The effectiveness of Self-instructions in the treatment of patients with Chronic Fatigue Syndrome (CFS): a randomised controlled study.

The effect of Self-instructions on fatigue severity and disabilities in patients with Chronic Fatigue Syndrome (CFS): a randomised controlled study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24671

Enrollment

171

Registered

2006-01-20

Start date

2006-02-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Chronic Fatigue Syndrome

Interventions

After a baseline assessement patients are randomly assigned to one of two conditions. In the Self-instruction condition patients receive a self-instruction book and email a therapist once every two w

Eligibility

Inclusion criteria

Inclusion criteria: 1. > 18 years old; 2. Being able to speak and read Dutch; 3. Meeting the 1994 research criteria for CFS as formulated by the US Center for Disease Control; 4. Severely fatigued (having a CIS-fatigue severity score of >= 35); 5. Severely disabled (weigthed totalscore on the Sickness Impact Profile of >=700); 6. Being motivated for treatment of CFS; 7. Given written informed consent for participation in the study.

Exclusion criteria

Exclusion criteria: 1. Patient does not meet the herefore mentioned inclusion criteria; 2. Patient is currently engaged in a legal procedure concerning disability-related financial benefits.

Design outcomes

Primary

Measure	Time frame
1. Fatigue (measured with the CIS-Fatigue severity); 2. Disabilities (measured with the SIP total score and SF-36 subscale 'physical functioning'); 3. The CIS-f, SIP and SF-36 are used in two asessements, a baseline and a post-treatment (or post waiting list) assessment;. 4. Determine the effect of the treatment the difference in CIS-f, SIP and SF-36 scores between baseline and post-treatment for the treatment condition is compared with the difference scores of the waitinglist condition.	—

Measure

Time frame

1. Fatigue (measured with the CIS-Fatigue severity); 2. Disabilities (measured with the SIP total score and SF-36 subscale 'physical functioning'); 3. The CIS-f, SIP and SF-36 are used in two asessements, a baseline and a post-treatment (or post waiting list) assessment;. 4. Determine the effect of the treatment the difference in CIS-f, SIP and SF-36 scores between baseline and post-treatment for the treatment condition is compared with the difference scores of the waitinglist condition.

—

Secondary

Measure	Time frame
Psychological distress measured with the SCL-90 (symptom checklist 90).	—

Contacts

Public ContactG. Bleijenberg

University Medical Center St. Radboud, Expert Center Chronic Fatigue, P.O. Box 9011

g.bleijenberg@nkcv.umcn.nl+31 (0)24 3610030

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)