<?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>IRCT201202159028N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-08-27</date_registration>
      <primary_sponsor>Shiraz medical university</primary_sponsor>
      <public_title>Impact of a psycho-education  on  patients with bipolar disorder</public_title>
      <acronym></acronym>
      <scientific_title>Impact of a systematic intervention program on quality of life, relapse prevention and medication compliance in patients with bipolar disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/9654</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>bipolar mood disorder.</hc_freetext>
      <i_freetext>Intervention 1: Patients in intervention group, received standard pharmacotherapy for BpD and also enrolled for simple individual psychoeducation.&#13;
&#13;
Program consisted of 8 sessions each consisting of a 50 minute session per week of a short form of psychoeducation course, derived from studies of Colom, F. and Vieta,E. (19).&#13;
Sessions of psychoeducation were performed by a psychiatry resident who was blinded to treatment. All psychoeducation treatment sessions for all patients were performed by the same resident who conducted a one-on-one session with each individual patient.&#13;
&#13;
Psychoeducation programs and discussions were presented to the patients in the following format:&#13;
&#13;
Session 1: Understanding BpD. and its aetiology.&#13;
&#13;
Session 2: Familiarisation with symptoms of mania and hypomania.&#13;
&#13;
Session 3: Understanding signs of depression and other psychological episodes.&#13;
&#13;
Session 4: Awareness of causes and prognosis.&#13;
&#13;
Session 5: Education about the function, types and adverse side effect of mood stabiliser medication.&#13;
&#13;
Session 6: Functions, types and adverse effects of antimanic and antidepressant medications. Patients also receive information about the risk of discontinuation of these medications. &#13;
&#13;
Session 7: Learning how to detect any future episodes of relapse.&#13;
&#13;
Session 8: Strategies and plans ought to be taken upon early detection of symptoms and self directed to new situations.&#13;
&#13;
These 8 weekly scheduled sessions were conducted face to face in the clinic of psychology at Hafez Hospital.&#13;
&#13;
The first 10 minutes of each sitting was allocated to establishing rapport with the patient, and a short question and answer session. During this period, the patients were asked to explain, in their own words, their understanding of all presented material. Any misconstrued discussed and explained in detail. &#13;
&#13;
After first 10 minutes the researcher gave all relevant information in layman language about the particular topics for 40 minutes. The strategies and plans for early detections of symptoms discussed.&#13;
&#13;
After 8 sessions of face to face simple individual education, intervention continued by way of scheduled monthly telephone contact to remind patients of their next appointment. Each telephone contact consisted of a 10-minute question and answer session where the patient’s queries were thoroughly responded to. &#13;
&#13;
 Follow-up telephone contact for each patient was then scheduled for the subsequent 18 months. Intervention 2: Patients who were randomised in the control group were continuing standard pharmacotherapy by their psychiatrists of choice.</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>Ali Javadpour MD</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Psychiatric Department , Hafez Hospital , Shiraz , Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+7 116271531</telephone>
        <email>javadpoura@sums.ac.ir</email>
        <affiliation>Shiraz  University Of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Javadpour MD</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Psychiatric department, Hafez Hospital , Shiraz, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+7 116271531</telephone>
        <email>javadpoura@sums.ac.ir</email>
        <affiliation>Shiraz  University Of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria :  18-60 year old;   past history of 2 episodes during 2 years or 3 episodes during 5 years;  in euthymic phase.   &#13;
exclusion criteria:  &gt;60 years or &lt;18 years old;less than 2episodes during 2 years or less 3 episodes during 5 years;  in acute phase or with sever residual symptoms</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</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>Lifestyle</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Patients in intervention group, received standard pharmacotherapy for BpD and also enrolled for simple individual psychoeducation.&#13;
&#13;
Program consisted of 8 sessions each consisting of a 50 minute session per week of a short form of psychoeducation course, derived from studies of Colom, F. and Vieta,E. (19).&#13;
Sessions of psychoeducation were performed by a psychiatry resident who was blinded to treatment. All psychoeducation treatment sessions for all patients were performed by the same resident who conducted a one-on-one session with each individual patient.&#13;
&#13;
Psychoeducation programs and discussions were presented to the patients in the following format:&#13;
&#13;
Session 1: Understanding BpD. and its aetiology.&#13;
&#13;
Session 2: Familiarisation with symptoms of mania and hypomania.&#13;
&#13;
Session 3: Understanding signs of depression and other psychological episodes.&#13;
&#13;
Session 4: Awareness of causes and prognosis.&#13;
&#13;
Session 5: Education about the function, types and adverse side effect of mood stabiliser medication.&#13;
&#13;
Session 6: Functions, types and adverse effects of antimanic and antidepressant medications. Patients also receive information about the risk of discontinuation of these medications. &#13;
&#13;
Session 7: Learning how to detect any future episodes of relapse.&#13;
&#13;
Session 8: Strategies and plans ought to be taken upon early detection of symptoms and self directed to new situations.&#13;
&#13;
These 8 weekly scheduled sessions were conducted face to face in the clinic of psychology at Hafez Hospital.&#13;
&#13;
The first 10 minutes of each sitting was allocated to establishing rapport with the patient, and a short question and answer session. During this period, the patients were asked to explain, in their own words, their understanding of all presented material. Any misconstrued discussed and explained in detail. &#13;
&#13;
After first 10 minutes the researcher gave all relevant information in layman language about the particular topics for 40 minutes. The strategies and plans for early detections of symptoms discussed.&#13;
&#13;
After 8 sessions of face to face simple individual education, intervention continued by way of scheduled monthly telephone contact to remind patients of their next appointment. Each telephone contact consisted of a 10-minute question and answer session where the patient’s queries were thoroughly responded to. &#13;
&#13;
 Follow-up telephone contact for each patient was then scheduled for the subsequent 18 months.</i_keyword>
      <i_keyword>Patients who were randomised in the control group were continuing standard pharmacotherapy by their psychiatrists of choice</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. medication adherence. recurrence.admision. Timepoint: 6 ,12 and 18 months after begining of study. Method of measurement: WHO QOL BREF. hamilton depression scale. Bech Rafaelsen mania scale. Medication adherence Rating scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Severity of depression and mania. Timepoint: at 6 T 12 and 18 months after begining of study. Method of measurement: Hamilon depression scale. Bech Rafaelsen mania scale.</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 medical university</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-12-26</approval_date>
        <contact_name>Ethics Commite of Shiraz medical university</contact_name>
        <contact_address>Shiraz medical university shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
