<?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>IRCT20210727052000N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-07</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of Acceptance and Commitment Therapy on the brain waves of patients with obsessive-compulsive disorder</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of acceptance and commitment therapy on electroencephalography, psychological flexibility, cognitive fusion, emotion regulation, symptom reduction, and oxytocin blood levels in people with obsessive-compulsive disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68025</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: People who meet the entry criteria are referred by professors, counseling centers, and psychiatric clinics in Zanjan province and are randomly assigned to the experimental and control groups. Random allocation is done using Excel software. For this, in the first column, we enter 20 numbers 1 and 20 numbers 2 (representing the test and control group, respectively). Then, in the second column, we generate 46 random numbers using the (RAND) function. We sort the data based on column values containing random numbers (ascending or descending). With this sorting, the order of placement of numbers 1 and 2 will also change and be placed randomly. Based on the order of appearance of numbers 1 and 2, the samples are assigned to two groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Obsessive-compulsive disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Acceptance and Commitment Therapy is third wave psychology therapy, the protocol used by Dr. Twohing was written. The said treatment, during 8 sessions of individual psychotherapy, seeks to increase the acceptance of unpleasant feelings, cognitive breakdown from disturbing annoying thoughts, and also to introduce the values of the patients in order to increase the psychological flexibility of the patients in general. Intervention 2: Control group: The control group will only benefit from the evaluation sessions, so they will not know whether they will be in the intervention group or 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Data will be made available to the journal and researchers only if needed, after de-identifying individuals.

When:
Researchers start accessing documents and data files after 6 months to a year after the publication of the article.

To whom:
Only the researchers and reviewers of the journal to which the article is submitted.

Conditions:
The data will be sent for review studies, where all analyzes must be supervised by one of the authors of the proposal.

Where to obtain:
After publishing the article, researchers can email the responsible author at elnaz48.mousavi@gmail.com to access the data. Or, if you wish, go to Shahid Beheshti Hospital to meet with Dr. Mousavi.

How to obtain:
If the reason is scientific and the email is sent after the publication of the article, the requested information will be sent to them at least one week after consultation with other authors.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Elnaz Mousavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti hospital, Ark square, Zanjan</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>45136-15788</zip>
        <telephone>+98 24 3354 4003</telephone>
        <email>elnaz48.mousavi@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Hassani alimolk</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Plaque 18, Shahed street, West Azarbayjan province, Naghadeh city</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>45136_15788</zip>
        <telephone>+98 44 3566 1160</telephone>
        <email>fatima.hassani75@yahoo.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having symptoms of obsessive-compulsive disorder
Coexistence with other anxiety disorders (social anxiety disorder, generalized anxiety disorder, panic disorder, specific phobia and transition phobia)
Age range between 18-60 years
Not suffering from severe psychiatric disorders (psychotic spectrum, bipolar disorder)
Not using drugs and alcohol in the last three months
Not receiving cognitive-behavioral interventions for at least 8 sessions in the last 5 years
Failure to receive drug therapy within a month before the start of the intervention
Interest of the participants to participate in the research based on the provisions of the written consent
No chronic medical illness</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Absence of more than two sessions
Receiving another similar psychological intervention at the same time as the current research
Drug therapy at the same time as intervention
Lack of consent to continue treatment during the intervention process
Aggravation of the person's problems during the intervention and the need to provide another intervention</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 - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Acceptance and Commitment Therapy is third wave psychology therapy, the protocol used by Dr. Twohing was written. The said treatment, during 8 sessions of individual psychotherapy, seeks to increase the acceptance of unpleasant feelings, cognitive breakdown from disturbing annoying thoughts, and also to introduce the values of the patients in order to increase the psychological flexibility of the patients in general.</i_keyword>
      <i_keyword>Control group: The control group will only benefit from the evaluation sessions, so they will not know whether they will be in the intervention group or the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sign and symptoms of obsessive-compulsive disorder. Timepoint: pre and post test, after 3 months follow-up. Method of measurement: Yale-Brown Obsessive-Compulsive Scale.</prim_outcome>
      <prim_outcome>Brain waves. Timepoint: pre, post and 3 months after intervention. Method of measurement: electroeencephalogram.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Cognitive fusion. Timepoint: pre, post and 3 months after intervention. Method of measurement: Cognitive fusion questionnaire.</sec_outcome>
      <sec_outcome>Cognitive emotion regulation. Timepoint: pre, post and 3 months after intervention. Method of measurement: Cognitive emotion regulation questionnaire.</sec_outcome>
      <sec_outcome>Psychological flexibility. Timepoint: pre, post and 3 months after intervention. Method of measurement: Acceptance and action questionnaire (II).</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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-17</approval_date>
        <contact_name>Ethics Committee of Zanjan University of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti hospital, Ark gate, Zanjan city, Zanjan province Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
