Protocol summary

Study aim
Determining the effectiveness of eye movement desensitization and reprocessing therapy on anxiety in undergraduate psychology students
Design
A randomized controlled and parallel group clinical trial on 30 female students with anxiety was conducted using a simple randomization method to randomize participants.
Settings and conduct
This study is being conducted at the Hamdeli Psychology Clinic in Semnan and includes female students with anxiety. Participants will be randomly divided into two groups: an experimental group that receives eye movement desensitization and reprocessing therapy, and a control group that only follows the center's routine programs.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Female student, 18-25 years old, pursuing a bachelor's degree in psychology, and having moderate to severe anxiety. Exclusion criteria: Severe psychiatric disorders, unstable psychiatric medication use, history of seizures or brain injury, concurrent medication, substance abuse, pregnancy, and inability to attend regularly.
Intervention groups
In this study, the experimental group will participate in eight 90-minute sessions of eye movement desensitization and reprocessing therapy over a period of one month. The content of the sessions includes identification of anxiety-provoking memories, bilateral eye movement stimulation, cognitive reprocessing, reinforcement of positive beliefs, and stabilization of relaxation. The control group will receive only the usual center programs and will not receive any related intervention.
Main outcome variables
Anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250311065038N1
Registration date: 2025-04-20, 1404/01/31
Registration timing: prospective

Last update: 2025-04-20, 1404/01/31
Update count: 0
Registration date
2025-04-20, 1404/01/31
Registrant information
Name
Arefeh Amirian
Name of organization / entity
Islamic Azad University, Semnan Branch
Country
Iran (Islamic Republic of)
Phone
+98 23 3333 9338
Email address
arefeham21@gmail.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2025-05-10, 1404/02/20
Expected recruitment end date
2025-06-10, 1404/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of eye movement desensitization and reprocessing therapy on anxiety in undergraduate psychology students
Public title
The effect of eye movement desensitization and reprocessing therapy on anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female undergraduate student in psychology (semesters 2 to 8). Age between 18 and 25 years at the time of study entry. Having a moderate to severe level of anxiety based on the Spielberger Anxiety Inventory score. Willingness and informed consent to participate in the research. Not receiving EMDR therapy in the past six months. Commitment to regular attendance at all treatment sessions and to complete pre- and post-tests.
Exclusion criteria:
Having a severe psychiatric disorder (such as psychosis, active bipolar disorder, schizophrenia, or borderline personality disorder) as clinically assessed. Unstable psychiatric medication use (start or change of medication within the last 6 weeks). History of severe brain injury or active seizures. Concurrent participation in other psychological or pharmacological treatments for anxiety at the time of the research. Drug or alcohol abuse within the last three months. Pregnancy or breastfeeding at the time of research. Unwillingness or inability to attend therapy sessions regularly and complete assessment procedures.
Age
From 18 years old to 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization is performed using a simple randomization method with an individual randomization unit. In order to divide participants into two intervention and control groups, 30 cards are prepared, 15 of which have the letter "M" (symbol of the intervention group) written on them and the other 15 have the letter "K" (symbol of the control group) written on them. Then, each participant randomly selects a card from the box containing these cards. Based on the letter written on the card, the individual is assigned to one of the two groups. This method ensures that all participants have an equal chance of being in each group and that the assignment process is carried out fairly and without bias.
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 Semnan Azad University
Street address
Islamic Azad University, University Town, Semnan
City
Semnan
Province
Semnan
Postal code
3513137111
Approval date
2025-01-27, 1403/11/08
Ethics committee reference number
IR.IAU.SEMNAN.REC.1403.110

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders

Primary outcomes

1

Description
Anxiety
Timepoint
Before the start of the intervention and after completing 8 intervention sessions.
Method of measurement
Spielberger Anxiety Inventory (1970)

Secondary outcomes

1

Description
Quality of Life
Timepoint
Before the start of the intervention and after completing 8 intervention sessions.
Method of measurement
World Health Organization Quality of Life Questionnaire (1996)

2

Description
Self-Efficacy Beliefs
Timepoint
Before the start of the intervention and after completing 8 intervention sessions.
Method of measurement
General Self-Efficacy Scale by Scherer et al. (1982)

