<?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>IRCT20230416057930N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-30</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of Cognitive Behavior Therapy on Shame/Guilt, Self- Esteem and Suicidal Ideation among Women Victims of Violence</public_title>
      <acronym>"CBT", which stands for "Cognitive Behavior Therapy." Cognitive behavior therapy is a type of psychotherapy that focuses on helping individuals change their negative thought patterns and behaviors to improve their mental health and well-being.</acronym>
      <scientific_title>Effectiveness of Cognitive Behavior Therapy on Shame/Guilt, Self- Esteem and Suicidal Ideation among Women Victims of Violence</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69809</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: experimental pre and post test, Randomization description: Randomization is an essential part of research design in order to ensure that the results obtained from a study are valid and reliable. Randomization refers to the process of randomly assigning participants to different groups in a study, such as a treatment group or a control group, to minimize the effects of any potential confounding variables.</study_design>
      <phase>1</phase>
      <hc_freetext>shame, guilt, low self-esteem, and suicidal ideation among victims of violence.</hc_freetext>
      <i_freetext>Intervention groups: experimental and control groupsIn the second phase of the study, after that pre-test (screening), the sample was divided into two groups (experimental and control groups). This study aimed to investigate the effectiveness of cognitive behavior therapy in managing emotional problems, shame/guilt, self-esteem, and suicidal ideation among women victims of violence. A pre-test and post-test experimental research design with a control group was used, and 50 participants were randomly assigned to either the experimental or control group (n = 25 each)..</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is The decision to share individual participant data (IPD) in a study on the effectiveness of cognitive behavior therapy (CBT) on shame/guilt, self-esteem, and suicidal ideation among women victims of violence depends on several factors, including ethical considerations, legal requirements, and resource limitations.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>islamia university of Bahawalpur</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamia university of Bahawalpur aisha hall</address>
        <city>Bahawalpur</city>
        <country1>Pakistan</country1>
        <zip>The postal code for </zip>
        <telephone>+92 306 4867569</telephone>
        <email>noormustafa0321@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>islamia university of Bahawalpur</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamia university of Bahawalpur aisha hall</address>
        <city>Bahawalpur</city>
        <country1>Pakistan</country1>
        <zip>The postal code for </zip>
        <telephone>+92 306 4867569</telephone>
        <email>noormustafa0321@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The terms inclusion and exclusion criteria relate to the makings that research participants must have to be considered for Participation and those that would rule them out. Women who meet the following criteria would be eligible to participate in research examining the effects of cognitive behavior therapy on shame/guilt, self-esteem, and suicidal thoughts among survivors of domestic abuse. Women, Participation in therapy, being over 18, having endured physical, sexual, or emotional abuse at some point of shame/guilt, low self-esteem, and suicidal ideation.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>While exclusion criteria refer to the characteristics that would disqualify someone from participating in the study, male and children,</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention groups: experimental and control groupsIn the second phase of the study, after that pre-test (screening), the sample was divided into two groups (experimental and control groups). This study aimed to investigate the effectiveness of cognitive behavior therapy in managing emotional problems, shame/guilt, self-esteem, and suicidal ideation among women victims of violence. A pre-test and post-test experimental research design with a control group was used, and 50 participants were randomly assigned to either the experimental or control group (n = 25 each).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Decreed shame /guilt and suicidal ideation and increased self-esteem. Timepoint: 45 minutes. Method of measurement: Guilt / Shame Proneness Scale (GASP) The Rosenberg Self‐esteem Scale (Rosenberg, 1965).	Beck Scale for Suicidal Ideation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>CBT can be a highly effective treatment for women who have experienced violence and are struggling with shame and guilt, low self-esteem, and suicidal ideation. However, it is important to note that every individual's experience and needs are unique, and treatment should be tailored to meet the specific needs of each individual. Timepoint: Culturally adapted cognitive behavioral therapy (CaCBT) using a manual named  باسط کی کہانی    was Victims of Violence" Self-help guidance As individual therapy over the duration of two months (once per week),. Method of measurement: Informed ConsentGuilt / Shame Proneness Scale (GASP) (Cohen et al., 2011).The Rosenberg Self‐esteem Scale (Rosenberg, 1965).Beck Scale for Suicidal Ideation (BSSI) (Beck &amp; Steer, 1988).</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>69809</sec_id>
        <issuing_authority>Iranian</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Effectiveness of Cognitive Behavior Therapy on Shame/Guilt, Self- Esteem and Suicidal Ideation among Women Victims of Violence</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-28</approval_date>
        <contact_name>islamia university of Bahawalpur</contact_name>
        <contact_address>Islamia university of Bahawalpur aisha hall Bahawalpur Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
