<?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>IRCT20211121053134N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-14</date_registration>
      <primary_sponsor>Ardabil University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effectiveness of the Community Reentry Program (CRP)  in adherence to treatment and control of symptoms of Bipolar Mood Disorder (BMD).</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effectiveness of the Community Reentry Program (CRP)  in adherence to treatment and control of symptoms of Bipolar Mood Disorder (BMD) in patients admitted to the psychiatric ward</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62787</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: Block randomization will be used. In this way, the patient randomly picks a card with two letters written on it. The letter I stands for intervention and the letter C stands for control. If a person takes a card that is I-C, that person will be placed in the intervention group, but the next person will be in the control group. If he takes the C-I card, that person will be placed in the control group and the next person will be placed in the intervention group. This action causes the number of groups to increase in parallel, Blinding description: All patients in the intervention and control groups receive the intervention. But only the intervention group receives CRP. Individuals in the control group receive unrelated training. Neither patient in the two groups is informed of what the main intervention is.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Bipolar Mood Disorder (BMD-I).</hc_freetext>
      <i_freetext>The  Community Reenter Program (CRP) is a subset of the more comprehensive program, The Independent and Social Life Skills Program, developed by the Psychiatric Rehabilitation Clinical Research Center at UCLA, for people with long-term and recurrent mental disorders, especially schizophrenia. "Bipolar disorder and major depression are designed. The purpose of the Return to Community program is to provide patients with the information and skills necessary for an independent social life and to enable them to benefit from psychosocial rehabilitation services." The Return to Community program combines new educational materials in discharge planning and application in the community with areas of drug treatment management, symptom self-management, and leisure and recreation programs. Is used..</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 In the content of the article that will be written, data analysis and treatment protocol and study will be done.
The informed consent form will be provided as a side file only to the printing journal.
  In terms of personal information, no individual will be made available to any institution</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>مهریار ندرمحمدی</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ardabil - Sarein Station; Imam Khomeini St., not far from Shariati Square, Fatemi Educational and Medical Center</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5614733775</zip>
        <telephone>+98 45 3323 2520</telephone>
        <email>mehriar46@yahoo.com</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehriar Nader Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ardabil - Sarein Station; Imam Khomeini St., not far from Shariati Square, Fatemi Educational and Medical Center</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5614733775</zip>
        <telephone>+98 45 3323 2520</telephone>
        <email>mehriar46@yahoo.com</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having BMD disorder
Hospitalization in the psychiatric ward</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Comorbidity with mental retardation
Comorbidity with schizophrenia
Comorbidity with other psychotic disorders
Duration of the disorder less than 6 months
Comorbidity with addiction</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>296/41</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>296/41</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The  Community Reenter Program (CRP) is a subset of the more comprehensive program, The Independent and Social Life Skills Program, developed by the Psychiatric Rehabilitation Clinical Research Center at UCLA, for people with long-term and recurrent mental disorders, especially schizophrenia. "Bipolar disorder and major depression are designed. The purpose of the Return to Community program is to provide patients with the information and skills necessary for an independent social life and to enable them to benefit from psychosocial rehabilitation services." The Return to Community program combines new educational materials in discharge planning and application in the community with areas of drug treatment management, symptom self-management, and leisure and recreation programs. Is used.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Signs and symptoms of bipolar disorder, drug adherence, aggression, and social relationships are outcome variables that are assessed with the following questionnaires. 1- Young Mania 2- Morisky Drug Adherence Questionnaire 3- Phillips Social Support Questionnaire 4- Bass Perry Aggression Questionnaire. Timepoint: Before each intervention session (8 to 12 sessions) and after discharge from the ward (up to 2 months each week). Method of measurement: Use a self-report questionnaire: 1- Young Mania 2- Morisky Drug Adherence Questionnaire 3- Phillips Social Support Questionnaire 4- Bass Perry Aggression Questionnaire.</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>Ardabil University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-16</approval_date>
        <contact_name>Ethics committee of Ardabil University of Medical Sciences</contact_name>
        <contact_address>Address: Ardabil, Daneshgah st. Ardabil Complex Univesity Ardabil Ardabil Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
