<?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>IRCT20250817066892N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-10-26</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>A comparative study of two psychological treatment methods on the well-being and adjustment of parents of patients with schizophrenia.</public_title>
      <acronym>ACT-CBT Schizo Parents</acronym>
      <scientific_title>A comparison of the effectiveness of Acceptance and Commitment Therapy and Cognitive-Behavioral Therapy on emotional adaptation, mental well-being, and psychological flexibility in parents of patients with schizophrenia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-11-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/85586</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The process of random allocation of participants to three groups of interventions and control includes both creating a random sequence and concealing the random allocation. Firstly, using the random sequence rule, 60 papers for participants of the interventions and control groups (which will be marked with A, B, and C and will not be defined to avoid bias) will be thrown into a lottery container and then the papers will be removed from the lottery container - without replacement - and the created sequence will be recorded. Then, using the snooze method, 60 envelopes will be prepared and each of the random sequences created will be recorded on a card and will be placed in the envelopes in order, and the envelopes will be also numbered. Then, the envelopes will be given to the participants based on the order of entering the study, so the grouping of each will be determined.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Schizophrenia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: The intervention that this group will receive is acceptance and commitment therapy. Nine individual 90-minute sessions based on Hayes’ protocol, delivered once per week by a licensed clinical psychologist. The intervention focuses on six core processes: cognitive defusion, acceptance, contact with the present moment, self-as-context, values clarification, and committed action. Sessions are conducted in a private counseling room. Intervention 2: Intervention group 2: The intervention that this group will receive is acceptance and commitment therapy. Nine individual 90-minute sessions, delivered once per week by a licensed clinical psychologist. The sessions include cognitive restructuring, identifying and challenging maladaptive thoughts, behavioral activation, stress management, and problem-solving training. The intervention is based on established CBT principles and guidelines, and sessions are conducted in a private counseling room. Intervention 3: Control group: Participants in this group will not receive any active psychological intervention during the study period and will continue their usual care. After the completion of the trial, they will be provided with an educational package on psychological skills.</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 Participant privacy and confidentiality will be maintained; individual data will not be shared</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Bahareh Abdollahzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mehr Counseling Center, No. 76, West 28th Alley, South Allameh Street, West Sarv Street, Saadat Abad, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1997763114</zip>
        <telephone>+98 21 8868 0901</telephone>
        <email>Bahar.abdh@yahoo.ca</email>
        <affiliation>Islamic azad university of tonekabon</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Bahareh Abdollahzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>South allameh Ave</address>
        <city>No. 76, West 28th Alley, Saadat Abad Avenue, South Allameh Avenue, Tehran, Iran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۹۸۷۶۳۱۱۴</zip>
        <telephone>+98 21 8868 0901</telephone>
        <email>Bahar.abdh@yahoo.ca</email>
        <affiliation>Islamic azad university tonekabon branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Parents of patients with schizophrenia who have an active file at the Tehran Welfare Organization
Diagnosing emotional problems, mental well-being, and psychological resilience based on questionnaire scores
Ability to read and write</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Being diagnosed with a mental illness by a psychiatrist
Having acute and chronic physical illnesses such as epilepsy, skeletal disorders, and respiratory insufficiency
Using psychiatric drugs at the time of study admission
Unable to complete questionnaires
Failure to attend the initial intervention sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F20-F29</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>اختلال اسکیزوفرنی</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: The intervention that this group will receive is acceptance and commitment therapy. Nine individual 90-minute sessions based on Hayes’ protocol, delivered once per week by a licensed clinical psychologist. The intervention focuses on six core processes: cognitive defusion, acceptance, contact with the present moment, self-as-context, values clarification, and committed action. Sessions are conducted in a private counseling room.</i_keyword>
      <i_keyword>Intervention group 2: The intervention that this group will receive is acceptance and commitment therapy. Nine individual 90-minute sessions, delivered once per week by a licensed clinical psychologist. The sessions include cognitive restructuring, identifying and challenging maladaptive thoughts, behavioral activation, stress management, and problem-solving training. The intervention is based on established CBT principles and guidelines, and sessions are conducted in a private counseling room.</i_keyword>
      <i_keyword>Control group: Participants in this group will not receive any active psychological intervention during the study period and will continue their usual care. After the completion of the trial, they will be provided with an educational package on psychological skills.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Emotional adjustment score. Timepoint: Before intervention (pre-test), after intervention (post-test), 3 months after intervention (follow-up). Method of measurement: Emotional Adjustment Scale by Rabio et al. (2007).</prim_outcome>
      <prim_outcome>Psychological Well-Being score. Timepoint: Before intervention (pre-test), after intervention (post-test), 3 months after intervention (follow-up). Method of measurement: Psychological Well-Being Questionnaire by Goyers and Margamiov (2003).</prim_outcome>
      <prim_outcome>Cognitive flexibility score. Timepoint: Before intervention (pre-test), after intervention (post-test), 3 months after intervention (follow-up). Method of measurement: Cognitive Flexibility Inventory by Denis and Vendral (2010).</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>2025-07-22</approval_date>
        <contact_name>Research Ethics Committee of Islamic Azad University, Tonekabon Branch</contact_name>
        <contact_address>Vali Abad Ave, Khalij Fars Blv, Tonekabon Tonekabon Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
