<?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>IRCT20230411057882N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-03-01</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>Feeling of social exclusion and anxiety in patients with comorbid psychiatric disorders and substance abuse</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of group supportive counseling and group existential psychotherapy on improving the feeling of social exclusion and anxiety in patients with comorbid psychiatric disorders and substance abuse</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75564</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Education/Guidance, Blinding description: Participants are non-randomly divided into case and control groups. The control group receives routine hospital services, and the case group receives relevant interventions.
Due to the fact that the implementation of the interventions is done by specialists based in the hospital, therefore, the researcher, the outcome assessor, the data analyst, and the data safety and monitoring committee are completely unaware of these divisions.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Psychiatric disorder.</hc_freetext>
      <i_freetext>Intervention 1: Supportive counseling: Supportive counseling sessions based on self-compassion will be done in a group based on a protocol with the components of a supportive counseling approach. The content of this educational protocol includes things such as teaching empathy, teaching sympathy, teaching forgiveness and accepting mistakes, teaching acceptance of problems, and teaching the development of valuable and sublime feelings. This protocol will be implemented in 8 1-hour sessions (weekly) by a trained social worker with a doctorate in social work. Intervention 2: Group existential psychotherapy: group meaning therapy sessions will be conducted based on a protocol with components of the existential therapy approach based on the framework of Hotzel's treatment plan. The content of this educational protocol includes things such as philosophical education of the nature of being human, education of meaning and inner self-exploration, education of the concepts of loneliness, interpersonal, intrapersonal and existential types in very simple language, education of recognition of responsibility and accountability as an inevitable part of the human condition and responsibility. that man is responsible for the difficult conditions of life, training to control negative thoughts and ruminations; It is searching and trying to find meaning in various aspects of life and in the worst conditions of life and rebuilding oneself and getting familiar with all kinds of experimental, attitudinal and creative values. This protocol will be implemented in 10 1-hour sessions (weekly) by a trained social worker with a doctorate in social work.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Due to the principle of confidentiality, the data file of the participants will not be published.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Latifian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kodakyar Ave., Daneshjo Blvd., Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713871</zip>
        <telephone>+98 21 2230 7421</telephone>
        <email>maryamlatifian1993@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Latifian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kodakyar Ave., Daneshjo Blvd., Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713871</zip>
        <telephone>+98 21 2230 7421</telephone>
        <email>maryamlatifian1993@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18 years old
Having the required ability to participate in group meetings
Diagnosis of psychiatric disorder by a psychiatrist
Diagnosis of drug use history by hospital specialists</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Not being able to read and write
Unwillingness to participate in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F99</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mental disorder, not otherwise specified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Supportive counseling: Supportive counseling sessions based on self-compassion will be done in a group based on a protocol with the components of a supportive counseling approach. The content of this educational protocol includes things such as teaching empathy, teaching sympathy, teaching forgiveness and accepting mistakes, teaching acceptance of problems, and teaching the development of valuable and sublime feelings. This protocol will be implemented in 8 1-hour sessions (weekly) by a trained social worker with a doctorate in social work.</i_keyword>
      <i_keyword>Group existential psychotherapy: group meaning therapy sessions will be conducted based on a protocol with components of the existential therapy approach based on the framework of Hotzel's treatment plan. The content of this educational protocol includes things such as philosophical education of the nature of being human, education of meaning and inner self-exploration, education of the concepts of loneliness, interpersonal, intrapersonal and existential types in very simple language, education of recognition of responsibility and accountability as an inevitable part of the human condition and responsibility. that man is responsible for the difficult conditions of life, training to control negative thoughts and ruminations; It is searching and trying to find meaning in various aspects of life and in the worst conditions of life and rebuilding oneself and getting familiar with all kinds of experimental, attitudinal and creative values. This protocol will be implemented in 10 1-hour sessions (weekly) by a trained social worker with a doctorate in social work.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Feeling of social exclusion. Timepoint: Pre-test - post-test - follow-up after 3 months. Method of measurement: Exclusion Perception Scale.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Pre-test - post-test - follow-up after 3 months. Method of measurement: DASS-21 anxiety 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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-01-24</approval_date>
        <contact_name>Ethics committee of university of social welfare and rehabilitation science</contact_name>
        <contact_address>Kodakyar Ave., Daneshjo Blvd., Evin Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
