xml: <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/NCT06011135</url>
    </required_header>
    <id_info>
      <org_study_id>IRAS 320892</org_study_id>
      <nct_id>NCT06011135</nct_id>
    </id_info>
    <brief_title>Exploring Worry in CFS/ME</brief_title>
    <official_title>Exploring Worry in the Context of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): A Qualitative Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>King's College London</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>South London and Maudsley NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>King's College London</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 study will be building on the findings of Kalfas et al 2022 paper exploring the&#xD;
        prevalence of generalised worry in patients with Myalgic Encephalomyelitis/ Chronic Fatigue&#xD;
        Syndrome (ME/CFS) before and after Cognitive Behavioural Therapy (CBT). The research was&#xD;
        conducted in South London and Maudsley NHS Foundation Trust's (SLaM) Persistent Physical&#xD;
        Symptoms Research and Treatment Unit. Previous research has indicated a bidirectional&#xD;
        relationship between fatigue and worry (Kalfas et al., 2022); the findings of this paper&#xD;
        suggest both that many ME/CFS patients experience comorbid problematic generalised worry and&#xD;
        that there is a positive association between severity of worry and levels of fatigue (Kalfas&#xD;
        et al, 2022). It appears that CBT for ME/CFS indirectly treats worry, however effect sizes&#xD;
        are small to moderate, and treatment outcomes may improve if CBT treatments incorporate&#xD;
        strategies that target generalised worry (Kalfas et al 2022). The aims of this project are to&#xD;
        further explore worry in this group of patients through qualitative methods.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A recent study carried out in SLaM explored how common worry is in people who have received&#xD;
        Cognitive Behavioural Therapy (CBT) for CFS/ME. Over 70% were struggling with worry, and the&#xD;
        more severe their level of worry was, the more severe their fatigue was likely to be.&#xD;
        Indirectly, CBT appeared to slightly reduce how much people struggle with worry which&#xD;
        queried: could CBT for CFS/ME be improved if we had a better understanding of worry in this&#xD;
        context?&#xD;
  &#xD;
        Worry in CFS/ME is not well understood; the present study aims to explore worry in people who&#xD;
        have a diagnosis of CFS/ME through qualitative interviews, with the hope of gathering&#xD;
        information to inform future treatments.&#xD;
  &#xD;
        CFS/ME is a long-term condition, meaning treatments aim to manage rather than cure. It can&#xD;
        range from a mild illness to severely disabling. National UK guidance states CBT should be&#xD;
        offered to those living with CFS/ME. CBT treatments recognise that how our bodies function is&#xD;
        closely linked to our thoughts, feelings, and behaviour. Research into CBT for CFS/ME shows&#xD;
        it can improve levels of fatigue, distress, and how much people can do physically, however,&#xD;
        in most studies improvements are small. CBT has stronger evidence for treating mental health&#xD;
        difficulties, such as anxiety and depression. These difficulties are more common in people&#xD;
        who have a diagnosis of CFS/ME, particularly Generalised Anxiety Disorder (GAD) which has&#xD;
        been reported to be as high as 34%, in comparison to up to 7% of the general population.&#xD;
        There has been little research into anxiety and how it affects fatigue, but research has&#xD;
        identified a 'bidirectional relationship' between the two. This study is building on the&#xD;
        finding that over 70% of people with CFS/ME could be struggling with significant worry that&#xD;
        doesn't meet the criteria for GAD but causes distress and impacts fatigue.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Exploration of how people with a diagnosis of CFS/ME experience worry</measure>
      <time_frame>31/05/2024</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>How can this exploration of how people with a diagnosis of CFS/ME experience worry inform future research into targeted CBT interventions in the context of ME/CFS.</measure>
      <time_frame>31/05/2024</time_frame>
    </primary_outcome>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Chronic Fatigue Syndrome</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>No intervention</intervention_name>
      <description>No intervention - qualitative study only using semi-structured interview</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          A purposeful sample of patients will be recruited from SLaM's Persistent Physical Symptoms&#xD;
          Research and Treatment Unit. We are interested to collect the views of patients pre,&#xD;
          during, and post CBT treatment to support with the secondary aim of the project which is to&#xD;
          use the discussions to make recommendations for targeted CBT treatments. Patients will&#xD;
          therefore be eligible to participate at any stage of their treatment following initial&#xD;
          assessment.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  have a diagnosis of ME/CFS according to NICE criteria;&#xD;
  &#xD;
            -  have agreed to CBT for ME/CFS following their initial assessment;&#xD;
  &#xD;
            -  are/were struggling with comorbid generalised worry as determined by a score of 45 or&#xD;
