Investigating the effect of narrative exposure therapy on symptoms of depression and post-traumatic stress in nurses with experience working in Corona wards
Investigating the effect of narrative exposure therapy on the symptoms of Dysthymic Disorder and post-traumatic stress in nurses with experience working in corona wards
Design
This is a randomized clinical trial with a control group and a parallel design. This non-blinded study will be conducted on at least 60 qualified nurses. A simple randomization method is used for randomization and the participants are randomly assigned to two intervention and control groups.
Settings and conduct
This study, which will be conducted in Al-Zahra Hospital in Isfahan city, is not blinded. At the beginning of the study, the information collection checklist will be completed by visiting in person in three work shifts, morning, evening, and night. After providing the necessary explanations about the objectives of the research, written informed consent will be obtained from qualified nurses, and depression and post-accident stress questionnaires will be provided to them, and treatment sessions will begin.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Bachelor's and master's degree in nursing; At least 6 months of work experience in the care of patients with corona
Exclusion criteria: History of participating in psychotherapy sessions; History of neurological disease
Intervention groups
The intervention group will receive narrative exposure therapy for 6 sessions of 33 minutes once a week. The control group will not receive any intervention.
Main outcome variables
Dysthymia, post-traumatic stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230905059365N1
Registration date:2023-09-25, 1402/07/03
Registration timing:prospective
Last update:2023-09-25, 1402/07/03
Update count:0
Registration date
2023-09-25, 1402/07/03
Registrant information
Name
Zahra Ebrahimi
Name of organization / entity
Isfahan (Khorasgan) Branch ,Ialamic Azad University ,Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 3777 2298
Email address
z.ebrahimh@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-11, 1402/07/19
Expected recruitment end date
2024-01-09, 1402/10/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of narrative exposure therapy on symptoms of depression and post-traumatic stress in nurses with experience working in Corona wards
Public title
The effect of narrative exposure therapy on symptoms of depression and post-traumatic stress in nurses with experience working in Corona wards.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Bachelor's and master's degree in nursing
At least 6 months of work experience in the care of patients with corona
Exclusion criteria:
History of participating in psychotherapy sessions
History of neurological disease
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Using the simple random method. The names of the participants are written on the card. The cards are put into a box that cannot be seen from outside. One of the colleagues of the plan is asked to remove one card from the container at a time. The names of the 30 cards that are selected first are placed in the first intervention group, the second 8 selected cards are placed in the first control group, and the remaining 8 in the second 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
Ethics Committee of Islamic Azad University, Khorasgan branch
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Approval date
2023-05-20, 1402/02/30
Ethics committee reference number
IR.IAU.KHUISF.REC.1402.062
Health conditions studied
1
Description of health condition studied
Dysthimic Disorder
ICD-10 code
F34.1
ICD-10 code description
Dysthymic disorder
2
Description of health condition studied
post-traumatic stress disorder
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder (PTSD)
Primary outcomes
1
Description
Dysthymia
Timepoint
The beginning of the study, the end of the study (6 weeks after the start of the study), one month after the end of the study
Method of measurement
Using depression questionnaire
2
Description
Post-traumatic stress
Timepoint
The beginning of the study, the end of the study (6 weeks after the start of the study), one month after the end of the study
Method of measurement
Using the post-traumatic stress questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive narrative exposure therapy for 6 sessions of 33 minutes once a week.
Category
Treatment - Other
2
Description
The control group will not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Zahra Ebrahimi Hajat Aghaei
Street address
Faculty of Nursing and Midwifery, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahahn
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
meshkini@miums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Khorasgan branch
Full name of responsible person
Dr. Majid Meshkini
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Kermanshah
Postal code
8155139998
Phone
+98 31 3535 4001
Email
meshkini@miums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Khorasgan branch
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
Address of Islamic Azad University, Khorasgan branch
Full name of responsible person
Zahra Ebrahimi Hajat Aghaei
Position
Master of nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
zamofaso@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Khorasgan branch
Full name of responsible person
Dr. Maryam Radmehr
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
zamofaso@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Address of Islamic Azad University, Khorasgan branch
Full name of responsible person
Zahra Ebrahimi Hajat Aghaei
Position
Nursing master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
zamofaso@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD