<?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>IRCT20250311065037N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-04-07</date_registration>
      <primary_sponsor>Islamic Azad University, Semnan branch</primary_sponsor>
      <public_title>The effect of emotional schema therapy on insecure attachment styles, emotional regulation, and cognitive flexibility</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Emotional Schema Therapy on Insecure Attachment Styles, Emotional Regulation, and Cognitive Flexibility in Couples on the Brink of Divorce</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82665</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 28 people (14 couples) will be randomly divided into two groups: intervention and control. For this purpose, a simple random allocation method will be used. First, each of the 14 couples will be given a unique number from 1 to 14. These numbers will then be entered into the Random Allocation Software (RAS). The software will randomly select 7 numbers and assign them to the intervention group. The remaining 7 numbers will be assigned to the control group. To ensure that the randomization is carried out correctly and to prevent any bias, the allocation process will be carried out by an independent person who is not involved in the research. This randomization method ensures that each participant has an equal chance of being placed in one of the groups and that the number of people in each group is balanced, Blinding description: In this study, blinding is done one-way, so that participants are unaware of the type of intervention they are receiving. To this end, all participants attend therapy sessions that are identical in appearance and physical environment. Therapists, who are aware of the type of intervention, consistently implement the same procedure for all groups, and there are no obvious differences between sessions for participants. In order to maintain blinding, participants are not provided with information about the exact type of intervention. They are only informed that they are participating in a study to investigate the effectiveness of emotional schema therapy. No additional explanation of the details of the treatments is given to participants until the end of the study to reduce the effects of bias.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Marital Conflicts.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The experimental group undergoes an emotional schema therapy intervention, which is held in 12 weekly 90-minute sessions. This intervention is designed to reduce insecure attachment styles, improve emotional regulation, and increase cognitive flexibility in couples on the verge of divorce. Initially, participants are introduced to the basic concepts of emotional schemas, their role in emotion regulation, and their impact on attachment styles. Then, cognitive and behavioral techniques are taught to identify and modify emotionally maladaptive schemas, especially in the context of couple relationships. In subsequent sessions, participants perform exercises such as cognitive restructuring, increasing tolerance for unpleasant emotions, modifying dysfunctional behavioral patterns in intimate relationships, and creating effective emotion regulation strategies. In the final stages, the focus is on strengthening cognitive flexibility, accepting emotions, changing dysfunctional attachment styles, and improving emotional interactions in couple relationships. Finally, the skills learned in the sessions will be reviewed and consolidated to better manage emotional and communication challenges in life together. Intervention 2: Control group: This group does not receive any intervention and serves only as a comparison. Participants in this group continue to receive the usual care and standard support or counseling services that they normally receive. During the study, no therapeutic intervention related to emotional schema therapy is implemented for them. The purpose of this approach is to leave the control group without intervention so that the results of this group can be compared with the group that has undergone emotional schema therapy intervention. This method allows for a precise assessment of the effects of the therapeutic intervention on insecure attachment styles, emotional regulation, and cognitive flexibility in couples on the verge of divorce.</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 principles.

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 atisotoudeh9@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>Atiyeh Mazarei Sotoudeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 64, First Floor, Unit 2, Moallem Square, Varzesh Blvd</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3514744185</zip>
        <telephone>+98 23 3343 4657</telephone>
        <email>atisotoudeh9@gmail.com</email>
        <affiliation>Islamic Azad University, Semnan Branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Salehyan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, University Town, Semnan</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513137111</zip>
        <telephone>+98 23 3365 4040</telephone>
        <email>maryam.salehyan@gmail.com</email>
        <affiliation>Islamic Azad University, Semnan branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The couple's age must be between 25 and 45 years old.
The couple is on the verge of divorce and has a case pending in counseling centers or family court.
Individuals must not have severe psychiatric disorders such as schizophrenia or bipolar disorder, which is determined through medical records or an initial interview.
Both people must be willing to participate in intervention sessions and complete an informed consent form.
Couples must be able to attend all scheduled intervention sessions and pre- and post-tests.
Individuals must have the ability to understand and respond to questionnaires and related activities in Persian.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The occurrence of severe family or psychological problems during the study that make it difficult to continue participation will result in withdrawal from the study.
If one or both partners refuse to continue participating in the research, they will be excluded from the study.
Individuals will be withdrawn from the study if acute physical or psychological conditions arise that make continuation of the intervention inappropriate.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z63.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Problems in relationship with spouse or partner</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 undergoes an emotional schema therapy intervention, which is held in 12 weekly 90-minute sessions. This intervention is designed to reduce insecure attachment styles, improve emotional regulation, and increase cognitive flexibility in couples on the verge of divorce. Initially, participants are introduced to the basic concepts of emotional schemas, their role in emotion regulation, and their impact on attachment styles. Then, cognitive and behavioral techniques are taught to identify and modify emotionally maladaptive schemas, especially in the context of couple relationships. In subsequent sessions, participants perform exercises such as cognitive restructuring, increasing tolerance for unpleasant emotions, modifying dysfunctional behavioral patterns in intimate relationships, and creating effective emotion regulation strategies. In the final stages, the focus is on strengthening cognitive flexibility, accepting emotions, changing dysfunctional attachment styles, and improving emotional interactions in couple relationships. Finally, the skills learned in the sessions will be reviewed and consolidated to better manage emotional and communication challenges in life together.</i_keyword>
      <i_keyword>Control group: This group does not receive any intervention and serves only as a comparison. Participants in this group continue to receive the usual care and standard support or counseling services that they normally receive. During the study, no therapeutic intervention related to emotional schema therapy is implemented for them. The purpose of this approach is to leave the control group without intervention so that the results of this group can be compared with the group that has undergone emotional schema therapy intervention. This method allows for a precise assessment of the effects of the therapeutic intervention on insecure attachment styles, emotional regulation, and cognitive flexibility in couples on the verge of divorce.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Insecure Attachment Styles. Timepoint: Before the start of the intervention and after completing 12 intervention sessions. Method of measurement: Brennan et al.'s Close Relationship Experience Questionnaire (1998).</prim_outcome>
      <prim_outcome>Emotion Regulation. Timepoint: Before the start of the intervention and after completing 12 intervention sessions. Method of measurement: Gross and John's Emotion Regulation Questionnaire (2003).</prim_outcome>
      <prim_outcome>Cognitive flexibility. Timepoint: Before the start of the intervention and after completing 12 intervention sessions. Method of measurement: Dennis and Vanderwal Cognitive Flexibility Questionnaire (2010).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Depression. Timepoint: Before the start of the intervention and after completing 12 intervention sessions. Method of measurement: Beck Depression Inventory - Second Edition (1996).</sec_outcome>
      <sec_outcome>Anxiety. Timepoint: Before the start of the intervention and after completing 12 intervention sessions. Method of measurement: Spielberger State-Trait Anxiety Inventory (1983).</sec_outcome>
      <sec_outcome>Health-related Quality of Life – Mental Health. Timepoint: Before the start of the intervention and after completing 12 intervention sessions. Method of measurement: En: World Health Organization Quality of Life Questionnaire – Short Form (WHOQOL-BREF, 26 items).</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>2024-12-30</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>
