The objective of this study is to investigate wether a minimal intervention is an effective treatment for patients with chronic fatigue syndrome type idiopathic chronic fatigue.Objectives:- What is the effect of a minimal intervention for CFS-ICF…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
chronisch vermoeidheidssyndroom type idiopathische chronische vermoeidheid
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome variables are fatigue severity and level of disabilities.
Fatigue severity will be measured with subscale *fatigue severity* of the
Checklist Individual Strength (CIS). The Sickness Impact profile will be used
to measure functional disability in ambulation, home management, mobility,
alertness behavior, sleep/rest, work, limitations, social interactions,
recreation and pastimes. Physical and social disabilities are measured with the
*physical functioning* and *social functioning* subscale of the Medical
Outcomes Survey Short Form-36 (SF-36).
Secondary outcome
The secondary outcome variable is the level op psychological distress measured
with the symptom Checklist 90 (SCL-90).
Background summary
Minimal interventions are developed to improve the efficiency of psychological
therapy provision, presuming that less severe patients suffice with a less
intensive treatment. The Nijmegen Expert Centre for Chronic Fatigue
demonstrated in a randomised controlled study that a minimal intervention for
patients with chronic fatigue syndrome (CFS), consisting of guided
self-instructions based on cognitive behavioral therapy (CBT), lead to a
significant reduction of fatigue and disabilities compared to a waiting list
condition. To examine the hypothesis whether minimal interventions are also
suitable for patients with less severe symptoms of chronic fatigue, this study
will determine the effect of guided self instructions for patients with CFS
type idiopathic chronic fatigue (CFS-ICF). Patients with CFS-ICF experience
just as patients with CFS: severe fatigue lasting longer than six months and
leading to impairments. However, the impairments and disabilities are
insufficient to justify the diagnosis CFS they fulfill the criteria for
CFS-ICF and suffer fromm there symptoms. Just for this group of patients such a
minimal intervention could be a suitable treatment. In an earlier study the
intervention was successful for 27% of the patients. We expect that with
CFS-ICF patients we reach a much higher percentage of successful treatments.
Testing the effectiveness of a minimal intervention with CFS-ICF patients
contributes to the development of efficient care for chronic fatigue. This
study joins up to the randomised clinical trial that determines the effect of a
minimal intervention for CFS patients in primary care, carried out by social
psychiatric nurses.
Study objective
The objective of this study is to investigate wether a minimal intervention is
an effective treatment for patients with chronic fatigue syndrome type
idiopathic chronic fatigue.
Objectives:
- What is the effect of a minimal intervention for CFS-ICF patients with regard
to level of fatigue en disabilities compared to a waiting list condition?
- What are the characteristics of CFS-ICF patients who do improve by a minimal
intervention?
Study design
Referred patients are randomised after informed consent in one of the two
conditions:
1) Minimal intervention with email support by a therapist
2) Waiting list control group. The patient will wait 6 months before starting
with the minimal intervention
Intervention
The self-instructions are derived from the protocol for CBT that is developed
on the basis of a model of perpetuating factors of CFS. It*s aim is to change
fatigue related cognitions and to improve gradual the physical activity of the
patient. The minimal interventions consist of a self help booklet with
exercises, supported by email contact with the therapist. In this self help
booklet, patients can follow the instructions week by week. The patient is
asked to send an email about the progression and the problems with the program
every two weeks. The self help booklet is the improved version of the booklet
that as has been tested in a previous study. The duration of the minimal
intervention is 6 months.
Study burden and risks
There are no specific risk factors. Extend of the burden for patients is
limited. Patients that have to wait 6 months for the intervention have to fill
in the assesment once more. Because of the many patients refferd to the Expert
Centre Chronic Fatigue fro treatment it takes usually around 6 months before
patients can start with a treatment. So there is almost no difference between
patients that have to wait 6 months and patients that receive treamtent
following the usual procedure.
Toernooiveld 214
6525 EC Nijmegen
NL
Toernooiveld 214
6525 EC Nijmegen
NL
Listed location countries
Age
Inclusion criteria
*18 years or older
* Able to speak, read and write Dutch language
* CIS fatigue score of 35 or higher
* Sickness Impact Profile between 450 and 700 and/or 3 or less CDC symptoms
Exclusion criteria
See inclusion criteria
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL24487.091.08 |