<?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>IRCT20191214045733N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-28</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparing the effectiveness of cognitive-behavioral therapy (CBT) and Acceptance and Commitment Therapy (ACT) on anxiety, perceived stress and coping with pain in patients with Leukemia</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of cognitive-behavioral therapy (CBT) and Acceptance and Commitment Therapy (ACT) on anxiety, perceived stress and coping with pain in patients with Leukemia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44411</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block randomization was performed by the statistical consultant as follows: Randomization was performed in three groups: Acceptance and Commitment Therapy, Cognitive-Behavioral Therapy, and Control group. Block randomization was done by building blocks of sequences so that the same number of participants was assigned to study groups within each group. We first coded the groups in Latin letters as follows:
 A = Acceptance and Commitment Therapy, B = Cognitive-Behavioral Therapy, and C= Control Group
In this study with three groups A, B and C we created the following six groups and assign 1 to 6 each:
ABC-ACB-BAC-BCA-CAB-CBA
Then we used a random number table to select one of these blocks whenever the numbers 1, 2, 3, 4, 5 and 6 appear, and if the other number appears, considered null and go to the next choice. In fact, we obtained a random sequence of numbers with a random number table that we considered the order of assignment for each number. As such, the number of people in the groups was approximately equal.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Leukemia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group One: Acceptance and commitment Therapy - For the first experimental group, 9 sessions of 90-minute Acceptance and commitment Therapy will be taught in groups (Hayes, 2004). Intervention 2: Second Group Intervention: Cognitive Behavioral Therapy - For the second group Cognitive Behavioral Therapy (Beck, 1988) will be administered in 12 sessions and each session for 90 minutes. Intervention 3: Control group: No Intervention.</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:
Manouchehr Faryabi, Postal address: Kerman, Jiroft, Azadi St., No.313

How to obtain:
The request will be sent by email to:  faryabi_m@yahoo.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Manouchehr Faryabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 313, Azadi Street,</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7861733869</zip>
        <telephone>+98 34 4326 4000</telephone>
        <email>faryabi_m@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Manouchehr Faryabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 313, Azadi Street,</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7861733869</zip>
        <telephone>+98 34 4326 4000</telephone>
        <email>faryabi_m@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 30 to 80 years
Having a minimum reading and writing literacy
Normal listening ability
Informed consent to attend therapy sessions</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having any chronic diseases like diabetes, heart disease and lung disease
Having any physical or mental disability
Any drug use
Taking any sedative medication
History of psychiatric illness
Absence in more than 3 treatment sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C91</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Lymphoid leukemia</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>Intervention Group One: Acceptance and commitment Therapy - For the first experimental group, 9 sessions of 90-minute Acceptance and commitment Therapy will be taught in groups (Hayes, 2004).</i_keyword>
      <i_keyword>Second Group Intervention: Cognitive Behavioral Therapy - For the second group Cognitive Behavioral Therapy (Beck, 1988) will be administered in 12 sessions and each session for 90 minutes.</i_keyword>
      <i_keyword>Control group: No Intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Measurement will be done in pre-test, post-test and follow-up three months after post-test. Method of measurement: Beck Anxiety Inventory (1988).</prim_outcome>
      <prim_outcome>Coping with pain. Timepoint: Measurement will be done in pre-test, post-test and follow-up three months after post-test. Method of measurement: Pain coping strategies Questionnaire Roseneshteil and kiev (2000).</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 Cohen et.al (1983).</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>Hormozgan University of Medical Sciences</contact_name>
        <contact_address>Shahid Chamran Blvd, Bandar Abbas University of Medical Sciences Bandar Abbas Hormozgan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
