Given that the Oxford criteria is used for many such trials in the UK, the cohort may not be that different.
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Background
(from: http://www.iop.kcl.ac.uk/departments/?locator=1029)
(I've given each sentence its own paragraph)SAPC annual conference 2010 abstracts
7-9 July 2010, University of East Anglia
P033
Effectiveness of counselling, graded exercise and a booklet plus usual care for people with chronic fatigue in primary care: a randomised trial
Presenter: Leone Ridsdale
Coauthors M King, M Hurley, N Donaldson
Introduction
The research aimed to evaluate the effectiveness of Graded Exercise Therapy (GET), Counselling (COUNS) and a Booklet on CBT plus usual care (BUC) for people presenting with chronic fatigue.
Methods
A randomized controlled trial in South East England recruited patients who presented to the GP for fatigue of at least 3 months, and evaluated fatigue as a main outcome using the Chalder scale at baseline, 6 months and 1 year.
Outcomes included anxiety, depression and satisfaction measures.
Results
222 people were recruited.
Reduction in the mean Fatigue scale
at six months was 8.6 (95% c.i. 6.6 to 10.5) for BUC, 10.1 (95% c.i. 7.5 to 12.9) for GET and 8.6 (95% c.i. 6.4 to 10.8) for COUNS,
and
at one year was 10.2 (95% c.i. 8.3 to 12) for BUC, 10.7 (95% c.i. 8.6 to 12.8) for GET and 9.2 (95% c.i. 7.2 to 11.2 ) for COUNS.
There were no significant difference between the groups for main fatigue and other outcomes including anxiety and depression.
Patient satisfaction was greater in GET and COUNS groups.
Conclusions
Fatigue symptoms tend to remit over time.
One year after presentation, a CBT booklet plus usual care is associated with similarly reduced symptoms as active therapies, but the latter satisfies patients more.
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Background
(from: http://www.iop.kcl.ac.uk/departments/?locator=1029)
A Randomised Trial to Compare the Effect of Graded Exercise and Counselling With Usual Care Plus a Booklet for Patients With Fatigue in Primary Care
Purpose of the Study
General practitioners report a large number of patients approaching them describing symptoms of prolonged and unexplained fatigue.
Symptoms can range in severity from recently feeling tired for most of the time (chronic fatigue) up to fatigue of more than 6 months duration which is worsened by physical exertion and is coupled with some of the following: muscle aches, sleep disruption, poor concentration, forgetfulness, mood swings, enlarged glands, sore throat, a higher temperature, anxiety/depression, loss of appetite, nausea and feeling faint/dizzy (and thus warranting a diagnosis of Chronic Fatigue Syndrome CFS). Chronic Fatigue often starts after a period of illness (virus/infection) and has been linked to glandular fever.
Chronic fatigue and CFS (also called ME Myalgic Encephalomyelitis) has been shown to respond to certain types of intervention, namely Cognitive Behaviour Therapy (CBT), counselling and Graded Exercise Therapy (GET) (Ridsdale et al, 2001; Whiting et al, 2001). The CBT & GET treatments were most effective for the CFS group when given for longer periods (13 sessions) instead of shorter periods (6 sessions).
CBT has also proved effective when given in a booklet form after an interview with a nurse (Chalder et al, 1997).
Considering these outcomes, it was of interest to see how a comparison of treatment conditions of GET, counselling and regular GP care plus a CBT booklet influenced the fatigue outcome of patients randomised to one of those treatments (see Trial Protocol
http://www.iop.kcl.ac.uk/departments/?locator=1029&context=1102 ), following a G.P referral for unexplained fatigue of over 3 months duration (see referral guidelines for GPs
http://www.iop.kcl.ac.uk/departments/?locator=1029&context=1101 ).
Level of fatigue was measured at the start, at post treatment (6
months) and one year from the start using a questionnaire format.
Principal Investigator: Dr Leone Ridsdale
Research Worker: Dr Elizabeth Shephard.
This study is funded by the Wellcome Trust http://www.wellcome.ac.uk/
Fatigue study updated figures for May 2008 http://www.iop.kcl.ac.uk/iopweb/blob/downloads/locator/l_1029_May08_flowchart_update.doc
Downloads:
Referral Form http://www.iop.kcl.ac.uk/iopweb/blob/downloads/locator/l_1029_referralform.pdf
Patient Info Sheet
http://www.iop.kcl.ac.uk/iopweb/blob/downloads/locator/l_1029_patientinfosheet.pdf