<?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>IRCT20190711044173N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-10-31</date_registration>
      <primary_sponsor>ISLAMIC AZAD UNIVERSITY</primary_sponsor>
      <public_title>Effectiveness of  a cost effective cognitive behavioural program on improvement mentall health in MS</public_title>
      <acronym>EUPERMPWMS</acronym>
      <scientific_title>Efficacy of the Unified Protocol on Emotion Regulation and mindfulness in People with Multiple Sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40779</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: All patients, met all inclusion criteria, were assigned to treatment and control groups using computer-generated random numbers, Blinding description: The blinded researchers did randomization. This study was a clinical elevator-blinded, data-collector Blinded, analyst-blinded, and statistician blinded study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple sclerosis.</hc_freetext>
      <i_freetext>The sessions were structured based on the Transdiagnostic Therapy basics developed by Barlow et al. Group(2018 edition) therapy consisted of 12 weekly sixty-minute sessions.. The subjects who were randomly assigned to two groups . Transdiagnostic intervention based on group intervention and consist of 12 session and 8 modules:  1) Increasing motivation: Motivational interviewing for participation and involvement of patients during therapy, providing treatment logic and setting treatment goals. 2)Providing psychological education, recognition of emotions, tracking emotional experiences, and training . 3)Training  emotional awareness, learning to see emotional experiences (emotions and response to emotions) especially using mindfulness techniques. 4)IAssessment and cognitive reassessment, awareness of the impact and interaction between thoughts and emotions, identification of maladaptive automated evaluations and common  5)Examining EDBs, knowledge and identification of their effects on emotional experiences, identifying maldaptive EDBs, and creating alternatives for acting through behaviors. 6)Knowledge and tolerance of physical senses, increase awareness of the role of emotional feelings in emotional experiences, practice exercises or visceral confrontation in order to be aware of physical sensations and increase tolerance of these symptoms7)Visceral confrontation and confrontation with situational emotions, awareness of the logic of emotional confrontation, training how to prepare the fear hierarchy, avoidance and design of repeated and effective emotional exposure exercises, visual, objective and avoidance.8)Prevention of recurrence, overview of treatment concepts and discussion about  patient's healing and progress.</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:
Results will send to a peer reviewed  international journal without selectivity.

When:
After trearment without delay

To whom:
All reserchers who confirm an existing study in line with this research must be provided an academic email.

Conditions:
Represnt an Academic Email and IRB code

Where to obtain:
Prencipal Invistigator

How to obtain:
Send an email, Provided by an Academic Email and IRB code

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nabi Nazari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>koosha apatement parvaz street,etemadie</address>
        <city>hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>63952555711</zip>
        <telephone>+98 81 3555 2719</telephone>
        <email>nazariirani@gmail.com</email>
        <affiliation>islamic azad university hamedan branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nabi Nazari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mosivand boulvared</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>651811574</zip>
        <telephone>+98 81 3448 1000</telephone>
        <email>nazariirani@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of MS for three years or more
Fluent in Persian
Internet availibility</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Other Chronic physical illnesses (such as insulin-dependent diabetes and chemotherapy for cancer)
Pregnancy or lactation,
Evidence of current or past schizophrenia, psychosis, or organic mental disorder, bipolar disorder, or organic mental disorder
Drug abuse history or drug dependence except for nicotine
Absenteeism for more than three sessions
Presence of comorbid neurological disorders such as Alzheimer, Parkinson's disease, Dementia</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>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The sessions were structured based on the Transdiagnostic Therapy basics developed by Barlow et al. Group(2018 edition) therapy consisted of 12 weekly sixty-minute sessions.. The subjects who were randomly assigned to two groups . Transdiagnostic intervention based on group intervention and consist of 12 session and 8 modules:  1) Increasing motivation: Motivational interviewing for participation and involvement of patients during therapy, providing treatment logic and setting treatment goals. 2)Providing psychological education, recognition of emotions, tracking emotional experiences, and training . 3)Training  emotional awareness, learning to see emotional experiences (emotions and response to emotions) especially using mindfulness techniques. 4)IAssessment and cognitive reassessment, awareness of the impact and interaction between thoughts and emotions, identification of maladaptive automated evaluations and common  5)Examining EDBs, knowledge and identification of their effects on emotional experiences, identifying maldaptive EDBs, and creating alternatives for acting through behaviors. 6)Knowledge and tolerance of physical senses, increase awareness of the role of emotional feelings in emotional experiences, practice exercises or visceral confrontation in order to be aware of physical sensations and increase tolerance of these symptoms7)Visceral confrontation and confrontation with situational emotions, awareness of the logic of emotional confrontation, training how to prepare the fear hierarchy, avoidance and design of repeated and effective emotional exposure exercises, visual, objective and avoidance.8)Prevention of recurrence, overview of treatment concepts and discussion about  patient's healing and progress</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression. Timepoint: before allocation. Method of measurement: The hospital anxiety and depression scale (HADS): , Structured Clinical Interview for DSM-IV (SCID).</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: before allocation , post intervention, three month follow up. Method of measurement: The hospital anxiety and depression scale (HADS): , Structured Clinical Interview for DSM-IV (SCID).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Depression. Timepoint: , post intervention, three month follow up. Method of measurement: The hospital anxiety and depression scale (HADS): , Structured Clinical Interview for DSM-IV (SCID).</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>U1111-1238-0965</sec_id>
        <issuing_authority>Who International Clinical Trials</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>ISLAMIC AZAD UNIVERSITY</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-28</approval_date>
        <contact_name>Ethics Commitee of NATIONAL INSTITUTE FOR MEDICAL RESEARCH DEVELOPMENT</contact_name>
        <contact_address>Floor 13, Block A, Ministry of Health &amp; Medical Education Headquarters, Between Zarafashan &amp; South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
