<?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>IRCT20210614051580N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-14</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of mindfulness counseling on self-esteem and psychological distress of HIV positive women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of mindfulness counseling on self-esteem and psychological distress of HIV positive women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60095</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: How to make a block accident (9 blocks of 6). Create two groups A and B naming. After adding 6 of the two groups A and B, we write, for example, ABABAB -AAABBB-ABBAAB-BBBAAA
Assign one combination to each block and assign people in each block to treatment groups.
The randomization list is based on a table of random numbers.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Human Immunodeficiency Viruses.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Counseling is done by a trained researcher and supervised by a consultant professor at the center. Women in the intervention group undergo 8 sessions of group counseling (one session per week) with a mindfulness-based cognitive therapy approach aimed at improving self-esteem and psychological disturbance of HIV-positive women. Group sessions, one 90-minute session per week as scheduled between the counselor and clients. Full awareness of thoughts and feelings Emphasizing the non-permanence of negative feelings, that thoughts are not true, and the ways in which thoughts can be viewed from different angles, and people's new beliefs are discussed. The content of the sessions is as follows: Session 1: (Automatic guidance) Raisin-conscious mind-eating exercise: A meditation in which participants spend a few minutes examining the sensory-visual, olfactory, and taste characteristics of a raisin seed. And Body Exercise: A meditation in which participants focus their attention on the senses in different parts of the body through breathing. Session 2: (Facing Obstacles) Practice Examining the Body and Practicing Thoughts and Emotions: Participants visualize a scenario such as a friend not saying hello, then examine their reactions to such an event and the impact on mood. Session 3: (Presence of mind from breathing) Three-minute breathing space and conscious mind walking Participants are invited to move according to the breathing pattern, the position of the legs and body sensations caused by attention. Session 4: (Staying in the present) Meditation practice of seeing and hearing: Participants are asked to focus their attention on visual sights or sounds and to slowly return to these senses when their mind wanders. Session 5: (Reception) 40 minutes of sitting meditation, review exercise: Participants pay attention to breathing, body senses, sounds and thoughts. Also pay attention to the confusion of the mind. Session 6: (Thoughts are not facts) Sitting meditation 40 minutes Imagine thoughts as images on a movie screen or passing clouds or river leaves. Session 7: (Self-care) Pointing to the relationship between mood and activity: Preparing a list of activities and dividing them into increasing and decreasing the level of mood and energy Session 7: (Using what has been learned) Review of past content, reflection. Intervention 2: Control group: Due to the fact that the control group did not receive any intervention despite the low level of self-esteem and psychological turmoil. In order to make the research ethical, after completing the study, an educational booklet and a summary of the contents of the sessions are given to them.</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:
All data is potentially shareable after unidentified individuals

When:
Access period starts 6 months after the results are published

To whom:
The data will be available only to researchers working in academic and scientific institutions

Conditions:
The data can be used for future studies.

