR-2009-15

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 3 patient groups, including a placebo group

Computer-assisted cognitive training

Experimental group

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).

Treatment:

Behavioral: Computer-assisted cognitive training

Computerized active condition

Active Comparator group

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.

Treatment:

Other: Computerized active condition

Treatment as usual

Placebo Comparator group

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

Treatment:

Other: Treatment as usual (TAU)