Chronic Fatigue SyndromeNCT06011135
Exploring Worry in CFS/ME
An observational study of Chronic Fatigue Syndrome, run by King's College London at 1 site in United Kingdom.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Fatigue Syndrome
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2023to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A purposeful sample of patients will be recruited from SLaM's Persistent Physical Symptoms Research and Treatment Unit. We are interested to collect the views of patients pre, during, and post CBT treatment to support with the secondary aim of the project which is to use the discussions to make recommendations for targeted CBT treatments. Patients will therefore be eligible to participate at any stage of their treatment following initial assessment.
Who may be able to join
- have a diagnosis of ME/CFS according to NICE criteria;
- have agreed to CBT for ME/CFS following their initial assessment;
- are/were struggling with comorbid generalised worry as determined by a score of 45 or above on the Penn State Worry Questionnaire (collected routinely with all patients referred to the service).
- Informed consent to taking part in the study
Who cannot join
- Patients who have been closed to the service longer than 3 months
- Patients with a diagnosis of long-Covid
- Patients who are under 18
- Patients who do not have a diagnosis of CFS/ME
- Patients who have not agreed to CBT for CFS/ME as part of their treatment
- Patients who score below the threshold on the PSWQ
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Kings College London
London
Ellen Rhodes, 020 7848 0002, ellen.rhodes@kcl.ac.uk
About this study
Official title: Exploring Worry in the Context of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): A Qualitative Study
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.
Read the detailed description
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.
- Conditions
- Chronic Fatigue Syndrome
- Being tested
- No intervention
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention - qualitative study only using semi-structured interview
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploration of how people with a diagnosis of CFS/ME experience worry
Measured: 31/05/2024
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.
Measured: 31/05/2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start1 Oct 2023 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011135
- Sponsor's protocol ID
- IRAS 320892
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data to be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Worry in the Context of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): A Qualitative Study
- ClinicalTrials.gov ID
- NCT06011135
- Acronym / sponsor ID
- IRAS 320892
- Conditions
- Chronic Fatigue Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A purposeful sample of patients will be recruited from SLaM's Persistent Physical Symptoms Research and Treatment Unit. We are interested to collect the views of patients pre, during, and post CBT treatment to support with the secondary aim of the project which is to use the discussions to make recommendations for targeted CBT treatments. Patients will therefore be eligible to participate at any stage of their treatment following initial assessment.
Key inclusion criteria (4 listed)
- have a diagnosis of ME/CFS according to NICE criteria;
- have agreed to CBT for ME/CFS following their initial assessment;
- are/were struggling with comorbid generalised worry as determined by a score of 45 or above on the Penn State Worry Questionnaire (collected routinely with all patients referred to the service).
- Informed consent to taking part in the study
Key exclusion criteria (6 listed)
- Patients who have been closed to the service longer than 3 months
- Patients with a diagnosis of long-Covid
- Patients who are under 18
- Patients who do not have a diagnosis of CFS/ME
- Patients who have not agreed to CBT for CFS/ME as part of their treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention - qualitative study only using semi-structured interview | Other | – |
Primary outcome
Exploration of how people with a diagnosis of CFS/ME experience worry
Time frame: 31/05/2024
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: No. No individual participant data to be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Fatigue Syndrome, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ellen Rhodes (020 7848 0002, ellen.rhodes@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exploration of how people with a diagnosis of CFS/ME experience worry (time frame: 31/05/2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.