<?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>IRCT20180710040411N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-07</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>Effectiveness of acceptance and commitment therapy on the sense of coherence,Locus of Control and post-traumatic growth in patients with spinal cord injury and MS</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of acceptance and commitment therapy on the sense of coherence,Locus of Control and post-traumatic growth in patients with spinal cord injury and MS</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/33524</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Random sampling is used to select the samples and random assignment of the subjects to the experimental and control groups is also performed.</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 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
Aged between 20 and 55 years old
have at least a diploma education
. reside in Tehran
At least one year has passed since the time of the lesion.
Maximum five years from the time of the lesion.
The ability to use your upper extremity.
Inclusion  Criteria‏  for ms
have at least a diploma education
reside in Tehran
Based on the ICF indicator, the ability to Use of upper limbs
at least one year from the end of the illness.
maximum five years from the end of the illness
Aged between 20 and 55 years old</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 more than two absentee sessions
.Have brain damage
Exclusion   Criteria‏  for ms
Have alcohol or drugs use
have more than two absentee sessions
have memory problems.
Simultaneously undergo another psychological treatment
Multiple sclerosis is benign</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 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>The sense of coherence: the sense of mental integrity, a general orientation, a penetrating, sustainable and dynamic basis of assurance that the life events to which one is confronted is comprehensible, structured, and explainable, resources to deal with them And these events are meaningful and worthy of engagement. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: ‎Antonovsky 's Sense of coherence scale.</prim_outcome>
      <prim_outcome>Locus of Control: The concept of Locus of Control refers to the ability of humans to control environmental conditions and events. On the basis of this concept, people are divided into two categories: one, people with an internal Locus of Control, who perceive themselves to dominate their feelings, behavior, and living conditions, actively seek to modify and reform it, and the successes and They attribute their failures to their intrinsic factors.Second, individuals who have external control, who do not control themselves on their own circumstances and events, attribute their life events to external factors such as the chance, fate, and power of others. Indeed, it seems that these people do not rely on their abilities and efforts. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Julian Rotter's Locus of Control scale.</prim_outcome>
      <prim_outcome>Post-traumatic Growth: Post-traumatic Growth As the mental experience of a positive mental change, the individual's struggle with a traumatic event is defined. An increase in the appreciation of life, the new priorities in life, the enhancement of personal self-esteem, the identification of new opportunities, the improvement of intimate relationships or spiritual change are examples of these positive psychological changes. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Tedeschi &amp; Calhoun post-traumatic traumatic growth scale.</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>
