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THE EFFICACY OF COGNITIVE BEHAVIOURAL INTERNET THERAPY FOR ADULT PATIENTS WITH CHRONIC FATIGUE SYNDROME: A RANDOMISED CONTROLLED TRIAL.

THE EFFICACY OF COGNITIVE BEHAVIOURAL INTERNET THERAPY FOR ADULT PATIENTS WITH CHRONIC FATIGUE SYNDROME: A RANDOMISED CONTROLLED TRIAL. - CBIT for CFS.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39926
Enrollment
240
Registered
2013-03-19
Start date
2013-04-01
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

chronisch vermoeidheidssyndroom chronic fatigue/ ME

Interventions

Patients allocated to the CBIT learn how to change fatigue perpetuating cognitions and behaviour. The treatment is based on the protocol for individual face to face cognitive behavioural therapy. Th

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: * >= 18 years * Able to speak, read and write Dutch language * Meet the 1994 US Center for Disease Control and Prevention criteria for chronic fatigue syndrome * Score >= 35 on the Checklist Individual Strength (CIS), fatigue severity sub-scale * Have a total score of >= 700 on the Sickness Impact Profile r_08 (SIPr08) * Give written informed consent

Exclusion criteria

Exclusion criteria: Patients who are engaged in a legal procedure concerning disability-related financial benefits cannot start treatment. This is a temporary exclusion criteria. If the legal procedure is finished patients can enter the study.

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is fatigue severity. Fatigue severity will be measured with the subscale *fatigue severity* of the Checklist Individual Strength (CIS)[8, 9].

Secondary

MeasureTime frame
Secondary outcome measures are: • level of disabilities ((Sickness Impact Profile total score and Short Form 36 Health Survey (=RAND-36 in Dutch) subscale physical functioning)) • level of psychological distress (total score on Symptom CheckList-90) • proportion of patients with clinical significant improvement on 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 1.96 (Jacobson & Truax, 1991) between baseline and T1/ T2, and a score of

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)