<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03840707</url>
  </required_header>
  <id_info>
    <org_study_id>CHUC-068-18</org_study_id>
    <nct_id>NCT03840707</nct_id>
  </id_info>
  <brief_title>LIFEwithIBD: Living With Intention, Fullness and Engagement With Inflammatory Bowel Disease</brief_title>
  <acronym>LIFEwithIBD</acronym>
  <official_title>LIFEwithIBD: Living With Intention, Fullness and Engagement With Inflammatory Bowel Disease: The Impact of a Group Intervention and an ICT-based Transcultural Intervention on Physical and Mental Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Coimbra</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centro Hospitalar e Universitário de Coimbra, E.P.E.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Coimbra</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This investigation aims to apply and test the feasibility of an acceptance, mindfulness and&#xD;
      compassionate-based intervention structured for inflammatory bowel disease patients.&#xD;
      LIFEwithIBD programme for inflammatory bowel disease thus comprises 9 weekly group sessions,&#xD;
      lasting 1 and a half hour each, run in small groups at a Gastroenterology Service at the&#xD;
      Coimbra's University Hospital. For each week participants have assigned homework (e.g.,&#xD;
      mindfulness exercises). The efficacy of LIFE-IBD Group Intervention to improve quality of&#xD;
      life, mental health, and disease activity-related scores will be tested in a sample of&#xD;
      Portuguese patients. Additionally, this study expected that the observable changes after the&#xD;
      intervention completion will be attributed to changes in emotional regulation processes and&#xD;
      maintained over the follow-up periods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The sample will include diagnosed inflammatory bowel disease patients recruited at a&#xD;
      Gastroenterology Service at the Coimbra's University Hospital, a national reference centre&#xD;
      for IBD. Patients will be approached by their doctor to assess their level of interest in the&#xD;
      investigation. Patients who demonstrate interest will go through a Screening interview&#xD;
      conducted by a psychologist that aims explain the structure and arms of the investigation, to&#xD;
      collect demographic data, and whether the patient meets the inclusion criteria for the study.&#xD;
      After sample collection, participants will be randomly assigned to one of two conditions:&#xD;
      experimental group (n=75) or control group (n=75). The experimental group will be divided&#xD;
      into five subgroups of 15 participants. The first group will function as a pilot group to&#xD;
      test the suitability of the programme. The intervention will include 8 weekly sessions, with&#xD;
      the duration of 90 minutes each. Groups will have two therapists with experience in ACT and&#xD;
      CFT-based interventions. All participants will continue on receiving the recommended&#xD;
      pharmacological treatment for IBD (TAU). This will allow the comparison between the&#xD;
      participants receiving the LIFE-IBD Group Intervention+TAU (experimental group) and the&#xD;
      participants only receiving TAU (control group). The frequency of engagement with the&#xD;
      programme at home practises will be analysed as moderator of the efficacy of the programme.&#xD;
      Both groups will concurrently complete a protocol of measures to assess main three areas: a)&#xD;
      psychological processes; b) quality of life and psychopathology; c) current medical status.&#xD;
      These assessments will occur in four different times: before the start of the LIFEwithIBD&#xD;
      programme M0), after the final session of the programme (M1), and 3 (M2) and 6 months (M4)&#xD;
      after that.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 27, 2019</start_date>
  <completion_date type="Actual">February 28, 2021</completion_date>
  <primary_completion_date type="Actual">February 28, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Indicators of psychopathology (DASS-21)</measure>
    <time_frame>From Baseline to 3-months follow-up</time_frame>
    <description>Indicators of psychopathology, namely depression, anxiety and stress symptoms will be measured by Depression, Anxiety and Stress Scale-21. DASS-21 assesses levels of depression, anxiety, and stress symptoms. Respondents are asked to indicate how frequently they experienced such symptoms over the previous week on a 4-point scale (ranging from 0 = &quot;Did not apply to me at all&quot; to 3 = &quot;Applied to me very much, or most of the time&quot;). Results of each subscale are calculated by the sum of the results of the seven items. The scale provides three notes, one per subscale, where the minimum is &quot;0&quot; and the maximum is &quot;21&quot;. Higher results correspond to more negative affective states.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perception of Quality of Life (World Health Organization Brief Quality of Life Assessment Scale)</measure>
    <time_frame>From Baseline to 3-months follow-up</time_frame>
