<?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>IRCT20200213046480N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-09</date_registration>
      <primary_sponsor>The University of Lorestan</primary_sponsor>
      <public_title>Comparison of the effectiveness of acceptance and commitment therapy (ACT) and unified transdiagnostic treatment (UP) in colorectal cancer patients</public_title>
      <acronym></acronym>
      <scientific_title>A comparison of the effectiveness of acceptance and commitment therapy (ACT) and unified transdiagnostic treatment (UP) in psychological distress, meta-emotion beliefs, acceptance and post-traumatic growth in colorectal cancer patients comorbid with stress</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46305</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The block randomization method is performed by the statistical consultant as follows: randomization is performed in three groups: acceptance and commitment therapy, unified transdiagnostic treatment and control. First, a list of eligible individuals is provided and coded. In block randomization, the number of participants in all groups will be very close together by making blocks of sequences so that the same number of participants are assigned to study groups within each group. We first code the groups in Latin letters as follows: A = acceptance and commitment therapy, B = unified transdiagnostic treatment, and C = control group. In this study with three groups A, B and C, we create the following six groups and assign a number from 1 to 6 to each group: ABC-ACB-BAC-BCA-CAB-CBA, Then, using the table of random numbers, we contract that if the numbers 1, 2, 3, 4, 5, and 6 appear in order, one of these blocks will be selected, and if another number appears, we will assume it to be void and move on to the next selection. In fact, we have obtained a random sequence of numbers with a table of random numbers that for each number we consider the desired order of assignment. In this way, the number of people in the groups will be approximately equal.</study_design>
      <phase>N/A</phase>
      <hc_freetext>colorectal cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Treatment sessions based on Unified Transdiagnostic Treatment book of Barlow &amp; et al will be performed according to the protocol (1 session per week, each session about 90 minutes – 8 sessions during 2 months). Measurements will be performed again in three times: the middle of treatment, the end of treatment and once in two months after the end of treatment. Intervention 2: Intervention group 2: Treatment sessions based on Acceptance and Commitment Therapy book of Hayes, Strosahl, &amp; Wilson will be performed according to the protocol (1 session per week, each session about 90 minutes – 8 sessions during 2 months). Measurements will be performed again in three times: the middle of treatment, the end of treatment and once in two months after the end of treatment. Intervention 3: Control group: This group of 15 randomly selected individuals will receive no treatment for two months. However, the control group, which has been bothering to participate in the research, at the end of the study period is freely and intensively subject to one of the treatments of Acceptance and Commitment Therapy or Unified Transdiagnostic Treatment.</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:
Demographic data, methodical data, Data analysis

When:
As the results are published

To whom:
Researchers working in universities and medical centers

Conditions:
In clinical and therapeutic work

Where to obtain:
Email: A.kazemi04@yahoo.com  Phone: 00989167491925 Kazemipour Ahmad

How to obtain:
It will take a month to process.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ahmad Kazemipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5th Kilometer of Khorramabad-Boroujerd Highway, Khorramabad, Lorestan</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>44316-68151</zip>
        <telephone>+98 66 3312 0106</telephone>
        <email>A.kazemi04@yahoo.com</email>
        <affiliation>The University of Lorestan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ahmad Kazemipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 3, West Lale, Velayat Blvd.</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>44316-68151</zip>
        <telephone>+98 66 3326 9287</telephone>
        <email>kazemipour.ah@fh.lu.ac.ir</email>
        <affiliation>The University of Lorestan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Have a minimum score of 19 or higher on the stress subscale of the DASS-21 questionnaire
Age ranging from 30 to 60 years
Starting treatment under 6 months</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to participate in treatment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C18.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of colon, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Diagnosis</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Treatment sessions based on Unified Transdiagnostic Treatment book of Barlow &amp; et al will be performed according to the protocol (1 session per week, each session about 90 minutes – 8 sessions during 2 months). Measurements will be performed again in three times: the middle of treatment, the end of treatment and once in two months after the end of treatment.</i_keyword>
      <i_keyword>Intervention group 2: Treatment sessions based on Acceptance and Commitment Therapy book of Hayes, Strosahl, &amp; Wilson will be performed according to the protocol (1 session per week, each session about 90 minutes – 8 sessions during 2 months). Measurements will be performed again in three times: the middle of treatment, the end of treatment and once in two months after the end of treatment.</i_keyword>
      <i_keyword>Control group: This group of 15 randomly selected individuals will receive no treatment for two months. However, the control group, which has been bothering to participate in the research, at the end of the study period is freely and intensively subject to one of the treatments of Acceptance and Commitment Therapy or Unified Transdiagnostic Treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Psychological distress. Timepoint: The middle of treatment, after treatment and two months after the end of treatment. Method of measurement: Depression Anxiety and Stress Scale.</prim_outcome>
      <prim_outcome>Meta-emotion beliefs. Timepoint: The middle of treatment, after treatment and two months after the end of treatment. Method of measurement: Meta-Emotions Scale.</prim_outcome>
      <prim_outcome>Acceptance. Timepoint: The middle of treatment, after treatment and two months after the end of treatment. Method of measurement: Acceptance and Action Questionnaire.</prim_outcome>
      <prim_outcome>Post-traumatic growth. Timepoint: The middle of treatment, after treatment and two months after the end of treatment. Method of measurement: Post-traumatic Growth 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>The University of Lorestan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-22</approval_date>
        <contact_name>Ethics committee of Lorestan University of Medical Sciences</contact_name>
        <contact_address>Lorestan University of Medical Sciences, Anooshirvan Rezaei Square, Khorramabad, Lorestan. khorramabad Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
