<?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>IRCT20160815029377N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-03-05</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>Exploring the impact of the Adaptive Disclosure technique on reducing the severity of post-traumatic stress disorder symptoms in veterans: a randomized controlled trial</public_title>
      <acronym></acronym>
      <scientific_title>Exploring the impact of the Adaptive Disclosure technique on reducing the severity of post-traumatic stress disorder symptoms in veterans: a randomized controlled trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>58</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81129</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomized block assignment will be carried out using the online platform Sealedenvelope. For this purpose, considering the total sample size of 58 participants and the existence of two groups (intervention and control), the block sizes will be multiples of two (either 2 or 4). Therefore, based on the number of blocks, the resulting sequence, and the predefined code, participants will be allocated to the two groups: intervention (A) and control (B).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Post-traumatic stress disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After obtaining the ethical approval code, clinical trial registration code, and other necessary permissions from Yasuj University of Medical Sciences, the researcher will visit Shahid Rajaee Hospital and Salman Hospital in Yasuj to collect data. Following coordination with hospital and department authorities, and providing adequate information regarding the nature of the research, as well as necessary explanations about the relevant questionnaire, the questionnaire will be distributed among veterans with post-traumatic stress disorder (PTSD) who meet the inclusion criteria and give informed consent. The completed questionnaires will be collected by the researcher.For the intervention group, the adaptive disclosure technique will be implemented in six weekly sessions, each lasting one and a half hours. In the first session, the patient's current symptoms will be assessed, a detailed history will be collected, and trauma exposure will be reviewed. In the second session, the patient’s experiences with veterans' traumatic events will be explored in-depth, along with addressing “hot cognitions” that negatively affect emotions, interpersonal communication in decision-making, and problem-solving abilities. In the third session, harmful thought patterns will be addressed, effective coping strategies will be developed, and the trauma narrative will be constructed. In the fourth session, core beliefs and challenges will be identified, the impact of the trauma will be further explored, and healthier ways of thinking will be introduced. In the fifth session, new and positive goals will be set, self-esteem will be enhanced, and new behavioral patterns will be reinforced. The final session will focus on strengthening new behavioral patterns and assisting the patient in adapting to life after trauma. Through this session, the therapist will address any persistent symptoms or destructive behaviors while helping the patient develop a sense of self-efficacy and increase their ability to manage PTSD symptoms. The therapist will also guide the patient in anticipating and coping with potential difficulties, as well as provide resources for long-term support. During this period, no intervention will be provided to the control group. Immediately after the intervention, both groups will complete the research questionnaire again, and the collected data will be analyzed. Intervention 2: Control group: During the intervention period, no intervention will be provided to the control group.</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 No more information available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Malekzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yasuj, Mehran, Abu Zar Boulevard, Eram Boulevard, Research and Technology Department, Yasuj University of Medical Sciences.</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591741417</zip>
        <telephone>+98 74 3334 6078</telephone>
        <email>mzh541@yahoo.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Malekzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yasuj, Mehran, Abu Zar Boulevard, Eram Boulevard, Research and Technology Department, Yasuj University of Medical Sciences.</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591741417</zip>
        <telephone>+98 74 3334 6079</telephone>
        <email>mzh541@yahoo.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18 years or older
Psychiatric veterans with a diagnosis of post-traumatic stress disorder (co-occurring disorders such as depression, anxiety, or treated substance abuse or dependency problems are permitted.)
Have sufficient insight to receive the adaptive disclosure technique through the Mental State Examination (MSE)
Have informed consent to enter the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of interest in continuing participation in the study.
Suicidal behavior or homicide, requiring urgent or emergency evaluation or treatment within the past three months.
Serious Axis I mental disorders such as psychotic disorders or Bipolar I disorder are not eligible.
Simultaneous enrollment in any cognitive-behavioral therapy, group therapy, or any other treatment involving systematic disclosure of disturbing memories related to the establishment.
Loss of self-insight.
Inability to communicate.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Post-traumatic stress disorder (PTSD)</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: After obtaining the ethical approval code, clinical trial registration code, and other necessary permissions from Yasuj University of Medical Sciences, the researcher will visit Shahid Rajaee Hospital and Salman Hospital in Yasuj to collect data. Following coordination with hospital and department authorities, and providing adequate information regarding the nature of the research, as well as necessary explanations about the relevant questionnaire, the questionnaire will be distributed among veterans with post-traumatic stress disorder (PTSD) who meet the inclusion criteria and give informed consent. The completed questionnaires will be collected by the researcher.For the intervention group, the adaptive disclosure technique will be implemented in six weekly sessions, each lasting one and a half hours. In the first session, the patient's current symptoms will be assessed, a detailed history will be collected, and trauma exposure will be reviewed. In the second session, the patient’s experiences with veterans' traumatic events will be explored in-depth, along with addressing “hot cognitions” that negatively affect emotions, interpersonal communication in decision-making, and problem-solving abilities. In the third session, harmful thought patterns will be addressed, effective coping strategies will be developed, and the trauma narrative will be constructed. In the fourth session, core beliefs and challenges will be identified, the impact of the trauma will be further explored, and healthier ways of thinking will be introduced. In the fifth session, new and positive goals will be set, self-esteem will be enhanced, and new behavioral patterns will be reinforced. The final session will focus on strengthening new behavioral patterns and assisting the patient in adapting to life after trauma. Through this session, the therapist will address any persistent symptoms or destructive behaviors while helping the patient develop a sense of self-efficacy and increase their ability to manage PTSD symptoms. The therapist will also guide the patient in anticipating and coping with potential difficulties, as well as provide resources for long-term support. During this period, no intervention will be provided to the control group. Immediately after the intervention, both groups will complete the research questionnaire again, and the collected data will be analyzed.</i_keyword>
      <i_keyword>Control group: During the intervention period, no intervention will be provided to the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>قبل The severity of post-traumatic stress disorder (PTSD) symptoms is measured using the Post-Traumatic Stress Disorder Checklist (PCL), with a score range of 17 to 85. The score is obtained by summing the responses to 17 items based on a Likert scale. The cutoff score for diagnosing PTSD is set at 50 for military personnel samples and has been validated exclusively for military populations. Timepoint: Before the intervention begins and immediately after the intervention ends. Method of measurement: Post-Traumatic Stress Disorder Checklist (PCL).</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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-09</approval_date>
        <contact_name>Research Ethics Committees of Yasuj University of Medical Sciences</contact_name>
        <contact_address>Yasuj University of Medical Sciences, Research Deputy of Yasuj University of Medical Sciences Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
