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| [ Print-friendly version ] |
| Chronic fatigue syndrome (CFS): cognitive behavioural therapy or rehabilitation? |
| ISRCTN | ISRCTN77567702 |
| ClinicalTrials.gov identifier | |
| Public title | Chronic fatigue syndrome (CFS): cognitive behavioural therapy or rehabilitation? |
| Scientific title | Is a multidisciplinary rehabilitation treatment more effective than monodisciplinary cognitive behavioural therapy for patients with chronic fatigue syndrome? A multicentre randomised controlled trial |
| Acronym | FatiGo |
| Serial number at source | N/A |
| Study hypothesis | This study aims to evaluate the effects of both treatment approaches in outpatient rehabilitation on fatigue severity and quality of life for patients with chronic fatigue syndrome (CFS). Our hypothesis is that the multidisciplinary treatment will result in a significantly greater decrease in fatigue severity and a higher level of quality of life compared to patients treated with cognitive behavioural therapy. |
| Lay summary | |
| Ethics approval | The Ethics Board of Rotterdam and surroundings (Toetsingscommissie Wetenschappelijk Onderzoek Rotterdam e.o.) have approved the study on the 18th November 2008 (ref: 2008/22 [NL19992.101.08, ABRv4]) |
| Study design | Multicentre, single-blind randomised controlled trial |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Chronic fatigue syndrome (CFS) |
| Participants - 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. 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: 1. Is of new onset, that is to say it has not been lifelong 2. Is not the result of ongoing exertion 3. Is not substantially alleviated by rest 4. 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: 5. Self-reported impairment in memory or concentration 6. Sore throat 7. Tender cervical lymph nodes 8. Muscle pain 9. Multi-joint pains 10. Headache 11. Unrefreshing sleep 12. Post-exertional malaise lasting 24 hours or longer Other additional inclusion criteria for this study are: 13. Patients are willing to participate in a treatment which is set up to change behaviour 14. Aged between 18 years and 60 years, either sex 15. Able to speak, understand and write the Dutch language |
| Participants - exclusion criteria |
1. Any medical condition that may explain the presence of chronic fatigue
2. A psychotic, major or bipolar depressive disorder (but not an uncomplicated depression) 3. Dementia 4. Anorexia or bulimia nervosa 5. Alcohol and/or drug abuse 6. Severe obesity (body mass index [BMI] greater than or equal to 45) 7. Pregnancy 8. Not able to speak, understand or write the Dutch language 9. Patients who had cognitive behavioural therapy (CBT) and multidisciplinary rehabilitation therapy (MRT) in the past involving CFS |
| Anticipated start date | 27/11/2008 |
| Anticipated end date | 01/07/2011 |
| Status of trial | Completed |
| Patient information material | Can be found at: http://www.rcbreda.nl (Dutch only) |
| Target number of participants | 240 |
| Interventions |
After the intake, patients will be randomly divided into two groups: cognitive behavioural therapy (CBT) and multidisciplinary rehabilitation therapy (MRT):
1. Cognitive behavioural therapy (CBT): CBT is based on process variables of a CFS model. This model shows that high physical attributions will decrease physical activity and increase fatigue and functional impairment. A low level of sense of control over symptoms and focusing on physical sensations have a direct causal effect on fatigue. In CFS precipitating and perpetuating factors are important. The perpetuating factors become the focus of the intervention in CBT. An important subject in the therapy is the balance between activity and rest and the patients' responsibility to see to it. Negative beliefs regarding the symptoms of fatigue, self-expectations or self-esteem are identified and patients are encouraged to challenge them the conventional way. Specific lifestyle changes are encouraged if deemed appropriate. At the end of the therapy relapse prevention is addressed. Patients who are assigned to this group will attend 16 individual therapy sessions of one hour duration, spread out over 6 months with a psychologist or behavioural therapist. 