<?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>IRCT201106084076N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-11-27</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of mindfulness based stress reduction on HIV patients</public_title>
      <acronym>MBSR2</acronym>
      <scientific_title>The effect of mindfulness based stress reduction (MBSR) on CD4+ T Lymphocyte Count and Medical and Psychological Symptoms of HIV/AIDS infected patients referring to counseling center for behavioral diseases in Imam Khomeini Hospital, 2008</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2008-06-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>245</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4247</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>HIV  infected people.</hc_freetext>
      <i_freetext>Participants in the MBSR condition attended eight weekly group-based MBSR classes. MBSR is implemented in a class setting, in which sitting meditation, gentle mindful hatha yoga, a body scan meditation, and other approaches to cultivate mindfulness in everyday living are introduced. A psychologist who was formally trained in the MBSR program at the University of Massachusetts Center delivered the classes. In brief, session 1 and 2 consisted of a mindfulness body scan practice. Session 3 and 4 consisted of awareness of body postures via light Hatha yoga practices. Sessions 5 through 7 consisted of sitting mindfulness meditation. Session 8 consisted of a retreat lasting 6-7 hours, which incorporated all the practices learned in sessions 1 through 7. During the final session, a general discussion took place regarding encountering stress and how to apply MBSR techniques in daily life. Participants in control group received their usual clinical attention. Control group was provided with educational information and pamphlets about living healthy with HIV/AIDS. Education content focused on the following topics: 1) routes of HIV transmission, 2) HIV prevention, 3) facts and expectations about HIV drug therapy, and 4) maintaining positive behavior and cognitions while living with HIV. A psychologist was also available for the control group members during the intervention period to provide individual counselling..</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>Maryam Foroughi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini hospital , Keshavarz Blvd, valiasr sq, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>11468654</zip>
        <telephone>+98 21 6694 7984</telephone>
        <email>Maryam.foroughi@ gmail.com</email>
        <affiliation>Iranian research center for HIV/ AIDS</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Minoo Mohraz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini hospital , Keshavarz . Blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>11468546</zip>
        <telephone>+98 21 6694 7984</telephone>
        <email>minoomohraz@ams.ac.ir</email>
        <affiliation>Iranian Research center for HIV/ AIDS</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>HIV positive patients were eligible to participate in the study if they had these conditions:&#13;
HIV+ confirmed by Western Blot,      &#13;
CD4 &gt;200,&#13;
 Age&gt;18, and&#13;
 Age≤55,&#13;
patients were excluded if they had:&#13;
current substance addiction, &#13;
current psychosis, &#13;
history of post-traumatic stress disorder, &#13;
or if they had CD4 count under 200,&#13;
or were clinically symptomatic (e.g., herpes zoster, oral candidiasis, shingles, significant weight loss)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B24</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified human immunodeficiency virus [HIV] disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Participants in the MBSR condition attended eight weekly group-based MBSR classes. MBSR is implemented in a class setting, in which sitting meditation, gentle mindful hatha yoga, a body scan meditation, and other approaches to cultivate mindfulness in everyday living are introduced. A psychologist who was formally trained in the MBSR program at the University of Massachusetts Center delivered the classes. In brief, session 1 and 2 consisted of a mindfulness body scan practice. Session 3 and 4 consisted of awareness of body postures via light Hatha yoga practices. Sessions 5 through 7 consisted of sitting mindfulness meditation. Session 8 consisted of a retreat lasting 6-7 hours, which incorporated all the practices learned in sessions 1 through 7. During the final session, a general discussion took place regarding encountering stress and how to apply MBSR techniques in daily life. Participants in control group received their usual clinical attention. Control group was provided with educational information and pamphlets about living healthy with HIV/AIDS. Education content focused on the following topics: 1) routes of HIV transmission, 2) HIV prevention, 3) facts and expectations about HIV drug therapy, and 4) maintaining positive behavior and cognitions while living with HIV. A psychologist was also available for the control group members during the intervention period to provide individual counselling.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>CD4 lymphocyte count. Timepoint: Participants did CD4 count at pretest, immediate posttest, and 3, 6, 9 and 12 month post-intervention follow-up periods. Method of measurement: CD4 count was determined by flow cytometry.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Medical Symptom Checklist (MSCL) which is a 115-item self-report measure of physical symptomatology that quantifies the number of common medical symptoms occurring in the previous month, and Symptom Checklist-90-Revised (SCL-90R) includes a 90-item self-report of mental health measured on a 5-point rating scale to assess a broad range of psychological problems and symptoms of psychopathology. Timepoint: Participants completed the self-report questionnaires at pretest, immediate posttest, and 3, 6, 9 and 12 month post-intervention follow-up periods. Method of measurement: MSCL and SCL-90R Questionnaires.</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>2007-09-23</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>Keshavarz Blvd, Ghods St Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
