<?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>IRCT20200113046118N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-11</date_registration>
      <primary_sponsor>Salman Farsi University of Kazerun</primary_sponsor>
      <public_title>The Effectiveness of Acceptance and Commitment Therapy for Reducing Interference and improving Verbal and Visual Working Memory in Patients with Multiple Sclerosis</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Acceptance and Commitment Therapy for Reducing Interference and improving Verbal and Visual Working Memory in Patients with Multiple Sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45234</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Simple individual randomization with  random number table that create one- digit column in the random number table, by the size of population, and then units are randomly selected. Finally, any number smaller than or equal to the size of the population was considered as the sample of choice. Also, by using sequentially numbered opaque sealed envelopes (SNOSE). according to the order of entry of eligible participants, one of the envelopes was opened sequentially and their assigned group was identified.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple Sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: The intervention was acceptance and commitment therapy for Multiple sclerosis. The experimental group according to the model adapted from ACT’s six-session protocol for chronic illness in the form of 120-minute sessions once a week and the control group received no therapeutic intervention. Following the completion of the sessions, both groups were given a post-test. At the end of the sessions, post-test was performed on both groups. The main content of the intervention was psychoeducation about MS’s thoughts, emotions and behavior, avoidance, relaxation via mindfulness and cognitive restructuring (e.g. Introducing values by purpose, Cognitive Fusion, Problem-solving strategies, Establishing effective relationships to valuable life, Identify obstacles in the path of values and The practice of conscious acceptance ). The practice of each session was reviewed via whatsapp for the group between the sessions. Intervention 2: Control group: The control group did not receive any treatment during the treatment period, but after running the post-test the control and groups received therapy in one session.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is The data is not important for release, but the result obtained from the data is important and release</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Davoodi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babune Avenue, alley 6, Davoodi’s house</address>
        <city>Kazerun</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7315654486</zip>
        <telephone>+98 71 4225 2956</telephone>
        <email>Dr.s.davoodi2010562@gmail.com</email>
        <affiliation>Salman Farsi University of Kazerun</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Davoodi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Babune Avenue, alley 6, Davoodi’s house</address>
        <city>Kazerun</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7315654486</zip>
        <telephone>+98 71 4225 2956</telephone>
        <email>Dr.s.davoodi2010562@gmail.com</email>
        <affiliation>Salman Farsi University of Kazerun</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The participants were selected with  regard to the inclusion having a history of the disease for over 3 years and being diagnosed with mild Ms</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>not having addiction
not having cancer
not having epilepsy
not having renal failure
not having heart disease
not having major psychological problems such as psychosis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention was acceptance and commitment therapy for Multiple sclerosis. The experimental group according to the model adapted from ACT’s six-session protocol for chronic illness in the form of 120-minute sessions once a week and the control group received no therapeutic intervention. Following the completion of the sessions, both groups were given a post-test. At the end of the sessions, post-test was performed on both groups. The main content of the intervention was psychoeducation about MS’s thoughts, emotions and behavior, avoidance, relaxation via mindfulness and cognitive restructuring (e.g. Introducing values by purpose, Cognitive Fusion, Problem-solving strategies, Establishing effective relationships to valuable life, Identify obstacles in the path of values and The practice of conscious acceptance ). The practice of each session was reviewed via whatsapp for the group between the sessions.</i_keyword>
      <i_keyword>Control group: The control group did not receive any treatment during the treatment period, but after running the post-test the control and groups received therapy in one session.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Interference is the relative processing speed, which is most simply argued as the fact that faster processes can affect slower ones, but the opposite is not true. Timepoint: The evalution of this variable was when patient only receive drug therapy and didn't receive psychological. Method of measurement: Computerized Stroop Test evaluates the capacity to attend to specific characteristics of a stimulus, ignoring characteristics irrelevant to the task. In this test, 48 matching and 48 mismatching colored words (red, blue, yellow and green) were shown to the subjects. The term matching words refers to the words whose color and name are the same, and mismatching words refer to those whose color and name are different. A total of 96 words were randomly and sequentially presented. The subjects were asked to say each word’s color, regardless of its meaning. Each stimulus was shown on the screen for two seconds, and the stimuli were presented at the intervals of 800 milliseconds. According to the researchers, the mismatching color-word task (second phase of the experiment) measured interference. The degree of interference was obtained by subtracting the number of correct mismatching words from that of correct matching ones.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Working memory resources include verbal and visual working memory. Visual memory plays a key role in the formation and manipulation of mental images. On the other hand, verbal memory covers the phonological loop. The verbal information provided verbally enters the phonological loop directly, immediately and automatically, and is stored phonologically for a short time. Timepoint: The evalution of this variable was when patient only receive drug therapy and didn't receive psychological. Method of measurement: Wechsler Memory Scale - Third Edition (WMS-III) has 18 subscales (11 primaries and 7 optional subscales), and 8 scores are obtained from the 11 primary subscales. In this research, only two subscales were used to measure verbal and visual working memory. Visual Memory Subscale is a visual rehabilitation test, in which the subject is asked to use his/her memory to draw the simple shapes provided to him/her for 10 seconds. The total scores of forward and reverse digit span subtest were also used to measure verbal working memory.</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>Maryam Davoodi</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-11</approval_date>
        <contact_name>Islamic Azad University of Kazerun</contact_name>
        <contact_address>5 km Kazeroon- Bushehr road Kazerun Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
