*Is a multidisciplinary rehabilitation treatment more effective than monodisciplinary cognitive behavioural therapy for patients with chronic fatigue syndrome? A multicentre randomised controlled trial*

Completed

• Conditions: somatoforme stoornissen; Chronic fatigue syndrome (CFS); Myalgic encephalomyelitis (ME)

• Registration Number: NL-OMON39182
• Lead Sponsor: Revant, Revalidatiecentrum Breda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 122

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified