Objective: to study the effects of cognitive rehabilitation in improvement of cognitive function in patients with schizophrenia.
Methods: For 20 subjects with schizophrenia that are admitted in Roozbeh Hospital, cognitive remediation will be performed in 10 sessions with Cogpack that contains tasks for improvement of attention and memory. Attention , memory and executive function will be assessed before & after rehabilitation by Cambridge Neuropsychological Test Automated Battery (CANTAB) software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012090810782N1
Registration date:2012-09-29, 1391/07/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-09-29, 1391/07/08
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
Vice Chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2012-04-03, 1391/01/15
Expected recruitment end date
2012-11-05, 1391/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preliminary study of the effect of cognitive rehabilitation in improvement of cognitive function in patients with schizophrenia
Public title
Effect of cognitive rehabilitation in schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-55 years old; schizophrenia; residing in Tehran; stable mental state; ( PANSS <50 ) or (CGI < 4 ); normal IQ; education level > 8years; stable treatment regime
Exclusion criteria: Addiction; having significant neurologic disorder; positive history of head trauma
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committeee of TUMS Vice Chancellor for Reaserch
Street address
Ghods-Keshavarz Blvd Crossroad
City
Tehran
Postal code
Approval date
2012-09-10, 1391/06/20
Ethics committee reference number
18217
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Executive function
Timepoint
First session & after 10 sessions of intervention
Method of measurement
Cambridge Neuropsychological Test Automated Battery (CANTAB)
2
Description
Attention
Timepoint
First session & after 10 sessions of intervention
Method of measurement
Cambridge Neuropsychological Test Automated Battery (CANTAB)
3
Description
Memory
Timepoint
First session & after 10 sessions of intervention
Method of measurement
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Secondary outcomes
empty
Intervention groups
1
Description
Cognitive rehabilitation by Cogpack that includes 10 sessions of rehabilitation (2-3 per week)
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Azadeh Sedighnia.MD
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences Vice Chancellor for Research
Full name of responsible person
Ms. Moamaee
Street address
Ghods-Keshavarz Blvd Crossroad
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 Vice Chancellor for Research
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
Resident of Psychiatry
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar Ave
City
Tehran
Postal code
1333795914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
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
Associate Professor of Psychiatry
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar Ave
City
Tehran
Postal code
1333795914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
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
Resident of Psychiatry
Other areas of specialty/work
Street address
City
Tehran
Postal code
1333795914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
Azadehsedighnia@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)