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Comparison of the effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) on internalized stigma in patients with major depressive disorder.

Protocol summary

Study aim
Assessing the impact of Eye Movement Desensitization and Reprocessing on internalized stigma in patients with major depression disorder
Design
A randomized controlled trial with parallel groups and 72 participants, using an online platform called Sealed Envelope for randomization.
Settings and conduct
The researcher will first obtain the necessary permits and, with a letter of introduction, refer to the hospitals affiliated with Yasuj University of Medical Sciences. After obtaining informed written consent, all samples will complete the demographic information form and the Beck Depression Inventory. Then, the pre-test will be taken using the Internalized Stigma Mental Illness questionnaire. The Eye Movement Desensitization and Reprocessing intervention will be performed individually. Immediately after the intervention ends and during the three-month follow-up, the post-test will be taken.
Participants/Inclusion and exclusion criteria
Inclusion criteria: a definitive diagnosis of depression, a history of hospitalization for depression, willingness to participate in the intervention, ability to communicate effectively, signing an informed consent form, completing physical health, and not participating in mindfulness or cognitive behavioral therapies concurrently. Exclusion criteria: individuals who had attempted suicide or self-harmed and individuals with substance or alcohol dependence.
Intervention groups
The Eye Movement Desensitization and Reprocessing intervention will be administered to each individual in the intervention group, depending on individual needs and treatment progress, for a maximum of seven sessions, with a duration of 90 minutes in the first session and 45 minutes in the following sessions every other day. The control group will receive treatment as usual.
Main outcome variables
Reducing internalized stigma in patients with major depressive disorder.

General information

Reason for update
Acronym
EMDR
IRCT registration information
IRCT registration number: IRCT20250111064354N1
Registration date: 2025-03-09, 1403/12/19
Registration timing: registered_while_recruiting

Last update: 2025-03-09, 1403/12/19
Update count: 0
Registration date
2025-03-09, 1403/12/19
Registrant information
Name
Negin Shojaossadati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3382 4619
Email address
nshojayi7@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-03-05, 1403/12/15
Expected recruitment end date
2025-06-08, 1404/03/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) on internalized stigma in patients with major depressive disorder.
Public title
"Investigating the effect of Eye Movement Desensitization and Reprocessing in Internalized Stigma"
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with major depressive disorder have been hospitalized at least once due to the severity of this disorder. Individuals should be ready and willing to participate in Eye Movement Desensitization and Reprocessing sessions. Individuals must be able to communicate and collaborate with researchers and therapists. Participants must sign an informed consent form and be aware of the research and treatment process. Participants must have fully functional five senses, especially vision and hearing. Not participating in mindfulness courses or cognitive behavioral therapies at the same time.
Exclusion criteria:
Participants who have attempted suicide or engaged in serious self-harm resulting in hospitalization within the past month will be excluded from the study. Individuals who are dependent on drugs or alcohol will not be allowed to participate in the study.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible study participants will be randomly assigned to two intervention groups and a control group in blocks of multiples of two (2, 4). This process will be conducted randomly using an online platform called Sealed Envelope. The list of participant allocations to study groups will be extracted through this method based on the total sample size.
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 Yasuj University of Medical Sciences
Street address
Yasuj University of Medical Sciences, Next to Imam Sajjad Hospital
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Approval date
2025-02-23, 1403/12/05
Ethics committee reference number
IR.YUMS.REC.1403.160

Health conditions studied

1

Description of health condition studied
Internalized stigma
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Internalized stigma
Timepoint
The post-test will be taken by the internalized stigma of mental illness scale after seven sessions (immediately after the interventions are completed) and in the three-month follow-up.
Method of measurement
The Internalized Stigma of Mental Illness Scale

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group: Eligible study participants will receive eye movement desensitization and reprocessing intervention individually, up to seven sessions depending on individual needs and treatment progress, with a duration of 90 minutes in the first session and 45 minutes in the following sessions, every other day.
Category
Treatment - Other

2

Description
The control group: Participants in this group will receive treatment as usual.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rajaee hospital
Full name of responsible person
Mohammad Behnammoghadam
Street address
Imam Hussein Square
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591873118
Phone
+98 74 3322 2291
Email
rajaeey@yums.ac.ir
Web page address
https://rajaeey.yums.ac.ir/

2

Recruitment center
Name of recruitment center
Shahid Rajaee hospital
Full name of responsible person
Mohammad Behnammoghadam
Street address
Nurse Square, Baladian Street
City
Gachsaran
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591873118
Phone
+98 74 2222 4811
Fax
+98 74 2222 2324
Email
rajaeeg@yums.ac.ir
Web page address
https://rajaeeg.yums.ac.ir/

3

Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Mohammad Behnammoghadam
Street address
The end of Sepah Street
City
Dehdasht
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591873118
Phone
+98 74 3226 5905
Fax
+98 74 3226 8400
Email
emamkhomeini@yums.ac.ir
Web page address
https://emamkhomeini.yums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed Amin Hossali Motlagh
Street address
Yasuj University of Medical Sciences, Next to Imam Sajjad Hospital
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3334 6078
Fax
+98 74 3334 6079
Email
aminhomo@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Mohammad Behnammoghadam
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Yasuj University of Medical Sciences, Next to Imam Sajjad Hospital
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3323 4115
Email
mbehnam1363@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Mohammad Behnammoghadam
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Yasuj University of Medical Sciences, Next to Imam Sajjad Hospital
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3323 4115
Email
mbehnam1363@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Negin Shojaossadati
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Yasuj University of Medical Sciences, Next to Imam Sajjad Hospital
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3323 4115
Fax
Email
nshojayi7@gmail.com
Web page address

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
Patient information and data will be made available to other researchers and writers upon request while maintaining confidentiality and privacy.
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
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
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
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