<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/NCT04408651</url>
  </required_header>
  <id_info>
    <org_study_id>LIIT</org_study_id>
    <nct_id>NCT04408651</nct_id>
  </id_info>
  <brief_title>Low Intensity Internet Therapy for Chronic Illness (@LIIT.CI)</brief_title>
  <official_title>Low Intensity Internet Therapy for Chronic Illness (@LIIT.CI): Testing the Efficacy of ACT and CFT Interventions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Coimbra</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      Chronic illness (CI) presents a significant and negative effect on quality of life and mental&#xD;
      health. Further, emotion regulation has been considered of particular importance on the&#xD;
      determination of chronic patients' well-being. Evidence suggests that Acceptance and&#xD;
      Commitment Therapy (ACT) is an effective approach to improve psychological health in patients&#xD;
      with CI. Further, there is some, although limited, evidence, that self-compassion training&#xD;
      may be also useful in this context, and the inclusion of self-compassion elements in ACT&#xD;
      interventions has even been the focus of attention by recent studies. Nevertheless, no study&#xD;
      yet has compared the efficacy of these two types of intervention in CI. This is the aim of&#xD;
      the present project - to analyse, in a low intensity eHealth intervention context, whether&#xD;
      ACT or Compassion Focused Therapy (CFT) present superiority over the other in improving&#xD;
      mental health and illness-related outcomes in CI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Actual">August 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depression and anxiety (Hospital Anxiety and Depression Scales; HADS)</measure>
    <time_frame>Changes in results from: immediately pre-intervention and immediately post-intervention assessments</time_frame>
    <description>Higher scores indicate more depression and anxiety symptoms (0-21)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Illness shame (Chronic Illness Shame Scale; CISS)</measure>
    <time_frame>Changes in results from: immediately pre-intervention and immediately post-intervention assessments</time_frame>
    <description>Higher scores indicate higher levels of illness shame (0-28)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological Flexibility (Comprehensive assessment of ACT processes; CompACT)</measure>
    <time_frame>Changes in results from: immediately pre-intervention and immediately post-intervention assessments</time_frame>
    <description>Higher scores indicate higher levels of psychological flexibility (0-108)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-compassion (Self-compassion scale; SCS)</measure>
    <time_frame>Changes in results from: immediately pre-intervention and immediately post-intervention assessments</time_frame>
    <description>Higher scores indicate higher levels of self-compassion (subscale of the Self-compassion scale) (13-65)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-criticism (Self-compassion scale; SCS)</measure>
    <time_frame>Changes in results from: immediately pre-intervention and immediately post-intervention assessments</time_frame>
    <description>Higher scores indicate higher levels of self-cristicism (subscale of the Self-compassion scale) (13-65)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive fusion (Cognitive Fusion Scale; CFQ-7)</measure>
    <time_frame>Changes in results from: immediately pre-intervention and immediately post-intervention assessments</time_frame>
    <description>Higher scores indicate higher levels of cognitive fusion (0-28)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Fear of contracting COVID-19 (Fear of contracting COVID-19 scale; FCCS)</measure>
    <time_frame>Changes in results from: immediately pre-intervention and immediately post-intervention assessments</time_frame>
    <description>Higher scores indicate more fear of contracting COVID-19 (9-45)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Chronic Medical Conditions</condition>
  <arm_group>
    <arm_group_label>Acceptance and Commitment Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Compassion-Focused Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>LIIT.CI ACT</intervention_name>
    <description>4-week online self-management intervention based on Acceptance and Commitment Therapy and adapted to people with chronic medical conditions</description>
    <arm_group_label>Acceptance and Commitment Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>LIIT.CI CFT</intervention_name>
    <description>4-week online self-management intervention based on Compassion-Focused Therapy and adapted to people with chronic medical conditions</description>
    <arm_group_label>Compassion-Focused Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 65&#xD;
&#xD;
          -  Previous diagnosis of a physical chronic medical condition&#xD;
&#xD;
          -  Easy access to internet and to a computer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Receiving psychological intervention&#xD;
&#xD;
          -  Diagnosis of a severe psychiatric disorder (e.g., schizophrenia, bipolar disorder) or&#xD;
             cognitive impairment.&#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>Inês Trindade</name>
      <address>
        <city>Coimbra</city>
        <zip>3000-115</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 16, 2022</last_update_submitted>
  <last_update_submitted_qc>May 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2022</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>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04408651
org study id: LIIT
nct id: NCT04408651
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chronic illness (CI) presents a significant and negative effect on quality of life and mental
      health. Further, emotion regulation has been considered of particular importance on the
      determination of chronic patients' well-being. Evidence suggests that Acceptance and
      Commitment Therapy (ACT) is an effective approach to improve psychological health in patients
      with CI. Further, there is some, although limited, evidence, that self-compassion training
      may be also useful in this context, and the inclusion of self-compassion elements in ACT
      interventions has even been the focus of attention by recent studies. Nevertheless, no study
      yet has compared the efficacy of these two types of intervention in CI. This is the aim of
      the present project - to analyse, in a low intensity eHealth intervention context, whether
      ACT or Compassion Focused Therapy (CFT) present superiority over the other in improving
      mental health and illness-related outcomes in CI.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Depression and anxiety (Hospital Anxiety and Depression Scales; HADS)
time frame: Changes in results from: immediately pre-intervention and immediately post-intervention assessments
description: Higher scores indicate more depression and anxiety symptoms (0-21)
measure: Illness shame (Chronic Illness Shame Scale; CISS)
time frame: Changes in results from: immediately pre-intervention and immediately post-intervention assessments
description: Higher scores indicate higher levels of illness shame (0-28)
measure: Psychological Flexibility (Comprehensive assessment of ACT processes; CompACT)
time frame: Changes in results from: immediately pre-intervention and immediately post-intervention assessments
description: Higher scores indicate higher levels of psychological flexibility (0-108)
measure: Self-compassion (Self-compassion scale; SCS)
time frame: Changes in results from: immediately pre-intervention and immediately post-intervention assessments
description: Higher scores indicate higher levels of self-compassion (subscale of the Self-compassion scale) (13-65)
measure: Self-criticism (Self-compassion scale; SCS)
time frame: Changes in results from: immediately pre-intervention and immediately post-intervention assessments
description: Higher scores indicate higher levels of self-cristicism (subscale of the Self-compassion scale) (13-65)
measure: Cognitive fusion (Cognitive Fusion Scale; CFQ-7)
time frame: Changes in results from: immediately pre-intervention and immediately post-intervention assessments
description: Higher scores indicate higher levels of cognitive fusion (0-28)
measure: Fear of contracting COVID-19 (Fear of contracting COVID-19 scale; FCCS)
time frame: Changes in results from: immediately pre-intervention and immediately post-intervention assessments
description: Higher scores indicate more fear of contracting COVID-19 (9-45)
arm group label: Acceptance and Commitment Therapy
arm group type: Experimental
arm group label: Compassion-Focused Therapy
arm group type: Experimental
intervention type: Behavioral
intervention name: LIIT.CI ACT
description: 4-week online self-management intervention based on Acceptance and Commitment Therapy and adapted to people with chronic medical conditions
arm group label: Acceptance and Commitment Therapy
intervention type: Behavioral
intervention name: LIIT.CI CFT
description: 4-week online self-management intervention based on Compassion-Focused Therapy and adapted to people with chronic medical conditions
arm group label: Compassion-Focused Therapy
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: Principal Investigator
mesh term: Chronic Disease
sharing ipd: Undecided