<?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>IRCT20200307046713N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-19</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of the effectiveness of stress inoculation and Compassion-Focused therapy on resiliency and anger rumination and perceived stress in the hypertensive women</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of stress inoculation and Compassion-Focused therapy on resiliency and anger rumination and perceived stress in the hypertensive women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47147</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Using the block randomization method by the statistical consultant, the following randomization is done in 3 groups of stress immunization, compassion-based treatment and control: First, the list of names of qualified people is provided and coded. In block randomization, the number of participants in all groups will be very close, this is done by building blocks of sequences and intersections so that the same number of participants are allocated to study groups within each group. First, we encode the groups based on the Latin letters as follows:
 A = immunization against stress, B = compassionate treatment and C control group
In this study, with three groups A, B and C, we create the following six groups and assign the numbers 1 to 6 to each:
ABC-ACB-BAC-BCA-CAB-CBA
Then, using the table of random numbers, we contract that if the numbers 1, 2, 3, 4, 5, 6, and 6 appear in order, one of these blocks will be selected, and if another number appears, we will assume it to be null and void and move on to the next selection. In fact, we have obtained a random sequence of numbers with a table of random numbers, which we consider the order of the assigned allocation for each number. In this way, the number of people in the groups will be almost equal.</study_design>
      <phase>N/A</phase>
      <hc_freetext>hypertension.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: In the present study, the meaning of immunization against stress is 10 treatment sessions based on immunization intervention against stress Habibi et al.'s (2014), which are two sessions per week (for one and a half months) and each session. 90 minutes were held. The group also receives medical treatment for high blood pressure. Intervention 2: Intervention group II: Compassion focused therapy and a 90 minute 10 session treatment plan twice a week (for a month and a half) based on Compassion focused therapy Neff (2004) protocol and designed as a group experimental group subjects are provided. The group also receives medical treatment for high blood pressure. Intervention 3: Control group: No Intervention, but the group also receives medical treatment for high blood pressure.</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:
Only part of the data, such as information about the main outcome or the like, can be shared.

When:
Start of access period 6 months after printing results

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

Conditions:
Any type of analysis on the data delivered is permitted

Where to obtain:
Elahe Sadeghlou
Adress: No. 11, West Azerbaijan Ave., Valiasr Blvd.
Tel: +98 21 8457 9643

How to obtain:
The request will be sent by email to: e.sadeghlou@iaukishint.ac.ir

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elahe Sadeghlou</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 11, West Azerbaijan Ave., Valiasr Blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>2578695784</zip>
        <telephone>+98 21 8457 9643</telephone>
        <email>e.sadeghlou@iaukishint.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elahe Sadeghlou</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 11, West Azerbaijan Ave., Valiasr Blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>2578695784</zip>
        <telephone>+98 21 8457 9643</telephone>
        <email>e.sadeghlou@iaukishint.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Maximum age 60
high blood pressure
willingness to participate in medical intervention
minimal literacy
ability to listen normally
conscious consent to attend therapy sessions</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having chronic physical illness with high blood pressure such as diabetes
having severe depression
having mental disorders requiring immediate treatment
disrupting the normal course of treatment
amputation and severe physical disability
lack of cooperation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Essential (primary) hypertension</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: In the present study, the meaning of immunization against stress is 10 treatment sessions based on immunization intervention against stress Habibi et al.'s (2014), which are two sessions per week (for one and a half months) and each session. 90 minutes were held. The group also receives medical treatment for high blood pressure.</i_keyword>
      <i_keyword>Intervention group II: Compassion focused therapy and a 90 minute 10 session treatment plan twice a week (for a month and a half) based on Compassion focused therapy Neff (2004) protocol and designed as a group experimental group subjects are provided. The group also receives medical treatment for high blood pressure.</i_keyword>
      <i_keyword>Control group: No Intervention, but the group also receives medical treatment for high blood pressure.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Resilience. Timepoint: Measurement will be done in pre-test, post-test and follow-up three months after post-test. Method of measurement: Connor and Davidson Resilience Scale.</prim_outcome>
      <prim_outcome>Anger Rumination. Timepoint: Measurement will be done in pre-test, post-test and follow-up three months after post-test. Method of measurement: Anger Rumination Questionnaire.</prim_outcome>
      <prim_outcome>Perceived stress. Timepoint: Measurement will be done in pre-test, post-test and follow-up three months after post-test. Method of measurement: Perceived stress scale.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-07</approval_date>
        <contact_name>Ethics committee of Hormozgan University of Medical Sciences</contact_name>
        <contact_address>No. 64, Janbazan Ave., North Karegar Street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
