<?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>IRCT20200120046203N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-12</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>Trajectories of change in depressive symptoms during group behavioral activation</public_title>
      <acronym></acronym>
      <scientific_title>Assessment of the effectiveness of group behavioral activation on trajectories of change in depressive symptoms in patients diagnosed with major depressive disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-02-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45249</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>Condition 1: Major depressive disorder. Condition 2: Major depressive disorder.</hc_freetext>
      <i_freetext>Intervention group: behavioral activation, in 10 weeks, in 7 to 10 participant groups, the sessions content is as follows: First session learning patterns (groups introduction, introducing the concept of behavioral activation, starting self-monitoring), second session start changing patterns (relating self-monitoring to avoidance, introducing functional analysis of avoidance), third session taking action (changing avoidance into action, setting plans), fourth session understanding challenges (to learn about barriers of change), fifth session rumination (understanding rumination as a barrier to become active, learning the difference between productive and unproductive thinking, analysis of what makes individual ruminate, identifying behaviors to replace rumination), sixth session mindfulness and being present in the moment (introducing techniques to help individual become engaged in routine activities), seventh session empathizing with self (identifying how individuals speak to themselves that lead to rumination, findings ways to change it to a compassionate voice), eighth session planning ahead ( review of previous sessions and individual gains, working on barriers on the way of introduced techniques, plan for the future), ninth session values (aid participants to cope with their life situations through mindful ways of living rather than focusing on the outcome), tenth session resilience (to review future application of learned strategies in times of emotional distress,  plan for living a more enjoyable life, giving feedback on participation in group).</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 acquired data can be shared after identifying information being omitted and it will be shared with the academic and research centers as well as the Ministry of Health and Education if necessary.

When:
Accessible in 6 months after publication of results

To whom:
Academic staff, health policy makers

Conditions:
For assessment of usability in similar studies, for planning to improve health outcomes at community level

Where to obtain:
Sara Sardashti, through email contact

How to obtain:
Assessment by the person in charge, confirmation by the principal investigator

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Latif Moradveisi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Farschian (Sina) Hospital, Mirzadeh Eshghi Avenue</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6516848741</zip>
        <telephone>+98 81 3827 4184</telephone>
        <email>l.moradveisi@umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sara Sardashti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Farschian Sina Hospital, Mirzadeh Eshghi Avenue</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6516848741</zip>
        <telephone>0098138274184</telephone>
        <email>sarasardashti@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having the minimum age of 18 and maximum age of 65
Having the diagnosis of major depressive disorder based on clinical interview and Structured Clinical Interview for DSM 5 (SCID)
Participants tendency to participate in group versus individual therapy
Presence of moderate to severe depression based on Beck Depression Inventory II (BDI-II)
Minimum education level of primary school (5 years)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Presence or history of major neurological disorders (e.g. epilepsy, multiple sclerosis)
Presence of prolonged interpersonal issues hindering participation in group
Diagnosis of obsessive compulsive disorder
Diagnosis of antisocial personality disorder
Current or prior substance or alcohol use in the recent 12 months
Prior history of hypomanic or manic episode
Current or prior history of psychosis
History of organic brain damage
Simultaneous participation in other psychological therapies</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32</hc_code>
      <hc_code>F33</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, single episode</hc_keyword>
      <hc_keyword>Major depressive disorder, recurrent</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: behavioral activation, in 10 weeks, in 7 to 10 participant groups, the sessions content is as follows: First session learning patterns (groups introduction, introducing the concept of behavioral activation, starting self-monitoring), second session start changing patterns (relating self-monitoring to avoidance, introducing functional analysis of avoidance), third session taking action (changing avoidance into action, setting plans), fourth session understanding challenges (to learn about barriers of change), fifth session rumination (understanding rumination as a barrier to become active, learning the difference between productive and unproductive thinking, analysis of what makes individual ruminate, identifying behaviors to replace rumination), sixth session mindfulness and being present in the moment (introducing techniques to help individual become engaged in routine activities), seventh session empathizing with self (identifying how individuals speak to themselves that lead to rumination, findings ways to change it to a compassionate voice), eighth session planning ahead ( review of previous sessions and individual gains, working on barriers on the way of introduced techniques, plan for the future), ninth session values (aid participants to cope with their life situations through mindful ways of living rather than focusing on the outcome), tenth session resilience (to review future application of learned strategies in times of emotional distress,  plan for living a more enjoyable life, giving feedback on participation in group)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression score in Beck Depression Inventory. Timepoint: Assessment of depression score at baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 1 month after the last week. Method of measurement: Beck Depression Inventory.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-15</approval_date>
        <contact_name>Ethics committee of Hamedan University of Medical Sciences</contact_name>
        <contact_address>Farshchian Hospital, Mirzadeh Eshghi Street Hamedan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