               above on the Penn State Worry Questionnaire (collected routinely with all patients&#xD;
               referred to the service).&#xD;
  &#xD;
            -  Informed consent to taking part in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who have been closed to the service longer than 3 months&#xD;
  &#xD;
            -  Patients with a diagnosis of long-Covid&#xD;
  &#xD;
            -  Patients who are under 18&#xD;
  &#xD;
            -  Patients who do not have a diagnosis of CFS/ME&#xD;
  &#xD;
            -  Patients who have not agreed to CBT for CFS/ME as part of their treatment&#xD;
  &#xD;
            -  Patients who score below the threshold on the PSWQ&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ellen Rhodes</last_name>
      <phone>020 7848 0002</phone>
      <email>ellen.rhodes@kcl.ac.uk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Kings College London</name>
        <address>
          <city>London</city>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Ellen Rhodes</last_name>
        <phone>020 7848 0002</phone>
        <email>ellen.rhodes@kcl.ac.uk</email>
      </contact>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fatigue Syndrome, Chronic</mesh_term>
      <mesh_term>Syndrome</mesh_term>
      <mesh_term>Fatigue</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>No individual participant data to be shared with other researchers.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06011135
  org study id: IRAS 320892
  nct id: NCT06011135
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study will be building on the findings of Kalfas et al 2022 paper exploring the
        prevalence of generalised worry in patients with Myalgic Encephalomyelitis/ Chronic Fatigue
        Syndrome (ME/CFS) before and after Cognitive Behavioural Therapy (CBT). The research was
        conducted in South London and Maudsley NHS Foundation Trust's (SLaM) Persistent Physical
        Symptoms Research and Treatment Unit. Previous research has indicated a bidirectional
        relationship between fatigue and worry (Kalfas et al., 2022); the findings of this paper
        suggest both that many ME/CFS patients experience comorbid problematic generalised worry and
        that there is a positive association between severity of worry and levels of fatigue (Kalfas
        et al, 2022). It appears that CBT for ME/CFS indirectly treats worry, however effect sizes
        are small to moderate, and treatment outcomes may improve if CBT treatments incorporate
        strategies that target generalised worry (Kalfas et al 2022). The aims of this project are to
        further explore worry in this group of patients through qualitative methods.
  A recent study carried out in SLaM explored how common worry is in people who have received
        Cognitive Behavioural Therapy (CBT) for CFS/ME. Over 70% were struggling with worry, and the
        more severe their level of worry was, the more severe their fatigue was likely to be.
        Indirectly, CBT appeared to slightly reduce how much people struggle with worry which
        queried: could CBT for CFS/ME be improved if we had a better understanding of worry in this
        context?
  
        Worry in CFS/ME is not well understood; the present study aims to explore worry in people who
        have a diagnosis of CFS/ME through qualitative interviews, with the hope of gathering
        information to inform future treatments.
  
        CFS/ME is a long-term condition, meaning treatments aim to manage rather than cure. It can
        range from a mild illness to severely disabling. National UK guidance states CBT should be
        offered to those living with CFS/ME. CBT treatments recognise that how our bodies function is
        closely linked to our thoughts, feelings, and behaviour. Research into CBT for CFS/ME shows
        it can improve levels of fatigue, distress, and how much people can do physically, however,
        in most studies improvements are small. CBT has stronger evidence for treating mental health
        difficulties, such as anxiety and depression. These difficulties are more common in people
        who have a diagnosis of CFS/ME, particularly Generalised Anxiety Disorder (GAD) which has
        been reported to be as high as 34%, in comparison to up to 7% of the general population.
        There has been little research into anxiety and how it affects fatigue, but research has
        identified a 'bidirectional relationship' between the two. This study is building on the
        finding that over 70% of people with CFS/ME could be struggling with significant worry that
        doesn't meet the criteria for GAD but causes distress and impacts fatigue.
  observational model: Other
  time perspective: Other
  measure: Exploration of how people with a diagnosis of CFS/ME experience worry
  time frame: 31/05/2024
  measure: How can this exploration of how people with a diagnosis of CFS/ME experience worry inform future research into targeted CBT interventions in the context of ME/CFS.
  time frame: 31/05/2024
  intervention type: Other
  intervention name: No intervention
  description: No intervention - qualitative study only using semi-structured interview
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 99 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ellen Rhodes
  phone: 020 7848 0002
  email: ellen.rhodes@kcl.ac.uk
  facility: 
  contact: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Fatigue Syndrome, Chronic
  mesh term: Syndrome
  mesh term: Fatigue
  sharing ipd: No
  ipd description: No individual participant data to be shared with other researchers.