This research investigates the efficacy of group cognitive remediation therapy on decreasing symptoms and improvement of functions in patients with schizophrenia. In a Randomized Clinical Trial, 40 patients who were hospitalized in Razi educational psychiatric treatment center with diagnosis of schizophrenia randomized in 2 groups with 20 patients. The first group received medication and cognitive remediation therapy, 2 sessions in a week for 16 sessions and control group received only medication. Positive and negative symptoms, behavioral and cognitive functions evaluated and compared 3 times, before treatment (pre-test), at the middle of the treatment (session 8), and after the treatment (post-test) by the research tools.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901282511N5
Registration date:2010-04-17, 1389/01/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-04-17, 1389/01/28
Registrant information
Name
Neda Ali Beigi
Name of organization / entity
University of social welfare and rehabilitation
Country
Iran (Islamic Republic of)
Phone
+98 21 8876 1317
Email address
nedapsych@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Social Welfare and Rehabilitation
Expected recruitment start date
2008-12-21, 1387/10/01
Expected recruitment end date
2009-05-24, 1388/03/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of Cognitive- Remediation Therapy on symptoms and function improvement in Patients with Schizophrenia
Public title
The efficacy of Cognitive- Remediation Therapy on symptoms and function improvement in Patients with Schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having a certain diagnosis of schizophrenia according to both DSMIV- TR criteria and psychiatrist diagnosis and SCID structured interview confirm the diagnosis, age 25 to 50 years, havivg persistent symptoms for at least 1 year despite adequate trials of antipsychotic medication, education level of at least grade 5
Exclusion criteria: Having brain injury, dementia, or any specific neurological disorder which need special care, not being in acute phase, having evidences for serious side effects of any antipsychotic drugs which leads to specific treatment other than treatment as usual, current abuse or poisoning or withdrawal of drugs (using cigarette as usual is not criteria for exclusion), receiving ECT for at least 6 months prior to or during the therapy
Age
From 25 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Social Welfare and Rehabilitation
Street address
University of Social Welfare and Rehabilitation Kodakyar. daneshjoo. blv. Evin. Tehran
City
Tehran
Postal code
1566969611
Approval date
2008-08-10, 1387/05/20
Ethics committee reference number
801-200
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Negative symptoms
Timepoint
before treatment- session8- after treatment
Method of measurement
Negative symptoms scale (SANS)
2
Description
Positive symptoms
Timepoint
before treatment- session8- after treatment
Method of measurement
Positive symptoms scale (SAPS)
3
Description
Behavioral function
Timepoint
Before treatment- session 8- After treatment
Method of measurement
Behavioral function scale (NOSIE)
4
Description
Cognitive function
Timepoint
Before treatment- session 8- After treatment
Method of measurement
Cognistat (NCSE)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Cognitive remediation therapy, 16 sessions which last 45 minutes, 2 session in a week. Each session had a defined structure. Therapsists were 5 exprienced and trained psychologists trianed for cognitive remediation therapy by resrearcher.
Category
Rehabilitation
2
Description
Control group: no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi psychiatric hospital
Full name of responsible person
Neda Ali beigi
Street address
Amin abad- shahr-e -rey
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Social Welfare and Rehabilitation
Full name of responsible person
Neda Ali beigi
Street address
Clinical psychology department, Kodakyar. daneshjoo. Blvd., Evin, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Social Welfare and Rehabilitation
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
University of Social Welfare and Rehabilitation
Full name of responsible person
Neda Ali beigi
Position
Ph. D in clinical psychology
Other areas of specialty/work
Street address
Clinical psychology department, University of Social Welfare and Rehabilitation, Kodakyar, Daneshjoo. Blvd., Evin, Tehran
City
Tehran
Postal code
1566969611
Phone
+98 21 8842 2868
Fax
Email
nedapsych@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation
Full name of responsible person
Neda Ali beigi
Position
PhD in clinical psychology
Other areas of specialty/work
Street address
Clinical psychology department, University of Social Welfare and Rehabilitation, Kodakyar, Daneshjoo. Blvd., Evin, Tehran
City
Tehran
Postal code
1566969611
Phone
+98 21 8842 2868
Fax
Email
nedapsych@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation
Full name of responsible person
Neda Ali beigi
Position
PhD in clinical psychology
Other areas of specialty/work
Street address
Clinical psychology department, University of Social Welfare and Rehabilitation, Kodakyar, Daneshjoo. Blvd., Evin, Tehran
City
Tehran
Postal code
1566969611
Phone
+98 21 8842 2868
Fax
Email
nedapsych@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)