Condition category
Mental and Behavioural Disorders
Date applied
18/05/2001
Date assigned
18/05/2001
Last edited
29/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alison Wearden

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0200212

Study information

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)

Acronym

FINE

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Chronic fatigue syndrome (CFS)

Intervention

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

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

21/06/2004

Overall trial end date

25/07/2008

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

360

Participant 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

Recruitment start date

21/06/2004

Recruitment end date

25/07/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Manchester
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

Research Office
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 275 2227
john.rogers@manchester.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) (G0200212)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/16603058
2010 results of qualitative study in: http://www.ncbi.nlm.nih.gov/pubmed/20178588
2010 results of randomised controlled trial in: http://www.ncbi.nlm.nih.gov/pubmed/20418251
2011 results of patient engagement in: http://www.ncbi.nlm.nih.gov/pubmed/21457596
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/22192566
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22844025
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23327355
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26657793

Publication citations

  1. Results of qualitative study

    Chew-Graham C, Dowrick C, Wearden A, Richardson V, Peters S, Making the diagnosis of Chronic Fatigue Syndrome/Myalgic Encephalitis in primary care: a qualitative study., BMC Fam Pract, 2010, 11, 16, doi: 10.1186/1471-2296-11-16.

  2. Results of patient engagement

    Chew-Graham C, Brooks J, Wearden A, Dowrick C, Peters S, Factors influencing engagement of patients in a novel intervention for CFS/ME: a qualitative study., Prim Health Care Res Dev, 2011, 12, 2, 112-122, doi: 10.1017/S146342361000037X.

  3. Results

    Peters S, Wearden A, Morriss R, Dowrick CF, Lovell K, Brooks J, Cahill G, Chew-Graham C, , Challenges of nurse delivery of psychological interventions for long-term conditions in primary care: a qualitative exploration of the case of chronic fatigue syndrome/myalgic encephalitis., Implement Sci, 2011, 6, 132, doi: 10.1186/1748-5908-6-132.

  4. Results

    Wearden AJ, Dunn G, Dowrick C, Morriss RK, Depressive symptoms and pragmatic rehabilitation for chronic fatigue syndrome., Br J Psychiatry, 2012, 201, 3, 227-232, doi: 10.1192/bjp.bp.111.107474.

  5. Results

    Richardson G, Epstein D, Chew-Graham C, Dowrick C, Bentall RP, Morriss RK, Peters S, Riste L, Lovell K, Dunn G, Wearden AJ, , Cost-effectiveness of supported self-management for CFS/ME patients in primary care., BMC Fam Pract, 2013, 14, 12, doi: 10.1186/1471-2296-14-12.

  6. Wearden AJ, Riste L, Dowrick C, Chew-Graham C, Bentall RP, Morriss RK, Peters S, Dunn G, Richardson G, Lovell K, Powell P, Fatigue Intervention by Nurses Evaluation--the FINE Trial. A randomised controlled trial of nurse led self-help treatment for patients in primary care with chronic fatigue syndrome: study protocol. [ISRCTN74156610]., BMC Med, 2006, 4, 9, doi: 10.1186/1741-7015-4-9.

  7. Wearden AJ, Dowrick C, Chew-Graham C, Bentall RP, Morriss RK, Peters S, Riste L, Richardson G, Lovell K, Dunn G, , Nurse led, home based self help treatment for patients in primary care with chronic fatigue syndrome: randomised controlled trial., BMJ, 2010, 340, c1777.

  8. Results

    Goldsmith LP, Dunn G, Bentall RP, Lewis SW, Wearden AJ, Therapist Effects and the Impact of Early Therapeutic Alliance on Symptomatic Outcome in Chronic Fatigue Syndrome, PLoS One, 2015, 10, 12, e0144623, doi: 10.1371/journal.pone.0144623.

Additional files

Editorial Notes

29/06/2016: Publication reference added.