<?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>IRCT20211113053052N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-27</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of the effectiveness of interpersonal psychotherapy with cognitive behavioral therapy on alexithymia, emotional regulation and psychological capital of male Substance abuser</public_title>
      <acronym>IPT and CBT</acronym>
      <scientific_title>Comparison of the effectiveness of interpersonal psychotherapy with cognitive behavioral therapy on alexithymia, emotional regulation and psychological capital of male Substance abuser</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60772</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Education/Guidance, Randomization description: To conduct this research, first a list of addiction treatment centers was prepared. Then, a center was selected for research using a simple random method (lottery) based on the names of the centers, by a person who was not aware of the objectives of the project.  this person will randomly select 75 of the center's clients using a random number table. Again in a simple random method, using a random number table and a concealment method (numbered, sealed and opaque envelopes), this person will assign the participants into experimental and control groups, Blinding description: Participants in the experimental group will not aware about the control group. They will also initially be unaware of which group they belong to.
Questionnaires will be completed under the supervision of an individual unaware of the objectives of the research.
The analyzer is only aware of the hypotheses, and the data will be provided to him with sufficient supervision.</study_design>
      <phase>N/A</phase>
      <hc_freetext>substance abusers.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group a: In this study, interpersonal psychotherapy training was taught to participants in twelve sessions per 42 days. Intervention 2: The intervention group b: In this study, participants were taught a cognitive behavioral therapy training package in ten sessions per 35 days. Intervention 3: The control group: The control group did not receive any 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:
All documents of this study include: information about the main outcomes of the study, statistical analysis map, informed consent form and clinical study report, in a file entitled: "Comparison of the effectiveness of interpersonal psychotherapy with cognitive-behavioral therapy on alexithymia, emotional regulation and psychological capital in substance abusers", can be shared.

When:
The start of the access period is 6 months after the results are published.

To whom:
Researchers working in academic and scientific institutions as well as officials of addiction treatment centers can apply for the file.

Conditions:
Those who receive this file can use the data and results in addiction treatment centers and conduct research.

Where to obtain:
Applicants can send their application to the e-mail address: ali.saeedi1352@yahoo.com to receive the documents.

How to obtain:
Send your request to receive the research documentation file to the e-mail: ali.saeedi1352@yahoo.com. after reviewing, the requested documents and data will be sent to your e-mail within 72 hours.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Saeedi Rashk Olya</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3rd North dead end, No. 30, Komeil Ave., Jomhouri Blvd.</address>
        <city>kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618873646</zip>
        <telephone>+98 34 3212 0723</telephone>
        <email>ali.saeedi1352@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Saeedi Rashk olya</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3rd North dead end, No. 30, Komeil Ave., Jomhouri Blvd.</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618873646</zip>
        <telephone>+98 34 3212 0723</telephone>
        <email>ali.saeedi1352@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being a substance abuser according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition criteria
Absence of severe mental disorders
having a minimum education of primary school level
Willingness to participate in the study
Age between 15 to 50 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Absences of more than two sessions
unwillingness to continue participating in research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group a: In this study, interpersonal psychotherapy training was taught to participants in twelve sessions per 42 days.</i_keyword>
      <i_keyword>The intervention group b: In this study, participants were taught a cognitive behavioral therapy training package in ten sessions per 35 days.</i_keyword>
      <i_keyword>The control group: The control group did not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Alexithymia score in Toronto alexithymia scale. Timepoint: Evaluation of alexithymia (before intervention), 42 days after intervention (post-test) . Method of measurement: Toronto Alexithymia scale (TAS-20).</prim_outcome>
      <prim_outcome>Emotion regulation score in the cognitive emotional regulation questionnaire. Timepoint: Evaluation of emotional regulation (before intervention), 42 days after intervention (post-test). Method of measurement: Cognitive emotional regulation questionnaire developed by Garnowski.</prim_outcome>
      <prim_outcome>Psychological capital score in the Luthans psychological capital questionnaire. Timepoint: Evaluation of Psychological capital (before intervention), 42 days after intervention (post-test). Method of measurement: Psychological capital questionnaire 24 developed by Luthans.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-12</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Kerman Branch</contact_name>
        <contact_address>Islamic Azad University, Kerman Branch, Valiasr Blvd., Kerman kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
