<?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>IRCT201509224076N17</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-11-02</date_registration>
      <primary_sponsor>Vice chancellor for research, Tehran university of medical sciences</primary_sponsor>
      <public_title>The effect of Acceptance and Commitment Therapy on HIV Infected patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Acceptance and Commitment Therapy (ACT) on Mindfulness Skills , Thought Suppression , Thought Control , Inflexibility , And Valued living Among HIV Infected patients .</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4261</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>HIV AIDS.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This study is conducted to determine the effectiveness of Acceptance and Commitment Therapy (ACT) on mindfulness skills, thought suppression, thought control, inflexibility and valued living in patients with AIDS  in Tehran. A Pretest-Posttest, two-group, quasi-experimental design is used as the research method. The study population consist of AIDS patients who referred to the clinic of research center for HIV/AIDS and sexually transmitted diseases in Imam Khomeini hospital in fall/winter 2015-16, of which 30 volunteers ( who meet the inclusion criteria, consist of: being HIV positive and consent to participate; being in age range of 30 to 58 years old) are selected and randomly divide into control and experimental groups. The questionnaire of Kentucky Inventory of Mindfulness Skills (used by Baer et al., 2004), the questionnaire of thought suppression (used by Schmidt et al., 2009), thought control questionnaire (used by Luciano et al., 2009), the inflexibility questionnaire (used by Bond et al., 2003) and valued living questionnaire (used by Wilson et al., 2010), are applied as the research tools. Intervention 2: Control group: there are not 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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Minoo Mohraz MD</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iranian research Center for HIV AIDS (IRCHA),Imam Hospital, Keshavarz BLVd , Valiasr Sq   Tehran  Iran, Islamic Republic Of</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6694 7984</telephone>
        <email>ircha@tums.ac.ir</email>
        <affiliation>Iranian research Center for HIV AIDS (IRCHA)</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Minoo Mohraz MD</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iranian research center for HIV AIDS, Imam Hospital, Keshavarz BLVd , Valiasr Sq  Tehran  Tehran  Iran, Islamic Republic Of</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6658 1583</telephone>
        <email>ircha@tums.ac.ir</email>
        <affiliation>Iranian research center for HIV AIDS</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: being HIV positive and consent to participate; being in age range of 30 to 58 years old.&#13;
Exclusion criteria: Participants are excluded if they do not meet the inclusion criteria</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>58 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>Human immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseases</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: This study is conducted to determine the effectiveness of Acceptance and Commitment Therapy (ACT) on mindfulness skills, thought suppression, thought control, inflexibility and valued living in patients with AIDS  in Tehran. A Pretest-Posttest, two-group, quasi-experimental design is used as the research method. The study population consist of AIDS patients who referred to the clinic of research center for HIV/AIDS and sexually transmitted diseases in Imam Khomeini hospital in fall/winter 2015-16, of which 30 volunteers ( who meet the inclusion criteria, consist of: being HIV positive and consent to participate; being in age range of 30 to 58 years old) are selected and randomly divide into control and experimental groups. The questionnaire of Kentucky Inventory of Mindfulness Skills (used by Baer et al., 2004), the questionnaire of thought suppression (used by Schmidt et al., 2009), thought control questionnaire (used by Luciano et al., 2009), the inflexibility questionnaire (used by Bond et al., 2003) and valued living questionnaire (used by Wilson et al., 2010), are applied as the research tools.</i_keyword>
      <i_keyword>Control group: there are not any intervention in this group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mindfulness Skills. Timepoint: Before intervention and 6 months after intervention. Method of measurement: The questionnaire of Kentucky Inventory of Mindfulness Skills.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Thought Suppression. Timepoint: Before intervention and 6 months after intervention. Method of measurement: The questionnaire of thought suppression (used by Schmidt et al.).</sec_outcome>
      <sec_outcome>Thought Control. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Thought control questionnaire (used by Luciano et al.).</sec_outcome>
      <sec_outcome>Inflexibility. Timepoint: Before intervention and 6 months after intervention. Method of measurement: The inflexibility questionnaire (used by Bond et al.).</sec_outcome>
      <sec_outcome>Valued living. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Valued living questionnaire (used by Wilson et al.).</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>Vice chancellor for research, Tehran university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-06-28</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Central building of TUMS, Ghods St, Keshavarz Blvd, Valiasr Sq  Tehran    Iran, Islamic Republic Of Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
