This study aims to investigate the effectiveness of psycho educational treatment on the positive and negative symptoms of patients with chronic schizophrenia.
Design
The training will be run by a psychiatrist assistant who is familiar with psychological training techniques, within 6 weeks of each week, 1 session, 1-5 hours per hour. Patients will be evaluated before the intervention, after the end of the intervention session and one month after the intervention, with Beck Depression Inventory, Beck Anxiety Inventory, SF-36, and Positive and Negative Syndrome Scale. After sampling by available method, the samples were randomly divided into two groups of case and control. Given that the total sample size is 48, 12 blocks of 4 are prepared by the statistical expert. This study is a phase 3 clinical trial.
Settings and conduct
The clinic of Shafa hospital / Patients will be included in the study after obtaining informed consent, observing the criteria for entry and exit from the study.
Participants/Inclusion and exclusion criteria
The study population includes all outpatient psychiatric patients with chronic schizophrenia who referred to the healing hospital during the recovery period (all patients referring to the Shafa Hospital based on DSM-5 criteria for the diagnosis of chronic schizophrenia) And in controlled condition - patients should have at least cycle education - age of patients aged 18-35 - not suffering from any other medical and psychological illness - willingness to enter the study - lack of substance and alcohol .
Intervention groups
Intervention group: The intervention group will be treated as common with psychotherapy based on psychological training.
Control group: Individuals in the routine drug therapy group (olanzapine will receive 20 to 25 mg twice daily or risperidone 6 mg daily twice daily).
Main outcome variables
Positive and negative symptoms of schizophrenia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150427021965N12
Registration date:2019-08-26, 1398/06/04
Registration timing:registered_while_recruiting
Last update:2019-08-26, 1398/06/04
Update count:0
Registration date
2019-08-26, 1398/06/04
Registrant information
Name
Homa Zarrabi
Name of organization / entity
Guilan University of Medical Sceinces,«Kavosh » Cognitive Behaviour Sciences and Addiction Researc
Country
Iran (Islamic Republic of)
Phone
+98 13 3366 6268
Email address
shafakavosh@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial of the Effectiveness of Psycho educational Therapy on the Positive and Negative Symptoms of people with Chronic Schizophrenia Disorder
Public title
Psycho educational Therapy and Positive and Negative Symptoms of patients with Chronic Schizophrenia Disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All patients referred to the clinic of the Shafa Hospital who has a diagnosis of chronic schizophrenia based on DSM-5 criteria and in controlled conditions.
Members must have at least elementary education.
Patients aged 18-35 years old
Have the desire to enter the study.
Exclusion criteria:
Having other psychiatric disorders
Having physically debilitating disease
Age
From 18 years old to 35 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two groups with psychiatric intervention based on psychological training and control group. Given that the total number of samples is 24, 6 blocks of 4 are provided by a statistic expert. Then the assistant allocates patients into each group through closed envelopes. The intervention group will be under the common treatment (medical treatment) along with psychotherapy based on psychological training, and the control group will only be treated as commonly.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Blinding will not be done in this study. Patients and therapists are aware of the study. After sampling by available method, the specimens were randomly divided into two groups of case and control. Given that the total number of samples is 24, 12 blocks are provided by expert statistician. Blocking will be used to create the number of samples assigned to each treatment group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Old Building of School of Health, In front of the 17th Shahrivar Hospital, Shahid Siadati Avenue, Namjoo St.
City
Rasht
Province
Guilan
Postal code
41446-66949
Approval date
2019-06-26, 1398/04/05
Ethics committee reference number
IR.GUMS.REC.1398.133
Health conditions studied
1
Description of health condition studied
Schizophrenia Disorder
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Positive symptoms of schizophrenia disorder
Timepoint
Patients will be evaluated before the intervention, after the end of the intervention session and one month after the intervention.
Method of measurement
Patients will be evaluated by Positive and Negative Syndrome Scale (PNSS).
2
Description
Negative symptoms of schizophrenia disorder
Timepoint
Patients will be evaluated before the intervention, after the end of the intervention session and one month after the intervention.
Method of measurement
Patients will be evaluated by Positive and Negative Syndrome Scale (PNSS).
3
Description
Depression symptoms
Timepoint
Patients will be evaluated before the intervention, after the end of the intervention session and one month after the intervention.
Method of measurement
Patients will be evaluated by Beck Depression Scale.
4
Description
Symptoms of Anxiety
Timepoint
Patients will be evaluated before the intervention, after the end of the intervention session and one month after the intervention.
Method of measurement
Patients will be evaluated by Beck Anxiety Scale.
5
Description
Quality of Life
Timepoint
Patients will be evaluated before the intervention, after the end of the intervention session and one month after the intervention.
Method of measurement
Patients will be evaluated by SF36.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will be treated as common with psychotherapy based on psychological training. The training will be run by a psychiatrist assistant who is familiar with psychological training techniques, within 6 weeks of each week, 1 session, 1-5 hours per hour. Patients will be evaluated before the intervention, after the end of the intervention session and one month after the intervention, with BDI depression tests, BAI anxiety, SF-36 quality of life, and positive and negative PANSS symptoms. The intervention will take place in a group. In this research, an interventional program for psychological training will be used based on study (20) and will be organized in 6 sessions of 1-5 / 1 hour and weekly. The following is provided below for the implementation of the training sessions: Session 1: Explain the nature of the schizophrenia and its symptoms. Second session: Explaining the cause of schizophrenia and the importance of family role in emotional support of patients. Session 3: An explanation of the drug treatment and the importance of continuing it in the recovery process. Session Four: Identifying starters and the risk of recurrence. Session 5: Problem-Solving Interventions in Patients. Session Six: Identify Stressful and Emerging Factors and Train Stress Management Techniques.
Category
Rehabilitation
2
Description
Control group: Individuals in the routine drug therapy group (Olanzapine will receive 20 to 25 mg twice daily, or Risperidone 6 mg daily twice daily).
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa hospital clinic
Full name of responsible person
Homa Zarrabi
Street address
15 khordad avenue, Shafa Hospital
City
Rasht
Province
Guilan
Postal code
41939-55599
Phone
+98 13 3366 6268
Email
kavosh1400@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Homa Zarrabi
Street address
15 khordad St, Shafa hospital
City
Rasht
Province
Guilan
Postal code
55599 -41939
Phone
+98 13 3366 2360
Email
kavosh1400@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research assistance University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Aida Yahyazadeh
Position
Expert
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
15 khordad avenue, Shafa Hospital
City
Rasht
Province
Guilan
Postal code
41939-55599
Phone
+98 13 3366 6268
Email
aidayahyazadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Homa Zarrabi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
15 khordad avenue, Shafa Hospital.
City
Rasht
Province
Guilan
Postal code
41939-55599
Phone
+98 13 3366 6268
Email
kavosh1400@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Aida Yahyazadeh
Position
Expert
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
15 khordad avenue, Shafa Hospital.
City
Rasht
Province
Guilan
Postal code
41939-55599
Phone
+98 13 3366 6268
Email
aidayahyazadeh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be coded and unidentifiable, will be shared.
When the data will become available and for how long
Start the access period 3-6 months after printing the results
To whom data/document is available
All physicians and paramedics in the field of psychology
Under which criteria data/document could be used
For more information on rehabilitation methods for patients with psychiatric disorders