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

Not Applicable

Completed

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

Registration Number: ISRCTN74156610

Lead Sponsor: niversity of Manchester (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 360

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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: <br>1. Score on the physical functioning scale of the SF-36<br>2. Cost-effectiveness using the Euroquol<br>3. The score on the 11-item Fatigue Scale

Secondary Outcome Measures

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