Effects of a Cognitive Rehabilitation Program: a Neurocognitive Study

NCT02201888 | Completed

• 2 other identifiers: PR-2009-15PI09/90483
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Rehabilitation; Cognition

Outcome Measures

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)

  Six months

Study Arms (3)

Computer-assisted cognitive training

EXPERIMENTAL

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

Computerized active condition

ACTIVE COMPARATOR

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

Treatment as usual

PLACEBO COMPARATOR

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

Computer-assisted cognitive training BEHAVIORAL

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)

Computer-assisted cognitive training

Computerized active condition OTHER

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)

Computerized active condition

Treatment as usual (TAU) OTHER

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.

Treatment as usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Salvador Sarró, MD: lead
• Instituto de Salud Carlos III: collaborator
• Centro de Investigación Biomédica en Red de Salud Mental: collaborator
• Hermanas Hospitalarias del Sagrado Corazón de Jesús, Spain: collaborator

Study Sites (1)

FIDMAG Germanes Hospitalàries Research Foundation

Barcelona, Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Peter J McKenna, MD

  FIDMAG Germanes Hospitalàries Research Foundation

  STUDY DIRECTOR

• Jesus J Gomar, PhD

  FIDMAG Germanes Hospitalàries Research Foundation

  PRINCIPAL INVESTIGATOR

• Edith Pomarol-Clotet, MD, PhD

  FIDMAG Germanes Hospitalàries Research Foundation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief administrator

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: July 28, 2014
• Study Start: January 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: July 28, 2014

Record last verified: 2014-07

Locations

ES (1)