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

ISRCTN	ISRCTN74156610
DOI	https://doi.org/10.1186/ISRCTN74156610
Protocol serial number	G0200212
Sponsor	University of Manchester (UK)
Funder	Medical Research Council (MRC) (UK) (G0200212)

Submission date: 18/05/2001
Registration date: 18/05/2001
Last edited: 29/06/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Alison Wearden
Scientific

School of Psychological Sciences
Coupland 1 Building
Oxford Road
Manchester
M13 9PL
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	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)
Study acronym	FINE
Study objectives	1. Is pragmatic rehabilitation, delivered at home by nurses to CFS patients recruited from primary care, a clinically effective intervention in terms of reduced disability and fatigue when compared with treatment as usual delivered through the primary care team? 2. Is pragmatic rehabilitation, delivered at home by nurses to CFS patients recruited from primary care, a cost effective intervention when compared with treatment as usual delivered through the primary care team? 3. Is supportive listening, delivered at home by nurses to CFS patients recruited from primary care, a clinically effective intervention in terms of reduced disability and fatigue when compared with treatment as usual delivered through the primary care team? 4. Is supportive listening, delivered at home by nurses to CFS patients recruited from primary care, a cost effective intervention when compared with treatment as usual delivered through the primary care team? Can we demonstrate that the active component of pragmatic rehabilitation operates in addition to a non-specific treatment effect due to contact with a supportive therapist?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Chronic fatigue syndrome (CFS)
Intervention	1. Pragmatic rehabilitation 2. Supportive listening 3. Treatment as usual by GP
Intervention type	Other
Primary outcome measure(s)	The primary outcome measures will be patient-rated to avoid observer bias, and will be supplemented with an objective measure of the patients 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
Key secondary outcome measure(s)	1. A timed step-test to provide an objective measure of the patients exercise tolerance and cardiovascular fitness 2. Scores on the HAD to provide measures of depression and anxiety 3. A brief four-item sleep scale
Completion date	25/07/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	360
Key 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.
Key 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
Date of first enrolment	21/06/2004
Date of final enrolment	25/07/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Manchester

Manchester
M13 9PL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results of qualitative study	23/02/2010		Yes	No
Results article	results of randomised controlled trial	23/04/2010		Yes	No
Results article	results of patient engagement	01/04/2011		Yes	No
Results article	results	22/12/2011		Yes	No
Results article	results	01/09/2012		Yes	No
Results article	results	18/01/2013		Yes	No
Results article	results	14/12/2015		Yes	No
Protocol article	protocol	07/04/2006		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

29/06/2016: Publication reference added.