Effectiveness of a computerized cognitive remediation program on cognitive functioning of patients with schizophrenic disorders: A randomized controlled study
This study aims to investigate the effect of cognitive remediation on cognitive functioning in patients with schizophrenic disorders. Sixty two patients with schizophrenia or schizoaffective disorder aged 18 to 55 will be enrolled from Roozbeh Hospital. Participants will be allocated randomly to a treatment and a control group using random blocks (size=4) with concealed allocation. The raters will be blind to the allocated groups. Subjects in the intervention group will receive cognitive remediation as well as treatment as usual that usually include antipsychotic medications, and the control group will receive only treatment as usual. The cognitive remediation protocol consists of 10 one-hour sessions of computerized training using the Cog-pack software. Positive and Negative Syndrome Scale (PANSS) will be used to investigate psychotic symptoms. Clinical Global Impression scale (CGI) will be used for clinical evaluation of the patients in terms of illness severity upon entering the study. The Global Assessment of Functioning (GAF) and the Quality of Life questionnaire will be employed to assess global functioning and quality of life of patients. Five subscales of the adult Wechsler Test will be used to measure the baseline intelligence quotient (IQ) of the patients. Furthermore, illness and treatment history will be obtained using chart reviews as well as interviews with patients and their relatives. The CANTAB software (Cambridge Neuropsychological Test Automated Battery) will be employed to assess the cognitive functioning before and after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011810782N2
Registration date:2016-05-28, 1395/03/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-28, 1395/03/08
Registrant information
Name
Vandad Sharifi
Name of organization / entity
Tehran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
vsharifi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-02-04, 1394/11/15
Expected recruitment end date
2017-08-06, 1396/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of a computerized cognitive remediation program on cognitive functioning of patients with schizophrenic disorders: A randomized controlled study
Public title
Effectiveness of cognitive remediation in schizophrenia
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with DSM-IV schizophrenia or schizoaffective disorder, aged 18 to 55 years and with education not less than 3rd grade in guidance school. Patients will be clinically stable and not acutely psychotic (Clinical Global Impression scale score less than 4, and Positive and Negative Syndrome Scale score less than 50). The dosage and the type of antipsychotic medications patients will receive at least during the three weeks prior to the study will be unchanged. At least 12 hours before the intervention, patients will receive their last dose of a benzodiazepine (if any) but no antihistamine medication will be administered.
Exclusion criteria:
Receiving electroconvulsive therapy (ECT) within six weeks prior to the study, mental retardation, uncorrected visual impairment, concurrent consumption of substances with the exception of nicotine and caffeine, a history of head trauma followed by loss of consciousness, suffering from a major neurological disorder (including epilepsy, Parkinson’s disease, dementia, multiple sclerosis, or any motor disability), severe worsening of illness during study requiring a change in medical treatments.
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Ghods Avenue, Keshavarz Boulevard
City
Tehran
Postal code
Approval date
2016-02-08, 1394/11/19
Ethics committee reference number
IR.TUMS.REC.1394.1898
Health conditions studied
1
Description of health condition studied
Schizoaffective Disorder
ICD-10 code
F25
ICD-10 code description
Schizoaffective disorder
2
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Executive function
Timepoint
Before and after the intervention
Method of measurement
CANTAB Battery
2
Description
Attention
Timepoint
Before and after the intervention
Method of measurement
CANTAB Battery
3
Description
Memory
Timepoint
Before and after the intervention
Method of measurement
CANTAB Battery
Secondary outcomes
1
Description
Global Function
Timepoint
Before and after the intervention
Method of measurement
Global Assessment of Functioning
2
Description
Quality of life
Timepoint
Before and after the intervention
Method of measurement
Quality of life questionnaire
3
Description
Severity of illness
Timepoint
Before and after the intervention
Method of measurement
Positive and Negative Syndrome Scale, and Clinical global impression
Intervention groups
1
Description
Computer assisted cognitive remediation that consists of 10 training sessions using tasks in Cogpack software for improvement of memory, attention and executive functions. Sessions are delivered in 2-3 per week frequency.
Category
Rehabilitation
2
Description
Treatment-as-usual that usually consists of antipsychotic medications in standard maintenance dosage prescribed by a physician and accompanied by patient education.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Azadeh Sedighnia
Street address
South Kargar Avenue
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice chancellor for research and technology,Tehran University of Medical Sciences
Street address
Ghods Avenue, Keshavarz Boulevard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Roozbeh Hospital
Full name of responsible person
Azadeh Sedighnia
Position
Psychiatrist
Other areas of specialty/work
Street address
South Kargar Avenue
City
Tehran
Postal code
Phone
+98 21 5541 9151
Fax
Email
Azadehsedighnia@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Roozbeh Hospital
Full name of responsible person
Vandad Sharifi
Position
Psychiatrist/Professor
Other areas of specialty/work
Street address
South Kargar Avenue
City
Tehran
Postal code
Phone
+98 21 5541 9151
Fax
Email
Vsharifi@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Roozbeh Hospital
Full name of responsible person
Azadeh Sedighnia
Position
Psychiatrist
Other areas of specialty/work
Street address
South Kargar Avenue
City
Tehran
Postal code
Phone
+98 21 5541 9151
Fax
Email
Azadehsedighina@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)