The effect of an educational intervention on post-traumatic stress disorder and social cognitive theory constructs in women with sexual assault experience
manage PTSD, change health behavior and encourage them to pursue health care as a result of improving the quality of life in women who experienced sexual assault.
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, on 40 patients. A table of random numbers was used for randomization.
Settings and conduct
The training will be provided in the place of welfare and forensic medicine. In parallel with the intervention group, double-blinding, the control group, a 1-hour session of routine training will be provided without focusing on specific theoretical structures, and during the study, they will benefit from services and care without deprivation. The questioner will not know about the groups.
Participants/Inclusion and exclusion criteria
18 to 45 years
Women who have experienced at least one sexual assault with a gap of at least one month from the incident
People who according to the score obtained (score 35 to 70 for low PTSD severity and score 70 to 105 for moderate PTSD severity) in the Mississippi questionnaire and confirmed by the team's clinical psychologist/psychiatrist have PTSD.
No drug use and no severe neurological and brain diseases at present, no mental retardation
Not suffering from major psychiatric disorders and being treated or having a history and psychiatric record
No pregnancy at the time of entering the study
Being literate in reading and writing (otherwise, reading and helping to complete questionnaires)
Intervention groups
Educational intervention for 6 sessions of 60 minutes one day a week for 6 weeks and the content of the program is based on social cognitive theory (SCT) for the intervention group and a parallel 1 hour session for the control group. will be
Main outcome variables
Behavior change and health follow-up by the individual; Improving and reducing the burden of post-traumatic stress disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230926059526N1
Registration date:2023-10-18, 1402/07/26
Registration timing:prospective
Last update:2023-10-18, 1402/07/26
Update count:0
Registration date
2023-10-18, 1402/07/26
Registrant information
Name
Nasrin Vafaeinezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 443 3926
Email address
www.nasrinvafa@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-02-04, 1402/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of an educational intervention on post-traumatic stress disorder and social cognitive theory constructs in women with sexual assault experience
Public title
The effect of an educational intervention on post-traumatic stress disorder and social cognitive theory constructs in women with sexual assault experience
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women who have experienced at least one sexual assault with an interval of at least one month from the incident (if there are symptoms of disorder, no maximum)
People who according to the score obtained (score 35 to 70 for low PTSD severity and score 70 to 105 for moderate PTSD severity) in the Mississippi Questionnaire with the ability to diagnose based on the DSM-5 diagnostic system and confirmed by the clinical psychologist/psychiatrist of the PTSD team are.
No drug use at the moment
Absence of severe neurological and brain diseases at present
absence of mental retardation
Not suffering from major psychiatric disorders and being treated or having a history and psychiatric record (psychotic disorders: psychosis, bipolar, schizophrenia)
No pregnancy at the time of entering the study
Being literate in reading and writing (otherwise, reading and helping to complete questionnaires)
Exclusion criteria:
Age
From 18 years old to 48 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
We will use the table of random numbers to allocate the sample in two intervention and control groups
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to double-blind the control group, a 1-hour session for the control group will be provided with the routine training of the mentioned centers without focusing on specific theoretical structures, and during the study they will use the services and routine care provided in the mentioned centers and will not be deprived and the questioner will not know about the groups.
Placebo
Not used
Assignment
Other
Other design features
. The people assigned to the intervention group will be invited to participate in 4 groups of 5 people according to their age and education, or according to the desire of not having a group member to participate in individual meetings.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences,Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2023-09-17, 1402/06/26
Ethics committee reference number
IR.MUI.NUREMA.REC.1402.103
Health conditions studied
1
Description of health condition studied
Post-traumatic stress disorder caused by sexual assault
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder (PTSD)
Primary outcomes
1
Description
Reducing and managing post-traumatic stress disorder, changing health behaviors and encouraging health care follow-up
Timepoint
Before and two months after the intervention
Method of measurement
Mississippi questionnaire/GSE-10 self-efficacy/awareness, attitude and performance of health-related behavior/background characteristics/perceived social support/
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Intervention group: Women who have experienced sexual assault, referred to the social emergency center of Isfahan Welfare and Forensic Medicine Organization, who have the conditions to enter the study, will form the sample of this research. An educational intervention has been designed and compiled by considering the structures of social cognitive theory and focusing on health-related behavior.
Category
Rehabilitation
2
Description
Control group: In order to double-blind the control group, a 1-hour session for the control group will be provided with the routine training of the mentioned centers without focusing on specific theoretical constructs, and during the study they will use the services and routine care provided in the mentioned centers and will not be deprived. and the questioner will not know about the groups.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Social Emergency Center and Forensic Medicine formed the environment of this research
Full name of responsible person
Dr. Mansour Firouzbakht
Street address
Isfahan
City
Isfahan
Province
Isfehan
Postal code
8165875735
Phone
+98 31 3661 3426
Fax
+98 31 3661 6310
Email
es@lmo.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Research Vice President of Isfahan Midwifery and Nursing Faculty of Medical Sciences
Street address
Isfahan University of Medical Sciences,Isfahan,Iran
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Fax
+98 31 3669 9398
Email
boroumandfar@nm.mui.ac.ir
Web page address
http://www.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Zahra boroumandfar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Iran. Esfahan. University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7536
Email
boroumandfar@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Boroumandfar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Iran. Esfahan. University of Medical Sciences
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7536
Email
boroumandfar@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra boroumandfar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Iran. Esfahan. University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7536
Email
boroumandfar@nm.mui.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
Undecided - It is not yet known if there will be 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