Stepped care for chronic fatigue syndrome compared to care as usual: a randomized noninferiority trial
Recruiting
- Conditions
- Chronic fatigue syndrome (CFS)
- Registration Number
- NL-OMON22165
- Lead Sponsor
- Radboud University Medical Centre, Nijmegen, The Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 363
Inclusion Criteria
Patients must meet the following inclusion criteria:
- >= 18 years;
Exclusion Criteria
Patients will be (temporarily) excluded if they are engaged in a legal procedure concerning disability-related financial benefits.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fatigue severity assessed with the CIS sub scale 'fatigue severity’.
- Secondary Outcome Measures
Name Time Method - Level of disabilities assessed with the total score of the Sickness Impact Profile 8;<br /><br>- Physical functioning assessed with the subscale physical functioning of the SF-36;<br /><br>- Level of psychological distress assessed with total score of Symptom CheckList-90;<br /><br>- Proportion of patients with clinical significant improvement in fatigue severity. Clinical significant improvement is defined as a reliable change index > 1.96 and a score of < 35 on the CIS Fatigue severity subscale; <br /><br>- Therapist time needed per patient to deliver stepped care or care as usual. <br>