To assess the difference in treatment effect (change between start and 6, 12, 54 and 78 months follow-up of fatigue severity and quality of life in patients with chronic fatigue syndrome) between individual multidisciplinary rehabilitation treatment…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
somatoforme stoornissen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters: fatigue severity (on the Checklist Individual
Strength), quality of life (measured by the Short-Form 36)
Secondary outcome
Secondary outcome parameters are:
Psychological wellbeing (Symptom Check List-90), depression and anxiety
(Hospital Anxiety and Depression Scale), sense of control in relation to CFS
complaints (Self-Efficacy Scale), somatic attributions (Causal Attribution
List), (the most important) functional activities which a patient wants to
improve during treatment (Patient Specific Complaints and Goals questionnaire),
impact of disease on both physical and emotional functioning (Sickness Impact
Profile), physical activity (measured by the Body Media Sensewear activity
monitor), self-rated improvement (five questions on 5 and 10-point
Likert-scale), life satisfaction (Life Satisfaction Questionnaire), utility
(EuroQol 6-D), mindfulness attention and awarenes (Mindfulness attention and
awareness scale) and treatment expectancy and credibility (Devilly and Borkovec
questionnaire). Treatment costs and additional expenses (work related costs,
health care and non-health care costs) will also be recorded (Trimbos/iMTA
questionnair for Costs associated with Psychiatric Illness).
Background summary
In the Netherlands approximately 30.000-40.000 patients suffer from Chronic
Fatigue Syndrome (CFS) (Health Counsil of The Netherlands, 2005). Systematic
reviews show that Cognitive Behavioural Therapy (CBT) and Graded Exercise
Therapy (GET) are the only interventions found to be beneficial. Interpretation
of the results for clinical practice is however limited because of the
considerable number of drop-outs and a significant number of non-responders in
the included RCTs.
Positive effects of multidisciplinary interventions for patients with CFS have
been seen in 4 non-controlled studies. Viner et al. (2004) evaluated the
effects of a multidisciplinary rehabilitation treatment for young patients with
chronic fatigue. Results showed positive effects on wellness, school attendance
and severity of CFS. A study by Post et al. (2006) with adolescents with
chronic pain and fatigue also showed strong positive effects on fatigue
severity, school/work attendance and general health after multidisciplinary
rehabilitation treatment. In the study by Torenbeek et al. (2006), in clinical
CFS patients, positive effects were found on fatigue severity, experienced
impairments and physical functioning. The results of a pilot study at
Rehabilitation Centre Breda, in which 36 patients participated, were promising
(Vos-Vromans, 2005). There was a significant improvement of fatigue severity
and activities of daily living 6 months after the start of treatment, which
persisted for 12 months after the start of treatment.
The difference in effectiveness between individual multidisciplinary
rehabilitation treatment and individual cognitive behavioural therapy for
treatment of CFS is as yet unknown. This study aims to evaluate the effects of
both treatment approaches in outpatient rehabilitation on fatigue severity and
quality of life in patients with CFS after treatment, 6 months after the end of
treatment and 4 and 6 years after the end of treatment.
Study objective
To assess the difference in treatment effect (change between start and 6, 12,
54 and 78 months follow-up of fatigue severity and quality of life in patients
with chronic fatigue syndrome) between individual multidisciplinary
rehabilitation treatment and individual cognitive behavioural therapy.
Study design
Patients with CFS referred to Rehabilitation Centre Breda, Rehabilitation
Centre Amsterdam and Rehabilitation Centre Blixembosch will be asked to
participate in this study. After inclusion (and signing the informed consent
form), patients will be randomly assigned to one of the two treatment groups
(cognitive behavioural therapy or multidisciplinary rehabilitation therapy).
Patients will be measured before the treatment starts, and at 6, 12, 54 and 78
months there will be a follow-up assessment. Outcomes of treatment will be
measured using valid and reliable assessment scales. The results of the
different therapy conditions on the different assessments will be compared
using an *intention to treat* approach. The longitudinal effect of MRT versus
CBT on the primary and secondary outcomes will be assessed using linear mixed
models.
Clarification:
Both treatments take 6 months to complete. The first assessment is directly
after treatment. The second assessment is 6 months after the end of treatment.
For the FatiGo II study (long term follow up study) the assesments are at 4 and
6 years after the end of treatment.
Intervention
After the inclusion (and signing informed consent form), patients will be
randomly divided into two groups: Cognitive Behavioural Therapy and
Multidisciplinary rehabilitation therapy. The multidisciplinary therapy
includes Cognitive behavioural therapy, Graded exercise therapy, Pacing and
Body awareness therapy. Patients will attend a 13 week program and one follow
up meeting 3 months later. Patients have weekly contact with a physiotherapist,
occupational therapist , psychologist or behavioural therapist (once every two
weeks) and a social worker (once every two weeks). Patients who are assigned to
cognitive behavioural thearpy will attend 16 individual therapy sessions,
spread out over 6 months with a psychologist or behavioural therapist.
Study burden and risks
The risks associated with participation can be considered negligible and the
burden is minimal. Two existing therapies that have been in practice for
several years will be investigated. Measurements (three times during the study)
are limited to filling out questionnaires (2 hours) and carrying an activity
monitor for one week. Everyt month, during one year, a patient is asked to fill
out a short questionnaire (5 minutes).
During FatiGo II study the patients are asked to fill in questionnaires at home
which takes 30 minutes to complete.
Brabantlaan 1
Breda 4817 JW
NL
Brabantlaan 1
Breda 4817 JW
NL
Listed location countries
Age
Inclusion criteria
Patients are included if they fulfil the CDC-94 criteria for CFS and score more or equal to 40 on the Checklist Individual Strength (CIS)-fatigue questionnaire (Prins et al. 2001).
CDC-94 criteria for CFS are as follows:
At least 6 months of persistent or recurring fatigue for which no physical explanation has been found and which:
- is of new onset, that is to say it has not been lifelong
- is not the result of ongoing exertion
- is not substantially alleviated by rest
- severely limits functioning
In combination with four or more of the following symptoms, persistent or regularly recurring over a period of 6 months and which must not have predated the fatigue:
- self-reported impairment in memory or concentration
- sore throat
- tender cervical lymph nodes
- muscle pain
- multi joint pains
- headache
- unrefreshing sleep
- post-exertional malaise lasting 24 hours or longer
- dementia
- anorexia or bulimia nervosa
- alcohol and/or drug abuse
- severe obesity;Other additional inclusion criteria for this study are:
- patients are willing to participate in a treatment which is set up to change behaviour
- age between 18 years and 60 years
- able to speak, understand and write the Dutch language
Exclusion criteria
Exclusion criteria
- any medical condition that may explain the presence of chronic fatigue
- a psychotic, major or bipolar depressive disorder (but not an uncomplicated depression)
- dementia
- anorexia or bulimia nervosa
- alcohol abuse or the use of drugs
- severe obesity
- pregnancy
- not able to speak, understand or read the Dutch language
- patients who had CGT or rehabilitation therapy in the past involving CFS.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ISRCTN | ISRCTN77567702 |
| CCMO | NL19992.101.08 |