<?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>IRCT20190812044518N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-10-08</date_registration>
      <primary_sponsor>Ferdowsi University of Mashhad</primary_sponsor>
      <public_title>Comparison of the Effectiveness of Mindfulness and Body Pysichotherapy on Hippocampus Modulation</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of Mindfulness and  Body Psychotherapy on Hippocampal Modulation (Volume and Function) and Depression and Executive Function in Patients with Post-Stroke Depression</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-02-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41503</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization using statistical site.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Post-stroke depression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: This intervention group receives mindfulness for sixteen one-hour sessions, two days a week. This stress reduction protocol is designed by Kabat Zain (1990). Techniques in this section include relaxation, meditation and meditation along with simple yoga exercises. Intervention 2: Intervention group 2: This group receives physical therapy intervention for thirty-six one hour sessions, three days a week. This protocol is based on a mix motor and psychological exercises designed by Rohrichet in 2013. Among the techniques in this section are systematic relaxation, balance exercises and rhythmic exercises with breathing and eye movement desentisation reprossesing. Intervention 3: Control group: Ten patients who don't receive any intervention in this group.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Data can be shared transparently and without identification variables

When:
Start access period one year after publishing the results in a reputable journal

To whom:
Data will be available only to university researchers and university affiliates

Conditions:
The data will be available only for the purpose of modeling the process and comparing the results and forecasting the scientific results...

Where to obtain:
Sending e mail to responsible author for access to data
Email sdoctornazmb@gmail.com

How to obtain:
The data will be made available to the researcher one or two weeks after receiving the email from the applicant.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sahar Sadat  Nazm Bojnourdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>18.., misagh Alley No.  Mirza kochak Khan St.</address>
        <city>Bojnourd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9414614201</zip>
        <telephone>0098 58 3226225</telephone>
        <email>sdoctornazmb@gmail.com</email>
        <affiliation>Mashhad Ferdowsi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>sahar sadat nazm bojnourdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 18, Misagh alley, Mirza Kochak Khan street</address>
        <city>Bojourd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9414614201</zip>
        <telephone>0098 58 3226225</telephone>
        <email>sdoctornazmb@gmail.com</email>
        <affiliation>Mashhad Ferdowsi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Lasting more than three months after a stroke
a left hemisphere lesion confirmed by a neurologist and an MRI or CT scan
A history of having stroke only for one time
ability to read and write
depression test score above ten</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The patient has a history of a second stroke
Simultaneous use of tobacco and smoking
The patient has a history of other chronic illnesses
The patient has a history of psychological illness other than depression
Patient with aphasia and impaired consciousness
The patient has acute economic problems</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: This intervention group receives mindfulness for sixteen one-hour sessions, two days a week. This stress reduction protocol is designed by Kabat Zain (1990). Techniques in this section include relaxation, meditation and meditation along with simple yoga exercises.</i_keyword>
      <i_keyword>Intervention group 2: This group receives physical therapy intervention for thirty-six one hour sessions, three days a week. This protocol is based on a mix motor and psychological exercises designed by Rohrichet in 2013. Among the techniques in this section are systematic relaxation, balance exercises and rhythmic exercises with breathing and eye movement desentisation reprossesing.</i_keyword>
      <i_keyword>Control group: Ten patients who don't receive any intervention in this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression score in Beck Questionnaire. Timepoint: Depression test scores are measured before the intervention as pre-test and also in the first intervention group at the end of the eighth week of mindfulness intervention and in the second intervention group at the end of the twelfth week, body pcychotherapy intervention. Method of measurement: Beck Depression Questionnaire.</prim_outcome>
      <prim_outcome>National Institutes of Health(NIH) Stroke Scale Questionnaire Score. Timepoint: National Institutes of Health(NIH) Stroke Scale Questionnaire Score is measured before the intervention as pre-test and also in the first intervention group at the end of the eighth week of mindfulness intervention and in the second intervention group at the end of the twelfth week, body pcychotherapy intervention. Method of measurement: National Institutes of Health(NIH) Stroke Scale Questionnaire.</prim_outcome>
      <prim_outcome>Wechsler Digit Span measurement tool Score. Timepoint: Wechsler Digit Span measurement tool Score is measured before the intervention as pre-test and also in the first intervention group at the end of the eighth week of mindfulness intervention and in the second intervention group at the end of the twelfth week, body pcychotherapy intervention. Method of measurement: Wechsler Digit Span measurement tool.</prim_outcome>
      <prim_outcome>Course block Computer Psychological Test Score. Timepoint: Course block Computer Psychological Test Score is  measured before the intervention as pre-test and also in the first intervention group at the end of the eighth week of mindfulness intervention and in the second intervention group at the end of the twelfth week, body pcychotherapy intervention. Method of measurement: Course block Computer Psychological Test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Wisconsin Card Test score. Timepoint: Wisconsin Card Test score is measured before the intervention as pre-test and also in the first intervention group at the end of the eighth week of mindfulness intervention and in the second intervention group at the end of the twelfth week, body pcychotherapy intervention. Method of measurement: Wisconsin Card Test.</sec_outcome>
      <sec_outcome>London Tower Test score. Timepoint: London Tower Test score is measured before the intervention as pre-test and also in the first intervention group at the end of the eighth week of mindfulness intervention and in the second intervention group at the end of the twelfth week, body pcychotherapy intervention. Method of measurement: London Tower Test.</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>Ferdowsi University of Mashhad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-08-23</approval_date>
        <contact_name>Ethics committee of Bojnourd University of Medical Sciences</contact_name>
        <contact_address>Bojnourd University of Medical Sciences, Janbaz Blvd, Talghni street Bojnourd North Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
