|- candidate number||3057|
|- NTR Number||NTR1223|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-feb-2008|
|- Secondary IDs||2007/266 CMO |
|- Public Title||Effects of a minimal cognitive behaviour therapy (CBT) intervention for patients with chronic fatigue syndrome (CFS) in primary care: a randomised controlled trial
- a first step towards stepped care- |
|- Scientific Title||Effects of a minimal cognitive behaviour therapy (CBT) intervention for patients with chronic fatigue syndrome (CFS) in primary care: a randomised controlled trial
- a first step towards stepped care- |
|- hypothesis||There are two research questions: 1. What is the effect of a minimal CBT intervention for CFS in primary care carried out by trained social psychiatric nurses? 2. What are the characteristics of CFS patients who do not improve by a minimal intervention?|
|- Healt Condition(s) or Problem(s) studied||Chronic Fatigue Syndrome (CFS)|
|- Inclusion criteria||1. CDC criteria for CFS |
2. Age between 18-65 years
3. Able to speak, read and write Dutch language
4. CIS fatigue score of 35 or higher, indicating severe fatigue
5. SF 36 physical and/or social functioning score of 70 or below.
|- Exclusion criteria||1. Patient does not meet the therefore mentioned inclusion criteria |
2. Patient is currently engaged in a legal procedure concerning disability-related financial benefits.
|- mec approval received||no|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2008|
|- planned closingdate||1-nov-2010|
|- Target number of participants||120|
|- Interventions||After a baseline assessment (T1) patients are randomly assigned to the intervention- or waiting list condition. The patients in the intervention condition start immediately with minimal intervention. This intervention consists of a self help booklet with exercises, supported by email contact with a social psychiatric nurse. The patient is asked to send and email about the progression and the problems with the program every two weeks. At the end of the treatment, after 6 months, second assessment will take place in both conditions (T2). At this point changes in both conditions will be compared to analyse the effect of the treatment. Subsequently, treatment will be offered to the patients in the waiting list condition. After six months, post treatment for the patients in the waiting list condition will take place (T3).|
|- Primary outcome||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. To measure the level of disability the Medical Outcomes Survey Short From (SF-36) is used. Physical and social disabilities are measured with the 'physical functioning' and 'social functioning' subscale fo the SF-36.|
|- Secondary outcome||The secondary outcome measure is the level of psychological distress measured with the Symptom Checklist 90 (SCL-90).|
|- Timepoints||T1: After a baseline assessment patients are randomly assigned to the intervention- or waiting list condition. |
T2: after 6 months, second assessment will take place in both conditions.
T3: after 6 months, post treatment for the patients in the waiting list condition will take place.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Drs. M. Tummers|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. G. Bleijenberg|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Chronic Fatigue Syndrome (CFS) is characterised by severe fatigue, lasting longer than six months and leading to functional impairment. It is not the result of an organic disease or ongoing exertion and is not alleviated by rest. There is an internationally accepted consensus definition for CFS. A recent report of the Dutch Health Council estimates that there are 30.000-40.000 people with CFS in the Netherlands. |
CBT directed at the perpetuating factors of CFS is an effective but intensive treatment, requiring well trained CBT therapists. The current treatment capacity in the Netherlands is very limited. It is probable that an intensive treatment is not necessary for each CFS patient. It is therefore important to strive for stepped care where the type of intervention is tailored to the specific needs of the patient.
In a model of stepped care for CFS patients, as a first step patients are diagnosed in primary care and -if indicated- treated with a less intense form of CBT also in primary care, preferably near a Mental Health institute where as a second step also more intensive CBT for CFS can be offered. There is enough evidence for the last step: CBT is an evidence based treatment for CFS. For the first step there is less evidence. In a recent not yet published study by our Expert Centre for Chronic Fatigue a minimal intervention, consisting of a self help booklet supported by email contact by a CBT therapist, appeared to be effective in reducing fatigue and impairment significantly compared with a waiting list.
Our study concerned CFS patients referred to our Centre, a specialized CFS clinic. If not all patients need an intensive treatment as regular CBT for CFS in a specialised CFS clinic, it is very probable that this is also the case for CFS patients in primary care. Therefore it is useful to know whether such minimal intervention strategy is also effective in primary care carried out by others than CBT therapists. Many general practitioners work in close cooperation with social psychiatric nurses. These nurses will be trained and supervised to carry out this minimal intervention in (recently) by the general practitioner diagnosed CFS patients.
Testing the effectiveness of such a minimal intervention contributes to the development of stepped care for CFS patients, to application of CBT in earlier stages of the condition and to facilitation of further implementation of CBT for CFS. Furthermore it is important to know the characteristics of the patients who do not benefit from this first step in stepped care. This can help to decide for which patients a minimal intervention suffices and which patients have to be referred directly to an intensive CBT for CFS.
This is a randomised controlled trial in which the minimal intervention condition is compared with a waiting list condition. Patients are included if they meet the 1994 US Center for Disease Control criteria for CFS, are severely fatigued and disabled and gave their written informed consent. Consecutive patients are randomly assigned to the minimal intervention or the waiting list condition. The main outcome measures are fatigue severity (CIS) and functional impairment (SF-36).
|- Main changes (audit trail)|
|- RECORD||8-feb-2008 - 18-okt-2015|