<?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>IRCT20210708051815N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-07-15</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of ACT in Spouses of Military Personnel with PTSD</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Acceptance and Commitment Therapy on Dyadic Functioning, Emotion Regulation, and Symptoms of Secondary Post-Traumatic Stress Disorder in Spouses of Military Personnel with PTSD</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/89901</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After confirming eligibility criteria and obtaining written informed consent, participants were randomly allocated to either the intervention group (Acceptance and Commitment Therapy [ACT]) or the wait-list control group with a 1:1 allocation ratio. Randomization was performed using a computer-generated random number table. Each participant was assigned a unique identification code, and allocation to the study groups was carried out according to the predetermined random sequence. To ensure balanced group sizes, participant allocation continued until 26 individuals were assigned to each group. The allocation list was maintained by the principal investigator, and all outcome assessments were conducted at baseline (pretest), post-intervention (posttest), and the three-month follow-up according to the assigned group, Blinding description: Allocation and sessions were conducted under blinding by a clinical supervisor.</study_design>
      <phase>N/A</phase>
      <hc_freetext>PTSD.</hc_freetext>
      <i_freetext>Intervention 1: Participants in the intervention group received group-based Acceptance and Commitment Therapy (ACT) based on the standard protocol developed by Hayes and colleagues. The intervention consisted of eight weekly sessions, each lasting 90 minutes, delivered by a clinical psychologist trained in ACT. The sessions covered the six core ACT processes, including acceptance, cognitive defusion, present-moment awareness, self-as-context, values clarification, and committed action. Homework assignments and experiential exercises were provided at the end of each session to facilitate the application of therapeutic skills in daily life. The total duration of the intervention was 8 weeks. No medications or medical devices were used during the intervention. Intervention 2: Control group: Participants in the control group did not receive Acceptance and Commitment Therapy during the study period and continued to receive routine care, if needed. For ethical considerations, they were offered the ACT program after completion of the post-intervention assessments.</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:
Upon request from the corresponding author and research supervisor, access to data is possible, subject to confidentiality.

When:
Up to 5 years after the research is completed

To whom:
Researchers and university faculty members

Conditions:
Conducting additional scientific research

Where to obtain:
Responsible author

How to obtain:
First, a written request via email or post to the responsible author / review by the research team / submission of documents

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amirmasoud Mirbagheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd-Safaieh-End of Shahid Ghandi Boulevard-Soroush Street-Arash Complex-Unit 164</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>894913775</zip>
        <telephone>+98 936 300 8905</telephone>
        <email>goosheamm@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Esfandiar Azad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Vanak Square, Mulla Sadra Street, South Sheikh Bahai Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۳۵۹۱۵۳۸۱</zip>
        <telephone>+98 21 8804 0060</telephone>
        <email>sfazad13@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Spouses of military personnel with PTSD whose partners are still alive.
The spouses must not have a history of major psychiatric disorders or hospitalization due to psychological problems.
In addition, during the pre-intervention assessment, these individuals must score above the cut-off point on the research instruments, indicating the presence of the symptom. A score higher than 50 on the PCL-5 for the military individual.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Development of a physical or psychological illness during the study leading to hospitalization and discontinuation of the ACT treatment process.
Changes in life structure, such as divorce during the study.
Dropping out of therapy sessions or عدم adherence to therapeutic assignments.</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>Participants in the intervention group received group-based Acceptance and Commitment Therapy (ACT) based on the standard protocol developed by Hayes and colleagues. The intervention consisted of eight weekly sessions, each lasting 90 minutes, delivered by a clinical psychologist trained in ACT. The sessions covered the six core ACT processes, including acceptance, cognitive defusion, present-moment awareness, self-as-context, values clarification, and committed action. Homework assignments and experiential exercises were provided at the end of each session to facilitate the application of therapeutic skills in daily life. The total duration of the intervention was 8 weeks. No medications or medical devices were used during the intervention.</i_keyword>
      <i_keyword>Control group: Participants in the control group did not receive Acceptance and Commitment Therapy during the study period and continued to receive routine care, if needed. For ethical considerations, they were offered the ACT program after completion of the post-intervention assessments.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dyadic functioning: The World Health Organization states that the health and dynamics of couples depend on their patterns of perception, cognition, emotional system, and behavior, all of which are structural components of dyadic functioning. Timepoint: PreTest-PostTest-fallow up. Method of measurement: ECS.</prim_outcome>
      <prim_outcome>Emotion Regulation: Emotion regulation refers to any process or action through which a person influences their emotions or emotional expression. Timepoint: PreTest-PostTest-fallow up. Method of measurement: DERS.</prim_outcome>
      <prim_outcome>Secondary Post-Traumatic Stress Disorder Syndrome: Secondary trauma refers to the transmission of symptoms similar to PTSD from the affected person to someone who is in close proximity to these symptoms. Timepoint: PreTest-PostTest-fallow up. Method of measurement: STQ.</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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-03-17</approval_date>
        <contact_name>Ethics committee of baghyatallah university of medical sciences</contact_name>
        <contact_address>Mollasadra st, vanak sq sheykh bahayi st,Tehran,Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
