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-

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- - Guided self-treatment for CFS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31835

Enrollment

120

Registered

2008-05-20

Start date

2007-11-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronisch vermoeidheidssyndroom chronic fatigue Chronic Fatigue Syndrome

Interventions

The minimal intervention consists of a self help booklet with exercises, supported by email contact with the nurse. In this self help booklet patient can follow the instructions week by week. The pa

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: See inclusion criteria

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)