<?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>IRCT2015120925450N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-11-26</date_registration>
      <primary_sponsor>Vice Chancellor for research of  Iran  University of Medical Sciences</primary_sponsor>
      <public_title>Coping strategy training to family caregivers of people with chronic mental disorders</public_title>
      <acronym></acronym>
      <scientific_title>The effect of coping strategies training on the burden and quality of life among the family caregivers of&#13;
People with chronic mental disorders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>94</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21286</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>chronic mental disorders(schizophrenia,bipolar).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: A non-randomized clinical trial is a test group and control. And for caregivers in the intervention group teaching coping strategies consists of 8 training sessions with given objectives will be for 2 months, during 8 consecutive weeks (week 1 time) and each session lasts 90 minutes in groups and each group consisted of 10 people the groups will be held. The first meeting of coping strategies training program content: Introduction, Introduction and referrals, training program outlines and goals, second session: Introduction to Mental Disorders (definition, etiology, signs and symptoms), the third session: conceptualization and description of stress, symptoms and its consequences on life, sources of stress, the fourth session: the importance of learning coping strategies, problem-focused coping strategies are familiar with the types of emotion-driven and ineffective, the fifth session: effective methods of coping include stress management, time management, decision skills making, management, lifestyle (sleep, rest and exercise), sixth session: Introduction to other ways to reduce caregiver's anxiety such as relaxation techniques, deep breathing seventh session: verbal and non-verbal communication, body language, how to communicate with the patient and conflict resolution related to the effective use of resources, support, eighth session: Analysis and review past sessions, will be. Intervention 2: Control group: control group will not be any intervention pamphlet prepared for the control group and in the end they will be delivered.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehrnoosh Inanloo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr, Shahid Yassami, School of Nursing and Midwifery, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1997613883</zip>
        <telephone>+98 21 8888 2885</telephone>
        <email>inanloo.mehr@gmail.com/inanlo.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences,School of Nursing and Midwifery</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehrnoosh Inanloo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr,Shahid Yassami, School of Nursing and Midwifery, Iran</address>
        <city>Thran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1997613883</zip>
        <telephone>+98 21 8888 2885</telephone>
        <email>inanloo.mehr@gmail.com  inanlo.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences,School of Nursing and Midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: a - watch out: aged 60 -18 years, literacy, health, sight and hearing, did not receive previous training on coping strategies, mental illness and chronic physical well-known lack of care, non-disorder drug abuse or drug dependence, lack of crisis situation in care in the last six months (severe stress, death of close family members), lack of responsibility for the emotional and physical care of a sick patient (b): passed at least 1 year of diagnosis; exclusion criteria from the study: lack of desire to continue to receive training and participate in the research, participate in the second session of the eighth meeting of the classes, participate in similar training sessions in parallel</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>V</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>F20,F31</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: A non-randomized clinical trial is a test group and control. And for caregivers in the intervention group teaching coping strategies consists of 8 training sessions with given objectives will be for 2 months, during 8 consecutive weeks (week 1 time) and each session lasts 90 minutes in groups and each group consisted of 10 people the groups will be held. The first meeting of coping strategies training program content: Introduction, Introduction and referrals, training program outlines and goals, second session: Introduction to Mental Disorders (definition, etiology, signs and symptoms), the third session: conceptualization and description of stress, symptoms and its consequences on life, sources of stress, the fourth session: the importance of learning coping strategies, problem-focused coping strategies are familiar with the types of emotion-driven and ineffective, the fifth session: effective methods of coping include stress management, time management, decision skills making, management, lifestyle (sleep, rest and exercise), sixth session: Introduction to other ways to reduce caregiver's anxiety such as relaxation techniques, deep breathing seventh session: verbal and non-verbal communication, body language, how to communicate with the patient and conflict resolution related to the effective use of resources, support, eighth session: Analysis and review past sessions, will be</i_keyword>
      <i_keyword>Control group: control group will not be any intervention pamphlet prepared for the control group and in the end they will be delivered.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Burden. Timepoint: Before and two months after intervention. Method of measurement: Zarit burden interview.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life. Timepoint: Before and two months after intervention. Method of measurement: Quality of Life Questionnaire sf36.</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>Vice Chancellor for research of  Iran  University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-10-13</approval_date>
        <contact_name>Ethics Committee Of  Iran University Of Medical Sciences</contact_name>
        <contact_address>Ethics Committee, Iran University of Medical Sciences, Sheikh Shahid  Chamran highway lighting, the grace of Allah, Hemmat, Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
