somatoforme stoornissen Chronic fatigue syndrome (CFS) Myalgic encephalomyelitis (ME)
Conditions
Interventions
After the inclusion (and signing informed consent form), patients will be
randomly divided into two groups: Cognitive Behavioural Therapy and
Multidisciplinary rehabilitation therapy. The multidisci
Sponsors
Revant, Revalidatiecentrum Breda
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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: 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study parameters: fatigue severity (on the Checklist Individual Strength), quality of life (measured by the Short-Form 36) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Netherlands
Outcome results
None listed