Effects of a minimal CBT intervention for CFS patients in primary care, carried out by social psychiatric nurses, a randomised controlled trial - a first step towards stepped care for CFS

Conditions: chronisch vermoeidheidssyndroom
chronic fatigue
Chronic Fatigue Syndrome

Registration Number: NL-OMON31835

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

- CDC criteria for CFS
- age between 18-65 years
- able to speak, read and write Dutch language
- CIS fatigue score of 35 or higher, indicating severe fatigue
- SF 36 physical and/or social functioning score of 70 or below

Exclusion Criteria

See inclusion criteria

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome variables are fatigue severity and functional disability.<br /><br>The Checklist Individual<br /><br>Strength (CIS) subscale for fatigue indicates the level of experienced fatigue<br /><br>over the past 2-week period and consists of 8 items that have to be answered on<br /><br>a 7-point scale. The score can range between 8 to 56. The scale is reliable,<br /><br>has a good validity, and is sensitive to change. To measure the level of<br /><br>disability the Medical Outcomes Survey Short Form-36 (SF-36) is used. Physical<br /><br>and social disabilities are measured with the physical functioning and<br /><br>social functioning subscale of the SF-36. The scores range from 0 (maximum<br /><br>limitations) to 100 (no limitations). The SF-36 is often used in treatment<br /><br>studies of CFS patients, is reliable and has a good validity.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome measure is the level op psychological distress measured<br /><br>with the Symptom Checklist 90 (SCL-90). The SCL-90 consists of 90 items scored<br /><br>on a 5-point Likert scale. The total score ranges from 90 to 450. A high total<br /><br>score reflects high psychological distress. This scale is widely used and the<br /><br>reliability and discriminating validity are good.</p><br>