<?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>IRCT20161110030822N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-24</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of Interpersonal Psychotherapy in Patients with Social Anxiety</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Interpersonal Psychotherapy in Patients with Social Anxiety Disorder with Comorbid Depressive Symptoms: Symptoms Reduction, Interpersonal Problems and Quality of Life Improvement, and Change of Therapeutic Mediators.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29431</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: After selecting the sample group and explaining the research objectives and methods and before obtaining informed consent, patients will be randomized using randomized software in two groups of interpersonal psychotherapy and control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Social Anxiety Disorder.</hc_freetext>
      <i_freetext>Intervention Group: Patients with social anxiety disorder participating in 12 weekly and individually sessions and receive interpersonal psychotherapy.   Control Group: Patients with social anxiety disorder who are in the waiting list and do not receive intervention..</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 title of the data will be ‘’the effectiveness of interpersonal psychotherapy on social anxiety disorder’’. All data can be shared after making participants anonymous.

When:
Six months after publishing results, everything will be accessible.

To whom:
The data from this research will be accessible only to mental health researchers and those who are working in academic and scientific institutions.

Conditions:
With respect to ethical considerations, the data from this research can be used for other research purposes. It is also possible to conduct any statistical analyses. All these processes require correspondence and coordination.

Where to obtain:
All applicants can contact Mr. Hamid Amiri through one of the following ways:
1. Email address: hamid.amiri@sbmu.ac.ir 
2. Phone number: +98 21 23031548
3. Adress: Department of Clinical Psychology, Taleghani Hospital, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.

How to obtain:
Within 10 working days after correspondence or a phone call, your request will be answered and the data will be sent to a valid email submitted by the applicant.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamid Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>SBUMS. ,Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19839-63113</zip>
        <telephone>+98 21 2303 1548</telephone>
        <email>hamid.amiri@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamid Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>SBUMS. ,Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19839-63113</zip>
        <telephone>+98 21 2303 1548</telephone>
        <email>hamid.amiri@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Minimum education should be middle school grade.
Participants should not have received psychological interventions over the past 3 years or drug treatment at least one month before the baseline measurement stage until the end of the follow-up.
The absence of psychiatric disorders necessitates urgent treatments such as substance use disorders, alcohol use disorder and psychotic disorders.
Having the motivation and satisfaction to participate in the research.
Diagnosis of social anxiety disorder with comorbid depressive symptoms</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Primary diagnosis of mood disorders and other anxiety disorders
The presence of psychiatric disorders requiring immediate treatment such as substance use disorders, alcohol use disorder and psychotic disorders.
Having complete criteria for personality disorders, except for avoidance personality disorder
Suicide Ideation or extreme thinking about self harm
IQ below the normal range
Missing more than 3 sessions of psychotherapy
participate simultaneously in another treatment plan</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F40.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Social phobias</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group: Patients with social anxiety disorder participating in 12 weekly and individually sessions and receive interpersonal psychotherapy.   Control Group: Patients with social anxiety disorder who are in the waiting list and do not receive intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Social anxiety symptoms. Timepoint: Before the intervention and the third, sixth, ninth sessions, after the intervention and follow up. Method of measurement: Social Phobia Inventory and Brief Fear of Negative Evaluation Scale.</prim_outcome>
      <prim_outcome>Beck Depression Inventory-II Score. Timepoint: Before the intervention and the third, sixth, ninth sessions, after the intervention and follow up. Method of measurement: Beck Depression Inventory-II.</prim_outcome>
      <prim_outcome>Interpersonal Problems. Timepoint: Before the intervention and the third, sixth, ninth sessions, after the intervention and follow up. Method of measurement: Inventory of Interpersonal Problems.</prim_outcome>
      <prim_outcome>Quality of Life. Timepoint: Before the intervention and the third, sixth, ninth sessions, after the intervention and follow up. Method of measurement: The World Health Organization Quality of Life.</prim_outcome>
      <prim_outcome>Social Support. Timepoint: Before the intervention and the third, sixth, ninth sessions, after the intervention and follow up. Method of measurement: Social Support Appraisals Scale.</prim_outcome>
      <prim_outcome>Interpersonal Stress. Timepoint: Before the intervention and the third, sixth, ninth sessions, after the intervention and follow up. Method of measurement: Life Distress Inventory and a researcher-made questionnaire.</prim_outcome>
      <prim_outcome>Emotion Regulation. Timepoint: Before the intervention and the third, sixth, ninth sessions, after the intervention and follow up. Method of measurement: Emotion Regulation Questionnaire and Difficulties in Emotion Regulation Scale.</prim_outcome>
      <prim_outcome>Interpersonal Skills. Timepoint: Before the intervention and the third, sixth, ninth sessions, after the intervention and follow up. Method of measurement: Interpersonal Communication Skills Scale.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-30</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
