<?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>IRCT2017061434533N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-09-25</date_registration>
      <primary_sponsor>Vice Chancellor for Research  of Social Welfare and Rehabilitation Sciences University.</primary_sponsor>
      <public_title>Effectiveness of Family-Based Interventions on Family Members of Bipolar Patients</public_title>
      <acronym></acronym>
      <scientific_title>A Clinical Trial to assess the Effectiveness of Family-Based Interventions on Severity of Symptoms, Stigma, Caregiver Burden, Emotion Expression and Coping Styles among Family Members of Bipolar Patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-03-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26367</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: For randomization all patients who met inclusion and exclusion criteria will select and we specify a code to each patient. Through  drawing randomly by  a blind person to purpose of study, patients allocate to intervention and control group.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Bipolar Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group: Family members will receive family- based psychotherapy within 3 10-member groups. Family based psychotherapy consists of 12 session. The duration of each session is 90 minutes. The sessions contain these topics: knowledge about the disease, bio-psycho-social model, symptoms of bipolarity, mood stabilizer medications, medication compliance, knowledge about mood swings, how to apply mood graphs, relation between mood and situations, family members as predisposing events, reviewing the level of activity, regulating restrictions before reaching problematic level, crisis management and problem solving, family members tension reduction practices and relapse prevention. Intervention 2: Control Group: It consist of family members of patients with bipolar spectrum disorders. They will not receive intervention. They only complete questionnaires on pretest, post test and follow-up.</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>Neda Ali Beigi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Chahar dehi Building, Razi psychiatric Hospital, Amin Abad, Shahr Rey, Tehran..</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 3340 1604</telephone>
        <email>nedapsych@gmail.com</email>
        <affiliation>Psychosis Research Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Neda Ali Beigi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University  of Social Welfare and Rehabilitation Sciences, Kodakyar st., Daneshjoo Blv, Velenjak.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8876 1317</telephone>
        <email>nedapsych@gmail.com</email>
        <affiliation>Psychosis Research Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Diagnosis of Bipolar Disorder based on DSM–IV-TR (American Psychiatric Association, 2000) and psychiatrists’ diagnostic interview; the Bipolar Disorder diagnosis should be confirmed by SCID (Structured clinical interview); The age range of 25 to 60 years old; Family member should be educated at least 8 grades; Patient should live with the family member before and after hospitalization; The family member should be psychological minded and  should have enough eager and ability to understand therapeutic constructs. &#13;
Exclusion criteria: The group participant has considerable mental disorder diagnosis that report in axis I in DSM-IV-TR diagnostic classification.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F31</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Bipolar affective disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group: Family members will receive family- based psychotherapy within 3 10-member groups. Family based psychotherapy consists of 12 session. The duration of each session is 90 minutes. The sessions contain these topics: knowledge about the disease, bio-psycho-social model, symptoms of bipolarity, mood stabilizer medications, medication compliance, knowledge about mood swings, how to apply mood graphs, relation between mood and situations, family members as predisposing events, reviewing the level of activity, regulating restrictions before reaching problematic level, crisis management and problem solving, family members tension reduction practices and relapse prevention.</i_keyword>
      <i_keyword>Control Group: It consist of family members of patients with bipolar spectrum disorders. They will not receive intervention. They only complete questionnaires on pretest, post test and follow-up.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Caregiver burden. Timepoint: before intervention, after intervention, 3months follow-up. Method of measurement: Zarit Caregiver Burdun Inventory.</prim_outcome>
      <prim_outcome>Stigma. Timepoint: before intervention, after intervention, 3months follow-up. Method of measurement: Michel King Stigma  Inventory.</prim_outcome>
      <prim_outcome>Coping styles. Timepoint: before intervention, after intervention, 3months follow-up. Method of measurement: CISS- Coping Inventory in stressful Situations.</prim_outcome>
      <prim_outcome>Emotion expression. Timepoint: before intervention, after intervention, 3months follow-up. Method of measurement: Emotional Expressiveness Questionnaire EEQ.</prim_outcome>
      <prim_outcome>Bipolar disorder symptoms. Timepoint: before intervention, after intervention, 3months follow-up. Method of measurement: YMRS Young mania rating scale.</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>Vice Chancellor for Research  of Social Welfare and Rehabilitation Sciences University.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-10-01</approval_date>
        <contact_name>Ethics committee of  University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>University of Social Welfare and Rehabilitation Sciences, Kodakyar st., Daneshjoo Blv, Velenjak. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
