<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20250311065038N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-04-20</date_registration>
      <primary_sponsor>Islamic Azad University, Semnan branch</primary_sponsor>
      <public_title>The effect of eye movement desensitization and reprocessing therapy on anxiety</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of eye movement desensitization and reprocessing therapy on anxiety in undergraduate psychology students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-05-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82791</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety.</hc_freetext>
      <i_freetext>Intervention 1: 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. Intervention 2: 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.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
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:
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:
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.

Conditions:
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.

Where to obtain:
If you need data, please contact arefeham21@gmail.com.

How to obtain:
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.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atefeh Bidukhti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, University Town, Semnan</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513137120</zip>
        <telephone>+98 23 3365 4045</telephone>
        <email>ate_danesh1362@yahoo.com</email>
        <affiliation>Islamic Azad University, Semnan Branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Izadi Mazidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, University Town, Semnan</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513137122</zip>
        <telephone>+98 23 3365 4042</telephone>
        <email>maryam.izadi.psy@gmail.com</email>
        <affiliation>Islamic Azad University, Semnan Branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <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.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>25 years</agemax>
      <gender>Female</gender>
      <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.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other anxiety disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>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.</i_keyword>
      <i_keyword>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.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Before the start of the intervention and after completing 8 intervention sessions. Method of measurement: Spielberger Anxiety Inventory (1970).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>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).</sec_outcome>
      <sec_outcome>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).</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Islamic Azad University, Semnan branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-01-27</approval_date>
        <contact_name>Ethics Committee of Semnan Azad University</contact_name>
        <contact_address>Islamic Azad University, University Town, Semnan Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
