The effect of self-instructions in the treatment of patients with Chronic Fatigue Syndrome type Idiopathic Chronic Fatigue (CFS-ICF) : a randomised controlled study.

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 from 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.
The two objectives of this study are 1) to evaluate the efficacy of the minimal intervention for CFS-ICF patients and 2) to find out for which CFS-ICF patients the minimal intervention is a suitable form of treatment. This is a randomised controlled trial in which the minimal intervention condition is compared with a waiting list condition. Patients are included if they 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 impairments (SIP).

There a two research questions:

1. What is the effect of a minimal intervention for CFS-ICF patients with regard to level of fatigue and disabilities compared to a waiting list condition?
2. What are the characteristics of CFS-ICF patients who do improve by a minimal intervention?

1. T1: after a baseline assessment patients are randomly assigned to the intervention- or waiting list condition;

2. T2: after 6 months, second assessment will take place in both conditions;

3. T3: after 12 months (6 months after T2), post treatment for the patients in the waiting list condition will take place.

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 the minimal intervention. This intervention consists of a self help booklet with exercises, supported by email contact with a therapist. The patient is asked to send an 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 condition 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 will take place (T3).