<?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>IRCT20160927030002N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-19</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of mental health literacy promotion program on emotional regulation strategies, social health and perceived stress</public_title>
      <acronym>MHL</acronym>
      <scientific_title>Investigating the effect of mental health literacy promotion program on emotional regulation strategies, social health and perceived stress of family caregivers of patients with chronic psychiatric disorders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69008</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Other design features: In this study, the samples are randomly divided into intervention and control groups, the intervention group receives mental health literacy training, but the control group does not receive training, Randomization description: The sampling method is based on available sampling and random allocation using spss software; In this way, by referring to the files of patients who are currently hospitalized or have a history of hospitalization in psychiatric wards, we will find the samples for our study that meet the criteria for entering the study by sampling method; Then the samples will be assigned number 1-60 and using spss software we will randomly assign numbers 1-60 in two test and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic psychiatric diseases such as schizophrenia, depression and bipolar.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Training to improve mental health literacy will take place during 6 sessions as follows: First session: Improving the knowledge of family caregivers about mental health. The second session: improving communication skills with the patient and the community. The third session: teaching strategies to reduce the stigma of the disease and negative attitudes to family caregivers. Fourth session: Training of family caregivers in the field of their own needs and those of people with mental disorders. Fifth session: Training of family caregivers in the field of patient rights and strategies for seeking help. Sixth session: introduction of supportive interventions to improve the mental health of the patient and family. Intervention 2: Control group: There is no intervention in this group. The members of this group will fill the relevant questionnaires at the same time as the intervention group before the intervention, immediately after and one month after the intervention, and after the end of the intervention to compensate for the deprivation of this group from training. provided, after completing the follow-up and filling of the questionnaires, training will be provided to them in an intensive session.</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:
After deidentifying people, a part of the data, such as information related to the results of the scores of emotion regulation strategies questionnaires, social health and participation perception stress participants in two control and test groups before and after the implementation of the intervention without specifying the identity of the informants and the information will be presented in the form of general statistical results.

When:
1 month after the results are published

To whom:
Researchers working in academic and scientific institutions

Conditions:
Having a valid certificate of activity in the mentioned organization

Where to obtain:
Musa Alavi 09138936489. Faculty of Midwifery Nursing, Isfahan. mousa_alavi@yahoo.com
Zainab Pirollahi 09190521377. Isfahan Midwifery Nursing School. zeynabpirallahi@gmail.com

How to obtain:
The applicant first applies through email, in the next step, if there is no response, she communicates through the contact number, and if she does not receive a response, the request for information is made in person.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mousa Alavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery Care Research Center, School of Nursing and Midwifery, Isfahan University of M</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 7588</telephone>
        <email>m_alavi@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zeynab Pirallahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jarib St. School of Midwifery Nursing</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174683461</zip>
        <telephone>+98 31 3792 3876</telephone>
        <email>zeynabpirallahi@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The participants should be willing to participate in the study.
The patient has a history of being hospitalized in a psychiatric ward for the past year or is currently hospitalized in a psychiatric ward.
The patient is suffering from a psychiatric disorder diagnosed by a psychiatrist, and his hospitalization in the psychiatric department is not solely due to substance abuse.
At least 6 months have passed since the onset of the disease of the sick member of the participants' family.
The participants have not experienced an unfortunate incident or severe stress such as the death of a loved one or divorce, etc. during the last six months.
The participants should not have a history of using drugs or alcohol.
The participants should not have a history of psychiatric diseases, which led to drug use or hospitalization in the psychiatric ward.
The participants must be literate in reading and writing and understand the Persian language.
The participant is solely responsible for the care of a sick family member.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Training to improve mental health literacy will take place during 6 sessions as follows: First session: Improving the knowledge of family caregivers about mental health. The second session: improving communication skills with the patient and the community. The third session: teaching strategies to reduce the stigma of the disease and negative attitudes to family caregivers. Fourth session: Training of family caregivers in the field of their own needs and those of people with mental disorders. Fifth session: Training of family caregivers in the field of patient rights and strategies for seeking help. Sixth session: introduction of supportive interventions to improve the mental health of the patient and family.</i_keyword>
      <i_keyword>Control group: There is no intervention in this group. The members of this group will fill the relevant questionnaires at the same time as the intervention group before the intervention, immediately after and one month after the intervention, and after the end of the intervention to compensate for the deprivation of this group from training. provided, after completing the follow-up and filling of the questionnaires, training will be provided to them in an intensive session.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Emotion regulation strategies. Timepoint: The beginning of the intervention (before the start of the intervention). Immediately after the last intervention session, one month after the last intervention session. Method of measurement: Gross and Jan's emotion regulation strategies questionnaire.</prim_outcome>
      <prim_outcome>Social health. Timepoint: The beginning of the intervention (before the start of the intervention). Immediately after the last intervention session, one month after the last intervention session. Method of measurement: Keyes Social Health Questionnaire.</prim_outcome>
      <prim_outcome>Perceived stress. Timepoint: The beginning of the intervention (before the start of the intervention). Immediately after the last intervention session, one month after the last intervention session. Method of measurement: Cohen's Perceived Stress 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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-05</approval_date>
        <contact_name>Ethics Committee of Faculty of Nursing, Management and Rehabilitation of Isfahan University of Medic</contact_name>
        <contact_address>Hezar Jarib St. Isfahan University of Medical Sciences. Building number 3. medical School. Ground Floor. Medical ethics group. Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
