<?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>IRCT20180722040555N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-02-17</date_registration>
      <primary_sponsor>Chaharmahal and Bakhtiari Province Prisons Organization</primary_sponsor>
      <public_title>Assessing the impact of prison environmental design on prisoners' behavioral mental health and reducing violence-related harms</public_title>
      <acronym></acronym>
      <scientific_title>Assessing the impact of prison environmental design on prisoners' behavioral mental health and reducing violence-related harms</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-05-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>94</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/88756</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, due to the nature of the intervention (environmental design at the level of physical spaces), the randomization unit at the prison ward level will be considered as a cluster. In order to control the effect of potential confounding variables such as [e.g., ward population density, security or semi-security status of the ward], the existing wards will first be stratified (classified) based on these variables. Then, in each stratum, the wards will be randomly assigned to two intervention groups (recipients of the new environmental design) and control (with usual environmental conditions) using a random number table.
To comply with the principle of allocation concealment, the randomization sequence will be prepared by someone outside the implementation team and kept in sealed, opaque envelopes to avoid bias in ward selection. Also, to reduce bias in the evaluation of the results, the evaluators of mental health and behavioral outcomes will be unaware of the ward allocation status (intervention or control).</study_design>
      <phase>3</phase>
      <hc_freetext>Behavioral mental health.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, prisoners residing in wards that are subject to the environmental design package will receive a 4-week intervention. The package will be designed and validated by a multidisciplinary team (architect, psychologist, social worker, and health) based on pre-test findings and valid scientific evidence. Interventions include optimizing lighting using warm white light to regulate circadian rhythms, painting spaces with calming blue and green colors to reduce irritability, creating green corners with natural plants or nature images to connect with the natural environment, improving the meeting room to reduce stress and improve emotional connection with the family, and organizing common spaces with standard shelving to reduce visual clutter. All changes will be implemented in coordination with prison authorities and in full compliance with security considerations. Intervention 2: Control group: No environmental design intervention is implemented in this 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Some data, such as information related to the main outcome or the like, can be shared after being de-identified.

When:
Access period starts 6 months after results are published.

To whom:
Researchers working in academic and scientific institutions

Conditions:
Non-personally identifiable data from this study will be made available to researchers solely for the purpose of conducting advanced statistical analyses, including secondary analyses, combined analyses with other studies, and complementary analyses with more advanced methods. Applicants for data and documentation must be qualified researchers (faculty members, postdoctoral researchers, or graduate students) from accredited academic or research institutions and must submit their application along with a written research proposal that has been approved by the ethics committee of the applicant institution. Acceptance and signing of a confidentiality and data use agreement is mandatory, according to which applicants undertake to use the data only for approved research purposes, refrain from any attempt to re-identify individuals, not provide the data to third parties, and provide the final results to the main research team. The use of documentation such as questionnaires and intervention protocols is permitted solely for research and educational purposes and any commercial use is prohibited. In all publications based on this data, it is mandatory to cite the original source and reference the basic study.

Where to obtain:
Principal Investigator Zohreh Karimiankakolaki Zohrehkarimian68@gmail.com

How to obtain:
Send an email to the principal investigator stating the reasons and conditions and respond within one working week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zohreh Karimiankakolaki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Street, Islamic Azad University, Shahrekord Branch</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8813733395</zip>
        <telephone>+98 38 3336 1000</telephone>
        <email>zohrehkarimian68@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zohreh Karimiankakolaki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Street, Islamic Azad University, Shahrekord Branch</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8813733395</zip>
        <telephone>+98 38 3336 1000</telephone>
        <email>zohrehkarimian68@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18
Prison stay equal to pre-test and post-test period
Ability to respond</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Severe documented psychiatric disorder or acute crisis
Severe speech/hearing impairment impeding responsiveness
Active use of psychoactive substances/medications interfering with results
Very serious crimes with security restrictions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z65</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Problems related to other psychosocial circumstances</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, prisoners residing in wards that are subject to the environmental design package will receive a 4-week intervention. The package will be designed and validated by a multidisciplinary team (architect, psychologist, social worker, and health) based on pre-test findings and valid scientific evidence. Interventions include optimizing lighting using warm white light to regulate circadian rhythms, painting spaces with calming blue and green colors to reduce irritability, creating green corners with natural plants or nature images to connect with the natural environment, improving the meeting room to reduce stress and improve emotional connection with the family, and organizing common spaces with standard shelving to reduce visual clutter. All changes will be implemented in coordination with prison authorities and in full compliance with security considerations.</i_keyword>
      <i_keyword>Control group: No environmental design intervention is implemented in this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mean score mental health  (depression, anxiety, stress). Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: Mental Health Questionnaire (DASS-21).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mean score of aggression. Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: Bass and Perry Aggression Questionnaire (AQ).</sec_outcome>
      <sec_outcome>Mean score of Prisoners’ Environmental Perception. Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: Prisoners’ Environmental Perception Questionnaire.</sec_outcome>
      <sec_outcome>Mean of score Objective Correctional Environment. Timepoint: Before the intervention and 2 months after the intervention. Method of measurement: Objective Correctional Environment Checklist.</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>Chaharmahal and Bakhtiari Province Prisons Organization</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-01-14</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Shaherekord Branch</contact_name>
        <contact_address>University Street, Islamic Azad University of Shahrekord Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
