The Effectiveness of eye movement desensitization and reprocessing on Improving Post-Traumatic Psychological Symptoms in Children and Adolescents, 6-18 Years Old, Surviving Earthquake
Determination of the Effectiveness of eye movement desensitization and reprocessing on Improving Post-Traumatic Psychological Symptoms in Children and Adolescents, 6-18 Years Old, Surviving Earthquake
Design
Clinical trial with control group, One-way blind, randomized
Settings and conduct
This study will be conducted in Kermanshah and Sarpol Zahab. Patients receive individualized weekly eye movement desensitization and reprocessing sessions. The duration of each session is 90 minutes. Two months after the intervention, the subjects will be re-evaluated during the follow-up period. In order to evaluate the effects of treatment, the subjects were evaluated one week before the end of the intervention, one week after, and two months after this period. This intervention is done by a qualified psychologist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having post-traumatic stress disorder (PTSD, depression, anxiety and behavioral problems)/ Children and adolescents aged 6-18 years/ consent of the child, adolescents and their parents in the research. Exit criteria: Incomplete questionnaires/ Failure to attend two or more counseling sessions.
Intervention groups
Intervention group: 17 participants will receive EMDR, which is an 8-step information processing therapy that utilizes many of the empirical pathological factors discussed. Control group: 17 participants who will receive the protocol of the Ministry of Health.
Main outcome variables
PTSD, depression, anxiety, behavioral problems
General information
Reason for update
Acronym
EMDR
IRCT registration information
IRCT registration number:IRCT20180421039369N3
Registration date:2019-09-30, 1398/07/08
Registration timing:prospective
Last update:2019-09-30, 1398/07/08
Update count:0
Registration date
2019-09-30, 1398/07/08
Registrant information
Name
Nasrin Jaberghaderi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 4622
Email address
nasrin.jaberghaderi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-22, 1398/07/30
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of eye movement desensitization and reprocessing on Improving Post-Traumatic Psychological Symptoms in Children and Adolescents, 6-18 Years Old, Surviving Earthquake
Public title
The Effectiveness of eye movement desensitization and reprocessing on Improving Post-Traumatic Psychological Symptoms in Children and Adolescents, 6-18 Years Old, Surviving Earthquake
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having post-traumatic stress disorder (PTSD, depression, anxiety and behavioral problems)
Children and adolescents aged 6-18 years
Referred to psychological centers and hospitals for post-traumatic stress disorder
consent of the child, adolescents and their parents in the research
Fluent in Persian
Not Developing medical conditions that are simultaneously with post-traumatic stress disorder
Not Developing Symptoms of psychosis and delusions
Not Consuming Psychiatric drugs, and psychotropic substances, narcotics and alcohol
Exclusion criteria:
Incomplete questionnaires
Failure to attend two or more counseling sessions
Age
From 6 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
After making the necessary adjustments among the referrals, 34 individuals will be selected by purposive sampling and then will be randomly assigned to number 1 and 2 individually (by hat), each code number of a group. Then 17 participants will be randomly assigned to the group receiving the EMDR (experimental group) intervention and 17 participants will be randomly assigned to the group that received the intervention protocol in the Ministry of Health (control group).
Blinding (investigator's opinion)
Single blinded
Blinding description
Unilateral blinding will be performed by independent and trained evaluators who are two clinical psychology MA students without evaluating the type of intervention and treatment subjects.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Central Building of Kermanshah University of Medical Sciences, Shahid Beheshti Blvd, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-07-08, 1398/04/17
Ethics committee reference number
IR.KUMS.REC.1398.410
Health conditions studied
1
Description of health condition studied
Post traumatic psychological symptoms
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder (PTSD)
Primary outcomes
1
Description
Post traumatic psychological symptoms
Timepoint
A week before the intervention, after the intervention, two months after the intervention
Method of measurement
Child Behavior Checklist (Achenbach)(ASEBA)/ Maria Kovas Depression Inventory (CDI)/ Revised Reynolds and Richmond Children's Anxiety Scale (RCMAS) /Trauma Symptoms Checklist for Children (TSCC-A) /PTSD Assessment Scale for Clinicians (CAPS-CA) / Anxiety and Depression Scale for Children (RCADS)
Secondary outcomes
1
Description
Post Traumatic Stress Disorder (PTSD)
Timepoint
A week before the intervention, after the intervention, two months after the intervention
Method of measurement
Trauma Symptoms Checklist for Children (TSCC-A) /PTSD Assessment Scale for Clinicians (CAPS -CA)
2
Description
Depression
Timepoint
A week before the intervention, after the intervention, two months after the intervention
Method of measurement
Maria Kovas Depression Inventory (CDI)/ Anxiety and Depression Scale for Children (RCADS)
3
Description
Anxiety
Timepoint
A week before the intervention, after the intervention, two months after the intervention
Method of measurement
Anxiety and Depression Scale for Children (RCADS) / Revised Reynolds and Richmond Children's Anxiety Scale (RCMAS)
4
Description
behavioral problems
Timepoint
A week before the intervention, after the intervention, two months after the intervention
Method of measurement
Behavior Checklist (Achenbach)(ASEBA)
Intervention groups
1
Description
Intervention group: The intervention group will receive desensitization treatment through eye movements and reprocessing. Eye movement desensitization and reprocessing (EMDR) is an eight-step information processing treatment that examine many empirical pathological factors. The past experiences are used as the fundamental basis in this treatment. It assesses pathology and examines present situations that trigger unpleasant emotions. Additionally, this treatment evaluates the positive beliefs, emotions and experiences needed for future mental health and normal behaviors. This treatment is a short-term trauma-based treatment approach for post-traumatic stress disorder, originally designed for PTSD. The main feature of this approach is that the patient keeps a distressing image of the trauma in mind while engaging in a series of involuntary eye movements.
Category
Behavior
2
Description
The control group will receive the Crisis Intervention Protocol.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah University of Medical Sciences
Full name of responsible person
Sajjad Reisi
Street address
Faculty of Medicine, Imam Reza Hospital, Shahid Shiroudi Blvd, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 84 3442 3968
Email
sajjad.reisi@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Central Building of Kermanshah University of Medical Sciences, Shahid Beheshti Blvd, Kermanshah
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 84 3442 3968
Email
farid_n32@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Sajjad Reisi
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Faculty of Medicine, Imam Reza Hospital, Shahid Shiroudi Blvd, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 84 3442 3968
Email
sajjad.reisi@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sajjad Reisi
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Faculty of Medicine, Imam Reza Hospital, Shahid Shiroudi Blvd, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 84 3442 3968
Email
sajjad.reisi@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Nasrin Jaberghaderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Medicine, Imam Reza Hospital, Shahid Shiroudi Blvd, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 84 3442 3968
Email
n_jaberghaderi@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