<?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>IRCT20190223042813N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-02</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effectiveness of Cognitive-Behavioral Group Therapy ; Cognitive Therapy based on Mindfulness and combined therapy of  Cognitive_ Behavioral /The recognition of the  Therapy based on Mindfulness on Improving Sleep Quality,  life  Quality Perceived Social Support and  Increase CD4  in Admitted HIV/AIDS to Ahwaz City</public_title>
      <acronym>HIV/AIDS</acronym>
      <scientific_title>The Comparison between of the Effectiveness of Cognitive-Behavioral Group Therapy ; Cognitive Therapy based on Mindfulness and combined therapy of  Cognitive_ Behavioral /The recognition of the  Therapy based on Mindfulness on Improving Sleep Quality,  life  Quality Perceived Social Support and  Increase CD4 in Admitted HIV/AIDS</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37858</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: An in-class randomized permutation block is used. Subjects are divided into 4 classes.
The first floor is women 30 to 50 years old
Second step women from 25 to 29 years old
Third of men is 30 to 50 years old
Fourth, 25-29 years
According to the sample size of 15 people in each treatment group, 45 people were enrolled in the study and each floor is 15 people. A group of segments was coded in each class
Group 1: Code 10, 11, 12 and .....................
The second group is code 20, 21, 22 and ............................
Group 3 code 30, 31, 32 and ..............................
The fourth group code 40, 41, 42 and ...................... Then, randomization is done in the treatment of CBT, MBCT, combination of both treatment and control group. . We encode groups based on latin letters.
A: CBT B: MBCT
C: Combination of both treatments D: Control group
We assign a number from 1 to 8 each.
ABCD. ACBD BACD.BCAD. CABD.CBAD. DABC.DACB We use a random number table to construct. On each floor, one of the numbers 1, 2, 3, 4, 5, 6, 7, 8, it turned out that one of these blocks is selected, and if another number appears We take the absurd and go to the next selection and invite selected people in groups A, B, C and D to attend class meetings separately.
For follow up, subjects will have 3-4 months of interventional therapy and a follow-up period of 2 months.</study_design>
      <phase>N/A</phase>
      <hc_freetext>HIV/AIDS.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group one: The effectiveness of the Cognitive-Behavioral Therapy Group's Agenda Therapy (Tashabala, 2018) on stigma HIV AIDS that was modified by this guideline. This treatment was presented in 8 sessions, once a week, in 45-minute sessions based on the treatment protocol. Intervention 2: Intervention Group II: The Effect of Mindfulness-Based Cognitive Therapy on Aging Using Garcia, Boras, Lopez &amp; McNeill 2016 for HIV, in which treatment is administered 8 sessions once a week for 45 minutes on a face-to-face basis. Treatment sessions were provided. Intervention 3: Intervention Group Three: Combined Cognitive-Behavioral Therapy / Mindfulness-Based Cognitive Therapy The combination of the Cognitive Behavioral Therapy Meeting Agenda (Tashabala, 2018) and the Mindfulness-Based Cognitive Therapy Agenda (Garcia et al., 2016) are both therapeutic approaches. Meetings are held once a week in 45-minute sessions. Intervention 4: control group: . Also, according to the treatments performed in the control group for each treatment group or 15-person treatment intervention in this study.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is It is not decided</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>shahla molavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Angle Street Children's Clinic. Behavioral Disease Counseling Center</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6187898434</zip>
        <telephone>+98 61 3445 4600</telephone>
        <email>shahla_molavi@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>shahla molavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zawei Street, Children's Health Center. Behavioral Diseases Center</address>
        <city>ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6187898434</zip>
        <telephone>+98 61 3445 4600</telephone>
        <email>shahla_molavi@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>. Age 25 to 50 years old
A resident of Ahvaz
Minimum cycle  education .
Ability to speak fluent  persian.
At least 350 CD4 patients</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having  history of mental illness,  depression mental disorder
Taking psychosocial drugs
Suicidal thoughts.
Having addiction</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B20</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>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group one: The effectiveness of the Cognitive-Behavioral Therapy Group's Agenda Therapy (Tashabala, 2018) on stigma HIV AIDS that was modified by this guideline. This treatment was presented in 8 sessions, once a week, in 45-minute sessions based on the treatment protocol.</i_keyword>
      <i_keyword>Intervention Group II: The Effect of Mindfulness-Based Cognitive Therapy on Aging Using Garcia, Boras, Lopez &amp; McNeill 2016 for HIV, in which treatment is administered 8 sessions once a week for 45 minutes on a face-to-face basis. Treatment sessions were provided.</i_keyword>
      <i_keyword>Intervention Group Three: Combined Cognitive-Behavioral Therapy / Mindfulness-Based Cognitive Therapy The combination of the Cognitive Behavioral Therapy Meeting Agenda (Tashabala, 2018) and the Mindfulness-Based Cognitive Therapy Agenda (Garcia et al., 2016) are both therapeutic approaches. Meetings are held once a week in 45-minute sessions.</i_keyword>
      <i_keyword>control group: . Also, according to the treatments performed in the control group for each treatment group or 15-person treatment intervention in this study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of lifeand. Timepoint: It will take 16 weeks to complete. For monitoring the subjects, 3 to 4 months of intervention and 2 months of Falwap are considered. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: It will take 16 weeks to complete. For monitoring the subjects, 3 to 4 months of intervention and 2 months of Falwap are considered. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Perceived social support. Timepoint: It will take 16 weeks to complete. For monitoring the subjects, 3 to 4 months of intervention and 2 months of Falwap are considered. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Changes in CD4 cells. Timepoint: It will take 16 weeks to complete. For monitoring the subjects, 3 to 4 months of intervention and 2 months of Falwap are considered. Method of measurement: Measuring the amount of cells cd4.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life, quality of life, perceived social support and changes in CD4 cells. Timepoint: It will take 16 weeks to complete. For monitoring the subjects, 3 to 4 months of intervention and 2 months of Falwap are considered. Method of measurement: questionnaire.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-04</approval_date>
        <contact_name>Ethics committee of AHVAZ branch Islamic Azad University</contact_name>
        <contact_address>Angle Street Aboozar Children's Clinic. Ahvaz Behavioral Counseling Counseling Center AHVAZ Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
