<?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>IRCT20181009041282N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-16</date_registration>
      <primary_sponsor>Ferdowsi University of Mashhad</primary_sponsor>
      <public_title>Comparison of the Effectiveness of Habit Reversal Training and Acceptance and Commitment Therapy to Drug Therapy on Patients with Trichotillomania</public_title>
      <acronym></acronym>
      <scientific_title>Compare the Effectiveness of Group Therapy Combination of Acceptance and Commitment Therapy and Habit Reversal Training to Drug Therapy in Reducing Symptoms, Anxiety and Depression of Patients with Trichotillomania</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34357</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First of all, 30 subjects who had inclusion criteria were selected and then assigned to two intervention groups and one control group using random block and Randomization.com site.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Trichotillomania. Condition 2: Anxiety. Condition 3: Depression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The first intervention group participates in 10 sessions and each session for 100 minutes of group therapy combination of habit reversal training and acceptance and commitment treatment. Acceptance and commitment therapy (ACT) encourages a person to accept what is beyond his control and commitment to social goals. In fact, ACT uses acceptance processes, mindfulness, and change in behavior and commitment to create psychological flexibility. Intervention 2: Intervention group: The second group receiving citalopram with a baseline of 40 mili gram per day, which reached 60 mili gram after 5 wee and in general, this medication will last for 8 weeks. Intervention 3: Control Group: The control group receives only 5 sessions and each session is for 40 minutes habit reversal training.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samaneh Eshaghzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi street</address>
        <city>Torbat Heydarieh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9516915169</zip>
        <telephone>+98 51 5222 6011</telephone>
        <email>s.eshaghzadeh0@gmail.com</email>
        <affiliation>Torbate-Heidaria University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samaneh Eshaghzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi street</address>
        <city>Torbat Heydarieh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9516915169</zip>
        <telephone>+98 51 5222 6011</telephone>
        <email>s.eshaghzadeh0@gmail.com</email>
        <affiliation>Torbate-Heidaria University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Clinical and psychiatric diagnosis of trichotillomania, anxiety and depression
Obtaining a minimum score in the Massachusetts General Hospital (MGH) hair pulling scale, beck depression inventory and beck anxiety inventory.
Age 18 to 50 years old.
Having at least elementary education.
Discontinue psycho-drug treatment at least one month before entering the plan.
Participants do not suffer from psychotic diseases that interfere with this research.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to cooperate in research
People with other mental and neurological diseases
People who receive different medical or psychological treatments</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F63.3</hc_code>
      <hc_code>F41</hc_code>
      <hc_code>F32.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Trichotillomania</hc_keyword>
      <hc_keyword>Other anxiety disorders</hc_keyword>
      <hc_keyword>Major depressive disorder, single episode, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The first intervention group participates in 10 sessions and each session for 100 minutes of group therapy combination of habit reversal training and acceptance and commitment treatment. Acceptance and commitment therapy (ACT) encourages a person to accept what is beyond his control and commitment to social goals. In fact, ACT uses acceptance processes, mindfulness, and change in behavior and commitment to create psychological flexibility.</i_keyword>
      <i_keyword>Intervention group: The second group receiving citalopram with a baseline of 40 mili gram per day, which reached 60 mili gram after 5 wee and in general, this medication will last for 8 weeks.</i_keyword>
      <i_keyword>Control Group: The control group receives only 5 sessions and each session is for 40 minutes habit reversal training.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Frequency and severity of hair pulling disorder symptoms. Timepoint: At the beginning of the study and after the intervention. Method of measurement: Via The Massachusetts General Hospital (MGH) Hair-Pulling Scale.</prim_outcome>
      <prim_outcome>Depression. Timepoint: At the beginning of the study and after the intervention. Method of measurement: Via Beck Depression Inventory.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: At the beginning of the study and after the intervention. Method of measurement: Via Beck Anxiety Inventory.</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>Ferdowsi University of Mashhad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-05-09</approval_date>
        <contact_name>Ethics Committee of Torbat Heydarieh University of Medical Sciences</contact_name>
        <contact_address>Razi street Torbat Heydarieh Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
