<?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>IRCT20220911055937N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-15</date_registration>
      <primary_sponsor>Ardakan University</primary_sponsor>
      <public_title>Effect of art therapy based on mindfulness in obsessive-compulsive disorder</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of mindfulness based on art therapy using watercolor painting on emotion regulation, mindfulness and obsessive-compulsive symptoms</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65930</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: A simple randomization method was used to assign the participants to the study groups; The individual was considered as randomization unit. The table of random numbers was used for randomization; First, numbers 01 to 40 were randomly assigned to participants. The direction of reading the numbers was determined from the top of the table. The first 20 numbers were considered for the experimental group and the second 20 numbers were considered for the control group. Also, random assignment concealment was used so that the assigned group is not known before assigning the individuals.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Obsessive compulsive disorder.</hc_freetext>
      <i_freetext>Intervention 1: Interventional group: Mindfulness is a method that can conducted using various techniques, including watercolor painting. The components of each session include techniques such as practicing attention and consciously focusing on drawing tools (pencil, brush, cardboard, paint, and water container) using different feelings; Drawing the emotions, physical sensations and inner feelings at the moment, with a pencil with closed eyes and the next time with open eyes (once with the right hand and once with the left hand). meditation, practicing attention and awareness of mind-body connection, awareness of the movement of the brush in the water and the resulting sound, mindfulness of color diffusion in the water inside the glass and focusing on changes in breathing rhythm were other components of the sessions. Drawing the inner feeling in the moment and drawing body sensations such as heat, cold, pain, itching, and burning were also practiced.. The content of mindfulness intervention sessions was taken from previous studies, however, painting techniques were used to implement the goals of each session. The tools used include all the necessary tools for watercolors painting, and the equipment used did not belong to any particular brand. In total, mindfulness intervention was conducted in 8 2-hour sessions. Two sessions were held every week and the interval between each session was three days. Intervention 2: Control group: The control group was on the waiting list but received three placebo sessions including general descriptions of the characteristics of obsessive compulsive disorder. The content of the sessions included the introduction of the guidelines of diagnostic and statistical manual of mental disorders (DSM) on the symptoms of obsessive-compulsive disorder. Each session lasted 45 minutes. The sessions were held weekly and the interval between each meeting was one week.</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 output of statistical software can be shared after de-identifying participants

When:
Access period starts 6 months after the results are published

To whom:
The researchers

Conditions:
Reasonable request

Where to obtain:
Corresponding Author (Saghar Ahmadi)

How to obtain:
Send email to correspondening author

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saghar Ahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 217, Safir Complex, Next to Nilfroshzadeh Alley, Azar st. Motahari, st</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8133817639</zip>
        <telephone>+98 31 3236 5457</telephone>
        <email>sagharahmadi30@yahoo.com</email>
        <affiliation>Ardakan University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saghar Ahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 217, Safir Complex, Next to Nilfroshzadeh Alley, Azar st. Motahari, st</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8133817639</zip>
        <telephone>+98 31 3236 5457</telephone>
        <email>sagharahmadi30@yahoo.com</email>
        <affiliation>Ardakan University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosing obsessive-compulsive disorder by a psychiatrist and using the cut-off point of the obsessive-compulsive symptoms scale
Physical ability to do homework
Age range 20 to 60 years</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Suffering from other psychological disorders
Participatiing in other psychotherapy interventions
Physical disability</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>Rehabilitation</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Interventional group: Mindfulness is a method that can conducted using various techniques, including watercolor painting. The components of each session include techniques such as practicing attention and consciously focusing on drawing tools (pencil, brush, cardboard, paint, and water container) using different feelings; Drawing the emotions, physical sensations and inner feelings at the moment, with a pencil with closed eyes and the next time with open eyes (once with the right hand and once with the left hand). meditation, practicing attention and awareness of mind-body connection, awareness of the movement of the brush in the water and the resulting sound, mindfulness of color diffusion in the water inside the glass and focusing on changes in breathing rhythm were other components of the sessions. Drawing the inner feeling in the moment and drawing body sensations such as heat, cold, pain, itching, and burning were also practiced.. The content of mindfulness intervention sessions was taken from previous studies, however, painting techniques were used to implement the goals of each session. The tools used include all the necessary tools for watercolors painting, and the equipment used did not belong to any particular brand. In total, mindfulness intervention was conducted in 8 2-hour sessions. Two sessions were held every week and the interval between each session was three days.</i_keyword>
      <i_keyword>Control group: The control group was on the waiting list but received three placebo sessions including general descriptions of the characteristics of obsessive compulsive disorder. The content of the sessions included the introduction of the guidelines of diagnostic and statistical manual of mental disorders (DSM) on the symptoms of obsessive-compulsive disorder. Each session lasted 45 minutes. The sessions were held weekly and the interval between each meeting was one week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Level of difficulty in emotion regulation score. Timepoint: The level of emotion regulation score was measured at three time points: Immediately before the intervention, Immediately after the intervention, Two months after the intervention. Method of measurement: The measuring of emotion regulation was performed using a standardized questionnaire of "the Difficulty in Emotion Regulation Questionnaire" which developed  by Gertz and Roemer.</prim_outcome>
      <prim_outcome>Level of mindfulness score. Timepoint: The level of mindfulness score was measured at three time points. Immediately before the intervention, immediately after the intervention, two months after the intervention. Method of measurement: The measuring of mindfulness was performed using a standardized questionnaire of "Five-Factor Mindfulness Questionnaire".</prim_outcome>
      <prim_outcome>Level of obsession symptoms. Timepoint: The level of obsessive symptoms was measured at three time points. Immediately before the intervention, Immediately after the intervention, Two months after the intervention. Method of measurement: The measuring of obsessive symptoms was performed using a standardized questionnaire of "Vancouver Algebraic Obsession Questionnaire".</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>Ardakan University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-28</approval_date>
        <contact_name>Ethics committee of Yazd University</contact_name>
        <contact_address>University Blvd, Safaeiyeh. Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
