Protocol summary

Study aim
Evaluation the Effect of Eye Movement Desensitization and Reprocessing (EMDR) on Depression in Spinal Cord Injury patients
Design
40 cases of Spinal Cord Injury patients , for sampling available, after a thorough explanation of the objectives of the study and informed consent, with the random assignment method of sand in control group (n = 20) and intervention group (n =20)
Settings and conduct
In intervention group, Eye Movement Desensitization and Reprocessing treatment method will be done individually conduct for each patient in the consultation room within 5 sessions in one and half hour over a month.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with a diagnosis of depressive disorder (DSM-V (based on scale by psychiatrists are admitted, the lack of history of suicide, seizures, strabismus, and vision problems. the exit criteria include: the patient's intolerance towards the method of therapy, the patient's dispatch centres de The novel was completed and the lack of other therapeutic sessions
Intervention groups
In intervention group, Eye Movement Desensitization and Reprocessing treatment method will be done individually conduct for each patient in the consultation room 90 minutes, within 5 sessions over a month. The control group received no intervention.
Main outcome variables
Depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181008041272N1
Registration date: 2018-10-24, 1397/08/02
Registration timing: retrospective

Last update: 2018-10-24, 1397/08/02
Update count: 0
Registration date
2018-10-24, 1397/08/02
Registrant information
Name
masoud Ghiasvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3377 5657
Email address
m.ghiasvand@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
2018-07-23, 1397/05/01
Actual recruitment end date
2018-10-23, 1397/08/01
Trial completion date
2018-10-23, 1397/08/01
Scientific title
Evaluation the Effect of Eye Movement Desensitization and Reprocessing (EMDR) on Depression in Spinal Cord Injury patients
Public title
Evaluation the Effect of Eye Movement Desensitization and Reprocessing (EMDR) on Depression in Spinal Cord Injury patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion Criteria: Having disability duo to Spinal Cord Injury (SCI) confirmation of presence depression acquisition of 0 -21 scores or 21-31 or >31 on Beck Depression Inventory-II (BDI-II) Tending to participate in research No CardioPulmonary disease No Strabismus
Exclusion criteria:
Having disability duo to Spinal Cord Injury (SCI) Tending to participate in research
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization algorithm is performed using Smith's method. By using randomized blocks method (four blocks of letters A and B), eligible samples are assigned to two intervention groups.The randomization tool consists of some cards which have a combinations of two letters A and two letters B. These combinations are then randomly selected each time to determine how the four samples are placed in each 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 Qazvin University of Medical Sciences
Street address
Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Approval date
2018-07-03, 1397/04/12
Ethics committee reference number
IR.QUMS.REC.1397.079

Health conditions studied

1

Description of health condition studied
Spinal Cord Injury
ICD-10 code
G95.9
ICD-10 code description
Disease of spinal cord, unspecified

Primary outcomes

1

Description
Depression
Timepoint
Before and after intervention
Method of measurement
The Beck Depression Inventory

Secondary outcomes

1

Description
depression
Timepoint
Before and after intervention
Method of measurement
The Beck Depression Questionnaire

Intervention groups

1

Description
Intervention group: Eye movement desensitization and reprocessing method will be done individually conduct for each patient in the consultation room within5 one-hour sessions over a month. The patient was following the rapid movements of the therapist's finger across his field of vision, with rapid eye movement. The therapist's finger was about 30 cm from the eyes of the subject and moved from right to left and vice versa in the patient's field of vision. This move included two rounds to the sides in one second, which was a cycle, and each 24-12 cycles were a set.The process is repeated to the extent that the levels of mental disorientation units are zero or minimized. At last, the Beck Questionnaire was completed.
Category
Rehabilitation

2

Description
Control group:The control group received no intervention.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Hadis Rehabilitation Center
Full name of responsible person
Yagobi Maryam
Street address
Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
34197-33577
Phone
+98 28 3333 1347
Email
icusalehi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mahram Manochehr
Street address
Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3337 5518
Email
chancellor@qums.ac.ir
Web page address
http://qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Masood Ghiasvand
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
34197-33577
Phone
+98 28 3337 5518
Email
m.ghiasvand@qums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Masood Ghiasvand
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
34197-33577
Phone
+98 28 3365 1169
Email
m.ghiasvand@qums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Masood Ghiasvand
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
34197-33577
Phone
+98 28 3365 1169
Email
m.ghiasvand@qums.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
No - There is not 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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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