    <description>Quality of life will be measure by World Health Organization Brief Quality of Life Assessment Scale.The WHOQOL-BREF is a 24-item measure of subjective perceptions of QoL. Items are rated on a 5-point Likert scale (higher scores indicate perceptions of higher QoL) and are distributed over four domains-physical health (e.g. &quot;To what extent do you feel that physical pain prevents you from doing what you need to do?&quot;), psychological health (e.g. &quot;How often do you have negative feelings such as blue mood, despair, anxiety, depression?&quot;-reverse item),social relationships (e.g. &quot;How satisfied are you with your personal relationships?&quot;), and environment. The scale also presents two additional items that evaluate general quality of life and general health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemical indicator: concentration levels of calprotectin</measure>
    <time_frame>From Baseline to 3-months follow-up</time_frame>
    <description>This biochemical indicator will be measured though concentration levels of calprotectin in unit of measure of miligram/liter (mg/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemical indicator: concentration levels of C-reactive protein (CRP)</measure>
    <time_frame>From Baseline to 3-months follow-up</time_frame>
    <description>This biochemical indicator will be measured though concentration levels of C-reactive protein (CRP) in unit of measure of microgram/gram (µg/g)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LIFEwithIBD Programme is a manualized acceptance, mindfulness and compassionate-based group intervention for inflammatory bowel disease patients. It included 9 weekly group sessions, 1.30h hours each, run in small groups (ranging from 10 to 15 participants).&#xD;
Participants in this group also receive inflammatory bowel disease treatment as usually performed at the Coimbra University Hospital.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Treatment as Usual (TAU) Standard personalized treatment of inflammatory bowel disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>LIFEwithIBD</intervention_name>
    <description>LIFEwithIBD programme is a psychotherapeutic programme based on Acceptance, Mindfulness and Compassion for inflammatory bowel disease patients&#xD;
Treatment as Usual (TAU): Standard personalized treatment of inflammatory bowel disease</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of IBD for more than 6 months (CD or UC)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  having started new treatment for IBD in the previous 6 months (in the case of anti-TNF&#xD;
             and immunosuppressive therapy) or 2 months (in the case of steroid or aminosalicylate&#xD;
             therapy)&#xD;
&#xD;
          -  cognitive impairment;&#xD;
&#xD;
          -  currently undergoing any form of psychological intervention;&#xD;
&#xD;
          -  current diagnosis of severe psychiatric illness (severe depression, psychotic illness,&#xD;
             bipolar disorder, substance abuse) or suicidal ideation;&#xD;
&#xD;
          -  diagnosis of other serious health condition;&#xD;
&#xD;
          -  pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centro Hospitalar e Universitário de Coimbra</name>
      <address>
        <city>Coimbra</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>November 5, 2021</last_update_submitted>
  <last_update_submitted_qc>November 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Coimbra</investigator_affiliation>
    <investigator_full_name>Inês A Trindade</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03840707
org study id: CHUC-068-18
nct id: NCT03840707
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This investigation aims to apply and test the feasibility of an acceptance, mindfulness and
      compassionate-based intervention structured for inflammatory bowel disease patients.
      LIFEwithIBD programme for inflammatory bowel disease thus comprises 9 weekly group sessions,
      lasting 1 and a half hour each, run in small groups at a Gastroenterology Service at the
      Coimbra's University Hospital. For each week participants have assigned homework (e.g.,
      mindfulness exercises). The efficacy of LIFE-IBD Group Intervention to improve quality of
      life, mental health, and disease activity-related scores will be tested in a sample of
      Portuguese patients. Additionally, this study expected that the observable changes after the
      intervention completion will be attributed to changes in emotional regulation processes and
      maintained over the follow-up periods.
The sample will include diagnosed inflammatory bowel disease patients recruited at a
      Gastroenterology Service at the Coimbra's University Hospital, a national reference centre
      for IBD. Patients will be approached by their doctor to assess their level of interest in the
      investigation. Patients who demonstrate interest will go through a Screening interview
      conducted by a psychologist that aims explain the structure and arms of the investigation, to
      collect demographic data, and whether the patient meets the inclusion criteria for the study.
