<?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>IRCT20240908062982N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-09-28</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effectiveness of schema therapy on the behavior and psyche of female prisoners</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of schema therapy on antisocial behavior, emotion regulation and psychological well-being of female prisoners</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78921</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Antisocial Behavior, Emotion Regulation, Psychological Well-being.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants in this group will receive schema therapy. The intervention consists of 10 weekly sessions, each lasting 90 minutes, conducted by a trained psychologist. These sessions are designed based on Young's schema therapy model and focus on identifying maladaptive schemas, restructuring thought patterns, and enhancing emotion regulation strategies. Intervention 2: Control group: The control group will not receive any intervention and will only serve as a baseline comparison to evaluate the effects of schema therapy in the intervention group. Their scores on psychological well-being, emotional regulation, and antisocial behavior will be measured at the start and after the completion of the therapeutic sessions.</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:
"Effectiveness of Schema Therapy on Antisocial Behavior, Emotion Regulation, and Psychological Well-being of Female Prisoners." The dataset includes anonymized participant data, focusing on key outcome measures such as antisocial behavior, emotion regulation, and psychological well-being. The dataset is derived from standardized questionnaires like Ryff's Psychological Well-being (2002), the Robinson &amp; O’Leary-Kelly Antisocial Behavior Scale (1998), and the Garnefski &amp; Kraaij Cognitive Emotion Regulation Questionnaire (2006).

When:
the dataset will be accessible starting six months after the publication of the research results. Access will remain open for a period of two years.

To whom:
the dataset will be available to academic researchers affiliated with universities and research institutions. Requests from researchers in non-academic sectors will be evaluated on a case-by-case basis.

Conditions:
the dataset is provided for academic research purposes, such as replication of results, meta-analysis, and further studies on the effectiveness of schema therapy. Usage must comply with data protection regulations, and no attempt to re-identify participants is allowed.

Where to obtain:
Name: Abbas Mokhtari
Email: Mokhtari_20001@yahoo.com
Phone Number: +98 9132894600

Name: Farima Fathi Hafshejani
Email: psyfathii@gmail.com
Phone Number: +98 9100865650

How to obtain:
Requests for data access will be reviewed within 30 days. Approved applicants will receive a data-sharing agreement, outlining the terms and conditions for using the dataset. Upon signing, the dataset will be made available.

Comments:
No additional fees will be charged for data access. Researchers are encouraged to cite the dataset in any publications resulting from its use.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farima Fathi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 2 , Second Floor., Next to Building Rose., End of Tohid Street., Gudal Cheshmeh</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8815755153</zip>
        <telephone>+98 38 3228 4492</telephone>
        <email>psyfathii@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farima Fathi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 2 , Second Floor., Next to Building Rose., End of Tohid Street., Gudal Cheshmeh</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8815755153</zip>
        <telephone>+98 38 3228 4492</telephone>
        <email>psyfathii@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having proper psychological insight
Patient consent to participate in the research
Not receiving any other training or treatment program
At least 2 months of their imprisonment are left
Regular participation in therapy sessions</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Absent more than 2 sessions
Not doing homework
People who were in solitary confinement
Transfer to another prison or early release</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>6D10.Z</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>اختلال شخصیت ضداجتماعی</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Participants in this group will receive schema therapy. The intervention consists of 10 weekly sessions, each lasting 90 minutes, conducted by a trained psychologist. These sessions are designed based on Young's schema therapy model and focus on identifying maladaptive schemas, restructuring thought patterns, and enhancing emotion regulation strategies.</i_keyword>
      <i_keyword>Control group: The control group will not receive any intervention and will only serve as a baseline comparison to evaluate the effects of schema therapy in the intervention group. Their scores on psychological well-being, emotional regulation, and antisocial behavior will be measured at the start and after the completion of the therapeutic sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The primary outcome variable is the score of antisocial behaviors, which is measured using the Robinson and O'Leary-Kelly Antisocial Behavior Questionnaire. Changes in the score will be evaluated before and after the intervention to assess the effectiveness of schema therapy. Timepoint: The measurement of outcome variables will be conducted at two time points: before the intervention (at the beginning of the study) and after the completion of therapy sessions (following 10 weekly sessions). Method of measurement: The measurement of the score of antisocial behaviors is conducted using the Robinson and O'Leary-Kelly Antisocial Behavior Questionnaire.</prim_outcome>
      <prim_outcome>Emotion Regulation Score: This variable is measured using the Cognitive Emotion Regulation Questionnaire (CERQ) developed by Garnefski and Kraaij. Changes in the score are assessed before and after the therapeutic intervention. Timepoint: The emotion regulation score will be measured at two time points: before the intervention (at the beginning of the study) and after the completion of therapy sessions (following 10 weekly sessions). Method of measurement: The emotion regulation score will be measured using the Garnefski and Kraaij’s Cognitive Emotion Regulation Questionnaire (CERQ).</prim_outcome>
      <prim_outcome>"Psychological well-being is measured using the Ryff Psychological Well-being Questionnaire. Changes in the scores of this questionnaire will be examined before and after the therapeutic intervention.". Timepoint: "Psychological well-being scores are measured at two time points: before the intervention (at the beginning of the study) and after the completion of the therapy sessions (following 10 weekly sessions).". Method of measurement: "The Ryff Psychological Well-being Questionnaire is used to assess psychological well-being scores.".</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-04-25</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Najafabad branch</contact_name>
        <contact_address>University of Najafabad, Imam Khomeini Blvd Najafabad Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