Where to obtain:
Send email to the responsible author Ms. Maryam Beheshtinasab

How to obtain:
After sending the email and reviewing the request and verifying the study, the request will be answered.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Beheshti Nasab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan St., Ahvaz University of Medical Sciences</address>
        <city>AHWAZ</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15794-61357</zip>
        <telephone>+98 61 3311 4329</telephone>
        <email>MARY.MIDWIFE@GMAIL.COM</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Beheshtinasab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan St., Ahvaz University of Medical Sciences</address>
        <city>AHWAZ</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15794-61357</zip>
        <telephone>+98 61 3311 4329</telephone>
        <email>MARY.MIDWIFER@GMAIL.COM</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in research
Married
Age between 20-40 years
Score less than 25 on the Cooper-Smith Questionnaire
Score less than 18 on the BECK Depression Inventory
Continuous participation in group meetings
HIV positive women</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Other physical and acute diseases and endocrine disorders such as diabetes and thyroid disorders based on the patient's medical record
Simultaneous use of counseling and other educational services in order to increase self-esteem
Having severe psychiatric disorders
Occurrence of stressful and unfortunate events during the last 3 months
Consumption of alcohol and psychotropic substances by the patient and his wife</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Human Immunodeficiency Virus [HIV] disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Counseling is done by a trained researcher and supervised by a consultant professor at the center. Women in the intervention group undergo 8 sessions of group counseling (one session per week) with a mindfulness-based cognitive therapy approach aimed at improving self-esteem and psychological disturbance of HIV-positive women. Group sessions, one 90-minute session per week as scheduled between the counselor and clients. Full awareness of thoughts and feelings Emphasizing the non-permanence of negative feelings, that thoughts are not true, and the ways in which thoughts can be viewed from different angles, and people's new beliefs are discussed. The content of the sessions is as follows: Session 1: (Automatic guidance) Raisin-conscious mind-eating exercise: A meditation in which participants spend a few minutes examining the sensory-visual, olfactory, and taste characteristics of a raisin seed. And Body Exercise: A meditation in which participants focus their attention on the senses in different parts of the body through breathing. Session 2: (Facing Obstacles) Practice Examining the Body and Practicing Thoughts and Emotions: Participants visualize a scenario such as a friend not saying hello, then examine their reactions to such an event and the impact on mood. Session 3: (Presence of mind from breathing) Three-minute breathing space and conscious mind walking Participants are invited to move according to the breathing pattern, the position of the legs and body sensations caused by attention. Session 4: (Staying in the present) Meditation practice of seeing and hearing: Participants are asked to focus their attention on visual sights or sounds and to slowly return to these senses when their mind wanders. Session 5: (Reception) 40 minutes of sitting meditation, review exercise: Participants pay attention to breathing, body senses, sounds and thoughts. Also pay attention to the confusion of the mind. Session 6: (Thoughts are not facts) Sitting meditation 40 minutes Imagine thoughts as images on a movie screen or passing clouds or river leaves. Session 7: (Self-care) Pointing to the relationship between mood and activity: Preparing a list of activities and dividing them into increasing and decreasing the level of mood and energy Session 7: (Using what has been learned) Review of past content, reflection</i_keyword>
      <i_keyword>Control group: Due to the fact that the control group did not receive any intervention despite the low level of self-esteem and psychological turmoil. In order to make the research ethical, after completing the study, an educational booklet and a summary of the contents of the sessions are given to them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-esteem. Timepoint: At the beginning of the study, week 8 and week 12 after the intervention. Method of measurement: Coopersmith Self-Esteem Questionnaire.</prim_outcome>
      <prim_outcome>Public self-esteem. Timepoint: At the beginning of the study, week 8 and week 12 after the intervention. Method of measurement: Coopersmith Self-Esteem Questionnaire.</prim_outcome>
      <prim_outcome>Social self-esteem. Timepoint: At the beginning of the study, week 8 and week 12 after the intervention. Method of measurement: Coopersmith Self-Esteem Questionnaire.</prim_outcome>
      <prim_outcome>Family self-esteem. Timepoint: At the beginning of the study, week 8 and week 12 after the intervention. Method of measurement: Coopersmith Self-Esteem Questionnaire.</prim_outcome>
      <prim_outcome>Academic-professional self-esteem. Timepoint: At the beginning of the study, week 8 and week 12 after the intervention. Method of measurement: Coopersmith Self-Esteem Questionnaire.</prim_outcome>
      <prim_outcome>Anxiety level. Timepoint: At the beginning of the study, week 8 and week 12 after the intervention. Method of measurement: Beck Depression Questionnaire.</prim_outcome>
      <prim_outcome>Stress levels. Timepoint: At the beginning of the study, week 8 and week 12 after the intervention. Method of measurement: Beck Depression Questionnaire.</prim_outcome>
      <prim_outcome>Level of depression. Timepoint: At the beginning of the study, week 8 and week 12 after the intervention. Method of measurement: Beck Depression Questionnaire.</prim_outcome>
      <prim_outcome>Psychological distress. Timepoint: At the beginning of the study, week 8 and week 12 after the intervention. Method of measurement: Beck Depression Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-23</approval_date>
        <contact_name>Ethics Committee of Ahvaz University of Medical Sciences</contact_name>
        <contact_address>Golestan St., Ahvaz University of Medical Sciences Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
