<?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>IRCT20230517058212N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-08-06</date_registration>
      <primary_sponsor>Islamic Azad University, Birjand branch</primary_sponsor>
      <public_title>Comparing the efficacy of schema therapy and dialectical behavior therapy in patients with depressive disorder</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of therapeutic schema and dialectical behavior therapy on cognitive regulation of emotion, cognitive flexibility and maladaptive strategies of worry in patients with depressive disorder.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70824</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this method, 45 people who were selected as samples were numbered from 1 to 45.And these numbers were placed randomly without any particular order in the form of rows and columns in the table.Then one row and one column of the table were randomly selected. The intersection point of the selected row and column was the starting point of sampling.From this point and at the choice of the researcher, a direction (up, down, left or right) was drawn to select the members of the experimental and control groups.The numbers 15-00 obtained from the direction of the researcher's movement were selected as the first test group, and the numbers 16-30 as the second test group, and the numbers 45-31 as the control group, Blinding description: In this study, the participants generally knew that they were undergoing psychotherapy.But they did not know that they were undergoing dialectical behavior therapy or schema therapy.Also, the data analyst did not know what treatment each participant was under or in which group they were (but the researcher did).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients with depressive disorder.</hc_freetext>
      <i_freetext>Intervention 1: Schema therapy: Schema therapy instructions and techniques were implemented on the experimental group during 8 sessions in the form of weekly 90-minute sessions.The first and second session: these sessions were dedicated to the implementation of the assessment phase and preliminary training of schema therapy.The third and fourth session: introduction, training and application of cognitive techniques was the challenge with the schema.Fifth and sixth sessions: Emotional (experimental) techniques were introduced and taught.7th and 8th sessions: training and implementation of behavioral pattern breaking techniques, persuading subjects to abandon incompatible coping styles and practice effective coping behaviors. Intervention 2: Dialectical behavior therapy: The dialectical behavior therapy training protocol was implemented in four weeks as a group for 8 sessions of 90 minutes.In the first session: after getting acquainted with the goals and rules, the group members were introduced to three mental states, logical, emotional and rational, in the comprehensive awareness skills section.The second session: in this session, in addition to the training of the mental states of the previous session, the training of the skills of what and how skills of comprehensive awareness were taught.The third session: what and how skills were practically taught in the group.Fourth session: In this stage, in addition to reviewing the exercises of the previous session, part of the emotional regulation skill was taught.Fifth session: Another part of emotional regulation skills was taught in this session.Sixth session: In this session, while reviewing the skills of the previous session, the skills of accepting emotions were taught.Seventh session: In this session, a part of the stress tolerance component was taught.In the eighth session, the review of the previous skills was considered as well as teaching how to generalize the skills outside the treatment session.</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:
Parts of the data, such as information about the intervention and its effect on dependent variables, can be shared.

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

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

Conditions:
Request for researchers engaged in research in the field of mental illnesses

Where to obtain:
1- The e-mail address of Zohre Jafarzade Jahormi is zjafarzade.j@gmail.com
2- Zohre Jafarzade's contact number: 09308352827

How to obtain:
First, the researcher introduces herself by sending her an email and explaining the reason for the need for data, and in less than a month, she will be answered and the data will be sent.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zohre Jafarzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ostad Motahari St., Alley 21</address>
        <city>Jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>74157-13548</zip>
        <telephone>+98 71 5433 1137</telephone>
        <email>Zjafarzade.j@gmail.com</email>
        <affiliation>Islamic Azad University, Birjand branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>zohre Jafarzade Jahromi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>21 Ostad Motahari St</address>
        <city>Jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>74157-13548</zip>
        <telephone>+98 71 5433 1137</telephone>
        <email>Zjafarzade.j@gmail.com</email>
        <affiliation>Islamic Azad University, Birjand branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Receive a diagnosis of moderate depression
Not taking medicine
Non-participation in any type of therapeutic intervention at the same time as participation in the research program
Expression of desire to participate in the program in writing</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Receive a diagnosis of personality disorders
The presence of mood problems caused by drug use or biological problems</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, single episode, moderate</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>Schema therapy: Schema therapy instructions and techniques were implemented on the experimental group during 8 sessions in the form of weekly 90-minute sessions.The first and second session: these sessions were dedicated to the implementation of the assessment phase and preliminary training of schema therapy.The third and fourth session: introduction, training and application of cognitive techniques was the challenge with the schema.Fifth and sixth sessions: Emotional (experimental) techniques were introduced and taught.7th and 8th sessions: training and implementation of behavioral pattern breaking techniques, persuading subjects to abandon incompatible coping styles and practice effective coping behaviors.</i_keyword>
      <i_keyword>Dialectical behavior therapy: The dialectical behavior therapy training protocol was implemented in four weeks as a group for 8 sessions of 90 minutes.In the first session: after getting acquainted with the goals and rules, the group members were introduced to three mental states, logical, emotional and rational, in the comprehensive awareness skills section.The second session: in this session, in addition to the training of the mental states of the previous session, the training of the skills of what and how skills of comprehensive awareness were taught.The third session: what and how skills were practically taught in the group.Fourth session: In this stage, in addition to reviewing the exercises of the previous session, part of the emotional regulation skill was taught.Fifth session: Another part of emotional regulation skills was taught in this session.Sixth session: In this session, while reviewing the skills of the previous session, the skills of accepting emotions were taught.Seventh session: In this session, a part of the stress tolerance component was taught.In the eighth session, the review of the previous skills was considered as well as teaching how to generalize the skills outside the treatment session.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Treatment of depressive disorder. Timepoint: Before the study, in the middle of the study (two weeks after the start of the treatment) and after finishing the treatmenttraining sessions. Method of measurement: Beck depression questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Cognitive regulation of emotion. Timepoint: After therapeutic interventions. Method of measurement: Using the cognitive emotion regulation strategies questionnaire of Garnevsky et al. (2002).</sec_outcome>
      <sec_outcome>Cognitive flexibility. Timepoint: After therapeutic interventions. Method of measurement: Using the Cognitive Flexibility Questionnaire of Dennis and Vanderwaal (2010).</sec_outcome>
      <sec_outcome>Maladaptive worry strategies. Timepoint: After therapeutic interventions. Method of measurement: Using the questionnaire of incompatible strategies, Meiryar et al. (1990).</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, Birjand branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-24</approval_date>
        <contact_name>Ethics Committee of Birjand University of Medical Sciences</contact_name>
        <contact_address>21 Ostad Motahari St Jahrom Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
