<?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>IRCT20170409033333N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-24</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effectiveness of Acceptance-Based Behavioral Therapy and pharmacotherapy in Posttraumatic stress disorder (PTSD)</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of Acceptance-Based Behavioral Therapy and pharmacotherapy in Posttraumatic stress disorder (PTSD)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-08-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>41</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28635</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: by random numbers table.</study_design>
      <phase>3</phase>
      <hc_freetext>Post traumatic stress disorder (PTSD).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: experimental group received ABBT in 12 individual sessions for 45 minutes, based on the guidelines for the development of the Roemer and Orsillo Psychological Disorders Protocol, which was coordinated by the present study authors for PTSD. : session1: Implementation of pre- test included Assessment of the severity of the symptoms of PTSD, experiential avoidance, quality of life, and valuable life. Introducing Acceptance-Based Behavioral Therapy, assessment of One’s Relationship with Internal Experiences, Challenging the control of negative thoughts and emotions (control as the problem: creative hopelessness ) and the Destructive Effects of Experiential Avoidance, Introductory Breathing Exercise, Introduction to self-monitoring. session 2-4: Introducing Mindfulness and Cognitive defuse, To teach mindfulness exercises included: Body scan practice, The Three Minute Breathing Space and Mindfulness practice in everyday life. session 5-7: Introducing Values and Values-Driven Behavior, Assessment of Values, Goals, Actions, and Barriers, Increasing Engagement in Valued Activities. session 8-10: Introducing Acceptance and Enhancing Commitment, Cultivating Acceptance through Mindfulness skills and metaphors. session 11-12: Maintaining and Enhancing Mindfulness, Acceptance, and Commitment, implementation of post- test included Assessment of severity of the symptoms of PTSD, experiential avoidance, quality of life, and valuable life. Intervention 2: Control group: The control group received only pharmacotherapy at the same time as the experimental group. Pharmacotherapy was supervised by the psychiatrist for both groups. Each group received 50 to 200 mg of sertraline or fluoxetine 20 to 80 mg per day.  All subjects received medication at least 3 months ago.</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:
Research article

When:
2018

To whom:
free

Conditions:
For use in evidence-based treatments

Where to obtain:
email: ghazanfari.hadi67@gmail.com

How to obtain:
Hadi ghazanfari

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hadi ghaznafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran; Shahid Hemmat Highway, Next to the Milad Tower, Iran University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14665-354</zip>
        <telephone>+98 21 6655 1616</telephone>
        <email>ghazanfari.hadi67@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hadi ghazanfari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences, Hemmat Highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14665-354</zip>
        <telephone>+98 21 2254 9750</telephone>
        <email>ghazanfari.hadi67@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>the diagnosis of PTSD type of war
the lack of psychological treatment for at least one month before entering the study
having a minimum age of 18 and a maximum of 60 years
and the ability to read and write</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>having psychotic symptoms and substance abuse
having suicidal thoughts
having severe personality disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Post-traumatic stress disorder (PTSD)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: experimental group received ABBT in 12 individual sessions for 45 minutes, based on the guidelines for the development of the Roemer and Orsillo Psychological Disorders Protocol, which was coordinated by the present study authors for PTSD. : session1: Implementation of pre- test included Assessment of the severity of the symptoms of PTSD, experiential avoidance, quality of life, and valuable life. Introducing Acceptance-Based Behavioral Therapy, assessment of One’s Relationship with Internal Experiences, Challenging the control of negative thoughts and emotions (control as the problem: creative hopelessness ) and the Destructive Effects of Experiential Avoidance, Introductory Breathing Exercise, Introduction to self-monitoring. session 2-4: Introducing Mindfulness and Cognitive defuse, To teach mindfulness exercises included: Body scan practice, The Three Minute Breathing Space and Mindfulness practice in everyday life. session 5-7: Introducing Values and Values-Driven Behavior, Assessment of Values, Goals, Actions, and Barriers, Increasing Engagement in Valued Activities. session 8-10: Introducing Acceptance and Enhancing Commitment, Cultivating Acceptance through Mindfulness skills and metaphors. session 11-12: Maintaining and Enhancing Mindfulness, Acceptance, and Commitment, implementation of post- test included Assessment of severity of the symptoms of PTSD, experiential avoidance, quality of life, and valuable life.</i_keyword>
      <i_keyword>Control group: The control group received only pharmacotherapy at the same time as the experimental group. Pharmacotherapy was supervised by the psychiatrist for both groups. Each group received 50 to 200 mg of sertraline or fluoxetine 20 to 80 mg per day.  All subjects received medication at least 3 months ago.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The severity of the symptoms of PTSD. Timepoint: pretest and posttest. Method of measurement: questionnaire (Davidson Trauma Scale (DTS)).</prim_outcome>
      <prim_outcome>Experiential avoidance. Timepoint: pretest and post test. Method of measurement: questionnaire ( Action and acceptance questionnaire (AAQ)).</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: pretest and post test. Method of measurement: questionnaire( Quality of life questionnaire (SF-36)).</prim_outcome>
      <prim_outcome>Valued living questionnaire. Timepoint: pretest and post test. Method of measurement: 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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-02</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Hemmat Highway, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
