|- candidate number||1938|
|- NTR Number||NTR570|
|- Date ISRCTN created||14-feb-2006|
|- date ISRCTN requested||3-feb-2006|
|- Date Registered NTR||20-jan-2006|
|- Secondary IDs||2005/233 CMO|
|- Public Title||The effectiveness of Self-instructions in the treatment of patients with Chronic Fatigue Syndrome (CFS): a randomised controlled study. |
|- Scientific Title||The effect of Self-instructions on fatigue severity and disabilities in patients with Chronic Fatigue Syndrome (CFS): a randomised controlled study. |
|- hypothesis||There a two research questions: |
1. Do Self-instructions lead to a significant decrease of fatigue and functional impairments of CFS patiente compared to a waiting list condition?
2. For which patients are Self-instructions a suitable treatment method?
|- Healt Condition(s) or Problem(s) studied||Chronic Fatigue Syndrome (CFS)|
|- 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||1. Patient does not meet the herefore mentioned inclusion criteria;|
2. Patient is currently engaged in a legal procedure concerning disability-related financial benefits.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2006|
|- planned closingdate||1-sep-2007|
|- Target number of participants||171|
|- 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 weeks about their improvements. In the waiting list condition patients receive no treatment after the baseline assessment. After a period of 6 to 12 months patients get a second assessment. Both patients in the self-instruction and in the waiting list condition are then offered (regular) individual cognitive behavioural therapy (CBT) for CFS. As there is a waiting period of 6-12 months for individual CBT because of lack of treatment capacity participation in the self-instruction study will not lead to a longer waiting period for treatment as usual.|
|- Primary outcome||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 outcome||Psychological distress measured with the SCL-90 (symptom checklist 90).|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. G. Bleijenberg|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. G. Bleijenberg|
|- Sponsor/Initiator ||University Medical Center St. Radboud|
(Source(s) of Monetary or Material Support)
|University Medical Center St. Radboud|
|- 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 not alleviated by rest. The aetiology of CFS is unknown, but cognitions and behaviour can perpetuate CFS. Several controlled trials have shown that Cognitive Behaviour Therapy (CBT) aimed at these perpetuating factors leads to a reduction of fatigue and disabilities. In the Netherlands there are between 30.000 and 40.000 CFS patients while at the same time the availability of individual CBT for CFS is limited due to a limited treatment capacity. It is important to develop treatment programmes that require less treatment capacity. |
Furthermore, there is possibly a subgroup of CFS patient for whom a less intensive CBT treatment suffices. Because of this, the Expert Centre Chronic Fatigue of the Radboud University Nijmegen Medical Centre developed a Self-Instruction (SI) program based on the current protocol of individual CBT for CFS.
The two objectives of this study are
1) to evaluate the efficacy of the SI program for CFS and
2) to find out for which CFS patients specifically the SI is a suitable form of treatment.
This is a randomised controlled trial in which the SI 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 SI or a waiting list condition. All patients are assessed again after 6-12 months. The main outcome measures are fatigue severity (CIS) and functional impairment (SF-36 and SIP).
|- Main changes (audit trail)|
|- RECORD||20-jan-2006 - 5-jan-2010|