<?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>IRCT20250106064293N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-01-27</date_registration>
      <primary_sponsor>Islamic Azad University, Semnan Branch</primary_sponsor>
      <public_title>The effect of reality therapy on distress tolerance and rumination about loss in students with emotional breakdown</public_title>
      <acronym></acronym>
      <scientific_title>The effect of reality therapy on distress tolerance and rumination about loss in students with emotional breakdown</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-02-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81224</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, a simple randomization method was used to randomize participants. After selecting 30 people as a sample, each participant was randomly assigned to one of two intervention groups (real therapy) or control group. For this purpose, the numbers 1 to 30 were assigned to the participants and, using a random number table or random number generation software, the numbers corresponding to each participant were selected and assigned to one of the two groups. Randomization was performed individually, meaning that each participant was independently assigned to the intervention or control group. This method ensures that there is no bias in the assignment of individuals to the groups and that each person has an equal chance of being placed in each of the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Emotional Breakdown.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The experimental group will undergo a reality therapy intervention, which will be held in 5 120-minute sessions in a month. This intervention is designed to increase tolerance for distress and reduce rumination about loss caused by emotional breakdown. Initially, the feelings caused by loss and emotional breakdown are identified and accepted, and clients are introduced to the importance of the realities in life and their personal responsibilities. Then, reality therapy techniques are taught, including making changes in attitudes and beliefs, encouraging focus on present and future decisions, and strengthening a sense of meaning in life. In the next stages, clients will learn skills to manage and reduce rumination and mental turmoil through cognitive and behavioral strategies. Finally, the changes are consolidated and exercises to maintain the gains and prevent a return to previous patterns are made available to clients. Intervention 2: Control group: This group will not receive any treatment related to the study and will serve as a benchmark for comparison with the experimental group. Members of this group will simply follow the routine programs and standard care that they would normally receive. No program or intervention related to reality therapy will be provided to this group during the study. The goal is to keep the control group conditions unchanged so that the effects of the reality therapy intervention on distress tolerance and rumination can be accurately and reliably examined.</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 main outcome results of the research can be shared after de-identification and preserving the privacy of individuals.

When:
The data will be available one month after the results are published and after personally identifiable information has been removed.

To whom:
Research data and documentation will be available to researchers and scholars working in reputable academic and scientific institutions. In addition, researchers working in industry related to the research topic can also apply to receive data and documentation.

Conditions:
For the purpose of studying or conducting research, citing the source.

Where to obtain:
If you need data, please contact Jb.delara2000@gmail.com.

How to obtain:
After receiving the request and reviewing it by the principal investigator, the data will be sent to the applicant within a maximum of one week, along with a commitment not to publish the data without the name of the principal investigator.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Delara Doustmohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 6, Unit 1, Mozhgan Alley, Homayoun Alley, South Dibaji St, Dolat St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1959976191</zip>
        <telephone>+98 23 3365 4040</telephone>
        <email>Jb.delara2000@gmail.com</email>
        <affiliation>Islamic Azad University, Semnan Branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sakineh Izadi Mazidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, Semnan branch</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513137111</zip>
        <telephone>+98 23 3365 4040</telephone>
        <email>Maryam.izadi.psy@gmail.com</email>
        <affiliation>Islamic Azad University, Semnan Branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Experience of emotional breakdown in the past three months based on student self-report.
Age between 18 and 35 years.
Obtaining high scores on rumination and disturbance tolerance assessment tools (based on the specified cutoff point).
Willingness and commitment to participate in all therapeutic intervention sessions.
No use of other psychological or psychiatric treatments during the research period.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having severe psychiatric disorders such as bipolar disorder or schizophrenia (based on medical diagnosis history).
Taking psychiatric medications that may affect tolerance to agitation or rumination.
Experiencing other severe stressful events in the past three months (such as the loss of a loved one, a serious accident, or job loss).
The presence of any acute or chronic physical conditions that may prevent effective participation in intervention sessions.</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: The experimental group will undergo a reality therapy intervention, which will be held in 5 120-minute sessions in a month. This intervention is designed to increase tolerance for distress and reduce rumination about loss caused by emotional breakdown. Initially, the feelings caused by loss and emotional breakdown are identified and accepted, and clients are introduced to the importance of the realities in life and their personal responsibilities. Then, reality therapy techniques are taught, including making changes in attitudes and beliefs, encouraging focus on present and future decisions, and strengthening a sense of meaning in life. In the next stages, clients will learn skills to manage and reduce rumination and mental turmoil through cognitive and behavioral strategies. Finally, the changes are consolidated and exercises to maintain the gains and prevent a return to previous patterns are made available to clients.</i_keyword>
      <i_keyword>Control group: This group will not receive any treatment related to the study and will serve as a benchmark for comparison with the experimental group. Members of this group will simply follow the routine programs and standard care that they would normally receive. No program or intervention related to reality therapy will be provided to this group during the study. The goal is to keep the control group conditions unchanged so that the effects of the reality therapy intervention on distress tolerance and rumination can be accurately and reliably examined.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Distress Tolerance. Timepoint: Before the start of the intervention and after completing 5 intervention sessions. Method of measurement: Simons and Gahr's Distress Tolerance Questionnaire (2005).</prim_outcome>
      <prim_outcome>Rumination about loss. Timepoint: Before the start of the intervention and after completing 5 intervention sessions. Method of measurement: Rumination Questionnaire Eisma et al (2014).</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>2024-12-30</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>
