<?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>IRCT20260608069712N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-08-01</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The role of cognitive-behavioral therapies in promoting resilience and meaning in life in women with type 2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Study of the effectiveness of cognitive behavioral group therapy on perceived stress, emotional resilience, and meaning of life in women with type 2 diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/90925</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The statistical population of this study will include all women with type 2 diabetes who visit the hospital within the specified time period for the study and are given a definitive diagnosis of the disease by a specialist physician. In the sample selection stage, the available sampling method will be used. After selecting a sample size of 40 people, based on the study's entry and exit criteria, the participants will be randomly assigned to two groups: "cognitive-behavioral therapy" (intervention group) and "waiting list" (control group). Randomization will be performed using the random block method with variable sizes (4 and 6 people) by an independent statistician who is not involved in the implementation process. The random allocation list will be generated using the RAND function in Excel software and then placed in opaque, sealed, and numbered envelopes so that the researcher and participants are not aware of the allocation sequence (allocation concealment). The envelope will be opened and the allocation group will be informed only when each participant enters the study. To ensure the equality of baseline variables (such as anxiety level, age, and length of marriage), their distribution in the two groups will be examined during the statistical analysis stage.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Typw 2 Diabeted mellitus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Cognitive-behavioral therapy intervention; Duration of each session: 90 minutes; Total number of sessions: 8 sessions; Sequence of sessions: twice a week; Therapeutic tools used: Cognitive model training (connection of thoughts, feelings, and behaviors); Cognitive restructuring (identifying and challenging automatic thoughts); Relaxation and stress management techniques; Problem-solving exercises; and value-based activities to promote meaning in life. Summary of session content: Session 1: Pre-test, familiarization with the cognitive-behavioral model, and training on the relationship between diabetes, negative thoughts, and stress; Session 2: Identification of automatic thoughts and cognitive biases related to the disease and stress management; Session 3: Training in relaxation techniques (such as deep breathing) to reduce perceived stress; Session 4: Cognitive restructuring and challenging dysfunctional thoughts about the limitations caused by diabetes; Session 5: Training in problem-solving skills and coping with everyday challenges of diabetes management; Session 6: Behavioral exercises to increase emotional resilience in the face of physical changes; Seventh session: Focusing on finding meaning in life and identifying personal values ​​amid the challenges of the disease; Eighth session: Conclusion, teaching planning to prevent the return of stress, conducting a post-test, and determining the time for the follow-up test. Intervention 2: Control group: The control group will not receive any intervention during the research. However, to avoid factors that threaten the internal validity of the research, such as compensatory competition of the control group or demoralization, they are assured that they will receive the intervention at the next time (after data collection).</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Due to the failure to start research work, and consequently, the failure to write an article, which is a requirement for publishing data, I will publish the data as soon as the aforementioned problems are resolved.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehrsa Balalzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>West 6th Street, Kianabad</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6155714719</zip>
        <telephone>+98 61 3391 8542</telephone>
        <email>mehrsa.balalzadeh@iau.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehrsa Balalzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>West 6th Street, Kianabad</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6155714719</zip>
        <telephone>+98 61 3391 8542</telephone>
        <email>mehrsa.balalzadeh@iau.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women aged 20 to 40 years
Definitive diagnosis of type 2 diabetes by a specialist doctor</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Participation in other psychotherapy sessions in the 6 months prior to the study
Unwillingness to participate in research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus without complications</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: Cognitive-behavioral therapy intervention; Duration of each session: 90 minutes; Total number of sessions: 8 sessions; Sequence of sessions: twice a week; Therapeutic tools used: Cognitive model training (connection of thoughts, feelings, and behaviors); Cognitive restructuring (identifying and challenging automatic thoughts); Relaxation and stress management techniques; Problem-solving exercises; and value-based activities to promote meaning in life. Summary of session content: Session 1: Pre-test, familiarization with the cognitive-behavioral model, and training on the relationship between diabetes, negative thoughts, and stress; Session 2: Identification of automatic thoughts and cognitive biases related to the disease and stress management; Session 3: Training in relaxation techniques (such as deep breathing) to reduce perceived stress; Session 4: Cognitive restructuring and challenging dysfunctional thoughts about the limitations caused by diabetes; Session 5: Training in problem-solving skills and coping with everyday challenges of diabetes management; Session 6: Behavioral exercises to increase emotional resilience in the face of physical changes; Seventh session: Focusing on finding meaning in life and identifying personal values ​​amid the challenges of the disease; Eighth session: Conclusion, teaching planning to prevent the return of stress, conducting a post-test, and determining the time for the follow-up test.</i_keyword>
      <i_keyword>Control group: The control group will not receive any intervention during the research. However, to avoid factors that threaten the internal validity of the research, such as compensatory competition of the control group or demoralization, they are assured that they will receive the intervention at the next time (after data collection).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Perceived stress. Timepoint: 1. Pre-test: Before the intervention sessions begin.2. Post-test: Two weeks after the last intervention session.3. Follow-up: Four weeks (one month) after the last intervention session. Method of measurement: The method of measurement will be the Cohen et al. (1983) Perceived Stress Questionnaire.</prim_outcome>
      <prim_outcome>Emotional resilience. Timepoint: 1. Pre-test: Before the intervention sessions begin.2. Post-test: Two weeks after the last intervention session.3. Follow-up: Four weeks (one month) after the last intervention session. Method of measurement: The measurement method will be using the Connor and Davidson (2003) Emotional Resilience Scale.</prim_outcome>
      <prim_outcome>The meaning of life. Timepoint: 1. Pre-test: Before the intervention sessions begin.2. Post-test: Two weeks after the last intervention session.3. Follow-up: Four weeks (one month) after the last intervention session. Method of measurement: The measurement method will be using the Meaning of Life Questionnaire by Steger et al. (2006).</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>2026-04-28</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Ahvaz Branch</contact_name>
        <contact_address>Opposite Keshavarz Street, Farhang Shahr, Golestan Highway Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