      After sample collection, participants will be randomly assigned to one of two conditions:
      experimental group (n=75) or control group (n=75). The experimental group will be divided
      into five subgroups of 15 participants. The first group will function as a pilot group to
      test the suitability of the programme. The intervention will include 8 weekly sessions, with
      the duration of 90 minutes each. Groups will have two therapists with experience in ACT and
      CFT-based interventions. All participants will continue on receiving the recommended
      pharmacological treatment for IBD (TAU). This will allow the comparison between the
      participants receiving the LIFE-IBD Group Intervention+TAU (experimental group) and the
      participants only receiving TAU (control group). The frequency of engagement with the
      programme at home practises will be analysed as moderator of the efficacy of the programme.
      Both groups will concurrently complete a protocol of measures to assess main three areas: a)
      psychological processes; b) quality of life and psychopathology; c) current medical status.
      These assessments will occur in four different times: before the start of the LIFEwithIBD
      programme M0), after the final session of the programme (M1), and 3 (M2) and 6 months (M4)
      after that.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Indicators of psychopathology (DASS-21)
time frame: From Baseline to 3-months follow-up
description: Indicators of psychopathology, namely depression, anxiety and stress symptoms will be measured by Depression, Anxiety and Stress Scale-21. DASS-21 assesses levels of depression, anxiety, and stress symptoms. Respondents are asked to indicate how frequently they experienced such symptoms over the previous week on a 4-point scale (ranging from 0 = "Did not apply to me at all" to 3 = "Applied to me very much, or most of the time"). Results of each subscale are calculated by the sum of the results of the seven items. The scale provides three notes, one per subscale, where the minimum is "0" and the maximum is "21". Higher results correspond to more negative affective states.
measure: Perception of Quality of Life (World Health Organization Brief Quality of Life Assessment Scale)
time frame: From Baseline to 3-months follow-up
description: Quality of life will be measure by World Health Organization Brief Quality of Life Assessment Scale.The WHOQOL-BREF is a 24-item measure of subjective perceptions of QoL. Items are rated on a 5-point Likert scale (higher scores indicate perceptions of higher QoL) and are distributed over four domains-physical health (e.g. "To what extent do you feel that physical pain prevents you from doing what you need to do?"), psychological health (e.g. "How often do you have negative feelings such as blue mood, despair, anxiety, depression?"-reverse item),social relationships (e.g. "How satisfied are you with your personal relationships?"), and environment. The scale also presents two additional items that evaluate general quality of life and general health.
measure: Biochemical indicator: concentration levels of calprotectin
time frame: From Baseline to 3-months follow-up
description: This biochemical indicator will be measured though concentration levels of calprotectin in unit of measure of miligram/liter (mg/L)
measure: Biochemical indicator: concentration levels of C-reactive protein (CRP)
time frame: From Baseline to 3-months follow-up
description: This biochemical indicator will be measured though concentration levels of C-reactive protein (CRP) in unit of measure of microgram/gram (µg/g)
arm group label: Experimental group
arm group type: Experimental
description: LIFEwithIBD Programme is a manualized acceptance, mindfulness and compassionate-based group intervention for inflammatory bowel disease patients. It included 9 weekly group sessions, 1.30h hours each, run in small groups (ranging from 10 to 15 participants).
Participants in this group also receive inflammatory bowel disease treatment as usually performed at the Coimbra University Hospital.
arm group label: Control group
arm group type: No Intervention
description: Treatment as Usual (TAU) Standard personalized treatment of inflammatory bowel disease
intervention type: Behavioral
intervention name: LIFEwithIBD
description: LIFEwithIBD programme is a psychotherapeutic programme based on Acceptance, Mindfulness and Compassion for inflammatory bowel disease patients
Treatment as Usual (TAU): Standard personalized treatment of inflammatory bowel disease
arm group label: Experimental group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Portugal
responsible party type: Principal Investigator
investigator affiliation: University of Coimbra
investigator full name: Inês A Trindade
investigator title: Dr
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases