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A novel online program for fatigue; a feasibility study

A novel online program for fatigue; a feasibility study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN58998320
Enrollment
200
Registered
2020-03-06
Start date
2019-12-10
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic fatigue (CF) including both patients with chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME) and idiopathic chronic fatigue (ICF) Nervous System Diseases Postviral fatigue syndrome

Interventions

Current interventions as of 08/07/2024: This feasibility study of the online program will involve participants with chronic fatigue (CF) including diagnoses of chronic fatigue syndrome (CFS) or idiopa
n=50. It will also involve participants with a number of long-term physical health conditions (LTC’s)
defined as a condition that cannot, at present be cured
but can be controlled by medication and other therapies
and requires ongoing management over a period of years or decades
n=50 per LTC. From each group, 25 participants will be randomised into the active arm of the program and 25 into the sham/ control arm of the program. All participants will complete sessions of the c
including London Greater trusts (Hillingdon Hospital, Uxbridge
Royal Free Hospital and South London and Maudsley NHS Trust (research site)) as well as Oxfordshire (Oxford University Hospitals Fatigue Service), Somerset (CFS/ME Service Royal National Hospital for
Bristol CFS/ME Service). Recru

Sponsors

King's College London
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All participants must: 1. Meet caseness for fatigue (i.e. a score of 4 or more on the Chalder Fatigue Scale, 1993) 2. Be aged 18 years or older 3. Be fluent in English 4. Have normal or corrected-to-normal vision, hearing, manual dexterity 5. Not be currently undergoing psychological treatment 6. Have access to a computer or tablet with an internet connection In addition: Participants must either: 1. Have a diagnosis of chronic fatigue, including a diagnosis of chronic fatigue syndrome (CFS) or idiopathic chronic fatigue (ICF) Or: 2. Have one or more long-term physical health condition defined as a condition that cannot, at present be cured; but can be controlled by medication and other therapies; and requires ongoing management over a period of years or decades

Exclusion criteria

Exclusion criteria: 1. Under 18 years old 2. Do not meet caseness for fatigue (i.e. they score less than 4 or more on the Chalder Fatigue Scale, 1993) 3. Do not have an interpretation bias (i.e. they do not a negative bias index on the ambiguous scenarios task, Mathews & Mackintosh, 2000) 4. Not happy to be randomized to control group 5. Currently undergoing concurrent CBT treatment or other psychological therapies 6. Poor level of English (as assessed by researcher during initial interaction) 7. Impaired vision/hearing that would hinder use of tablet or computer 8. Impaired dexterity that would hinder use of a tablet or computer 9. No access to a tablet or computer with internet connection 10. Does not have a diagnosis of chronic fatigue or a long-term physical health condition 11. Involved in another research study (with the exception of observational studies)

Design outcomes

Primary

MeasureTime frame
Feasibility and acceptability of the intervention measured by: 1. Recruitment rate measured by screening questionnaire at baseline 2. Completion rate measured by number and stage of withdrawals 3. Qualitative analysis of semi-structured interviews post-intervention or at point of drop-out

Secondary

MeasureTime frame
Estimated effect sizes of changes in secondary outcome variables: 1. Interpretation bias is measured by Ambiguous Scenarios Task at baseline (T0), post-intervention (T1), 1 month (T2) and 3-months follow-up (T3) 2. Severity of fatigue is measured by Chalder Fatigue Scale at baseline (T0), post-intervention (T1), 1 month (T2) and 3-months follow-up (T3) 3. Disability is measured by Work and Social Adjustment Scale (WSAS) at baseline (T0), post-intervention (T1), 1 month (T2) and 3-months follow-up (T3) 4. Disability is measured by Short Form-36 Physical Functioning Scale (SF-36) at baseline (T0), post-intervention (T1), 1 month (T2) and 3-months follow-up (T3) 5. Depression is measured by Patient Health Questionnaire (PHQ9) at baseline (T0), post-intervention (T1), 1 month (T2) and 3-months follow-up (T3) 6. Anxiety is measured by Generalised Anxiety Disorder (GAD7) at baseline (T0), post-intervention (T1), 1 month (T2) and 3-months follow-up (T3) 7. Illness related cognitions and behavioural responses measured by Cognitive Behavioural Responses Questionnaire (shortened version) at baseline (T0), post-intervention (T1), 1 month (T2) and 3-months follow-up (T3) 8. Acceptance of fatigue is measured by Fatigue Acceptance Questionnaire (FAQ) at baseline (T0), post-intervention (T1), 1 month (T2) and 3-months follow-up (T3) 9. Flexible persistence in goal-directed behaviour is measured by Committed Action Questionnaire- short version (CAQ-8) at baseline (T0), post-intervention (T1), 1 month (T2) and 3-months follow-up (T3) 10. Influence of thoughts on actions is measured by the Cognitive Fusion Questionnaire (CFQ) at baseline (T0), post-intervention (T1), 1 month (T2) and 3-months follow-up (T3)

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026