Determining the Effect of Group-Based Cognitive-Behavioral Interventions in Social-Psychological Adjustment of Patients with Major Depressive Disorders
Design
First, all people who have the criteria for entry into the study complete the Bell Social Psycho-social Questionnaire. 104 patients with the criteria for study are selected. Patients will be treated with simple sampling in two groups: intervention and control. The intervention group participates in eight cognitive-behavioral training sessions. The control group will not receive any interventions during this period. After completing the intervention, both groups complete the Bell Compliance questionnaire. Finally, the data will be analyzed using statistical tests.
Settings and conduct
The study is a clinical trial with control group, pre-test and post-test.The place of the study is the Ebn-Sina Psychiatric hospital in Shiraz
Participants/Inclusion and exclusion criteria
Inclusion criteria (patients with non-psychotic depressive disorder with proper cognitive function)
Exclusion criteria (depressed patients with psychotic symptoms and cognitive impairment)
Intervention groups
The Intervention group includes Cognitive-Behavioral education. Meetings are organized in a group manner. There will be two 90-minute sessions per week.
The Control group does not receive Cognitive-Behavioral intervention. Receives pharmaceutical and public interventions
Main outcome variables
Improving social and psychological compatibility
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170808035579N1
Registration date:2018-01-14, 1396/10/24
Registration timing:registered_while_recruiting
Last update:2018-01-14, 1396/10/24
Update count:0
Registration date
2018-01-14, 1396/10/24
Registrant information
Name
Zakiye Ghelbash
Name of organization / entity
Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4254
Email address
stud2560279101@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Government - Shiraz University of Medical Sciences
Expected recruitment start date
2017-08-21, 1396/05/30
Expected recruitment end date
2018-01-30, 1396/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Group-Based Cognitive-Behavioral Therapy (CBT) in Psycho-Social Compatibility of Patients with Major Depression Disorder
Public title
Effect of Cognitive-Behavioral Therapy in Depression.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients With Major non-psychotic Depression
Are aged 18 to 60 years old
Reading and Writing skills
Exclusion criteria:
Patients in the active phase of psychosis
Patients who have learning difficulties
Destruction of the mental process
Patients who are not Psychologically favorable for Treatment through Group Therapy
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Using random numbers, 50 people will be selected from all participants with the criteria for entering the study.
All two-digit participant codes will be entered into the computer system of random numbers. Then start the first row or column. Two digit digits are smaller than the total number of participants. This process will continue until the selection of fifty numbers. Then again, using the Counterfeit Table, people will be divided into two groups of intervention and control. 25 pairs will be assigned to the intervention group and 25 individuals will be assigned to the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences and Health Services
Street address
Building of Shiraz University of Medical Sciences, Emam Hossein Square, Zand Street
City
Shiraz
Province
Fars
Postal code
713451978
Approval date
2017-05-20, 1396/02/30
Ethics committee reference number
IR.SUMS.REC.1396.29
Health conditions studied
1
Description of health condition studied
Major Depressive Disorder
ICD-10 code
F32.2
ICD-10 code description
Severe depressive episode without psychotic symptoms
Primary outcomes
1
Description
Social and psychological adjustment
Timepoint
Before the intervention, after the end of the intervention
Method of measurement
Bell Social Psychosocial Compliance Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Interventions include eight cognitive-behavioral training sessions. Each training session will be held for a period of 90 minutes. 30 minutes delivering lectures, 30 minutes of assignments, 30 minutes of group discussion
Category
Lifestyle
2
Description
Intervention in the control group (the control group will not receive any cognitive-behavioral psychotherapy interventions during the interventions, only general treatment will be performed.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebne-Sina Psychiatric Hospital
Full name of responsible person
Zakiye Ghelbash
Street address
Hafez Avenue., Ebne-Sina Hospital
City
Shiraz
Province
Fars
Postal code
7146676549
Phone
+98 71 3228 9601
Fax
+98 71 3228 6784
Email
ebnesina@sums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi
Street address
Shiraz, Central Building Of Shiraz University Of Medical Sciences, Zand St.
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3235 7282
Fax
+98 71 3230 7594
Email
vcrdep@sums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Zakiye Ghelbash
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Abiverdi Avenue
City
Shiraz
Province
Fars
Postal code
713452413
Phone
+98 71132357282
Fax
Email
z.ghelbashp@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Ladan Zarshenas
Position
PHD
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Namazai Square
City
Shiraz
Province
Fars
Postal code
0713451978
Phone
+98 71132357282
Fax
Email
zarshenas@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zakiye Ghelbash
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Abiverdi Avenue
City
Shiraz
Province
Fars
Postal code
0713231978
Phone
00
Fax
Email
z.ghelbasgp@yahoo.com
Web page address
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data from the study after the analysis will be reported in full
When the data will become available and for how long
Starting data access is six months after the results are printed
To whom data/document is available
Researchers working in scientific and research institutes
Under which criteria data/document could be used
Copying and printing data is illegal
From where data/document is obtainable
Fatemeh School of Nursing & Midwifery Shiraz
What processes are involved for a request to access data/document
Send an email to the research designer who agrees if the requirements are met