Determining the effect of desensitization with eye movements and reprocessing on the intensity of suicidal ideation of rape victims
Design
This research will be an experimental study. Due to the small size of the study population, the formula for calculating the sample size is not applicable and all patients with inclusion conditions will be included in the study. Patients are randomly divided into intervention and control groups in parallel Will be divided.
Settings and conduct
Patients admitted to a psychiatric hospital who have been sexually abused and subsequently diagnosed with major depressive disorder and suicidal ideation due to sexual abuse will be included in the study. In the first session, the EMDR process will be explained to the patient and the annoying scene of rape will be identified for the patient. They will be completed in ten minutes
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who have been raped in the past
Have been hospitalized with a diagnosis of major depressive disorder
Has a moderate to high suicidal ideation score (score 5 or higher)
Have criteria for post-traumatic stress disorder based on the DSMIV scale
People who are not satisfied with the treatment intervention are considered as a control group.
Intervention groups
Intervention group: For each patient, the standard EMDR treatment method will be held individually in a safe environment and the number of sessions between 6 sessions to 8 90-minute sessions will be held by a psychologist and researcher. Before and after the end of the interventions, the Beck Suicide Inquiry Questionnaire and subjective distress Questionnaire will be completed by patients and researchers.
Control group: In this group, no intervention will be performed and they will only receive routine hospital treatments
Main outcome variables
Subjective Distress
Suicidal thoughts
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190822044581N3
Registration date:2020-08-25, 1399/06/04
Registration timing:prospective
Last update:2020-08-25, 1399/06/04
Update count:0
Registration date
2020-08-25, 1399/06/04
Registrant information
Name
Naeem Abdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3222 3853
Email address
naiem.abdi@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Eye Movement Desensitization and Reprocessing(EMDR) as a treatment for Rape victims
Public title
Eye Movement Desensitization and Reprocessing(EMDR) as a treatment for Rape victims
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have been raped in the past
Patients have been hospitalized with a diagnosis of major depressive disorder
Has a moderate to high suicidal ideation score (score 5 or higher)
Have criteria for post-traumatic stress disorder based on the DSMIV scale
Exclusion criteria:
People who are not satisfied with the intervention are considered as a control group.
Age
From 15 years old to 60 years old
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
Samples will be randomly assigned between the two groups. During the random block assignment, the order of the participants in the intervention and control groups is as follows: by multiplying the number of study groups (two groups) by 2, the number of samples in each Block 4 will be calculated.
Then, by calculating the factorial of each sample block (4 = 4 = 4 3 × 2 24 1 = 24), the number of blocks created from all possible orders will be obtained as 24. Since the number of people in each block is 4 people And the estimated sample size will be based on the description of 60 people, by matching 13 random numbers produced by Sample Randomizer with the mentioned block numbers, the order of 60 people will be determined. Number one to sixty to the subject groups And controls are assigned and the random assignment list will be edited.
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
Yasuj University of Medical Sciences
Street address
Yasuj - Shahid Motahari Boulevard - Yasuj University of Medical Sciences
City
YASUJ
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Approval date
2018-09-08, 1397/06/17
Ethics committee reference number
IR.YUMS.REC.1397.087
Health conditions studied
1
Description of health condition studied
Suicidal thoughts
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Suicidal ideation: Beck suicidal ideation questionnaire will be used to assess suicidal ideation. The Beck Suicide Thought Scale is a 19-item tool. This questionnaire was developed to identify and measure the severity of attitudes, behaviors, and planning for suicide during the past week. The scale is set based on three point degrees from 0 to 2. The person's total score is calculated based on the sum of scores, which is from 0 to 38, and in this test, the higher the person's score, the higher his suicidal thoughts.
Timepoint
Before and after the intervention
Method of measurement
Beck Suicide Thought Questionnaire will be used to assess suicidal ideation. The Beck Suicide Thought Scale is a 19-item tool. This questionnaire was developed to identify and measure the severity of attitudes, behaviors, and planning for suicide during the past week. The scale is set based on three point degrees from 0 to 2. The person's total score is calculated based on the sum of scores, which is from 0 to 38, and in this test, the higher the person's score, the higher his suicidal thoughts.
2
Description
Subjective Distress: This scale, which is one of the self-reporting scales, was introduced by Wolfe. The range of scores can be graded on a 101-point scale between zero and 100 or on an 11-point scale between zero and 10. The person evaluates and reports the degree of discomfort at each stage and at the request of the therapist or researcher. Obviously, zero here means no mental distress and a score of 10 indicates the maximum amount of mental distress.
Timepoint
This questionnaire is completed by the patient and the researcher before and after each treatment session.
Method of measurement
This scale, which is one of the self-reporting scales, was introduced by Wolfe. The range of scores can be graded on a 101-point scale between zero and 100 or on an 11-point scale between zero and 10. The person evaluates and reports the degree of discomfort at each stage and at the request of the therapist or researcher. Obviously, zero here means no mental distress and a score of 10 indicates the maximum amount of mental distress.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the first session, the patient's medical history and information were collected in a safe place. The EMDR process is explained to the patient and the annoying scene of the rape is identified for the patient. For each patient, the standard EMDR treatment method will be performed individually in a safe environment and the number of sessions between 6 sessions to 8 90-minute sessions will be held by a psychologist and researcher. After the end of the treatment interventions, the above questionnaires will be collected again by the patients and the researcher. Patients will not be prohibited from their medication and will receive the medications prescribed by their treating physician. And only the method of desensitization with eye movements and reprocessing as a method of psychotherapy will be performed on the experimental group.
Category
Treatment - Other
2
Description
Control group: In this group, no intervention will be performed by the researcher and they will only receive routine hospital treatments
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaei Hospital in Yasuj
Full name of responsible person
Naeem Abdi
Street address
Governor's Square
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3333 7230
Email
abdi.naeim@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Yasouj University of Medical Sciences
Full name of responsible person
Dr. Hossein Mary oryad
Street address
Yasuj - Shahid Motahari Boulevard - Yasuj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3333 7230
Email
oryad.hossein@yums.ac.ir
Grant name
Vice Chancellor for Research, Yasuj University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Naeem Abdi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Yasuj - Shahid Motahari Boulevard - Yasuj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3333 7230
Email
abdi.naeim@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Naeem Abdi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Yasuj - Shahid Motahari Boulevard - Yasuj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3333 7230
Email
abdi.naeim@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Naeem Abdi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Yasuj - Shahid Motahari Boulevard - Yasuj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7519994799
Phone
+98 74 3333 7230
Email
abdi.naeim@yahoo.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
There is no more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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