Intervention groups

1

Description
Intervention group: The experimental group will undergo an eye movement desensitization and reprocessing (EMDR) therapy intervention. This intervention will be delivered over 8 weekly 90-minute sessions and is designed to reduce anxiety and reframe cognitive and emotional processing related to negative or stressful experiences in psychology students. Initially, participants will be introduced to the general framework of EMDR therapy, the Adaptive Information Processing (AIP) model, and the importance of identifying anxiety-provoking memories. Then, using cognitive assessment techniques, the therapist will identify the participant’s distressing mental image, associated negative beliefs, emotions, and physical responses. In the main stages of the treatment, participants will undergo bilateral stimulation (usually with rapid eye movements) to process and reorganize distressing memories in memory. This stimulation will accelerate cognitive processing and reduce the emotional burden of the memories. In each session, the individual's negative beliefs about themselves (such as "I am powerless" or "I am in danger") are identified and replaced with positive beliefs. At the end of the treatment process, participants are provided with exercises to consolidate positive beliefs, relax, and strengthen their ability to face anxiety-provoking situations. The ultimate goal of this intervention is to sustainably reduce anxiety, increase psychological resilience, and improve students' academic and social performance in real-life situations.
Category
Treatment - Other

2

Description
Control group: This group does not receive any therapeutic intervention and serves only as a benchmark for comparison with the experimental group. During the study period, individuals in this group continue their normal life and usual care routines and do not receive any treatment or program related to Eye Movement Desensitization and Reprocessing (EMDR) therapy. The aim of this approach is to maintain constant conditions in the control group in order to accurately compare the changes made in the intervention group. This comparison allows for the real impact of EMDR therapy on reducing anxiety in psychology students.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hamdeli Psychology Clinic
Full name of responsible person
Ali Mohebi
Street address
corner of Azadi 10, Azadi Street, Amirkabir Boulevard.
City
Semnan
Province
Semnan
Postal code
3519835689
Phone
+98 23 3336 1969
Email
info@hamdeliclinic.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University, Semnan branch
Full name of responsible person
Mohammad Karim Sohrabi
Street address
Islamic Azad University, University Town, Semnan
City
Semnan
Province
Semnan
Postal code
3513137111
Phone
+98 23 3365 6180
Email
karim_sohraby@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Semnan branch
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
Islamic Azad University, Semnan Branch
Full name of responsible person
Atefeh Bidukhti
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University, University Town, Semnan
City
Semnan
Province
Semnan
Postal code
3513137120
Phone
+98 23 3365 4045
Email
ate_danesh1362@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University, Semnan Branch
Full name of responsible person
Maryam Izadi Mazidi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University, University Town, Semnan
City
Semnan
Province
Semnan
Postal code
3513137122
Phone
+98 23 3365 4042
Email
maryam.izadi.psy@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University, Semnan Branch
Full name of responsible person
Arefeh Amirian
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 1, No. 21, Alley 13, Shura Street
City
Semnan
Province
Semnan
Postal code
3514615597
Phone
+98 23 3333 9338
Email
arefeham21@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
In this study, data and documentation will be shared in accordance with ethical principles and confidentiality considerations. Individual data of participants will only be published after removing identifying information and in the form of anonymous data. The original data, including the results related to the research variables, will be made available to qualified researchers in the form of a structured dataset without personal information. In addition to quantitative data, methodological documentation of the research, including the study protocol, data collection methods, intervention implementation instructions, and tools used, will also be shared.
When the data will become available and for how long
Data and documentation from this study will be available for one month after the publication of the final results. This time frame is intended to ensure thorough data analysis and ethical sharing of information.
To whom data/document is available
The data and documentation of this research will be available only to researchers and experts in the relevant scientific field who work in academic institutions, research centers, and reputable scientific organizations. Access requests from independent researchers will also be considered if they submit a relevant research plan and receive approval from the research ethics committee. Access to data for people working in industry will only be possible if they cooperate with academic or research centers and comply with research ethics.
Under which criteria data/document could be used
The data and documentation of this study may only be used for scientific and research purposes related to the subject of the study, and any commercial or promotional use is prohibited. Statistical analyses and meta-analyses are permitted in compliance with scientific and ethical principles. The use of data must be in such a way that the identity of the participants cannot be identified. Applicant researchers must submit a formal application, sign an ethical commitment letter, and receive approval from the research ethics committee. Reference to the original source is mandatory, and sharing of data with third parties without official permission is prohibited.
From where data/document is obtainable
If you need data, please contact arefeham21@gmail.com.
What processes are involved for a request to access data/document
After receiving the request and reviewing it by the principal investigator, the data will be sent to the applicant within a maximum of one week, along with a commitment not to publish the data without the name of the principal investigator.
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