<?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>IRCT20190708044156N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-23</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences,Deputy of Research, Gastroenterology Research Center</primary_sponsor>
      <public_title>effective of mindfulness and ACT on inflammatory bowel disease</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the Effectiveness of  Mindfulness Based Stress Reduction and Acceptance and Commitment Therapy on Physiological and Psychological Symptoms in Inflammatory Bowel Disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40931</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Each of the two treatments was presented to the experimental groups in 8 sessions. The Control group didn't receive any kind of treatment, Randomization description: in this study, we will use simple random sampling. participants get an identification number and after lottery, they will be in intervention number 1, intervention number 2 and control group, Blinding description: Blinding is used in this method of the first type, and the research is one-side blind, and we don't say to patients that they are in which groups study, and it is not necessary to tell patients how many groups in this study is there.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Inflammatory bowel disease.</hc_freetext>
      <i_freetext>Intervention 1: first Intervention group called "Acceptance and commitment therapy": it includes 8 psychological training sessions in 1.5 hours. each session is included one of these subjects: ACT introduction, creative hopelessness, acceptance, cognitive defusion, being in the present moment, self as a context, values, and committed action. Intervention 2: The second Intervention group called " Mindfulness-based stress reduction": includes 8 psychological training sessions in 1.5 hours. each session is included one of these subjects: MBSR introduction, creative perception, and reaction being body and mind in the present moment, the effect of perception conditioning on momentary and original experiences, stress and its communication with mindfulness, stressful communication, bringing practices to life texture, and continue with mindfulness. Intervention 3: Control group: Here we have 15 people who are pre-tested and post-tested but no intervention is done to compare with the experimental group.</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 data obtained from the questionnaires each have a score that only the individual's score in the primary variables with its secondary variables is published and does not refer to the identity of the individual.

When:
The onset of the date of access to the information is 6 months after complete treatment and publication of the results.

To whom:
Only those who are in the field of gastrointestinal diseases and psychology researchers as well as educational centers in these fields and academic fields as well as those who want to complete this plan have the right to receive data and information.

Conditions:
Researchers in the field of inflammatory bowel disease and all psychologists who seek a change in the brain wave of these individuals through with psychological approach.

Where to obtain:
Refer to Kerman Physiological Research Science Center and Afzalipour Research Center.

How to obtain:
After 6 months of the complete process of treatment, if the person requesting the information was among the people who could provide information to him, by asking questions about the impact of this information on the scientific study process or raising his level of knowledge, Its provided to him/her, By consulting with another person who contributing in this schema.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme Sheikh-ali Saghaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 4, Alley 44, Rezvan Blvd., Jomhuri Blvd., Kerman, Iran</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618988565</zip>
        <telephone>+98 34 3281 9168</telephone>
        <email>fateme.saghaie@gmail.com</email>
        <affiliation>Bahonar University of Kerman, Iran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Sheikh-ali Saghaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 4, Alley 44, Rezvan Blvd., Jomhuri Blvd., Kerman, Iran</address>
        <city>کرمان</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618988565</zip>
        <telephone>+98 34 3281 9168</telephone>
        <email>fateme.saghaie@gmail.com</email>
        <affiliation>Bahonar University of Kerman, Iran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inflammatory bowel disease patients who have inactive and under control disease</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients under 18 years
Patients over 65 years
pregnant females
patients currently attending psychiatric services
patients currently receiving antidepressant medication
patients who have received steroid medications in the past three months
patients who have previously undergone a stress management programme (relaxation techniques, psycho dynamic psychotherapy, cognitive behavioral therapy, hypnosis)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K51</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ulcerative colitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>first Intervention group called "Acceptance and commitment therapy": it includes 8 psychological training sessions in 1.5 hours. each session is included one of these subjects: ACT introduction, creative hopelessness, acceptance, cognitive defusion, being in the present moment, self as a context, values, and committed action.</i_keyword>
      <i_keyword>The second Intervention group called " Mindfulness-based stress reduction": includes 8 psychological training sessions in 1.5 hours. each session is included one of these subjects: MBSR introduction, creative perception, and reaction being body and mind in the present moment, the effect of perception conditioning on momentary and original experiences, stress and its communication with mindfulness, stressful communication, bringing practices to life texture, and continue with mindfulness.</i_keyword>
      <i_keyword>Control group: Here we have 15 people who are pre-tested and post-tested but no intervention is done to compare with the experimental group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Colitis physiological symptoms. Timepoint: before intervention, after intervention and 60 days after intervention. Method of measurement: Partial Mayo Scoring Index Assessment.</prim_outcome>
      <prim_outcome>Stress. Timepoint: before intervention, after intervention and 60 days after intervention. Method of measurement: Depression, Anxiety and Stress Scale questionnaire (DASS-21).</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: before intervention, after intervention and 60 days after intervention. Method of measurement: Depression, Anxiety and Stress Scale questionnaire (DASS-21).</prim_outcome>
      <prim_outcome>Depression. Timepoint: before intervention, after intervention and 60 days after intervention. Method of measurement: Depression, Anxiety and Stress Scale questionnaire (DASS-21).</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: before intervention, after intervention and 60 days after intervention. Method of measurement: world health quality of life questionnaire (BREF form).</prim_outcome>
      <prim_outcome>General Health. Timepoint: before intervention, after intervention and 60 days after intervention. Method of measurement: general health questionnaire (GHQ-28).</prim_outcome>
      <prim_outcome>Pain perception. Timepoint: before intervention, after intervention and 60 days after intervention. Method of measurement: Mcgill pain perception 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>Kerman University of Medical Sciences,Deputy of Research, Gastroenterology Research Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-08-24</approval_date>
        <contact_name>Kerman University of Medical Sciences ethics committee</contact_name>
        <contact_address>Kerman Medical Sciences Research Center, kerman, Somayeh Crossroads, at the beginning of Jihad Boulevard, at the beginning of Ibn Sina Street Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
