<?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>IRCT20250304064931N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-05-29</date_registration>
      <primary_sponsor>Khyber Medical University Peshawar</primary_sponsor>
      <public_title>Comparison of the Effectiveness of EEG-Based Neurofeedback Therapy Versus Conventional Therapies (Medication and Mindfulness-Based Cognitive Behavioral Therapy) in Improving Symptoms of Obsessive-Compulsive Disorder Patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of EEG-Based Neurofeedback Therapy Versus Conventional Therapies (Medication and Mindfulness-Based Cognitive Behavioral Therapy) in Improving Symptoms of Obsessive-Compulsive Disorder Patients: A Randomized Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-04-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/83149</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomized controlled trial (RCT) design, Randomization description: To implement random allocation, we will use OpenEpi software to generate a list of random numbers corresponding to participant IDs. Each eligible participant will be assigned a unique identifier, and based on the random number sequence, they will be allocated to either the intervention or control group in a 1:1 ratio. Allocation will be performed using a simple randomization approach without stratification or blocking. The randomization list will be prepared in advance by an independent statistician not involved in participant recruitment to maintain allocation concealment. The group assignments will be placed in sequentially numbered, opaque, sealed envelopes, which will be opened only after participant enrollment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Obsessive-Compulsive Disorder (OCD) is a chronic mental health condition characterized by persistent, intrusive thoughts (obsessions) and repetitive behaviors or mental acts (compulsions) that an individual feels compelled to perform. These symptoms can cause significant distress, interfere with daily functioning, and diminish quality of life. The study focused on understanding the clinical presentation, underlying mechanisms, and potential interventions for individuals affected by OCD. Emphasis was placed on early diagnosis, treatment outcomes, and the socio-cultural context influencing symptom expression and treatment adherence..</hc_freetext>
      <i_freetext>Intervention 1: Control group: Group A (treatment as usual). Intervention 2: Intervention group: Group B (mindfulness based cognitive therapy with medication). Intervention 3: Intervention group: roup C (electroencephalogram based neurofeedback with medication). Intervention 4: Intervention group: Group D (Mindfulness based cognitive therapy/Electroencephalogram based neurofeedback without medication).</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:
I will provide study protocols, data analysis, and codes

When:
After the completion of my thesis, I will provide for a long time.

To whom:
To IRCT and other members

Conditions:
For research and educational purposes

Where to obtain:
from websites and journals

How to obtain:
online

Comments:
N/A</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sumaira Mehreen</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Psychology, university of Peshawar, Khyber Pakhtunkhwa, Peshawar</address>
        <city>Peshawar</city>
        <country1>Pakistan</country1>
        <zip>25000</zip>
        <telephone>+92 345 9093113</telephone>
        <email>sumaira.mehreen@lrh.edu.pk</email>
        <affiliation>University of Peshawar</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sumaira Mehreen</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Psychology, university of Peshawar, Khyber Pakhtunkhwa, Peshawar</address>
        <city>Peshawar</city>
        <country1>Pakistan</country1>
        <zip>25000</zip>
        <telephone>+92 91 9211430</telephone>
        <email>sumaira.mehreen@lrh.edu.pk</email>
        <affiliation>University of Peshawar</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosed with Obsessive-Compulsive Disorder (OCD) according to DSM-5 criteria.
Aged between 18 and 40 years.
No neurological disorder (stroke, head injury, epilepsy, dementia).
No severe medical conditions (e.g., hepatic failure, renal failure).
No history of psycho-surgery or neurosurgical procedures.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Psychiatric comorbidity (schizophrenia, psychosis, delusional disorders).
Substance abuse or drug dependence.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F42</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obsessive-compulsive disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Group A (treatment as usual)</i_keyword>
      <i_keyword>Intervention group: Group B (mindfulness based cognitive therapy with medication)</i_keyword>
      <i_keyword>Intervention group: roup C (electroencephalogram based neurofeedback with medication)</i_keyword>
      <i_keyword>Intervention group: Group D (Mindfulness based cognitive therapy/Electroencephalogram based neurofeedback without medication)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Obsessive compulsive disorder. Timepoint: Before intervention (baseline), and on every follow up (monthly in group A for 3 months which is treatment as usual group, and weekly in treatment group B, C and D for 12weeks. Method of measurement: Yale brown obsessive compulsive scale (YBOCS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Lady Reading Hospital Peshawar</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>N/A</source_name>
      <source_name>N/A</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-01-14</approval_date>
        <contact_name>Institutional Review Board- Lady Reading Hospital Peshawar</contact_name>
        <contact_address>Soekarno Rd, Pipal Mandi, Peshawar, 25000 Peshawar Khyber Pakhtunkhwa Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
