<?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>IRCT20230820059199N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-26</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Interventions based on the Clubhouse model in mental patients</public_title>
      <acronym></acronym>
      <scientific_title>The investigation of Occupational engagement of people with mental illness participating in center based on Club House model</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72195</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The participants are divided into two groups by a simple randomization method. The randomization tool is a table of random numbers. The participants are divided into two control and intervention groups with a 1:1 allocation. Concealment is done using sealed and waxed opaque envelopes, Blinding description: Participants invited to the intervention and use of supportive interventions are blinded to study groups. Because both groups receive supportive interventions. Two occupational therapy experts who evaluated the data and outcome were blinded to the intervention groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>People with Chronic Mental Disease, Illness, Disorder, Disability.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention period will be held for 2 months, two sessions a week for 3 hours. The intervention program for the implementation of the Clubhouse model is such that it creates a modified environment for people with mental problems to strengthen their confidence and ability to fully participate in society by joining it. Clubhouse program activities are done in groups and include cooking, artistic activities such as painting and drawing, etc., health services such as sports, administrative activities, accounting and maintenance of the center and working with computers. In addition to group activities, the participants are provided with individual support to make the activities meaningful, and the research team is also in contact with their family members and counseling is done if needed. Intervention 2: Control group: The sessions are held in the form of art education (painting, fabric design, ornamental bracelets and music...) and occupational therapy for two days a week during 2 months in 3-hour 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:
Part of the data, such as information related to the main outcome, which is the level of employment in the occupational employment profile of chronic mental patients

When:
6 months after the results are published

To whom:
Researchers working in academic and scientific institutions

Conditions:
Any use of the data is permitted provided that the principal investigator of the study is informed.

Where to obtain:
Elaha Hojati Abed- Department of Occupational Therapy, School of Rehabilitation Sciences, Iran Medical Sciences- Email address

How to obtain:
6 months after the results are published, the applicant can receive a part of the data to the address specified by the main researcher by sending her/his request to the email address mentioned.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elahe Hojati Abed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>school of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari St., Maddkaran St., Mader Square, Mirdamad, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۳۴۸۷ ۱۵۴۵۹</zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>elahe_hojati@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elahe Hojati Abed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Occupational therapy departeman,School of Rehabilitation Sciences, Iran University of Medical Sciences Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1545913487</zip>
        <telephone>+98 21 2222 7124</telephone>
        <email>hojatiabed.e@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Have a psychiatric diagnosis and enter the plan with written consent. People who are in a certain range of psychosocial function (Global Assessment Function) with the general function assessment scale should be included in the groups.People who cannot enter the plan, people who have dementia and substance abuse as their primary diagnosis, or who do not agree to participate in the plan.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F20-F99</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mental and behavioural disorders: Schizophrenia, schizotypal and delusional disorders, Mood [affective] disorders,  Neurotic, stress-related and somatoform disorders,Behavioural syndromes associated with physiological disturbances and physical factors, Di</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention period will be held for 2 months, two sessions a week for 3 hours. The intervention program for the implementation of the Clubhouse model is such that it creates a modified environment for people with mental problems to strengthen their confidence and ability to fully participate in society by joining it. Clubhouse program activities are done in groups and include cooking, artistic activities such as painting and drawing, etc., health services such as sports, administrative activities, accounting and maintenance of the center and working with computers. In addition to group activities, the participants are provided with individual support to make the activities meaningful, and the research team is also in contact with their family members and counseling is done if needed.</i_keyword>
      <i_keyword>Control group: The sessions are held in the form of art education (painting, fabric design, ornamental bracelets and music...) and occupational therapy for two days a week during 2 months in 3-hour sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Level of engagement in occupation in Profile of Occupational Engagement in people with Severe mental illness. Timepoint: Before the start of the intervention, After the start of the intervention and 2 months after the intervention. Method of measurement: Profile of Occupational Engagement in people with Severe Mental Illness.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Level of performance in Canadian Occupational Performance Measure. Timepoint: Before the start of the intervention, After the start of the intervention and 2 months after the intervention. Method of measurement: Canadian Occupational Performance Measure.</sec_outcome>
      <sec_outcome>Level of satisfaction in Canadian Occupational Performance Measure. Timepoint: Before the start of the intervention, After the start of the intervention and 2 months after the intervention. Method of measurement: Canadian Occupational Performance Measure.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-22</approval_date>
        <contact_name>Ethics committee of Iran university medical of sciences</contact_name>
        <contact_address>occupational therapy department, Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari St., Maddkaran St., Mader Square, Mirdamad, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
