<?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>IRCT20240725062541N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-08-15</date_registration>
      <primary_sponsor>Islamic Azad University, Semnan branch</primary_sponsor>
      <public_title>The effectiveness of schema therapy on emotional deprivation, abandonment and quality of life in girls with emotional failure</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of schema therapy on emotional deprivation, abandonment and quality of life in girls with emotional failure, students of Qom Azad University</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-08-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78374</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, simple randomization method was used to randomize the participants. After determining 30 people as a sample, each participant was randomly assigned to one of the two intervention groups (schema therapy) or the control group. For this purpose, numbers 1 to 30 were assigned to each of the participants, and then using a random number table or computer software, the numbers of each participant were randomly selected and assigned to one of the two groups. In this process, the randomization unit was individual, in the sense that each person was independently assigned to the intervention or control group; Therefore, the entire randomization process was performed in a simple manner without initial grouping to ensure that there was no bias in the allocation of participants to groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Emotional Failure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this research, the experimental group will receive schema therapy in 10 one-hour sessions for one month. In the initial stages of schema therapy, the focus is on communicating and empathizing with clients and familiarizing with the basic concepts of primary maladaptive schemas. The assessment of the initial situation of the group and conceptualization of the problem is done according to the schema-oriented approach. Then, clients are introduced to the evolutionary origins and domains of schemas, and cognitive techniques such as schema validity test and a new definition of schema confirming evidence are taught. In the following, maladaptive schemas and ineffective coping responses will be identified, and opportunities will be provided to identify and release blocked emotions. With the progress of treatment, dysfunctional schemas and coping styles are modified and new strategies are practiced to establish healthy communication and replace maladaptive behaviors with efficient ones. In the end, the effectiveness of schema therapy is evaluated and the barriers to behavior change are investigated and the treatment results are summarized.Send feedbackSide panelsHistorySaved. Intervention 2: Control group: The control group does not receive any intervention and serves as a point of comparison in the study. In other words, this group only experiences standard and routine care, and no additional treatment or intervention related to the subject of the study is applied to them during the research period. The conditions of the control group are maintained in such a way that its results can be compared with the intervention group that is undergoing schema therapy treatment. The purpose of this method is to provide a basis for comparing and accurately evaluating the effects of schema therapy.</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:
Demographic data and the results of the main outcome of the research can be shared after de-identifying and preserving the privacy of individuals.

When:
Data can be made available 6 months after results are printed and after removing personally identifiable information.

To whom:
Study data and documentation will be available to researchers and researchers working in accredited academic and scientific institutions. These people can access the data by submitting a request and after reviewing and approving the request.

Conditions:
Research data and documents can be used for scientific and research purposes. Users must undertake to keep de-identified data confidential and to publish the results of analyzes in peer-reviewed scientific journals. Requests must be submitted in writing and include a full description of the purpose, methods, and type of analysis. After review and approval, users should share the results with the principal investigator to confirm the validity and accuracy of the analyses.

Where to obtain:
If you need the data, write to maryamsafarlo83@gmail.com.

How to obtain:
After receiving the request and reviewing it by the main researcher, the data will be sent to the applicant along with a letter of commitment stating that the data will not be published without the name of the main researcher within a maximum of 5 days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Safarlo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 43, 15 meters second, Safashehr</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3716986597</zip>
        <telephone>+98 25 3285 3521</telephone>
        <email>maryamsafarlo83@gmail.com</email>
        <affiliation>Islamic Azad University, Semnan branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Samadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, University Town, Semnan, Iran</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513137111</zip>
        <telephone>+98 23 3365 4040</telephone>
        <email>Samadi.rmb@gmail.com</email>
        <affiliation>Islamic Azad University, Semnan branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Participants should have symptoms of emotional deprivation.
Participants must have experienced an emotional failure in the recent past.
Participants must be girls and students of Islamic Azad University of Qom.
Candidates must be willing to participate in the study and implement treatments.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Participants who did not experience an emotional failure were not included in the study.
People with severe mental disorders (such as schizophrenia, bipolar disorder, etc.) are excluded from the study.
Participants who have previously undergone similar treatments are not included in this study.
People who do not want to participate in the study will not be included in the study.
People who are unable to regularly attend therapy sessions are excluded from the study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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>Intervention group: In this research, the experimental group will receive schema therapy in 10 one-hour sessions for one month. In the initial stages of schema therapy, the focus is on communicating and empathizing with clients and familiarizing with the basic concepts of primary maladaptive schemas. The assessment of the initial situation of the group and conceptualization of the problem is done according to the schema-oriented approach. Then, clients are introduced to the evolutionary origins and domains of schemas, and cognitive techniques such as schema validity test and a new definition of schema confirming evidence are taught. In the following, maladaptive schemas and ineffective coping responses will be identified, and opportunities will be provided to identify and release blocked emotions. With the progress of treatment, dysfunctional schemas and coping styles are modified and new strategies are practiced to establish healthy communication and replace maladaptive behaviors with efficient ones. In the end, the effectiveness of schema therapy is evaluated and the barriers to behavior change are investigated and the treatment results are summarized.Send feedbackSide panelsHistorySaved</i_keyword>
      <i_keyword>Control group: The control group does not receive any intervention and serves as a point of comparison in the study. In other words, this group only experiences standard and routine care, and no additional treatment or intervention related to the subject of the study is applied to them during the research period. The conditions of the control group are maintained in such a way that its results can be compared with the intervention group that is undergoing schema therapy treatment. The purpose of this method is to provide a basis for comparing and accurately evaluating the effects of schema therapy.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Abandonment. Timepoint: Before starting the intervention and after completing 11 intervention sessions. Method of measurement: Young's early maladaptive schema questionnaire (2003).</prim_outcome>
      <prim_outcome>Emotional Deprivation. Timepoint: Before starting the intervention and after completing 11 intervention sessions. Method of measurement: Young's early maladaptive schema questionnaire (2003).</prim_outcome>
      <prim_outcome>Quality of Life. Timepoint: Before starting the intervention and after completing 11 intervention sessions. Method of measurement: 36-question quality of life questionnaire (SF-36).</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, Semnan branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-07-30</approval_date>
        <contact_name>Ethics committee of Semnan Azad University</contact_name>
        <contact_address>Islamic Azad University, University Town, Semnan, Iran Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
