Effectiveness of Stepped Care for Chronic Fatigue Syndrome: A Randomized Noninferiority Trial Marcia Tummers, Hans Knoop, and Gijs Bleijenberg Radboud University Nijmegen Medical Centre Objective: In this randomized noninferiority study, the effectiveness and efficiency of stepped care for chronic fatigue syndrome (CFS) was compared to care as usual. Stepped care was formed by guided self-instruction, followed by cognitive behavior therapy (CBT) if the patient desired it. Care as usual encompassed CBT after a waiting period. Method: A total of 171 CFS patients were randomly allocated to stepped care or care as usual. Patients in both conditions were assessed 3 times: at baseline, after guided self-instruction or the waiting period, and after CBT. The primary outcome variables were fatigue severity (Checklist Individual Strength) and disabilities (Sickness Impact Profile and Medical Outcomes Survey Short Form–36). Results: An intention to treat analysis showed that stepped care (N  84) for CFS is noninferior to care as usual (N  85). Both conditions were equivalent in reducing fatigue severity, reducing disabilities, and increasing physical functioning. The treatment results of both conditions were in accordance with those of previous randomized controlled trials testing the effective- ness of CBT for CFS. The total therapist time needed to treat a patient was significantly less in the stepped care condition. Conclusions: Stepped care is as effective as CBT and is more time efficient for the therapist. Keywords: chronic fatigue syndrome, cognitive behavior therapy, stepped care Chronic fatigue syndrome (CFS) is characterized by severe fatigue that lasts longer than 6 months and leads to functional impairments. It is not the result of an organic disease or ongoing exertion and is not alleviated by rest (Fukuda et al., 1994). Besides severe fatigue and considerable functional impairments, most pa- tients report additional symptoms. According to the CFS criteria of the U.S. Centers for Disease Control (Fukuda et al., 1994), a patient must report four out of eight additional symptoms: unre- freshing sleep, postexertional malaise, headache, muscle pain, multi-joint pain, sore throat, tender lymph nodes, and concentra- tion and memory impairment. Cognitive behavior therapy (CBT) is an evidence-based treat- ment for CFS (Chambers, Bagnall, Hempel, & Forbes, 2006). Two recent meta-analyses showed that CBT for CFS leads to a reduc- tion in fatigue and disabilities (Malouff, Thorsteinsson, Rooke, Bhullar, & Schutte, 2008; Price, Mitchell, Tidy, & Hunot, 2008). The natural course of CFS without treatment is unfavorable; only 5% of the patients recover spontaneously (Cairns & Hotopf, 2005). CBT is not only superior to no intervention but is also more effective than guided support groups or relaxation training (Deale, Chalder, Marks, & Wessely, 1997; Prins et al., 2001). CBT is directed at changing fatigue-related cognitions and be- haviors that perpetuate fatigue at least to a significant degree. The treatment is aimed at decreasing the focus on bodily symptoms, increasing self-efficacy with respect to fatigue, changing the way patients communicate about CFS, regulating and/or increasing physical activity, and changing their attitude when dealing with the way others react to their symptoms. Recent research has shown that CBT is not only effective in randomized controlled trials (RCTs) conducted in tertiary university hospitals but also can be successfully implemented in a representative clinical practice set- ting (Scheeres, Wensing, Knoop, & Bleijenberg, 2008). However, wider implementation is hampered by the fact that CBT for CFS is an intensive treatment that requires 13 to 16 sessions, depending on the protocol used (Prins et al., 2001; Quarmby, Rimes, Deale, Wessely, & Chalder, 2007; Sharpe et al., 1996). Licensed cogni- tive behavior therapists need additional training and supervision to learn to treat CFS. In addition, the treatment capacity in the Netherlands is lacking (Gezondheidsraad, 2005). It is probable that not all patients need such an intensive treat- ment as CBT, which would make it possible to develop a form of stepped care. In stepped care, more intensive treatments are re- served for patients who do not benefit from simpler low-intensity treatments or for those who can be predicted not to benefit from such treatments (Newman, 2000). In the literature, it has already been proven that stepped care is effective for psychological inter- ventions (van’t Veer-Tazelaar et al., 2009). It has also been shown that for patients with chronic fatigue, a self-help booklet with support from a nurse is more effective than no treatment (Chalder, Wallace, & Wessely, 1997); a minimal intervention for patients with CFS, consisting of psychoeducation and a graded activity program, decreased the levels of fatigue and disabilities compared Marcia Tummers, Hans Knoop, and Gijs Bleijenberg, Expert Centre for Chronic Fatigue, Radboud University Nijmegen Medical Centre, Nijme- gen, the Netherlands. We would like to thank Rogier Donders for advising and helping us to handle the missing data observations and analysis. Correspondence concerning this article should be addressed to Marcia Tummers, Radboud University Nijmegen Medical Centre, Expert Centre for Chronic Fatigue, 4628, P.O. Box 9101, 6500 HB Nijmegen, The Netherlands. E-mail: m.tummers@nkcv.umcn.nl Journal of Consulting and Clinical Psychology © 2010 American Psychological Association 2010, Vol. 78, No. 5, 724 –731 0022-006X/10/$12.00 DOI: 10.1037/a0020052 724 This document is copyrighted by the American Psychological Association or one of its allied publishers. This article is intended solely for the personal use of the individual user and is not to be disseminated broadly.