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The effectiveness of cognitive behavioural therapy in groups for patients with Chronic Fatigue Syndrome (CFS): a randomised controlled study.

The effectiveness of cognitive behavioural therapy in groups for 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-OMON24062
Enrollment
204
Registered
2005-07-21
Start date
2007-01-01
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 basline assessment patients are randomly assigned to one of three conditions. The are two treatment conditions: small group (4 patients and 1 therapist) and large group (8 patients and two the

Sponsors

Radboud University Nijmegen Medical Centre
Lead Sponsor

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 Diasease 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. Motivated for treatment of CFS with CBT; 7. Having functioned good in groups before (self-report) and willing to follow a group treatment for CFS; 8. Given written informed consent for participation in the study.

Exclusion criteria

Exclusion criteria: 1. Patient does no meet the herefore mentioned inclusion criteria; 2. Patients is currently engaged in a legal procedure concerning disability-related financial benefits.

Design outcomes

Primary

MeasureTime frame
1. Fatigue severity (measured with the CIS subscale fatigue severity). 2. Disabilities (measured with the SIP total score and the SF-36 subscal 'physical functioning') The CIS-f, SIP and SF-36 are used in two assessments, a baseline and a post-treatment (or post-waiting list) assessment. The change score between post-treatment and baseline of each of the treatment conditions is compared with the difference score between post-waiting list and baseline assessment of the waiting list condition.

Secondary

MeasureTime frame
Psychological distress measured with the Symptom Checklist 90 (SCL_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)