Exploring Worry in CFS/ME

NCT06011135 | Unknown

• 1 other identifier: IRAS 320892
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Chronic Fatigue Syndrome

Outcome Measures

Primary Outcomes (2)

• Exploration of how people with a diagnosis of CFS/ME experience worry

  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.

  31/05/2024

Interventions

No intervention OTHER

No intervention - qualitative study only using semi-structured interview

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• South London and Maudsley NHS Foundation Trust: collaborator

Study Sites (1)

Kings College London

London, United Kingdom

Location

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ellen Rhodes

CONTACT

020 7848 0002; ellen.rhodes@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 25, 2023
• Study Start: October 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)