<?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>IRCT20180716040485N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-15</date_registration>
      <primary_sponsor>Islamic Azad University (IAU )</primary_sponsor>
      <public_title>Evaluation the effect of supportive-expressive dynamic psychotherapy in Bipolar Spectrum patients</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the effectiveness of supportive-expressive dynamic psychotherapy in improving the treatment outcome of Bipolar Spectrum Disorders in Male Hospitalized  Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32629</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The randomization method was simple and performed centrally using random numbers table. Each patient's record was assigned a number from 1 to 36 and then randomly assigned to intervention and control groups. Paired numbers were assigned to the control group and individual numbers to the intervention group. In total, 36 patients were divided into two groups of 18.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Bipolar Mood Disorders.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Adult male patients with bipolar disorder treated under medical treatment. Intervention 2: Intervention group: The men patients with bipolar disorder received drug treatment in addition to supportive expressive psychotherapy .This was an insight-based psychotherapy model and a selective psychotherapy for treating patients that had adequate ego strength, but for some reason should not or could not be enroll in long term psychoanalysis sessions.The main approach of therapy was insight based. The patient's response, however, was depend on factors such as the creating judgment free and supportive and emphatic which was mostly depending on factors such as the relationship between the therapist and the patient. The treatment lasted from 12 to 25 sessions in terms of the length of the treatment, and usually the number of sessions was once a week in the early stages of treatment, but when we entered the main phase of the treatment (middle phase), the number of sessions was twice a week.</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 No More Information is Available right now.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza Bornamanesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.288, Saeb st, Isfahan, Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8184813341</zip>
        <telephone>+98 31 3773 6684</telephone>
        <email>Bornamanesh@miau.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Bornamanesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 288, Saeb St</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8184813341</zip>
        <telephone>+98 31 3773 6684</telephone>
        <email>Bornamanesh@miau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having bipolar mood disorder based on psychiatrist's diagnosis
Hospitalized
Normal IQ.
Male gender.
Lack of  co-morbid physical and organic serious problems (Including sensory impairments such as deafness and blindness, severe physical disabilities)
No cognitive impairment that interferes with understanding and participating in treatment
The absence of other serious psychiatric disorders (e.g.psychotic symptoms , anxiety disorders,...)</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>The patient's unwillingness to continue the participation in study
Absence for more than one session and the absence in the session considered as compensated session
Hospital discharging</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>Diagnosis</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Adult male patients with bipolar disorder treated under medical treatment</i_keyword>
      <i_keyword>Intervention group: The men patients with bipolar disorder received drug treatment in addition to supportive expressive psychotherapy .This was an insight-based psychotherapy model and a selective psychotherapy for treating patients that had adequate ego strength, but for some reason should not or could not be enroll in long term psychoanalysis sessions.The main approach of therapy was insight based. The patient's response, however, was depend on factors such as the creating judgment free and supportive and emphatic which was mostly depending on factors such as the relationship between the therapist and the patient. The treatment lasted from 12 to 25 sessions in terms of the length of the treatment, and usually the number of sessions was once a week in the early stages of treatment, but when we entered the main phase of the treatment (middle phase), the number of sessions was twice a week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bipolar disorder level. Timepoint: BDRS scores at the beginning of the study (maintenance phase), immediately after the completion of psychological interventions 1 month, 3 months and 6 months after the start of the study in the supportive-psychotic recipient group, along with drug therapies. Method of measurement: The BDRS and its subscales in the sample of Iranian patients have a construct validity, ownership, distinction, and diagnosis that can be used in surveying and clinical trials.</prim_outcome>
      <prim_outcome>Relapse Rate. Timepoint: 1 Month after intervention, 3 Month After Interventions , 6 Month after Intervention. Method of measurement: Bipolar Disorder Rating Scale (BDRS).</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>Islamic Azad University (IAU )</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-02-25</approval_date>
        <contact_name>Institutional Research Ethics Committee  Islamic Azad University- Shiraz Branch</contact_name>
        <contact_address>5 km after Sadra Highway Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
