<?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>IRCT20141221020378N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-18</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Determination of the most important symptoms of bipolar disorder and treatment of the disease based on them</public_title>
      <acronym></acronym>
      <scientific_title>Diagnosis and Treatment of Bipolar Disorder Based on Symptoms Network Data Analysis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>6</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44772</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Bipolar Disorder.</hc_freetext>
      <i_freetext>In the new network theory of mental disorders, the causal relationship between symptoms and the importance of more central symptoms in treatment has been emphasized. Using data of the American Comorbidity Survey, the polychoric correlation matrix of the symptoms was extracted with the help of the psych software and the correlation map of the symptoms was plotted based on four indices: closeness, betweenness, strength, and expected effect. Using the unit scale, the algebraic sum of the indices was calculated and the most important indicators were identified. Then, the protocol was designed using a cognitive behavioral therapy and third-wave therapies to target more important symptoms. In the intervention phase, six patients with bipolar disorder were selected by convenience sampling method. The statistical method of this study will be replicated single-case experimental design that ethical in psychotherapy interventions in which each patient acts as their control group. The study will be conducted in the psychiatry ward of Hafez Hospital. After selecting patients and evaluating baseline in 3 sessions, psychotherapy interventions will be conducted in accordance with designed protocol in 12 sessions. Following psychotherapy interventions, patients will be evaluated for depression, anxiety and mania variables and the results are compared with pre-treatment conditions. To investigate the reliability of therapeutic effects, patients will be re-evaluated for aforementioned variables 1 month after the end of treatment..</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 are no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samira Ranaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Psychiatric Ward, Hafez Hospital, Chamran Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71946-34786</zip>
        <telephone>+98 71 3647 9531</telephone>
        <email>samira_ranaie@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Seyed Ali Dastgheib</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Psychiatric Ward, Hafez Hospital, Chamran Blvd</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71946-34786</zip>
        <telephone>+98 71 3647 9531</telephone>
        <email>adastgheib@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Bipolar disorder
Stable condition and adequate pharmacological treatment in the previous 3 months
Ages 15-54 years
No psychological treatment at the time or before entering the study
Signing a written consent</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>54 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Individuals in the acute phase of bipolar disorder
Active drug abusers
Borderline personality disorder
Severe physical disabilities
Mental retardation</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>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the new network theory of mental disorders, the causal relationship between symptoms and the importance of more central symptoms in treatment has been emphasized. Using data of the American Comorbidity Survey, the polychoric correlation matrix of the symptoms was extracted with the help of the psych software and the correlation map of the symptoms was plotted based on four indices: closeness, betweenness, strength, and expected effect. Using the unit scale, the algebraic sum of the indices was calculated and the most important indicators were identified. Then, the protocol was designed using a cognitive behavioral therapy and third-wave therapies to target more important symptoms. In the intervention phase, six patients with bipolar disorder were selected by convenience sampling method. The statistical method of this study will be replicated single-case experimental design that ethical in psychotherapy interventions in which each patient acts as their control group. The study will be conducted in the psychiatry ward of Hafez Hospital. After selecting patients and evaluating baseline in 3 sessions, psychotherapy interventions will be conducted in accordance with designed protocol in 12 sessions. Following psychotherapy interventions, patients will be evaluated for depression, anxiety and mania variables and the results are compared with pre-treatment conditions. To investigate the reliability of therapeutic effects, patients will be re-evaluated for aforementioned variables 1 month after the end of treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Assessment of Depression. Timepoint: Immediately after each session of treatment and 1 months after end of treatment. Method of measurement: Beck Depression Inventory; Hamilton Rating Scale for Depression.</prim_outcome>
      <prim_outcome>Assessment of Anxiety. Timepoint: Immediately after each session of treatment and 1 months after end of treatment. Method of measurement: Beck Anxiety Inventory.</prim_outcome>
      <prim_outcome>Assessment of Mania. Timepoint: Immediately after each session of treatment and 1 months after end of treatment. Method of measurement: 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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-15</approval_date>
        <contact_name>Ethics Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Hafez Hospital, Chamran Blvd Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
