<?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>IRCT20211210053342N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-08</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>En The effectiveness of Mindful Hypnotherapy on depression, Stress, Anxiety, Psychological Flexibility, Emotion Regulation, Rumination, Mental health, Self-Compassion and Resilience in Depressed Patients</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of Mindful Hypnotherapy on the psychological aspects of depressed patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62654</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be simple randomization method. the random unit is individuals. 34 patients with chronic migraine will be divided into intervention and control groups by Microsoft Excel software using Rand function. In this way, a table of random numbers will be prepared and the Randbetween function will be created and the patients will be divided into two groups of 17 people respectively, Blinding description: The outcome assessor in data collection after the intervention and the data analyst will be unaware of the objectives of the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Major depressive disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Mindful Hypnotherapy. This treatment will be performed in 8 one-hour individual sessions according to the Elkins protocol. Intervention 2: Control group: At first, the control group does not receive any intervention and only the results of their evaluations, which are done by the relevant questionnaires, will be compared with the intervention group. At the end of the study, for all members of the control group, Mindful hypnotherapy intervention will be performed in 8 one-hour individual sessions according to the Elkins protocol.</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:
Participants' data will be shared in the SPSS file using by code of participants (not using first and last name)

When:
Access to the data will be after the articles are published

To whom:
Access to the data will be after the articles are published

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

Where to obtain:
By receiving confirmation via email to the main executor or executors of the project

How to obtain:
Send an email to the main executor or other executors of the project and receive written confirmation through them

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hassan Khazraee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taleghani Educational Hospital, Shahid Beheshti University of medical science, Velenjak Region, Chamran High Way, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 2293 5548</telephone>
        <email>hassankhazraee@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hassan Khazraee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taleghani Educational Hospital, Shahid Beheshti University of medical science, Velenjak Region, Chamran High Way, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 2293 5548</telephone>
        <email>hassankhazraee@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Depression score higher than 28 in Beck Depression Inventory-II (BDI-II)
Having criteria for major depressive disorder according to DSM-5Age range between 18 and 50 years
Having informed consent to participate in the research and signing the informed consent form
At least a diploma educational degree</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Have a history of psychotherapy in the last 6 months
Participate in another psychological intervention simultaneously Recent drugs abuse
Existence of diagnostic indicators or history of borderline personality disorder, psychosis or schizophrenia due to interference with hypnosis
serious suicidal thoughts and any plan(s) to attempt suicide</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F33.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, recurrent severe without psychotic features</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Mindful Hypnotherapy. This treatment will be performed in 8 one-hour individual sessions according to the Elkins protocol.</i_keyword>
      <i_keyword>Control group: At first, the control group does not receive any intervention and only the results of their evaluations, which are done by the relevant questionnaires, will be compared with the intervention group. At the end of the study, for all members of the control group, Mindful hypnotherapy intervention will be performed in 8 one-hour individual sessions according to the Elkins protocol</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression. Timepoint: In the per-intervention and post-intervention stages. Method of measurement: Beck Depression Inventory (BDI-II).</prim_outcome>
      <prim_outcome>Stress. Timepoint: In the per-intervention and post-intervention stages. Method of measurement: Depression, Anxiety, Stress Scale (DASS-21).</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: In the per-intervention and post-intervention stages. Method of measurement: Depression, Anxiety, Stress Scale (DASS-21).</prim_outcome>
      <prim_outcome>Psychological Flexibility. Timepoint: In the per-intervention and post-intervention stages. Method of measurement: The Acceptance and Action Questionnaire (AAQ-2) and The Psychological Flexibility Questionnaire (PFQ).</prim_outcome>
      <prim_outcome>Emotion Regulation Difficulty. Timepoint: In the per-intervention and post-intervention stages. Method of measurement: Emotion Regulation Difficulty Scale (DERS).</prim_outcome>
      <prim_outcome>Rumination. Timepoint: In the per-intervention and post-intervention stages. Method of measurement: Mental rumination questionnaire.</prim_outcome>
      <prim_outcome>Mental health. Timepoint: In the per-intervention and post-intervention stages. Method of measurement: The Mental Health Continuum Short Form (MHC-SF).</prim_outcome>
      <prim_outcome>Self-Compassion. Timepoint: In the per-intervention and post-intervention stages. Method of measurement: Self-Compassion Scale (SCS).</prim_outcome>
      <prim_outcome>Resilience. Timepoint: In the per-intervention and post-intervention stages. Method of measurement: Brief Resilience Scale (BRS).</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-30</approval_date>
        <contact_name>Ethics Committees of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Floor 13, Block A, Ministry of Health &amp; Medical Education Headquarters, Between Zarafashan &amp; South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
