| Methods |
Multicentre, RCT |
| Participants |
Fulfilling operationalised criteria for ICF and for CFS
Patients visiting their physician with a main complaint of unexplained fatigue of at least 6 months' duration are recruited for the study
Inclusion criteria: meeting the operationalised criteria for ICF or CFS (CDC criteria); aged 18‐65 years; fluent in spoken Portuguese; capacity to provide informed consent
Exclusion criteria: presence of a concurrent somatic condition that can explain the fatigue symptoms; severe psychiatric disorders |
| Interventions |
SC or SC plus a self‐regulation‐based physical activity programme (4‐STEPS)
In addition to SC, participants in the intervention group received the 4‐STEPS programme consisting of the following.
2 face‐to‐face individual MI sessions aimed at exploring important health and life goals, increasing participants' motivation and confidence to be physically active and setting a specific personal physical activity goal. The first MI session takes place 1 week after the baseline assessment, and the second MI session takes place 2 weeks after the first. The MI session is delivered by a psychologist with MI training (member of the research team). The duration of the sessions is approximately 1 h. Details on topics addressed during the MI sessions are presented in Table 1 2 brief telephone counselling sessions: sessions take about 20 min and are provided 2 weeks and 6 weeks after the last MI session. Self‐regulation booklets: 2 booklets were designed to help participants change their level of physical activity (informational booklet and workbook). The informational booklet was provided at the end of the baseline assessment; the 'Step 1' part of the workbook is provided at the first MI session, and parts 'Step 2,' 'Step 3' and 'Step 4' are given during the second MI session. A pedometer to register physical activity on a daily basis (steps taken) during the 3‐month intervention period. Instructions on how to use the pedometer are given during the baseline assessment session Daily activities record: participants received several daily activity records (physical activities, mental activities and rest). The first daily activity record was given to the participant at the end of the first MI session; participants were asked to fill out the activity record during the time between the first and second MI sessions. This homework assignment aimed to evaluate participants' daily activities management while possibly recognising an erratic pattern of rest and activity (boom and bust cycle). At the end of the second MI session, participants received daily activities records that could be used to monitor changes in daily activity patterns during the subsequent 9 weeks Leaflet for family: at the end of the first MI session, participants receive a leaflet for their partner or significant other to increase social support
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| Outcomes |
Primary outcome: reduction in perceived fatigue severity, assessed using the Checklist of Individual Strength (CIS‐20R). A difference of 7 points between intervention and control groups for the main dimension (the subjective feeling of fatigue subscale) of the CIS‐20R was considered to be clinically significant |
| Notes |
ISRCTN: ISRCTN70763996
Copied from the published protocol: www.biomedcentral.com/1471‐2458/12/202 |
