<?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>IRCT20181128041782N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-04</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of behavioral activation group therapy in severity of depression, repetitive thoughts and functions of students</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of behavioral activation group therapy in severity of depression, repetitive thoughts and functions of students with major depressive disorder: A double blind randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35588</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After diagnosis by the psychiatrist, a list of patients with inclusion criteria is prepared and numbered and assigned to treatment and control groups by Random number generator V 1.3 software; so that all participants have equal chance of being in the groups, Blinding description: After sampling, any of participant will not aware from randomization and allocation to groups. The data analyzer is selected outside of the study and all of datas will be given to him as a code.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Major Depressive Disorder - Mild. Condition 2: Major Depressive Disorder - Moderate.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group will receive ten session of Behavioral Activation Group Therapy. This intervention based on C. W. Lejuez and Derek R. Hopko's protocol and includes psycho-education, activity monitoring, activity planning and values clarification. Intervention 2: Control group will receive only behavioral activation booklet، which contains the same topics with the intervention group and will be checked weekly by internet and and guidance will be provide if needed.</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 of the information related to main outcome will be published.

When:
Start the access period from 2023

To whom:
Researchers working in academic and scientific institutions

Conditions:
Access to documents is possible to inform other researchers. Access to documents is possible to work with the researcher.

Where to obtain:
1. Dr. Beheshti Hospital, Zanjan, Department of Clinical Psychology, Dr Omid Saed
2. Dr. Beheshti Hospital, Zanjan, Department of Clinical Psychology, Soleiman Saberi

How to obtain:
Documents will be shared only when the reason for the request is announced by phone or e-mail.

Comments:
Researchers can contact S.saberipsy@gmail.com to access the results and details.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Soleiman Saberi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zanjan University of Medical Sciences, Dr.Sobouti Blvd., Zanjan, Iran</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513956184</zip>
        <telephone>+98 24 3344 5211</telephone>
        <email>s.saberipsy@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Omid Saed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Clinical Psychology, Beheshti Hospital, Besat Ave, Arg Square</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۵۷۸۸-۴۵۱۳۶</zip>
        <telephone>+98 24 3354 2403</telephone>
        <email>o.saed@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being university student
Residence in Zanjan while researching
Tending to participate in research
Scores between 14 - 25 in beck depression inventory second edition and dajor depressive disorder diagnosis by the psychiatrist</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a history of psychosis, substance abuse, bipolar mood disorder and personality disorders
Depression related to medical condition
Previous psychological intervention specially cognitive behavioral therapy more than five sessions
Consume psychotropic drugs
The history of hospitalization and receiving electroconvulsive therapy (ECT)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32.0</hc_code>
      <hc_code>F32.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, single episode, mild</hc_keyword>
      <hc_keyword>Major depressive disorder, single episode, moderate</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group will receive ten session of Behavioral Activation Group Therapy. This intervention based on C. W. Lejuez and Derek R. Hopko's protocol and includes psycho-education, activity monitoring, activity planning and values clarification.</i_keyword>
      <i_keyword>Control group will receive only behavioral activation booklet، which contains the same topics with the intervention group and will be checked weekly by internet and and guidance will be provide if needed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression Severity. Timepoint: Pre-test, Post-test and follow up (Two months after post-test). Method of measurement: Beck Depression Inventory-II (BDI-II).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Repetitive thoughts. Timepoint: Pre-test, Post-test and Follow up (Two months after post- test). Method of measurement: Repetitive Thinking Questionnaire-31.</sec_outcome>
      <sec_outcome>Function of students. Timepoint: Pre-test, Post-test and Follow up (Two months after post- test). Method of measurement: Work (Educational) and Social Adjustment Scale.</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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-11-27</approval_date>
        <contact_name>Ethics committee of Zanjan University of Medical Scienses</contact_name>
        <contact_address>Zanjan University of Medical Sciences, Azadi Square Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
