<?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>IRCT20180710040411N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-24</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>The Effectiveness of Acceptance and Commitment Therapy on Cognitive Flexibility and Emotional Regulation of Patients with Spinal Cord Injury and MS Patients</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Acceptance and Commitment Therapy on Cognitive Flexibility and Emotional Regulation of Patients with Spinal Cord Injury and MS Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32431</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In order to select the samples in the experimental and control groups,  simple random method with Using random numbers, was used.  Randomizing unit was individually. Therefore, according to the inclusion and exclusion criteria among the patients with spinal cord and MS which were referred to the center of the SCI in Shahid Jalayipoor in Tehran and the MS Society of Iran in 2018, 60 patients (30 patients with sci  and 30 MS patients) were selected.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Spinal cord injury. Condition 2: multiple sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: 15 patients with SCI receiving 8 sessions of acceptance and commitment therapy. This treatment is a type of third wave of cognitive therapy that, instead of changing the thoughts works on responses to thoughts, allows them to accept them. By accepting emotions and changing the response to Thoughts in this therapy are a form of flexibility in the individual, and this flexibility makes one committed to act in its original and intrinsic values. Intervention 2: Intervention group:  intervention group 2: consists of 15 patients with MS who receive 8 sessions of acceptance and commitment therapy. This treatment is a type of third wave of cognitive therapy that, instead of changing the thoughts works on responses to thoughts, allows them to accept them. By accepting emotions and changing the response to Thoughts in this therapy are a form of flexibility in the individual, and this flexibility makes one committed to act in its original and intrinsic values. Intervention 3: Control group: Control group 1: has 15 patients with spinal cord injury who do not receive treatment. Intervention 4: Control group: Control group 2: consists of 15 patients with MS who do not receive treatment.</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:
The  results will be published without mentioning the names of the participants

When:
10 months

To whom:
Supervisors-Researchers - Journalists

Conditions:
The data will be published  without mentioning the names of individuals for presentation in research journals.

Where to obtain:
Will be consulted by the University's Ethics Committee

How to obtain:
About three months after the completion of the project, the results of the research will be received by the applicant.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Javad Kazemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Social Welfare and Rehabilitation Sciences., Khodakyar Alley., Student street., Shahid Shahriyari Square., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>65571-37347</zip>
        <telephone>+98 21 2218 0061</telephone>
        <email>kazemi012@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Javad Kazemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Social Welfare and Rehabilitation Sciences., Khodakyar Alley., Student street., Shahid Shahriyari Square., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>65571-37347</zip>
        <telephone>+98 21 2218 0061</telephone>
        <email>kazemi012@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria for sci
have at least a diploma education
reside in Tehran
Aged between 20 and 55 years old
At least one year has passed since the time of the lesion.
Maximum five years from the time of the lesion.
Inclusion criteria for MS
have at least a diploma education
reside in Tehran
Aged between 20 and 55 years old
at least one year pass from the end of the illness
maximum five years passed from the illness
Based on the ICF indicator, the ability to Use of upper limbs</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Exclusion criteria for sci
Have cervical spinal cord injury
Simultaneously undergo another psychological treatment
Have alcohol or drugs use.
Have brain damage
have more than two absentee sessions
Exclusion criteria for MS
Multiple sclerosis is benign
Using alcohol or drugs 
have more than two absent sessions
have memory problems
Simultaneously undergo another psychological treatment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T91.3</hc_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sequelae of injury of spinal cord</hc_keyword>
      <hc_keyword>Multiple sclerosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: 15 patients with SCI receiving 8 sessions of acceptance and commitment therapy. This treatment is a type of third wave of cognitive therapy that, instead of changing the thoughts works on responses to thoughts, allows them to accept them. By accepting emotions and changing the response to Thoughts in this therapy are a form of flexibility in the individual, and this flexibility makes one committed to act in its original and intrinsic values.</i_keyword>
      <i_keyword>Intervention group:  intervention group 2: consists of 15 patients with MS who receive 8 sessions of acceptance and commitment therapy. This treatment is a type of third wave of cognitive therapy that, instead of changing the thoughts works on responses to thoughts, allows them to accept them. By accepting emotions and changing the response to Thoughts in this therapy are a form of flexibility in the individual, and this flexibility makes one committed to act in its original and intrinsic values.</i_keyword>
      <i_keyword>Control group: Control group 1: has 15 patients with spinal cord injury who do not receive treatment.</i_keyword>
      <i_keyword>Control group: Control group 2: consists of 15 patients with MS who do not receive treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cognitive Flexibility: Cognitive Flexibility refers to the ability of individuals to focus on the present situation and to take advantage of opportunities to position them in pursuit of intrinsic goals and values, despite the presence of challenging or unwanted psychological events (for example, thoughts, feelings , Physiological emotions, mental images and memories). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>The emotional setting is a unique process that modifies the emotional experience to achieve social acceptance and relates to physical and psychological states in response to internal or external demands. Timepoint: Before intervention and 8 weeks after intervention. 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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-07-04</approval_date>
        <contact_name>The Ethics Committee of of the Educational Deputy of the University of Welfare and Rehabilitation Sc</contact_name>
        <contact_address>No.1, javadi ally., Mazandaran st., Emam Hossin sq., Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
