<?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>IRCT20250202064612N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-12-06</date_registration>
      <primary_sponsor>Hakim Tous Institute of Higher Education</primary_sponsor>
      <public_title>The effect of telehealth-based acceptance and commitment therapy (online) on perceived social support, caregiving burnout, and emotional health of caregivers of Parkinson's patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of telehealth-based acceptance and commitment therapy (online) on perceived social support, caregiving burnout, and emotional health of caregivers of Parkinson's patients: An intervention study with two-month follow-up</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-12-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/87776</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, random allocation will be performed using a simple randomization method with individual participants as the unit of randomization (each participant as an independent unit).  
For this purpose, SPSS software will generate a unique random number for each patient.  
Based on these numbers, participants will be allocated in a balanced manner (1:1 ratio) exclusively according to the software's random output, without consideration of any individual or clinical characteristics, to either the intervention group (ACT therapy) or control group.  
The allocation sequence will be generated by the software prior to the commencement of the enrollment process, Blinding description: In this study, the data analyst will be blinded to group allocation.  
Following data collection, the final dataset containing clinical information and questionnaire responses will be provided to the analyst without labels identifying the intervention or control groups (ACT/Control).  
Instead, groups will be identified with neutral codes (e.g., Group A and Group B).  
The decryption key for these codes will be disclosed only after completion of the initial analysis by the research supervisor (who is not involved in the analysis).  
This method ensures results remain free from interpretive bias.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mental health in caregivers of Parkinson's patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants in this group are caregivers of patients with Parkinson's disease who receive Acceptance and Commitment Therapy (ACT) via telehealth. The intervention consists of 8 weekly sessions, each lasting 45 minutes, based on Dr. Zettel's ACT treatment protocol, held via online video call. The content of the sessions focuses on increasing psychological resilience, improving caregiver burnout, promoting perceived social support, and increasing emotional well-being. The main techniques include mindfulness exercises, acceptance, cognitive distancing, value clarification, and commitment to action in line with these values. Intervention 2: Control group: Participants in this group are caregivers of patients with Parkinson's disease who will continue their usual medical care and standard follow-up without receiving ACT treatment during the study period. After the study ends, ACT treatment sessions will be offered to this group on an optional and free basis.</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:
The data will be displayed in the form of graphs and tables and SPSS file.

When:
It will be presented after the thesis defense and publication of the paper.

To whom:
Students of psychology and neuroscience, as well as specialists in the fields of neurology and psychiatry and paramedical fields related to Parkinson's disease

Conditions:
The data will only be sent for research studies and research analyses, and applicants are required to refer to my research and cite my article and thesis title in their own research.

Where to obtain:
People can send SMS to my email address and also my academic email if available and my contact number. Email: hesamfarzaneh98@gmail.com Number: 09919946489 Academic email: h.farzane@hakimtoos.ac.ir

How to obtain:
After submitting the applicant's request, along with a summary of the research plan and proposal, and a letter from their university's research committee to validate that the researcher is a genuine individual, they will be notified within one to two weeks.

Comments:
Any copying and misuse without reference to my thesis and research is prohibited and will be subject to legal action.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Farzaneh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshgah St.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9361633384</zip>
        <telephone>+98 991 994 6489</telephone>
        <email>h.farzane@hakimtoos.ac.ir</email>
        <affiliation>Hakim Tous Institute of Higher Education</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>mohammad farzaneh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshgah St.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9361633384</zip>
        <telephone>+98 991 994 6489</telephone>
        <email>h.farzane@hakimtoos.ac.ir</email>
        <affiliation>Hakim Tous Institute of Higher Education</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient care for at least 6 months
Ability to participate in online meetings
Informed consent to participate in research</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having severe mental disorders
Lack of commitment to attend meetings</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Parkinson's disease</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: Participants in this group are caregivers of patients with Parkinson's disease who receive Acceptance and Commitment Therapy (ACT) via telehealth. The intervention consists of 8 weekly sessions, each lasting 45 minutes, based on Dr. Zettel's ACT treatment protocol, held via online video call. The content of the sessions focuses on increasing psychological resilience, improving caregiver burnout, promoting perceived social support, and increasing emotional well-being. The main techniques include mindfulness exercises, acceptance, cognitive distancing, value clarification, and commitment to action in line with these values.</i_keyword>
      <i_keyword>Control group: Participants in this group are caregivers of patients with Parkinson's disease who will continue their usual medical care and standard follow-up without receiving ACT treatment during the study period. After the study ends, ACT treatment sessions will be offered to this group on an optional and free basis.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Increasing perceived social support. Timepoint: Pre-test and post-test and two-month follow-up. Method of measurement: Multidimensional Scale of Perceived Social Support (MSPSS),.</prim_outcome>
      <prim_outcome>Improving caregiver burnout. Timepoint: Pre-test and post-test and two-month follow-up. Method of measurement: Caregiver Burden Inventory (CBI).</prim_outcome>
      <prim_outcome>Increasing emotional health. Timepoint: Pre-test and post-test and two-month follow-up. Method of measurement: Emotional Style Questionnaire (ESQ).</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>Hakim Tous Institute of Higher Education</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-08-16</approval_date>
        <contact_name>Mashhad University of Medical Sciences</contact_name>
        <contact_address>Mashhad University of Medical Sciences, Health Knowledge City, Between Shahid Javan Square and Shahid Al Shahidi Square, End of Shahid Fakuri Boulevard, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
