Effects of a Cognitive Rehabilitation Program: a Neurocognitive Study

NCT ID: NCT02201888

Last Updated: 2014-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2014-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Computer-assisted cognitive training

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Computerized active condition

Intervention Type: 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.

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

Group Type: PLACEBO_COMPARATOR

Treatment as usual (TAU)

Intervention Type: 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.

Interventions

Computer-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.

Intervention Type: BEHAVIORAL

Computerized 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.

Intervention Type: OTHER

Treatment 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.

Intervention Type: OTHER

Other Intervention Names

Computer-assisted cognitive training (CRT); Computerized active condition (CC)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Centro de Investigación Biomédica en Red de Salud Mental

NETWORK

Sponsor Role: collaborator

Hermanas Hospitalarias del Sagrado Corazón de Jesús, Spain

UNKNOWN

Sponsor Role: collaborator

Salvador Sarró, MD

OTHER

Sponsor Role: lead

Responsible Party

Salvador Sarró, MD

Chief administrator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Peter J McKenna, MD

Role: STUDY_DIRECTOR

FIDMAG Germanes Hospitalàries Research Foundation

Jesus J Gomar, PhD

Role: PRINCIPAL_INVESTIGATOR

FIDMAG Germanes Hospitalàries Research Foundation

Edith Pomarol-Clotet, MD, PhD

Role: STUDY_CHAIR

FIDMAG Germanes Hospitalàries Research Foundation

Locations

FIDMAG Germanes Hospitalàries Research Foundation

Barcelona, Barcelona, Spain

Countries

Spain

Other Identifiers

PI09/90483

Identifier Type: OTHER

Identifier Source: secondary_id

PR-2009-15

Identifier Type: -

Identifier Source: org_study_id