<?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>IRCT20250821066936N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-02-06</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Counseling Based on Dialectical Behavior Therapy on the Intention of High-Risk Behavior in female Prisoners .</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Counseling Based on Dialectical Behavior Therapy on the Intention of High-Risk Behavior in female Prisoners in Ahvaz</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/85781</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: participants will be individually and randomly assigned to intervention or control groups in blocks of four. The randomization process will be performed by a person who is not belonged to research team using Sealed envelopes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>High Risk behavior.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: In this study, participants in the intervention group will undergo group counseling based on dialectical behavior therapy (DBT). Dialectical behavior therapy is a structured approach to cognitive-behavioral therapy designed to increase emotion regulation skills, distress tolerance, promote mindfulness, and improve interpersonal skills. The intervention is implemented in groups of 6 to 8 people by a trained researcher in the counseling room of Ahvaz Women's Prison. This program consists of 8 face-to-face sessions held one a week, each session lasting 90 to 60 minutes. The content of the sessions includes training and practice of mindfulness skills, distress tolerance, emotion regulation, and communication and interpersonal skills. The sessions will be conducted in a counseling room, with appropriate group chairs and arrangements, printed educational pamphlets, standard pre- and post-test questionnaires, and a whiteboard. This study is non-pharmaceutical and does not use any chemicals or drugs. Intervention 2: Control group: The female prisoners in the control group (30 people) will not receive any additional intervention (DBT) and will only receive the usual and routine prison care (health services, general counseling available in the prison, etc.) as in the intervention group. After the study period is completed and post-test data are collected, a brief educational pamphlet on high-risk behaviors and prevention methods will be provided to the control group.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No further information available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farydeh Shomeili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jundishapur University of Medical Sciences and Health Services,  Golestan Boulevard,  Highway  Golestsn</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 61 3311 4115</telephone>
        <email>ferrysho32@jmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mozhgan Javadnoori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur University of Medical Sciences Golestan Boulevard, Esfand street</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 61 3314 0000</telephone>
        <email>‫mojganjavadnoori@gmail.com‬</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being literate.  .
Having a court verdict of committing a felony and having at least three months left until the end of the sentence.
at least 2 Item with score 3 at the questionnaire of intention to high risk behavior</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Suffering from a mental illness (bipolar disorder, attention deficit disorder) according to medical records
 Incomplete response to the questionnaire
Absence more than two counseling sessions</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: In this study, participants in the intervention group will undergo group counseling based on dialectical behavior therapy (DBT). Dialectical behavior therapy is a structured approach to cognitive-behavioral therapy designed to increase emotion regulation skills, distress tolerance, promote mindfulness, and improve interpersonal skills. The intervention is implemented in groups of 6 to 8 people by a trained researcher in the counseling room of Ahvaz Women's Prison. This program consists of 8 face-to-face sessions held one a week, each session lasting 90 to 60 minutes. The content of the sessions includes training and practice of mindfulness skills, distress tolerance, emotion regulation, and communication and interpersonal skills. The sessions will be conducted in a counseling room, with appropriate group chairs and arrangements, printed educational pamphlets, standard pre- and post-test questionnaires, and a whiteboard. This study is non-pharmaceutical and does not use any chemicals or drugs.</i_keyword>
      <i_keyword>Control group: The female prisoners in the control group (30 people) will not receive any additional intervention (DBT) and will only receive the usual and routine prison care (health services, general counseling available in the prison, etc.) as in the intervention group. After the study period is completed and post-test data are collected, a brief educational pamphlet on high-risk behaviors and prevention methods will be provided to the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The primary outcome of this trial is intention of female prisoners who intend to engage in high-risk behaviors.". Timepoint: Pre- and post-intervention test. Method of measurement: Researcher-made high-risk behavior questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>This study does not have a secondary outcome variable. Timepoint: Before and after the study. Method of measurement: researcher-made questionnaire on intention to engage in high-risk behavior.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-07-15</approval_date>
        <contact_name>Ethics Committee of Ahvaz University of Medical sciences</contact_name>
        <contact_address>Ethics Committee of Ahvaz Jundishapur University of Ahvaz, Golestan Boulevard, Esfand street. Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
