<?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>IRCT20160625028633N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-28</date_registration>
      <primary_sponsor>Kurdistan University</primary_sponsor>
      <public_title>Effectiveness of Acceptance and Commitment Therapy (ACT) on Depression, Emotional regulation, Psychological well-being and Quality of life</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Acceptance and Commitment Therapy (ACT) on Depression, Emotional regulation, Psychological well-being and Quality of life in the individual with Physical and motor disabilities</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>103</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43816</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The simple randomization method was used, in which the subjects' names were first listed and assigned a number from 1 to 60 for each one. We threw the numbers into a box and started removing the numbers from the box. The first 30 numbers were assigned to the experimental group and the remaining 30 numbers were assigned to the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Depression. Condition 2: Emotional Regulation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group: Acceptance and commitment therapy is an empirically-based psychological intervention that utilizes acceptance and mindfulness strategies. The experimental group received eight sessions of acceptance and commitment therapy (one session per week) for 90 minutes. These sessions are based on the guidelines of Hayes and Wilson (2006, 2012). Each session will be counseled and treated with mindfulness training, pre-session review, potential supportive exercises, and homework assignments. Intervention 2: Control group: Routin care.</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 potentially unrecognizable data is shareable and the necessary explanations are given in the SPSS file

When:
Other researchers have access to research data 2 months after the results are published

To whom:
Data will be available only to researchers working in academic and scientific institutions

Conditions:
Used for educational and research programs

Where to obtain:
Researchers can contact the author to obtain the required documentation or data.
Sharmin Mozaffari, MA in Clinical Psychology, Kurdistan University
Email: sharmin70mozaffari@gmail.com
Contact Number: 00989187816605

How to obtain:
The research data includes SPSS software file with the necessary explanations

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehdi Zemestani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kurdistan University, Pasdaran Blve., Sanandaj, Iran</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>66177-15175</zip>
        <telephone>00988733664600-8</telephone>
        <email>m.zemestan@gmail.com</email>
        <affiliation>Kurdistan University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Zemestani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kurdistan University, Pasdaran Blve., Sanandaj, Iran</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>66177-15175</zip>
        <telephone>00988733664600-8</telephone>
        <email>m.zemestan@gmail.com</email>
        <affiliation>Kurdistan University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Moderate depression score based on the cut-off score of 17 on Beck Depression Inventory
Physical disability (Medium Level), and having a Smart card for Disability by the National Welfare Organization
Minimum diploma education
No psychotherapy during the past six months</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Co-morbidity with other mental disorders
having psychotic symptoms (hallucinations and delusions)
mental disability
personality disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.31</hc_code>
      <hc_code>R45</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mood disorder due to known physiological condition with depressive features</hc_keyword>
      <hc_keyword>Symptoms and signs involving emotional state</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group: Acceptance and commitment therapy is an empirically-based psychological intervention that utilizes acceptance and mindfulness strategies. The experimental group received eight sessions of acceptance and commitment therapy (one session per week) for 90 minutes. These sessions are based on the guidelines of Hayes and Wilson (2006, 2012). Each session will be counseled and treated with mindfulness training, pre-session review, potential supportive exercises, and homework assignments.</i_keyword>
      <i_keyword>Control group: Routin care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression. Timepoint: Before the intervention, Eight weeks after the intervention and one month after the end of the intervention. Method of measurement: Beck Depression Inventory (BDI-II).</prim_outcome>
      <prim_outcome>Emotional regulation. Timepoint: Before the intervention, Eight weeks after the intervention and one month after the end of the intervention. Method of measurement: Gross &amp; John Emotion Regulation 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>Kurdistan University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-05</approval_date>
        <contact_name>Ethics committee of Kurdistan University</contact_name>
        <contact_address>Kurdistan University, Pasdaran Blve., Sanandaj, Iran Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
