<?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>IRCT20200905048628N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-01</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effectiveness of the clinical guide for the treatment of sexual addiction disorder in individuals with and without a history of stimulant use</public_title>
      <acronym></acronym>
      <scientific_title>Developing a clinical guideline for treatment of sex addiction and comparing its efficacy in individuals with and without a history of stimulant use.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50771</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: People who enter the study are assigned to different groups based on the method of Balance Block Randomization. Mr. Arash Javaheri, a PhD student in addiction studies with a master's degree in clinical psychology, is in charge of randomization. When Mr. Javaheri evaluates the inclusion and exclusion criteria and obtaining informed consent, the people go to the receptionist of the medical center, who has a randomization table. The names of these people are recorded in the randomization table, respectively. A card is then given to the person with the randomization table code and the person's name written on the card. Subjects are required to carry this code with them whenever they refer for intervention or follow-up, and this is the basis for recording information in subsequent visits. The randomization method is simple and individual randomization unit. Using Excel software, the design consultant epidemiologist designed and plotted a balanced four-block table for study, Blinding description: In order to blind the study, after compiling the guide, we use a placebo for the comparison group, for this purpose, a similar intervention will be designed and presented for this group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>sexual addiction disorder, stimulant use disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: People with sexual addiction disorder; According to the handbook for guideline development (World Health Organization, 2012) and based on literature review, the clinical guide for the treatment of sexual addiction disorder in the form of 10 sessions of 90 minutes and one month follow-up will be developed and implemented as compilations of guidelines. The treatment will be done in the form of group therapy. Intervention 2: Intervention group 2: People with sexual addiction disorder and stimulant use disorder;  According to the handbook for guideline development (World Health Organization, 2012) and based on literature review, the clinical guide for the treatment of sexual addiction disorder in the form of 10 sessions of 90 minutes and one month follow-up will be developed and implemented as compilations of guidelines. The treatment will be done in the form of group therapy. Intervention 3: Control group 1: People with sexual addiction disorder; For the control group, the placebo will be presented in the form of books and educational videos in the field of treatment of sexual addiction disorder. Intervention 4: Control group 2: People with sexual addiction disorder and stimulant use disorder; For the control group, the placebo will be presented in the form of books and educational videos in the field of treatment of sexual addiction disorder.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Arash Javaheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 3, Moghadam Building, next to Imam Hossein Mosque, Golestan Alley, Alley 69 (Shahid Zamani), Jay St.</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8156139928</zip>
        <telephone>+98 31 3225 5571</telephone>
        <email>ajavaheri68@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arash Javaheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 3, Moghadam Building, next to Imam Hossein Mosque, Golestan Alley, Alley 69 (Shahid Zamani), Jay St.</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8156139928</zip>
        <telephone>+98 31 3521 9079</telephone>
        <email>ajavaheri68@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>receiving a diagnosis of stimulant use disorder
receiving a diagnosis of sexual addiction disorder</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Existence of mental retardation
Symptoms of psychosis
Bipolar disorder
Acute thoughts of suicide
Opioid use
Drug use
Having any organic disorders such as a history of head trauma with anesthesia, seizures, brain tumors, etc., which has led to cognitive and psychological disorders.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F52.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other sexual dysfunction not due to a substance or known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: People with sexual addiction disorder; According to the handbook for guideline development (World Health Organization, 2012) and based on literature review, the clinical guide for the treatment of sexual addiction disorder in the form of 10 sessions of 90 minutes and one month follow-up will be developed and implemented as compilations of guidelines. The treatment will be done in the form of group therapy.</i_keyword>
      <i_keyword>Intervention group 2: People with sexual addiction disorder and stimulant use disorder;  According to the handbook for guideline development (World Health Organization, 2012) and based on literature review, the clinical guide for the treatment of sexual addiction disorder in the form of 10 sessions of 90 minutes and one month follow-up will be developed and implemented as compilations of guidelines. The treatment will be done in the form of group therapy.</i_keyword>
      <i_keyword>Control group 1: People with sexual addiction disorder; For the control group, the placebo will be presented in the form of books and educational videos in the field of treatment of sexual addiction disorder.</i_keyword>
      <i_keyword>Control group 2: People with sexual addiction disorder and stimulant use disorder; For the control group, the placebo will be presented in the form of books and educational videos in the field of treatment of sexual addiction disorder.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>People who have a score of 53 or higher in the Hypersexual Behavior Inventory. Timepoint: Measuring the score of the Hypersexual Behavior Inventory before the intervention (pre-test), after the intervention (post-test) and 2-month follow-up. Method of measurement: Hypersexual Behavior 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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-11-30</approval_date>
        <contact_name>Research Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Room 503, Fifth Floor, Central Staff Building of Iran University of Medical Sciences,  between Chamran and Sheikh Fazlollah, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
