<?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>IRCT20231014059720N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-30</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Self-Awareness Skills on Stigma in Family Caregivers of Patients with Bipolar Disorder type 1</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Self-Awareness Skills on Stigma in Family Caregivers of Patients with Bipolar Disorder type 1</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>49</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73183</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Blocked
In order to randomly assign patients to study subjects while ensuring equal numbers in study groups, random permutation block method is used. For this purpose, blocks with sizes 2 and 4 are used, and a random list will be created through the website https://www.sealedenvelope.com.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Bipolar type 1.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The study population is the caregivers of patients with bipolar disorder type 1 hospitalized in the educational or therapeutic adult departments of Ibn Sina Hospital. Caregivers of patients who are interested in participating in the research will be invited. Then, a meeting will be held to state the objectives of the study, informed and written consent will be obtained from the caregivers of the patients, and they will be asked to complete the demographic checklist and the standard questionnaire of internal stigma of psychiatric patients by Ritscher et al. The sample size has been calculated by considering 20% ​​attrition for the group of 49 people. The intervention group will undergo self-awareness training for 4 weeks in the form of two 35-minute sessions per week (8 sessions), which are as follows.The intervention is taken from the book Life Skills Training authored by Hamed Barabadi, and in each session, first a brief explanation about the activity that is to be done, and then homework is completed in the classroom and at home. The assignments are classified as the mentioned items. 1- Definition of self-awareness 2- Definition of real self and ideal self 3- Emotions and its components 4- Self-image 5- Self-esteem 6- Trophy of victory 7- Filling placards of success 8- Introducing sources of self-awareness. After one month of the intervention, the questionnaires will be completed again by this group. Intervention 2: Control group: In the control group, after filling the relevant questionnaire, they do not receive any intervention and they only receive the usual interventions of the hospital, and after our interventions are completed and the questionnaire form is completed by the intervention group, the control group is invited to act after one month. come to receive the interventions taken from the life skills training book in one 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:
Its main implications are shared

When:
The access period starts one year after the results are published

To whom:
It is accessible to all people

Conditions:
The person to whom the data is sent must have a university degree in psychiatry or psychology and for what purpose he requests this information.

Where to obtain:
09050476711
Fallah Moghaddam Amir

How to obtain:
An email will be sent to him during a phone call with the number 09050476711, and after his request, information will be sent to him through the given email within a month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeed Vaghee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Educational complex of Shahid Dr. Kharazmi, university campus, east gate of Ferdowsi University of Mashhad, Azadi Square, Khorasan Razavi</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>VagheeS@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeed Vaghee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Educational complex of Shahid Dr. Kharazmi, university campus, east gate of Ferdowsi University of Mashhad, Azadi Square, Khorasan Razavi</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>VagheeS@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Entry criteria for caregivers: first-degree relative of the patient who is the main caregiver of the patient.
High school education
living in Mashhad and Iranian nationality
age at least 18 and at most 60 years old
no physical, hearing and visual impairments
no known mental disorders and no drug use in this context
no experience of another crisis such as divorce and Death of loved ones in the last six months
lack of medical education
Criteria for the admission of patients: Confirmation of a patient with type 1 bipolar disorders by a psychiatrist
at least six months have passed since the diagnosis of the disease
and have a history of at least one previous hospitalization in a psychiatric hospital.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>to be absent in one of the training sessions
After completing the training process, the main caregiver of the patient experiences such things as divorce or the death of a loved one until the post-test
During the research, participate in another educational program in this field.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F31</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Bipolar disorder</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: The study population is the caregivers of patients with bipolar disorder type 1 hospitalized in the educational or therapeutic adult departments of Ibn Sina Hospital. Caregivers of patients who are interested in participating in the research will be invited. Then, a meeting will be held to state the objectives of the study, informed and written consent will be obtained from the caregivers of the patients, and they will be asked to complete the demographic checklist and the standard questionnaire of internal stigma of psychiatric patients by Ritscher et al. The sample size has been calculated by considering 20% ​​attrition for the group of 49 people. The intervention group will undergo self-awareness training for 4 weeks in the form of two 35-minute sessions per week (8 sessions), which are as follows.The intervention is taken from the book Life Skills Training authored by Hamed Barabadi, and in each session, first a brief explanation about the activity that is to be done, and then homework is completed in the classroom and at home. The assignments are classified as the mentioned items. 1- Definition of self-awareness 2- Definition of real self and ideal self 3- Emotions and its components 4- Self-image 5- Self-esteem 6- Trophy of victory 7- Filling placards of success 8- Introducing sources of self-awareness. After one month of the intervention, the questionnaires will be completed again by this group.</i_keyword>
      <i_keyword>Control group: In the control group, after filling the relevant questionnaire, they do not receive any intervention and they only receive the usual interventions of the hospital, and after our interventions are completed and the questionnaire form is completed by the intervention group, the control group is invited to act after one month. come to receive the interventions taken from the life skills training book in one session.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The effect of self-awareness skill training on the stigma of family caregivers. Timepoint: before and one month after the end of the intervention. Method of measurement: Ritscher et al.'s internal stigma questionnaire of mental patients.</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>2023-10-08</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>No.31,27th Salman Farsi Ave. Sabzevar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
