The efficacy of Cognitive Behavioural Internet Therapy for adult patients with Chronic Fatigue Syndrome: a randomised controlled trial.
Completed
- Conditions
- -
- Registration Number
- NL-OMON25622
- Lead Sponsor
- Radboud University Nijmegen Medical CentreExpert Centre for Chronic FatiguePostbus 91016500HB Nijmegen
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 240
Inclusion Criteria
In order to be eligible to participate in this study, patients must meet all of the following criteria:
* >= 18 years;
Exclusion Criteria
Patients who meet any of the following criteria will be excluded from participation in this study:
- Engagement in a legal procedure concerning disability-related financial benefits.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure is fatigue severity assessed with the CIS subscale ‘fatigue severity’.
- Secondary Outcome Measures
Name Time Method Secondary outcome measures are: <br>- Level of disabilities assessed with the total score of the Sickness Impact Profile and Short Form 36 Health Survey subscale ‘physical functioning’ ;<br /><br>- Level of psychological distress (total score on Symptom CheckList-90);<br>- Proportion of patients with clinical significant improvement with respect to fatigue severity. Clinical significant improvement is defined as a reliable change index > 1.96 (Jacobson & Truax, 1991) between baseline and T1, and a score of < 35 on the CIS Fatigue Severity subscale at T1;<br>- Quality Adjusted Life Years (Euro Qol Group-6D);<br>- Number of sessions per patient;<br>- Therapist time per patient.