<?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>IRCT20211227053550N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-08</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of the educational program on mental health literacy of caregivers of psychiatric patients</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effectiveness of the educational program on mental health literacy of caregivers of psychiatric patients admitted to Ibn Sina Hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61040</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Eligible individuals will enter the study after obtaining informed consent (purpose-based sampling).Individuals randomly (random allocation using dedicated randomization sites such as sealed envelop) into two groups of intervention (three 90-minute group sessions of mental health literacy training at one-week intervals) and control (three 90-minute group sessions with skill training content Of life) will be divided.It should be noted that randomization will be done in blocks using 4 or 6 blocks.After random assignment, the type of group assigned to each person (for example, even and odd numbers) will be written on a sheet of paper, and each sheet will be placed in an envelope in the package.After informing the individuals, if the person (health care provider) is eligible to enter the study, he / she will be asked to complete the informed consent form.Then an envelope will be picked (allocation concealment) and the names and surnames of the people and their contact numbers will be written on it for further coordination and according to the code written in the envelope, the people are placed in one of the two intervention or control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Health literacy of caregivers of psychiatric patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For caregivers of people with psychiatric diseases, three sessions of mental health literacy training will be conducted by a psychiatric assistant and under the supervision of psychiatric professors in groups (in groups of 10 to 15 people). Each session lasts 90 minutes. Meetings will be held interactively with questions and answers. The content of the sessions is as follows: The first session (project introduction) Explaining the rules of participation in group meetings (timely attendance at meetings and the need to participate in both sessions), reviewing participants' knowledge about the concept of mental health, mental illness and causes of disorders Mental, explaining the concept of mental health, mental illness and its causes and correcting participants 'opinions, examining participants' knowledge about the symptoms of psychiatric disorders and their diagnosis, explaining the signs and symptoms of common and important psychiatric disorders (anxiety, mood, Psychotic). Session 2: Reviewing the topics of the previous session, reviewing people's opinions about the treatment of mental disorders and seeking professional help, explaining about the treatment of mental disorders (medication and psychotherapy), explaining the consequences of not treating mental disorders and the need for help Professional, reviewing individuals' knowledge of how to access and explaining mental health professional assistance. Session 3: Reviewing the topics of the previous session, examining people's opinions about the mentally ill (including their risk, their social and interpersonal skills, and the treatability of the disorder), explaining the stigma of mental disorders, and correcting participants' opinions through Group discussion, summary. At the end of the third session and two months after the end of the sessions, the participants will complete the Mental Health Literacy Scale again. Intervention 2: Control group: کلاس مهارت های زندگی.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Adeleh Abdolalizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Block 1, No.8, Andishe 72 Ave</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9187187463</zip>
        <telephone>+98 51 3620 5991</telephone>
        <email>abdolalizadeha981@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Adeleh Abdolalizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.8, Block.1, Andisheh Ave</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9187187463</zip>
        <telephone>+98 51 3620 5991</telephone>
        <email>abdolalizadeha981@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be a primary caregiver of the patient for at least 6 months
Without any acute symptoms of psychiatric disorders
Ability to read and write
Age between 18-60
The patient (hospitalized) meets the DSM-5 criteria for schizophrenia, bipolar disorder, or major depression and should not have substance use disorders other than nicotine
Having informed consent to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For caregivers of people with psychiatric diseases, three sessions of mental health literacy training will be conducted by a psychiatric assistant and under the supervision of psychiatric professors in groups (in groups of 10 to 15 people). Each session lasts 90 minutes. Meetings will be held interactively with questions and answers. The content of the sessions is as follows: The first session (project introduction) Explaining the rules of participation in group meetings (timely attendance at meetings and the need to participate in both sessions), reviewing participants' knowledge about the concept of mental health, mental illness and causes of disorders Mental, explaining the concept of mental health, mental illness and its causes and correcting participants 'opinions, examining participants' knowledge about the symptoms of psychiatric disorders and their diagnosis, explaining the signs and symptoms of common and important psychiatric disorders (anxiety, mood, Psychotic). Session 2: Reviewing the topics of the previous session, reviewing people's opinions about the treatment of mental disorders and seeking professional help, explaining about the treatment of mental disorders (medication and psychotherapy), explaining the consequences of not treating mental disorders and the need for help Professional, reviewing individuals' knowledge of how to access and explaining mental health professional assistance. Session 3: Reviewing the topics of the previous session, examining people's opinions about the mentally ill (including their risk, their social and interpersonal skills, and the treatability of the disorder), explaining the stigma of mental disorders, and correcting participants' opinions through Group discussion, summary. At the end of the third session and two months after the end of the sessions, the participants will complete the Mental Health Literacy Scale again.</i_keyword>
      <i_keyword>Control group: کلاس مهارت های زندگی</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Health literacy of caregivers of psychiatric patients. Timepoint: Before the classes, at the end of the third session and two months after the end of the sessions, the participants will complete the mental health literacy scale. Method of measurement: "Mental Health Literacy Scale"The questionnaire was developed by O'Connor et al. And consists of 35 questions and 6 attributes. These 6 attributes are:                                                                                                    1.Ability to diagnose disorders: It includes 8 questions that are scored using a 4-point Likert scale (very unlikely, unlikely, probable, very probable).                                                                                                          2.Knowledge of risk factors and causes: consists of 2 questions that are scored using a 4-point Likert scale (very unlikely, unlikely, probable, very probable).                                                                                                           3.Knowledge about self-medication: consists of 2 questions that are scored using a 4-point Likert scale (very unhelpful, unhelpful, beneficial, very beneficial).                                                                                                4.Knowledge of available professional help: consists of 3 questions that are graded using a 4-point Likert scale (very unlikely, unlikely, probable, very probable).                                                                                                  5.Knowledge of where to look for information: Contains 4 questions that are scored using a 5-point Likert scale (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree).                                       6.Attitudes about promoting appropriate diagnosis or supportive behavior: includes 16 questions using a 5-point Likert scale (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree) or (definitely willing, probably willing, Neither reluctant nor reluctant, probably reluctant, definitely reluctant) are scored.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-07</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>میدان آزادی، درب شرقی پردیس دانشگاه Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
