<?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>IRCT20190115042371N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-19</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effects of cognitive behavioral therapy and acceptance and commitment therapy in major depressive disorder after traumatic brain injury</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effects of cognitive behavioral therapy and acceptance and commitment therapy on cognitive flexibility, executive function, anxiety, depression, and quality of life of patient and caregiver in patients with major depressive disorder after traumatic brain injury</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37334</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The list of patients suffering from brain injury was given to us through the medical records unit. Then all these people were coded. Subsequently, with the help of a random number table, sixty of these people are selected and then in the same way, they are divided into three groups (n=20), Blinding description: Each group visits the hospital for treatment at different hours of the day, while the identity of the individuals in each group is hidden for other groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Traumatic brain injury. Condition 2: Major depressive disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Cognitive-behavioral group therapy (CBT). A treatment that will be done according to the 14-sessions protocol that has been adapted from Bieling et all. Intervention 2: Intervention group 2: Acceptance and Commitment Therapy model  (ACT). An intervention that will be implemented according to the protocol of 12 sessions proposed by Robert D. Zettle. Intervention 3: Control group: No therapies will be received and members will discuss their problems in several sessions.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Faghihi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Hospital, Kashan University of Medical Sciences</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8115187159</zip>
        <telephone>+98 31 5562 0634</telephone>
        <email>alifaghihi180@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Faghihi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti Hospital, Kashan University of Medical Sciences</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8115187159</zip>
        <telephone>+98 31 5562 0634</telephone>
        <email>alifaghihi180@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having MDD diagnosis after TBI means having a P-TBI-MDD diagnosis
Duration of TBI between one and four years
informed consent
Ages 18 to 45 years
Have at least 8 years of education
Lack of alcohol, substance, or drugs abuse
Not having dementia and delirium and mental disorders other than major depression</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Dissuading from participating in research
Abuse of alcohol, substance, or drugs after engaging in research
Having a disease or problems affecting function and mental health after engaging in research
Get absent in more than 2 sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S00-S09</hc_code>
      <hc_code>F32</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Injuries to the head</hc_keyword>
      <hc_keyword>Depressive episode</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Cognitive-behavioral group therapy (CBT). A treatment that will be done according to the 14-sessions protocol that has been adapted from Bieling et all</i_keyword>
      <i_keyword>Intervention group 2: Acceptance and Commitment Therapy model  (ACT). An intervention that will be implemented according to the protocol of 12 sessions proposed by Robert D. Zettle</i_keyword>
      <i_keyword>Control group: No therapies will be received and members will discuss their problems in several sessions</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Psychological flexibility. Timepoint: Before the intervention, in the middle of intervention, after intervention, three months after the intervention. Method of measurement: Acceptance and Action Questionnaire - II (AAQ-II).</prim_outcome>
      <prim_outcome>Executive functions. Timepoint: Before the intervention, in the middle of intervention, after intervention, three months after the intervention. Method of measurement: Wisconsin Card Sorting Test and Tower of London test.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before the intervention, in the middle of intervention, after intervention, three months after the intervention. Method of measurement: Beck Anxiety Inventory, and Depression Anxiety and Stress Scales 21.</prim_outcome>
      <prim_outcome>Depression. Timepoint: Before the intervention, in the middle of intervention, after intervention, three months after the intervention. Method of measurement: Beck Depression Inventory-II, and Depression Anxiety and Stress Scales 21.</prim_outcome>
      <prim_outcome>Quality of Life. Timepoint: Before the intervention, in the middle of intervention, after intervention, three months after the intervention. Method of measurement: Quality of Life after Brain Injury.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Problem solving. Timepoint: Before the intervention, in the middle of intervention, after intervention, three months after the intervention. Method of measurement: Wisconsin Card Sorting Test.</sec_outcome>
      <sec_outcome>Planning. Timepoint: Before the intervention, in the middle of intervention, after intervention, three months after the intervention. Method of measurement: Tower of London test.</sec_outcome>
      <sec_outcome>Caregiver anxiety. Timepoint: Before the intervention, after intervention, three months after the intervention. Method of measurement: Depression Anxiety and Stress Scales 21.</sec_outcome>
      <sec_outcome>Caregiver depression. Timepoint: Before the intervention, after intervention, three months after the intervention. Method of measurement: Depression Anxiety and Stress Scales 21.</sec_outcome>
      <sec_outcome>Caregiver quality of life. Timepoint: Before the intervention, after intervention, three months after the intervention. Method of measurement: Short Form Health Survey (SF-12).</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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-25</approval_date>
        <contact_name>Ethical Committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>Ethics Committee of Kashan University of Medical Sciences, Ghotb Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
