<?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>IRCT20210618051616N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-27</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparing the effectiveness of neurofeedback with Mindfulness-Based Cognitive Therapy, in depression risk factors; a follow-up period of 6 months</public_title>
      <acronym>MBCT</acronym>
      <scientific_title>Comparing the effectiveness of neurofeedback exercises with Mindfulness-Based Cognitive Therapy, in rumination, negative spontaneous thoughts and negative emotion regulation strategies in depression patients; a follow-up period of 6 months</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72451</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: People who met the entry criteria and were willing to participate in the research are identified. Then, Beck Depression Questionnaire was distributed among the people,  45 people who scored at least 30 from the Beck Depression Questionnaire (1961) were selected as samples. 15 cards are prepared in the name of the experimental group A (related to neurofeedback exercises), 15 cards are prepared in the name of the experimental group B (related to mindfulness-based cognitive therapy)  and 15 cards in the name of the control group. After the cards are dealt, the participants will be asked to take one card each and place themselves in their group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Major depressive disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group A:  Neurofeedback Treatment. The experimental group A receives neurofeedback training during 16 regular sessions and in a period of 8 weeks , three sessions in per week. For therapeutic intervention in this research, the Iranian neurofeedback device of the BIOLINE brand will be used, which can be implemented with the help of the computer system and related software (BIOSEES). Intervention 2: Intervention group B:  Mindfulness-Based Cognitive Therapy (MBCT). The experimental group B receives mindfulness treatment during 8 regular sessions and in a period of 8 weeks , 1 session in per week. For therapeutic interventions, the content of the mindfulness-based cognitive therapy sessions compiled by Segal will be used. Intervention 3: group C: group C (control)  will not receive any treatment 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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Hossein Hassani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 4, 1th floor, Zolfaqar Building, at the entrance of 27th Darya alley, Taleb Amoli street</address>
        <city>amol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4617868391</zip>
        <telephone>+98 11 4420 6185</telephone>
        <email>rahnemonclinic@gmail.com</email>
        <affiliation>Psychological counseling and services center-Rahnemon</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Hossein Hassani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 4, 1th floor, Zolfaqar Building, at the entrance of 27th Darya alley, Taleb Amoli street</address>
        <city>Amol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4617868391</zip>
        <telephone>+98 11 4420 6185</telephone>
        <email>rahnemonclinic@gmail.com</email>
        <affiliation>Psychological counseling and services center-Rahnemon</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Obtaining a minimum score of 30 from the Beck Depression Inventory (1961)</inclusion_criteria>
      <agemin>23 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>A history of physical disorder that involves mental processes.
Simultaneous use of other therapeutic interventions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, single episode, severe without psychotic features</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 A:  Neurofeedback Treatment. The experimental group A receives neurofeedback training during 16 regular sessions and in a period of 8 weeks , three sessions in per week. For therapeutic intervention in this research, the Iranian neurofeedback device of the BIOLINE brand will be used, which can be implemented with the help of the computer system and related software (BIOSEES).</i_keyword>
      <i_keyword>Intervention group B:  Mindfulness-Based Cognitive Therapy (MBCT). The experimental group B receives mindfulness treatment during 8 regular sessions and in a period of 8 weeks , 1 session in per week. For therapeutic interventions, the content of the mindfulness-based cognitive therapy sessions compiled by Segal will be used.</i_keyword>
      <i_keyword>group C: group C (control)  will not receive any treatment intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>RUMINATION. Timepoint: Evaluation before the start of the intervention, the end of the intervention (60 days) and 180 days after the end of the intervention (follow-up). Method of measurement: Rumination questionnaire (Nalen-Hoeksma and Maro - 1991).</prim_outcome>
      <prim_outcome>Automatic Negative Thoughts. Timepoint: Evaluation before the start of the intervention, the end of the intervention (60 days) and 180 days after the end of the intervention (follow-up). Method of measurement: Automatic Negative Thoughts questionnaire (Halon and Kendall -1980).</prim_outcome>
      <prim_outcome>Negative Strategies of Cognitive Emotion Regulation. Timepoint: Evaluation before the start of the intervention, the end of the intervention (60 days) and 180 days after the end of the intervention (follow-up). Method of measurement: Cognitive emotion regulation questionnaire (Garnefski et al. - 2001).</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>2022-08-22</approval_date>
        <contact_name>islamic azad university- sari branch</contact_name>
        <contact_address>7th km of DARYA road (Farah abad), Sari, Iran Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
