<?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>IRCT20200215046500N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-05</date_registration>
      <primary_sponsor>Raaz Counseling Center</primary_sponsor>
      <public_title>Comparison Effectiveness of Treatment Based on Acceptance and Commitment, Compassion-Based Therapy and Combination Therapy on Depression, Anxiety</public_title>
      <acronym></acronym>
      <scientific_title>Comparison Effectiveness of Treatment Based on Acceptance and Commitment, Compassion-Based Therapy and Combination Therapy on Depression, Anxiety, Chronic Pain, Quality of Life, Ineffective Attitudes, Compliance Therapy and Clinical Syndrome in Patients with Systemic Lupus</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>750</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45800</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Systemic lupus.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: in 12 sessions of group therapy based on two treatment approaches, compassion-based therapy and treatment based on acceptance and commitment on a weekly basis, two 90-minute sessions (treatment based on acceptance and commitment) and 120 minutes (treatment-based therapy). They performed at the Counseling and Psychotherapy Center. In the group meetings, after motivating the treatment and the sense of trust between the members of the group, the rules and techniques of treatment methods were taught. Intervention 2: Second intervention group: The experimental treatment group participated in 16 90-minute combination therapy sessions twice a week in the secret counseling center. The members of the group also learned verbal aikido skills after motivating them.</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 a part of the data, such as information about the main consequence or the like, can be shared.

When:
Start of access period from 1399

To whom:
Data will only be available to researchers working at academic and scientific institutions

Conditions:
Only general data for guidance

Where to obtain:
I am Dr. Ali Mohammad Rezaei-Secret Counseling Center-Shiraz, Ordibehesht St., Nab Coffee Building
09178843677

How to obtain:
The applicant must send his / her request to my e-mail with a complete explanation of why and what to do
RAMIN3677S@YAHOO.COM

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Mohammad Rezaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 3-Second Floor -- Mani Building - facing Karim Khani Citadel -- Jomhouri Boulevard-Shiraz</address>
        <city>shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7144914118</zip>
        <telephone>+98 71 3228 6128</telephone>
        <email>ramin3677s@yahoo.com</email>
        <affiliation>Arsanjan Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alimohammad Rezaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 3-Second Floor -- Mani Building - facing Karim Khani Citadel -- Jomhouri Boulevard-Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7144914118</zip>
        <telephone>+98 71 3231 9565</telephone>
        <email>ramin3677s@yahoo.com</email>
        <affiliation>Raaz Counseling and Psychotherapy Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>At least 6 months and a maximum of 2 years have elapsed since the diagnosis
Lack of physical illness other than lupus
Do not use psychiatric medications
Having the motivation to participate in the program during the initial interview
Lack of simultaneous participation in other psychological courses</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Absence of more than two sessions
There are physical problems that prevent the patient from attending treatment sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M32.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Drug-induced systemic lupus erythematosus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: in 12 sessions of group therapy based on two treatment approaches, compassion-based therapy and treatment based on acceptance and commitment on a weekly basis, two 90-minute sessions (treatment based on acceptance and commitment) and 120 minutes (treatment-based therapy). They performed at the Counseling and Psychotherapy Center. In the group meetings, after motivating the treatment and the sense of trust between the members of the group, the rules and techniques of treatment methods were taught.</i_keyword>
      <i_keyword>Second intervention group: The experimental treatment group participated in 16 90-minute combination therapy sessions twice a week in the secret counseling center. The members of the group also learned verbal aikido skills after motivating them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The percentage of people with a Beck questionnaire score above 15. Timepoint: Measurement period before the start of the intervention and three months after the start of treatment. Method of measurement: Beck Depression Questionnaire.</prim_outcome>
      <prim_outcome>The percentage of people with a Zong anxiety score above 44. Timepoint: Measurement period before the start of the intervention and three months after the start of treatment. Method of measurement: Zong Anxiety Questionnaire.</prim_outcome>
      <prim_outcome>The percentage of people with chronic pain scores above 30. Timepoint: Measurement period before the start of the intervention and three months after the start of treatment. Method of measurement: Revised Chronic Pain Questionnaire.</prim_outcome>
      <prim_outcome>The percentage of people whose quality of life score is below 15. Timepoint: Measurement period before the start of the intervention and three months after the start of treatment. Method of measurement: World Health Organization Quality of Life Questionnaire.</prim_outcome>
      <prim_outcome>The percentage of people whose scores of dysfunction are higher than 54. Timepoint: Measurement period before the start of the intervention and three months after the start of treatment. Method of measurement: Weizmann &amp; Beck's Ineffective Attitudes Questionnaire.</prim_outcome>
      <prim_outcome>The percentage of people whose treatment adherence score is less than 25. Timepoint: Measurement period before the start of the intervention and three months after the start of treatment. Method of measurement: Treatment Follow-up 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>Mehrnaz Mazarei</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-02-05</approval_date>
        <contact_name>Islamic Azad university-shahrekord Branch</contact_name>
        <contact_address>Unit 3-Second Floor -- Mani Building - facing Karim Khani Citadel -- Jomhouri Boulevard-Shiraz Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
