The effectivness of cognitive behavioral therapy in combination with Pharmacotherapy on symptom control and quality of life in patients with schizophreneia
This is an interventional study with before-after design. Patients with schizophrenia and without any neurological and medical disorders, aged from 20 to 50, with at least 8 classes education will be included. The diagnosis will be done according to the structured interview with SCID. Patienta will be enrolled in the study only after obtaining informed consent. Patients with any history of substance abuse will be excluded. The sample size would be 5 patients wich could be decreased to 3 patients due to drop out in follow up visits. The patients would be selected in outpatients clinics in Roozbeh Psychiatric Hospital. At the first visit, the patients will fill out the IS score ( Insight of patient to his/her disease and sigh and symptoms, treatment, PANSS score (positive and negative syndrome scale), GAF ( global assessment of function), QOL score (question form of WHO regarding quality life score ). In further visits , the cognitive-behavioral intervention would be performed by a resident of psychiatry for 14 to 16 sessions ( 2 sessions per week) according to Nicola wright's book. The sessions would be recorded and supervised by a CBT specialist . Only audio files of sessions would be kept after completion of sessions and would be accessed only by CBT therapist and the supervisor. The patients would be evaluated at the end of all sessions and 3 months after, with score sheets.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016110627691N2
Registration date:2017-04-07, 1396/01/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-07, 1396/01/18
Registrant information
Name
Zahra Mirsepassi
Name of organization / entity
Roozbeh Hospital- Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 1811
Email address
z-mirsepassi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectivness of cognitive behavioral therapy in combination with Pharmacotherapy on symptom control and quality of life in patients with schizophreneia
Public title
combination of cognitive behavioral therapy and medication in treatment of schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with schizophrenia disorder according to DSM- IV -TR classificationand interview ; age between 20 to 50 ٰ at least 8 classes education; Patients will enrolled in the study only after obtaining informed consent; CBT will be the only psychosocial intervention which will be provided to these patients. Exclusion criteria:, with at least 8 classes education;Patients with any history of substance abuse ;.patients with any history of neurological or medical disorders
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
5
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 committee of Tehran university of Medicalsciences
Street address
Medical school ,poorsina sreet,16 Azar avenue,Tehran,Iran
City
Tehran
Postal code
Approval date
2016-07-12, 1395/04/22
Ethics committee reference number
IR.TUMS.REC.1395.2769
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
positive symptoms
Timepoint
at the first and after termination of cognitive behavioral therapy sessions and 12 weeks after the last sessions
Method of measurement
positive and negative syndrome scale
2
Description
negative symptoms
Timepoint
at the first and after termination of cognitive behavioral therapy sessions and 12 weeks after the last sessions
Method of measurement
positive and negative syndrome scale
Secondary outcomes
1
Description
Quality of life
Timepoint
at the first and after termination of cognitive behavioral therapy sessions and 12 weeks after the last sessions
Method of measurement
World Health organizatin-Quality of life
2
Description
Insight
Timepoint
at the first and after termination of cognitive behavioral therapy sessions and 12 weeks after the last sessions
Method of measurement
Insight scale
3
Description
Global functional patients
Timepoint
at the first and after termination of cognitive behavioral therapy sessions and 12 weeks after the last sessions
Method of measurement
Global Assessment of functioning scale
Intervention groups
1
Description
Cognitive behavioral therapy for patients with schizophrenia , 14 to16 sessions (2 sessions per week) individually ,according to Nicola wright protocol
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Day center.Roozbeh Hospital
Full name of responsible person
Zahra Mirsepassi
Street address
Day center.Roozbeh Hospital.South KargarAvenue.Tehran.Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Science ،Deputy of resaerch
Full name of responsible person
Zahra Mirsepassi
Street address
Enghelab Avenue.Ghods street.Tehran University Of Medical Sciences
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 Science ،Deputy of resaerch
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
Zahra Mirsepassi
Position
Psychiatrist.Assistant professor
Other areas of specialty/work
Street address
Roozbeh Hospital.South Kargar Avenue.Tehran,Iran
City
Tehran
Postal code
Phone
+98 21 5541 4084
Fax
Email
zahesbanoo@yahoo.com
z-mirsepassi@sina-tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Roozbeh Hospital
Full name of responsible person
zahra Mirsepassi
Position
Psychiatrist.Assistant professor
Other areas of specialty/work
Street address
Roozbeh Hospital.South Kargar Avenue.Tehran.Iran
City
Tehran
Postal code
Phone
+98 21 5541 4084
Fax
Email
zahesbanoo@yahoo.com Z-mirsepassi@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Roozbeh Hospital
Full name of responsible person
Zahra Mirsepassi
Position
Psychiatrist.Assistant professor
Other areas of specialty/work
Street address
Rozbeh Hospital.South Kargar Avenue ,Tehran.Iran
City
Tehran
Postal code
Phone
+98 21 5541 4084
Fax
Email
zahesbanoo@yahoo.com Z-mirsepassi@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)