<?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>IRCT20200213046485N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-24</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Cognitive remediation in people with bipolar disorder</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of a short term computer-based cognitive remediation program on cognitive performance in people with bipolar disorder: A randomized controlled study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45876</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Subjects will be randomly assigned into intervention or control group via Blocked randomization method (Permuted block randomization). To create a randomized sequence the following website will be used: http://www.sealedenvelpe.com.
To conceal allocations, a randomized sequence is provided only for an specific individual. Then based on the sequence of subjects entering the program, the researcher asks that individual about the group in which each subject must be included. For every intervention according to the randomized sequence a number is assigned to each case.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Bipolar mood disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the present study, the intervention group, in addition to usual standard treatment, will receive the intervention which consists of 12 personal sessions of ninety-minute computer-based training for cognitive remediation, twice or three times a week, using the Cogpack software. Cogpack is a software composed of many exercises and tasks for improvement of different domains of cognition, like attention, memory, language, planning, etc. In this study we aim to use some of these exercises to improve attention, memory and executive function. All of the sessions are going to be conducted by an occupational therapist in day center of Roozbeh Hospital. Usual standard treatment will include medication treatment and patient and family psychoeducation. Intervention 2: Control group: The control group will only receive usual standard treatment including medication treatment and patient and family psychoeducation.</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 It has not been decided yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehrnoosh vahidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Roozbeh hospital, South Kargar Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>13337159140</zip>
        <telephone>+98 21 5541 2222</telephone>
        <email>mehrnoosh.vahidi@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Mirsepasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Roozbeh hospital, South Kargar Ave.</address>
        <city>Teharn</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>13337159140</zip>
        <telephone>+98 21 5541 2222</telephone>
        <email>z-mirsepassi@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>people with bipolar disorder in partial or complete remission ( Young Mania Rating Scale (Y-MRS) score less than 8 and Hamiltone Depression Rating Scale (HDRS) score less than 8)
Education level higher than 8th grade
IQ level above 70 based on Wechsler intelligence scale</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>A history of substance abuse (except nicotine and caffeine) within the past month
A history of Electroconvulsive therapy within the six weeks prior to the study
A history of head trauma followed by loss of consciousness
Comorbidity of major neurological disorders including epilepsy, Parkinson’s disease, dementia etc.
Acute episode or active phase of the disease which requires immediate intervention</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the present study, the intervention group, in addition to usual standard treatment, will receive the intervention which consists of 12 personal sessions of ninety-minute computer-based training for cognitive remediation, twice or three times a week, using the Cogpack software. Cogpack is a software composed of many exercises and tasks for improvement of different domains of cognition, like attention, memory, language, planning, etc. In this study we aim to use some of these exercises to improve attention, memory and executive function. All of the sessions are going to be conducted by an occupational therapist in day center of Roozbeh Hospital. Usual standard treatment will include medication treatment and patient and family psychoeducation.</i_keyword>
      <i_keyword>Control group: The control group will only receive usual standard treatment including medication treatment and patient and family psychoeducation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Executive function score. Timepoint: before and after intervention. Method of measurement: Stockings of Cambridge test of CANTAB battery tests.</prim_outcome>
      <prim_outcome>Visual memory score. Timepoint: before and after intervention. Method of measurement: Delayed matching to sample test of CANTAB  battery tests.</prim_outcome>
      <prim_outcome>Spatial working Memory score. Timepoint: before and after study. Method of measurement: Spatial working memory test of CANTAB  battery tests.</prim_outcome>
      <prim_outcome>Attention score no.1. Timepoint: before and after study. Method of measurement: Choice Reaction time test of CANTAB battery tests.</prim_outcome>
      <prim_outcome>Attention score no.2. Timepoint: Before and after intervention. Method of measurement: Rapid visual information processing test of CANTAB  battery tests.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life score. Timepoint: Before and after intervention. Method of measurement: Michalak Quality of Life in Bipolar Disorder scale.</sec_outcome>
      <sec_outcome>Clinical global impression score. Timepoint: Before and after intervention. Method of measurement: Clinical global impression scale.</sec_outcome>
      <sec_outcome>Global function score. Timepoint: before and after intervention. Method of measurement: Global Assessment of Functioning scale.</sec_outcome>
      <sec_outcome>Hamiltone depression rating scale score. Timepoint: before and after intervention. Method of measurement: Hamiltone depression rating scale.</sec_outcome>
      <sec_outcome>Young mania rating scale score. Timepoint: before and after intervention. Method of measurement: Young mania rating 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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-10</approval_date>
        <contact_name>Ethics committee of School of Medicine, Tehran University of Medical Sciences</contact_name>
        <contact_address>Roozbeh hospital, South Kargar Ave., Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
