<?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>IRCT20250521065821N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-07-29</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of cognitive behavioral therapy on anger control, distress tolerance, and negative automatic thoughts in single-parent women with symptoms of social anxiety</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of cognitive behavioral therapy on anger control, distress tolerance, and negative automatic thoughts in widowed women with symptoms of social anxiety</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-08-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/85140</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The selection will be done through a simple randomization method. According to this method, the names of each selected member will be written on paper as research samples, placed in a box for drawing, and then the pieces of paper will be drawn one by one. The first 15 individuals (1 to 15) will be part of the experimental group, and the next 15 individuals (16 to 30) whose names are drawn from the box will be members of the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Not applicable..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 1. First Session:The first session included psychoeducation, which consisted of:a) Teaching the basics of cognitive-behavioral therapy (CBT) and presenting the rationale for treatment.b) Educating about the fundamental principles of symptoms related to social anxiety disorder (SAD), introducing and discussing the cognitive-behavioral model of SAD.c) Encouraging patient engagement in therapy sessions and completing between-session assignments.d) Homework: Reviewing the cognitive-behavioral model worksheet for SAD.                      2. Second Session:a) Reviewing the treatment model.b) Educating the patient about anxiety and the role of avoidance in maintaining social anxiety.c) Raising awareness about the importance of exposure and the nature of exposure situations.d) Creating a fear and avoidance hierarchy.e) Homework: Daily recording of anxiety-provoking social situations.                                                                                                          3. Third Session:a) Introducing the patient to negative automatic thoughts and maladaptive beliefs.b) Teaching the patient skills to identify and categorize negative automatic thoughts and challenge them.c) Homework: Completing the automatic thought challenging worksheet.             4-5. Fourth and Fifth Sessions:a) Developing a fear and avoidance hierarchy.b) Introducing the patient to the video feedback technique.c) Conducting video feedback exposure in the session: (The patient is asked to speak in front of a video camera about what they have learned in previous therapy sessions. The recorded video is then played back for the patient and those present during the exposure).d) Homework: (The patient is asked to stand in front of a mirror daily for a few minutes and talk about a topic or describe their own characteristics).                                                      6-7. Sixth and Seventh Sessions:a) Preparing the patient for exposure in natural settings outside therapy sessions.b) Designing appropriate exposure situations for the patient based on the fear and avoidance hierarchy.c) Conducting exposure outside the therapy session.d) Providing feedback to the patient after exposure.e) Homework: The patient is asked to design and carry out several exposure situations and assess their anxiety levels before and after exposure.                                      8-9. Eighth and Ninth Sessions:a) Teaching assertiveness skills to the patient.b) Introducing the patient to assertiveness techniques and their different forms.c) Homework: The patient is asked to identify situations requiring assertiveness that they previously avoided and apply this skill.             10-11. Tenth and Eleventh Sessions:a) Relapse prevention.b) Identifying maintaining factors to prevent relapse in daily life.c) Preparing the patient to cope with temporary anxiety recurrence.d) Reviewing all therapy sessions, summarizing the patient's progress, and providing feedback.          12. Twelfth Session:Administering post-test questionnaires and thanking the participants. Intervention 2: Control group: They receive no training.</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:
Only part of the data, such as information related to the primary outcome or similar, can be shared.

When:
Access period begins 6 months after publication of results.

To whom:
The data will only be accessible to researchers affiliated with academic or scientific institutions.

Conditions:
Any type of analysis is permitted on the delivered data.

Where to obtain:
Via email: nargesyousefi0203@gmail.com

How to obtain:
The data will be sent after emailing narges yousefi Sheikh Robat and receiving approval from the research team members

