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A randomised controlled trial of nurse facilitated self-help treatment for patients in primary care with chronic fatigue syndrome

A randomised controlled trial of nurse facilitated self-help treatment for patients in primary care with chronic fatigue syndrome: the FINE trial (Fatigue Intervention by Nurses Evaluation)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN74156610
Enrollment
360
Registered
2001-05-18
Start date
2004-06-21
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Chronic fatigue syndrome (CFS) Mental and Behavioural Disorders Chronic fatigue syndrome

Interventions

1. Pragmatic rehabilitation 2. Supportive listening 3. Treatment as usual by GP

Sponsors

University of Manchester (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients 18 and over, who fulfil the Oxford criteria for CFS (Sharpe et al. 1991) [Prior to Feb'2005 the criteria was the Fukuda criteria], and who have a principal complaint of fatigue. Patients must score 4 or more on the 11-item Chalder fatigue scale, and 70% or less on the SF-36 physical functioning scale.

Exclusion criteria

Exclusion criteria: 1. Patients whose fatigue is explained by any active medial condition 2. Patients with schizophrenia, bipolar disorder, dementia, eating disorder, substance abuse, morbid obesity 3. Patients with current suicidal ideation 4. Patients with anti-social, borderline or paranoid personality disorder 5. Patients who cannot read or write English sufficiently well to participate 6. Patients who are incapable of giving informed consent

Design outcomes

Secondary

MeasureTime frame
1. A timed step-test to provide an objective measure of the patient?s exercise tolerance and cardiovascular fitness 2. Scores on the HAD to provide measures of depression and anxiety 3. A brief four-item sleep scale

Primary

MeasureTime frame
The primary outcome measures will be patient-rated to avoid observer bias, and will be supplemented with an objective measure of the patient?s exercise tolerance. These will be: 1. Score on the physical functioning scale of the SF-36 2. Cost-effectiveness using the Euroquol 3. The score on the 11-item Fatigue Scale

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 2, 2026