<?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>IRCT20250228064878N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-08-04</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effectiveness of Self-Working Package on Quality of Life, Psychological Flexibility, and Psychological Well-Being</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Self-Working Package on Quality of Life, Psychological Flexibility, and Psychological Well-Being among University Students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82135</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: The statistical population of the present study consists of all students enrolled at Khatam Al-Anbia University of Technology in Behbahan. From this population, a total of 30 participants will be selected through a multi-stage cluster random sampling method. In the first stage, one faculty will be randomly selected, followed by the random selection of one class from that faculty. To ensure random assignment of participants into experimental and control groups, a list of all students in the selected class will be prepared and entered into SPSS software. Using the Compute Variable function and the formula RV.UNIFORM(0,1), a new variable will be generated for each participant, assigning a random value between 0 and 1. The data will then be sorted based on these random values, and participants will be assigned sequentially into two equal groups—15 in the experimental group and 15 in the control group. This procedure guarantees that each participant has an equal probability of being placed in either group, thereby ensuring unbiased group allocation.</study_design>
      <phase>3</phase>
      <hc_freetext>Quality of Life, Psychological Flexibility, and Psychological Well-Being.</hc_freetext>
      <i_freetext>Intervention 1: Control group: No intervention is provided. They only complete the pre-test and post-test simultaneously with the experimental group. Intervention 2: Intervention group: They will receive the Self-Working Package therapeutic training program for 14 weeks, with two 2-hour sessions held each week. Additionally, before the main sessions, a single session will be conducted to establish rapport and explain the Self-Working therapeutic training model.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Ensuring the maximum confidentiality of the information of individuals involved in the research.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeed Ranginkaman</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 4, Shahid Farazmand St.</address>
        <city>Behbahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6361747254</zip>
        <telephone>+98 61 5282 4455</telephone>
        <email>saeed.ranginkaman@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Joharifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University of Ahvaz, Farhangshahr, Golestan Blvd.</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6134937333</zip>
        <telephone>+98 61 3334 8420</telephone>
        <email>rjoharifard@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having tendency to participate in research</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a personality disorder</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>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: No intervention is provided. They only complete the pre-test and post-test simultaneously with the experimental group.</i_keyword>
      <i_keyword>Intervention group: They will receive the Self-Working Package therapeutic training program for 14 weeks, with two 2-hour sessions held each week. Additionally, before the main sessions, a single session will be conducted to establish rapport and explain the Self-Working therapeutic training model.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life is defined as an individual’s perception of their position in life within the context of the culture and value systems in which they live, and in relation to their goals, expectations, standards, and concerns. This concept encompasses multiple dimensions, including physical health, psychological state, level of independence, social relationships, personal beliefs, and the individual’s relationship with salient features of their environment (World Health Organization, 1997). Timepoint: At the beginning of the study (prior to the intervention) and after the completion of the intervention (14 weeks after its initiation). Method of measurement: In this study, the scores obtained by the participants are derived from the short form of the World Health Organization Quality of Life questionnaire (WHOQOL-BREF, 1998).</prim_outcome>
      <prim_outcome>Psychological flexibility is defined as an individual’s ability to modify or shift from ineffective thoughts to more effective ones. This construct comprises three components: the ability to consider multiple alternative perspectives on life events and human behaviors, a willingness to interpret difficult situations as manageable, and the ability to generate multiple alternative solutions to challenging situations (Dennis &amp; Vander Wal, 2010). Timepoint: At the beginning of the study (prior to the intervention) and after the completion of the intervention (14 weeks after its initiation). Method of measurement: In this study, the scores are obtained by the participants from the Cognitive Flexibility Inventory (CFI).</prim_outcome>
      <prim_outcome>Psychological well-being is defined as a positive state of mental health, characterized by having a positive attitude toward oneself and others, a sense of purpose and meaning in life, satisfying and positive relationships, a sense of autonomy, environmental mastery, and personal growth. This concept was developed by Ryff (1989) as an indicator for assessing psychological health and individual functioning across various domains of life. Timepoint: At the beginning of the study (prior to the intervention) and after the completion of the intervention (14 weeks after its initiation). Method of measurement: In this study, the scores are obtained by the participants from the short form of the Ryff Psychological Well-Being Scale.</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</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-07-21</approval_date>
        <contact_name>Research Ethics Committee of Islamic Azad University - Ahvaz Branch</contact_name>
        <contact_address>Islamic Azad University of Ahvaz, Farhangshahr, Golestan Blvd. Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
