Determining the Effect of Cognitive-Behavioral Intervention on Prevention of Depression in Nursing Students in the First semester of Nursing and Midwifery Faculty
Design
Clinical trial with control group, pre-test and post-test, simple randomization using random numbers table
Settings and conduct
The study is an intervention group with control group. Participants in the intervention group are included in six sessions of cognitive-behavioral education. Group-based education will be implemented. The place of the study is the School of Nursing, Shiraz University of Medical Sciences
Participants/Inclusion and exclusion criteria
Entry criteria: Nursing students who are first semester, The desire to attend the study; Exit criteria: The presence of any psychiatric disorder
Intervention groups
Intervention group: The intervention group will participate in 6 sessions of cognitive-behavioral therapy, focusing on social skills
Control group: The control group will only participate in free discussion sessions
Main outcome variables
Depression Score in Beck Depression Inventory
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160404027216N7
Registration date:2018-12-08, 1397/09/17
Registration timing:retrospective
Last update:2018-12-08, 1397/09/17
Update count:0
Registration date
2018-12-08, 1397/09/17
Registrant information
Name
Fatemeh Vizeshfar
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4258
Email address
vizeshfarf@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-10, 1397/03/20
Expected recruitment end date
2018-07-01, 1397/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Cognitive- Behavior Therapy on the prevention of depression in nursing students
Public title
Effect of Cognitive-Behavior Therapy on the prevention of depression
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
First term nursing student
Tend to participate in the study
Exclusion criteria:
Use of any antidepressant medication
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
All positions of the two groups in the blocks of 4 were numbered from 1 to 6. Then numbers 1-6 were selected randomly and by placement. By selecting each number, the procedure for locating individuals using letters A and B was shown in a table. This was repeated so that the order of the two groups in the table was reached to 36
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
Ethics committee of Shiraz University of Medical Sciences
Street address
Namazi Square, Faculty of Nursing and Midwifery of Hazrat Fatemeh
City
Shiraz
Province
Fars
Postal code
13119–71936
Approval date
2018-03-11, 1396/12/20
Ethics committee reference number
IR.SUMS.REC.1396.158
Health conditions studied
1
Description of health condition studied
Mild Depression
ICD-10 code
F32.0
ICD-10 code description
Mild depressive episode
2
Description of health condition studied
Moderate depressive episode
ICD-10 code
F32.1
ICD-10 code description
Moderate depressive episode
3
Description of health condition studied
Severe depressive episode without psychotic symptoms
ICD-10 code
F32.2
ICD-10 code description
Severe depressive episode without psychotic symptoms
Primary outcomes
1
Description
Depression Score in Beck Depression Inventory
Timepoint
Before and after the intervention
Method of measurement
Beck depression inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will participate in six sessions of cognitive-behavioral group therapy focused on social skills. Which includes the description of depression disorder, assertiveness training, problem-solving skills training, anger control skill training, familiarity with depressive cognitive errors, and how to replace effective thoughts with ineffective thoughts, The participants will be divided into two groups of 8 and 9 persons
Category
Prevention
2
Description
Control group: The control group will participate in free-group sessions
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Nursing and Midwifery of Fatemeh Shiraz
Full name of responsible person
Zakiye Ghelbash
Street address
Namazi Square, Faculty of Nursing, Hazrat Fatemeh
City
Shiraz
Province
Fars
Postal code
7132145321
Phone
+98 71 3647 4254
Email
nurs_midwif@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Basir Hashemi
Street address
Imam Hossein Square, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
23247532543
Phone
+98 71 3213 4456
Email
nurs_midwif@sums.ac.ir
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
Golestan town, Shiraz
City
Shiraz
Province
Fars
Postal code
3254765876
Phone
+98 71 3154 7654
Email
z.ghelbashp@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fateme Vizeshfar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Namazai Square
City
Shiraz
Province
Fars
Postal code
34567834565
Phone
+98 71 3245 6765
Email
vizeshfar@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fateme Vizeshfar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Namazai Square
City
Shiraz
Province
Fars
Postal code
3435674334
Phone
+98 71 3456 7583
Email
vizeshfar@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
General data
When the data will become available and for how long
Six months after printing results
To whom data/document is available
Governmental and Research Organizations
Under which criteria data/document could be used
Submit a request to the research officer
From where data/document is obtainable
Deputy of Research of Shiraz University of Medical Sciences
What processes are involved for a request to access data/document