<?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>IRCT20220911055938N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-13</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of the Effectiveness of compassion therapy and eye movement desensitization and reprocessing therapy (EMDR) on patients with coronavirus (COVID-19)</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of compassion therapy and eye movement desensitization and reprocessing therapy (EMDR) on coronary anxiety, uncertainty intolerance, catastrophizing and coping efficiency of patients with coronavirus (COVID-19)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65860</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will run by using the Software Allocation Random. Since the total number of samples predicted for the present study is small (n=45), we will use the simple randomization method to assign subjects to three study groups. We will assign a unique number to every member of our study's sample (from 1 to 45). An independent researcher makes random allocation codes using computer-generated random numbers. Then, we will use the random allocation generator software to randomly assign each number to experimental and control groups, Blinding description: The study was single blind. The data analyst and the person conducting the assessments will be blind to the specific participant’s group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Coronavirus.</hc_freetext>
      <i_freetext>Intervention 1: compassion therapy intervention: Compassion-focused therapy consists of eight weekly 90-minute sessions conducted in a group setting. Each session will include introducing goals and topics related to that session, discussions, exercises inside the session, and exercises outside the session. Intervention 2: Eye movement desensitization and reprocessing therapy (EMDR) intervention: includes ten one-hour treatment sessions, individually and two weekly, based on the standard protocol of EMDR. Intervention 3: Control group: After the intervention phase of this study, control group patients can be treated by psychologists in the Behin psychology clinic.</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:
Data from participants' responses to coronary anxiety, uncertainty intolerance, catastrophizing and coping efficiency questionnaires in pre-test, post-test and follow up will analyze using SPSS software, and the results, without mentioning the names of the participants, were shared as study results.

When:
The access period starts 6 months after the results are published.

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

Conditions:
The data of this study will be provided for use by researchers in review or comparative studies.

Where to obtain:
Nasim Beyranvand, Department of Psychology, Islamic Azad University, Boroujerd Branch, Iran. imnasimb@gmail.com +98 991 653 6422

How to obtain:
The applicant provides information about their application via email. Up to two weeks after the request, if accepted, documents or data files will be sent.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nasim Beyranvand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshgah St.,Western Modarres Ave, Boroujerd, Iran.</address>
        <city>Boroujerd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6915136335</zip>
        <telephone>+98 66 3343 2180</telephone>
        <email>imnasimb@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahboobeh Chinaveh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshgah St.,Western Modarres Ave, Boroujerd, Iran.</address>
        <city>Boroujerd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6915136335</zip>
        <telephone>+98 66 3343 2180</telephone>
        <email>hivachinaveh@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>History of having coronavirus
No presence of any other mental disorders
No history of mental illness
No dependence on alcohol or drugs
Do not receive other current psychological treatment
Age between 20 - 40</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having suicidal thoughts and beliefs
Declining to participate in therapy sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B34.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Coronavirus infection, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>compassion therapy intervention: Compassion-focused therapy consists of eight weekly 90-minute sessions conducted in a group setting. Each session will include introducing goals and topics related to that session, discussions, exercises inside the session, and exercises outside the session.</i_keyword>
      <i_keyword>Eye movement desensitization and reprocessing therapy (EMDR) intervention: includes ten one-hour treatment sessions, individually and two weekly, based on the standard protocol of EMDR.</i_keyword>
      <i_keyword>Control group: After the intervention phase of this study, control group patients can be treated by psychologists in the Behin psychology clinic.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Coronary anxiety: the score obtained by the corona anxiety Questionnaire (Alipour et al. 2018). Timepoint: One week before the intervention, one week after the last intervention session, two months after the last intervention session. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Uncertainty intolerance: the score that participles will get from the uncertainty intolerance questionnaire. Timepoint: One week before the intervention, one week after the last intervention session, two months after the last intervention session. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Catastrophizing: the score participles will get from the catastrophizing subscale of the Rosenstiel and Keefe (1983) coping strategies questionnaire. Timepoint: One week before the intervention, one week after the last intervention session, two months after the last intervention session. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Coping efficiency: the score participles will get from the  Chesney et al.'s (2006) coping efficiency questionnaire. Timepoint: One week before the intervention, one week after the last intervention session, two months after the last intervention session. Method of measurement: 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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-19</approval_date>
        <contact_name>Research Ethics Committees of Islamic Azad University - Boroujerd Branch</contact_name>
        <contact_address>Imam Khomeini University Complex, 3 km Yadgar Imam Road, Nawab Square, Borujerd Boroujerd Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