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Narges Yousefi Sheikh Robat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 60, 3rd Street, Phase 3, Koroush District</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۱۶۴۸۷۸۷۸۴</zip>
        <telephone>009832242836</telephone>
        <email>nargesyousefi0203@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Iran Davodi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>South Kargar Boulevard؛ Farhang Shahr District؛ Golestan Highway</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6134937333</zip>
        <telephone>+98 61 3334 8421</telephone>
        <email>info@iauahvaz.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Non-attendance in educational classes concurrent with the training sessions of this study
Informed consent of the participant to participate in the research
Obtaining a low score on the anger control and distress tolerance questionnaire based on the questionnaire's cutoff score.
Obtaining a high score on the negative automatic thoughts questionnaire according to the questionnaire's cutoff score.
Absence of any specific physical or psychological illness affecting the treatment process.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Absence in more than 2 intervention sessions.
Concurrent use of psychiatric medications with this treatment.
Not participating in other psychological interventions.
Developing a pervasive 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>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 1. First Session:The first session included psychoeducation, which consisted of:a) Teaching the basics of cognitive-behavioral therapy (CBT) and presenting the rationale for treatment.b) Educating about the fundamental principles of symptoms related to social anxiety disorder (SAD), introducing and discussing the cognitive-behavioral model of SAD.c) Encouraging patient engagement in therapy sessions and completing between-session assignments.d) Homework: Reviewing the cognitive-behavioral model worksheet for SAD.                      2. Second Session:a) Reviewing the treatment model.b) Educating the patient about anxiety and the role of avoidance in maintaining social anxiety.c) Raising awareness about the importance of exposure and the nature of exposure situations.d) Creating a fear and avoidance hierarchy.e) Homework: Daily recording of anxiety-provoking social situations.                                                                                                          3. Third Session:a) Introducing the patient to negative automatic thoughts and maladaptive beliefs.b) Teaching the patient skills to identify and categorize negative automatic thoughts and challenge them.c) Homework: Completing the automatic thought challenging worksheet.             4-5. Fourth and Fifth Sessions:a) Developing a fear and avoidance hierarchy.b) Introducing the patient to the video feedback technique.c) Conducting video feedback exposure in the session: (The patient is asked to speak in front of a video camera about what they have learned in previous therapy sessions. The recorded video is then played back for the patient and those present during the exposure).d) Homework: (The patient is asked to stand in front of a mirror daily for a few minutes and talk about a topic or describe their own characteristics).                                                      6-7. Sixth and Seventh Sessions:a) Preparing the patient for exposure in natural settings outside therapy sessions.b) Designing appropriate exposure situations for the patient based on the fear and avoidance hierarchy.c) Conducting exposure outside the therapy session.d) Providing feedback to the patient after exposure.e) Homework: The patient is asked to design and carry out several exposure situations and assess their anxiety levels before and after exposure.                                      8-9. Eighth and Ninth Sessions:a) Teaching assertiveness skills to the patient.b) Introducing the patient to assertiveness techniques and their different forms.c) Homework: The patient is asked to identify situations requiring assertiveness that they previously avoided and apply this skill.             10-11. Tenth and Eleventh Sessions:a) Relapse prevention.b) Identifying maintaining factors to prevent relapse in daily life.c) Preparing the patient to cope with temporary anxiety recurrence.d) Reviewing all therapy sessions, summarizing the patient's progress, and providing feedback.          12. Twelfth Session:Administering post-test questionnaires and thanking the participants.</i_keyword>
      <i_keyword>Control group: They receive no training.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anger control. Timepoint: Measurements will be conducted at pre-test, post-test, and three-month follow-up after the post-test. Method of measurement: Spielberger Anger Questionnaire.</prim_outcome>
      <prim_outcome>Distress tolerance. Timepoint: Measurements will be conducted at pre-test, post-test, and three-month follow-up after the post-test. Method of measurement: Simmons and Gahr Distress Tolerance Questionnaire.</prim_outcome>
      <prim_outcome>Negative self-talk. Timepoint: Measurements will be conducted at pre-test, post-test, and three-month follow-up after the post-test. Method of measurement: Automatic Negative Thoughts Questionnaire (ATQ).</prim_outcome>
      <prim_outcome>Social anxiety. Timepoint: Measurements will be conducted at pre-test, post-test, and three-month follow-up after the post-test. Method of measurement: Social Anxiety Questionnaire.</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>2024-11-11</approval_date>
        <contact_name>The Ethics Committee in Research of Islamic Azad University - Ahvaz Branch</contact_name>
        <contact_address>South Kargar Boulevard؛ 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>
