An observational study in Chronic Fatigue Syndrome, sponsored by King's College London. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-25.
Sponsored by King's College London · Observational
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.
246 studies on the registry are indexed under Fatigue Syndrome, Chronic; 58 are open to participants now.
This study's planned enrollment of 15 is below the median of 150 across 71 observational studies indexed under Fatigue Syndrome, Chronic.
Browse Fatigue Syndrome, Chronic studies →King's College London is the lead sponsor of 506 studies on the registry; 125 are open to participants now.
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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.
Exclusion Criteria:
No intervention - qualitative study only using semi-structured interview
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
Plan to share: No — No individual participant data to be shared with other researchers.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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King's College London