Marques 2012

Trial name or title	Protocol for the "four steps to control your fatigue (4‐STEPS)" randomised controlled trial: a self‐regulation based physical activity intervention for patients with unexplained chronic fatigue
Methods	Multi‐centre, randomised controlled trial (RCT)
Participants	Fulfilling operationalised criteria for idiopathic chronic fatigue (ICF) and for chronic fatigue syndrome (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); between 18 and 65 years of age; 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	Standard care (SC) or standard care plus a self‐regulation based physical activity programme (4‐STEPS) In addition to standard care, participants in the intervention group received the 4‐STEPS programme consisting of the following. 2 face‐to‐face individual motivational interviewing (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 hour. Details on topics addressed during the MI sessions are presented in Table 1 2 brief telephone counselling sessions: Sessions take about 20 minutes and are provided 2 weeks and 6 weeks after the last MI session. Details on topics addressed during the telephone sessions are presented in Table 1 Self‐regulation (SR) booklets: 2 booklets were designed to help patients 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. Details on topics addressed in the SR booklets are presented in Table 2 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 (Table 2) Daily activities record (Table 2): 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 received a leaflet for their partner or significant other to increase social support
Outcomes	The primary outcome was the reduction in perceived fatigue severity, which was assessed by 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
Starting date	The 4‐STEPS RCT started in January 2011
Contact information	Marta Marques: mmarques@ispa.pt
Notes	ISRCTN: ISRCTN70763996 Copied from the published protocol: http://www.biomedcentral.com/1471‐2458/12/202