<?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>IRCT20240705062335N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-08-12</date_registration>
      <primary_sponsor>Shahed University</primary_sponsor>
      <public_title>Investigating the Effect of Acceptance and Commitment Therapy (ACT) in Peyronie’s Disease</public_title>
      <acronym>ACT</acronym>
      <scientific_title>Calculating the Contribution of Flexibility Components in Predicting Sexual Distress and Satisfaction Based on Intimacy and Attachment Orientation in Men with Sexual Dysfunction and Investigating the Efficacy of Acceptance and Commitment Therapy Based on the Most Contributions Components on Sexual Distress and Satisfaction in Men Recovered from Peyronie's Disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>3</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77775</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Peyronie.</hc_freetext>
      <i_freetext>Intervention group: considering that the current study is a single case intervention, therefore each subject is considered his own control group. In this study, 3 subjects are subjected to a pre-test before the start of the study, and after receiving treatment based on acceptance and commitment, they are evaluated in 4 sessions..</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Ahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 7, Shishe Alley, Northern Ayatollah Khamenei' Street, ghorveh</address>
        <city>Ghorveh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6661774861</zip>
        <telephone>+98 87 3523 2064</telephone>
        <email>mohammad-ahmadi@shahed.ac.ir</email>
        <affiliation>Shahed University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Ahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 7, Shishe Alley, Northern Ayatollah Khamenei' Street, ghorveh</address>
        <city>Ghorveh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6661774861</zip>
        <telephone>+98 87 3523 2064</telephone>
        <email>mohammad-ahmadi@shahed.ac.ir</email>
        <affiliation>Shahed University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having at least a diploma
Being sexually active
Existence of high sexual distress and low sexual satisfaction based on the Multidimensional Sexuality Questionnaire (MSQ)</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>60 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Absence of one session of treatment sessions
Suffering from severe psychological disorders based on the SCL90 questionnaire
Suffering from sexual dysfunction based on the BMSFI screening questionnaire and clinical interview
History of diabetes, cardiovascular and neurological diseases
History of prostate or pelvic surgery
Drug and alcohol addiction
Taking psychiatric medications</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N48.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Induration penis plastica</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: considering that the current study is a single case intervention, therefore each subject is considered his own control group. In this study, 3 subjects are subjected to a pre-test before the start of the study, and after receiving treatment based on acceptance and commitment, they are evaluated in 4 sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The score that a person obtains in the sexual anxiety and sexual depression subscales of the Multidimensional Sexuality Questionnaire. Timepoint: Measuring sexual anxiety and sexual depression before starting the intervention and 7, 14, 21, 28 and 60 days after starting to receive the Acceptance and Commitment Therapy. Method of measurement: Multidimensional Sexuality Questionnaire.</prim_outcome>
      <prim_outcome>Individual's score in the sexual satisfaction subscale of the Multidimensional Sexuality Questionnaire. Timepoint: Measuring sexual satisfactory before starting the intervention and 7, 14, 21, 28 and 60 days after starting to receive the Acceptance and Commitment Therapy. Method of measurement: Multidimensional Sexuality 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>Shahed University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-05-27</approval_date>
        <contact_name>Shahed university Committee for Ethics in Research</contact_name>
        <contact_address>Shahed University, opposite Holy shrine of Imam Khomeini, Khalij Fars Expressway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