2. Multidisciplinary rehabilitation therapy (MRT): MRT includes CBT, GET, Pacing and Body awareness therapy (investigational treatment): 2.1. CBT: as above 2.2. Graded exposure therapy (GET): a structured and supervised activity management that aims at a gradual but progressive increase in aerobic activities. It is completed by graded activity and graded exposure in which a gradual and progressive increase of physical and mental activities is trained. The activities include activities of daily living, occupational and social or leisure activities. 2.3. Pacing: helps the patient divide energy over the day/week. Eventually they are encouraged to carry out a gradual increase in physical and mental activity. 2.4. Body awareness therapy: teaches the patient to be aware of healthy physical sensations and to link them in the mind (body mentalisation). Patients will be taught to react adequately to disturbances in the balance between the daily workload and the capacity to deal with it. The balance between activity and rest is also linked to the patients inner control and healthy physical sensations. MRT includes the following: 1. Two weeks: observation (2 sessions of 1 hour psychology, 2 sessions of 1 hour with a social worker, 2 sessions of 1/2 hour occupational therapy, 2 sessions of 1/2 hour physiotherapy) 2. Two weeks: no therapy 3. Ten weeks therapy (5 sessions of 1 hour psychology, 4 sessions of 1 hour with a social worker, 26 sessions of 1/2 hour physiotherapy and 20 sessions of 1/2 hour occupational therapy) 4. Six weeks no therapy 5. One session of 1 hour with a social worker (after 6 weeks of no therapy) 6. Two sessions of both 1/2- 1 hour of therapy with the therapists choice by the participants. During MRT therapy, a participant sees the physician in rehabilitation three times (20 minutes per visit). The total duration of both treatments is 6 months. The duration of follow up for both treatments is also 6 months. |
| Primary outcome measure(s) | Fatigue severity measured using the Checklist Individual Strength at baseline, 6 months and 12 months after start of therapy. |
| Secondary outcome measure(s) |
1. Quality of life measured using the 36-item Short-Form Health Survey (SF-36)
2. Psychological wellbeing measured using Symptom Check List-90 3. Sense of control in relation to CFS complaints measured using Self-Efficacy Scale 4. Somatic attributions measured using Causal Attribution List 5. Mindfulness measured using Mindfulness Attention Awareness Scale 6. Functional activities (the most important) which a patient wants to improve during treatment measured using Patient Specific Complaints and Goals questionnaire 7. Impact of disease on both physical and emotional functioning measured using Sickness Impact Profile 8. Physical activity measured using the Body Media Sensewear activity monitor 9. Self-rated improvement measure using five questions on 5 and 10-point Likert-scale 10. Life satisfaction measured using Life Satisfaction Questionnaire 11. Utility measured using EuroQol 6-D 12. Treatment expectancy and credibility measured using Devilly and Borkovec questionnaire All outcomes are measured at baseline, 6 and 12 months after start of therapy. Treatment costs and additional expenses (work related costs, health care and non-health care costs) are measured using Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness which will be measured every month (from baseline until 12 months after start of therapy). |
| Sources of funding |
1. Rehabilitation Centre Breda (Netherlands)
2. The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 60-60800-98-024) 3. The Rehabilitation Fund (Revalidatiefonds) (Netherlands) (ref: 2007176/SW) 4. The Nuts-Ohra Foundation (Stichting Nuts Ohra [SNO]) (Netherlands) (ref: 0801-06) 5. Myalgic encephalomyelitis/chronic fatigue syndrome Foundation Netherlands (ME/CVS Stichting Nederland) (Netherlands) |
| Trial website | |
| Publications | |
| Contact name | Ms Desiree Vos-Vromans |
| Address |
Rehabilitation Centre Breda
Brabantlaan 1 |
| City/town | Breda |
| Zip/Postcode | 4817 JW |
| Country | Netherlands |
| Tel | +31 (0)76 533 1885 |
| d.vos-vromans@rcbreda.nl | |
| Sponsor | The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) |
| Address | Laan van Nieuw Oost Indië 334 |
| City/town | Den Haag |
| Zip/Postcode | 2593 CE |
| Country | Netherlands |
| Sponsor website: | http://www.zonmw.nl |
| Date applied | 02/02/2009 |
| Last edited | 27/02/2009 |
| Date ISRCTN assigned | 27/02/2009 |
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| © 2012 ISRCTN unless otherwise stated. | |
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