Journal of Consulting and Clinical Psychology Vol. 76, #1, pp 163-171 Januari 2008 URL: http://content.apa.org/journals/ccp http://content.apa.org/journals/ccp/76/1/163.html Implementing Cognitive Behavioral Therapy for Chronic Fatigue Syndrome in a Mental Health Center: A Benchmarking Evaluation --------------------------------------------------------------------------- Korine Scheeres, Michel Wensing, Hans Knoop, and Gijs Bleijenberg Radboud University Nijmegen Medical Centre - Korine Scheeres, Hans Knoop, and Gijs Bleijenberg, Expert Centre Chronic Fatigue, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands; - Michel Wensing, Centre for Quality of Care Research, Radboud University Nijmegen Medical Centre. - Correspondence concerning this article should be addressed to Korine Scheeres, Expert Centre Chronic Fatigue, Radboud University Nijmegen Medical Centre (4628), P.O. Box 9101, 6500 HB Nijmegen, the Netherlands. E-mail: k.scheeres@nkcv.umcn.nl Received March 21, 2007 Revision received September 19, 2007 Accepted October 26, 2007 Objective: This study evaluated the success of implementing cognitive behavioral therapy (CBT) for chronic fatigue syndrome (CFS) in a representative clinical practice setting and compared the patient outcomes with those of previously published randomized controlled trials (RCTs) of CBT for CFS. > Method: The implementation interventions were the following: spreading > information about the new treatment setting to general practitioners and > CFS > patients; training mental health center (MHC) therapists in CBT for CFS; > and > organizing changes in the MHC patient workflow. Patient outcomes were > documented with validated self-report measures of fatigue and physical > functioning before and after treatment. The comparison of the treatment > results with RCT results was done following the benchmark strategy. > > Results: One-hundred forty-three CFS patients were referred to the MHC, of > whom 112 started treatment. The implementation was largely successful, but > a > weak point was the fact that 32% of all referred patients dropped out > shortly > after or even before starting treatment. Treatment effect sizes were in > the > range of those found in the benchmark studies. > > Conclusions: CBT for CFS can successfully be implemented in an MHC. > Treatment > results were acceptable, but the relatively large early dropout of > patients > needs attention. > > Keywords: chronic fatigue syndrome, cognitive behavioral therapy, > benchmark > strategy, implementation, transportability of treatment manual > > > Chronic fatigue syndrome (CFS) is characterized by severe and unexplained > fatigue that lasts for at least 6 months (Fukuda et al., 1994). It results > in > a strong reduction in physical and mental functioning (Bombardier & > Buchwald, > 1996; Jason et al., 2000). Systematic reviews have shown that cognitive > behavioral therapy (CBT) and graded exercise therapy (GET) are currently > the > only evidence-based treatments for CFS (Afari & Buchwald, 2003; Chambers, > Bagnall, Hempel, & Forbes, 2006; Whiting et al., 2001) with improvement > rates of around 70% and 55%, respectively. CBT for CFS is only scarcely > available in some specialist medical hospitals, hence many CFS patients > have > no access to it or can only start treatment after a waiting time of > several > years (Cairns & Hotopf, 2005). Therefore, as a step toward nationwide > implementation, a pilot implementation and evaluation project was set up > that > took place in an outpatient mental health center (MHC). The present > article > focuses on the success of this implementation and on treatment outcomes in > patients. > > It has been demonstrated that, after training, CBT for CFS can effectively > be > performed by therapists who are inexperienced with CFS (Bazelmans, Prins, > Hoogveld, & Bleijenberg, 2004; Prins et al., 2001). The transportability > of > randomized controlled trial (RCT) results to clinical practice settings, > however, has scarcely been studied as yet. So far only one study evaluated > whether CBT for CFS can be delivered with the same effectiveness outside > the > RCT context (Quarmby, Rimes, Deale, Wessely, & Chalder, 2006), but this > study > was done in a CFS specialist clinic that had previously participated in a > clinical trial of CBT for CFS. > > Since rigorous evaluations such as RCTs always imply controlled > conditions, > it is unclear to what extent their positive effects can be generalized to > clinical practice (Rothwell, 1995; Weersing, 2005; Whiting et al., 2001). > Treatment effects may be more modest outside RCTs because of lower > criteria > for including patients and absence of direct access to CFS experts > (Weersing, > 2005; Wilson, 1995). This study therefore evaluated the treatment results > of > CBT for CFS in a clinical practice setting in comparison with previous RCT > results. > > When performing a benchmark study, it is important that the treatment > location that is being compared with an RCT condition represents a real > practice setting. Shadish, Navarro, Matt, and Phillips (2000) have > formulated > 10 clinical representativeness codes that can be checked to see to what > degree a certain setting is clinically representative. These codes concern > issues like the kind and heterogeneity of the patient problems, the > referral > route, or the connection with a research institute. In the present study, > an > MHC was chosen as clinical practice setting because it has the right > facilities and sufficient CBT therapists to perform the 16-session CBT for > CFS treatments, and at the same time it fulfils most of the Shadish > criteria > for clinical representativeness. > > Secondly, the present study aimed to evaluate the success of the > implementation itself and to assess the problems that arose during the > implementation process. On the basis of explorations of possible barriers, > the following implementation interventions were applied to create the > basic > conditions for successful implementation. Firstly, general practitioners > (GPs) were informed of the study because none of the GPs in the regions > concerned were familiar with the availability of CBT for CFS in the MHC. > Secondly, CFS patients themselves were informed. Since not all CFS > patients > are still visiting their GP after several years of illness, informing them > directly might increase the number of CFS patients entering the MHC. The > third intervention implied selecting and training behavioral therapists in > CBT for CFS and making arrangements with them about the treatment > procedures. > Fourth and finally, many employees of the MHC who might have been in > contact > with CFS patients were informed to pay attention to and cooperate with the > CFS implementation project. The process evaluation aimed to assess the > impact > of these implementation interventions on the delivery of CBT to CFS > patients > and to analyze the problems that might occur during such an implementation > process. > > > Method > > Study Design > > This study is a clinical evaluation of implementing CBT for CFS and a > comparison of the clinical MHC treatment results with relevant RCTs, using > the so-called benchmark strategy (Wade, Treat, & Stuart, 1998; Weersing, > 2005). > > > Treatment Setting > > The MHC was a regional mid-sized institution located in the east of the > Netherlands, covering mostly rural and some urbanized areas. It had > locations > in four separate subregions; the CBT for CFS treatment was offered at two > of > them. This MHC was the main provider of mental health care in this area, > offering services for the full range of problems and patients, both > outpatient > and inpatient. > > > Patients and Procedures > > Inclusion criteria for referral to the MHC were as follows: All patients > had > to be referred by a GP or another physician, had to be diagnosed by this > doctor as having CFS based on the Centers for Disease Control­94 (CDC-94) > criteria (Fukuda et al., 1994), should be 18 years or older, and should > not > be engaged in a claim for disability-related benefits. This last criterion > was an exclusion criterion since this is known to be a predictor for a > negative treatment outcome (Prins, Bazelmans, van der Werf, van der Meer, > & > Bleijenberg, 2002). Patients were classified as CFS and included in this > study if they scored at least 27 (which is the point of 1 SD above the > mean > score of healthy individuals) on the Fatigue Severity subscale of the > Checklist Individual Strength (CIS-20; Vercoulen, Alberts, & Bleijenberg, > 1999) and <70 on the Physical Functioning or Social Functioning subscales > of > the Rand-36 (Steward, Hays, & Ware, 1998). The patient inclusion period > was 6 > months shorter (namely 20 months) than was the implementation and > evaluation > period (26 months), so all included patients could finish their treatment > in > time. > > > Implementation Interventions > > Informing GPs and CFS patients. > Information letters and brochures were distributed repeatedly to all GPs > in > the surrounding regions, namely four times with time intervals of about 4 > months. Additionally, some small group education sessions about CFS were > organized, and announcements about the new treatment setting were made in > local newspapers. The focus was on informing GPs about the treatment > possibility, educating them about the diagnostic criteria for CFS, and > also > encouraging them to refer CFS patients. To inform CFS patients, brochures > were spread among libraries, pharmacies, and so on, and advertisements > were > placed in local newspapers. > > Training therapists. > Nine behavioral therapists, three men and six women, took part. They were > selected on the basis of their prior education in CBT and on their > willingness and availability to participate 1 day per week for at least 2 > years in this project. None of the therapists had previous experience with > CFS. Their number of years working as a behavioral therapist varied from 2 > to 13 years. At the start of the project, two experts in CBT trained the > therapists for CFS during two blocks of 2 days each. Additionally, the > therapists were supervised every 2 weeks for 2 years. > > Informing and instructing MHC employees. > Employees directly involved in the project, like some secretaries and > diagnostic assistants, were settled into the procedures and were asked to > cooperate in the development of the patient flow design. Less involved > employees were informed about the project and were instructed on whom to > contact when dealing with a CFS patient. > > > Treatment Protocol > > The CBT for CFS treatment protocol has been described in a manual for > therapists (Bazelmans, Prins, & Bleijenberg, 2006; Bleijenberg, Prins, & > Bazelmans, 2003). It prescribes 16 one-hour sessions over a period of 6 to > 8 > months. In the treatment, first the model of perpetuating factors is > explained and the therapist attempts to motivate the patient for CBT. > Next, > fatigue-related cognitions are challenged to diminish somatic > attributions, > to improve sense of control over symptoms, and to facilitate behavioral > change. At the same time, a structured physical activity program starts. > After regulating and gradually increasing physical activity, a work > rehabilitation plan is developed. Patients without gainful employment work > on > rehabilitation in other personal goals. From the start, patients define > their > own criteria for recovery and formulate personal therapy aims. The final > sessions deal with relapse prevention and further improvement of > self-control. > > > Measurement > > Treatment outcomes. > Treatment results were measured with validated measures for fatigue > severity > and physical functioning. Severe fatigue was measured with the Fatigue > Severity subscale of the CIS-20 (Vercoulen et al., 1997, 1999), which has > high reli- ability (Cronbach's alpha=.92) and good discriminant validity > and > is also used in two of the four benchmark RCTs (Prins et al., 2001; > Stulemeijer, de Jong, Fiselier, Hoogveld, & Bleijenberg, 2005). Physical > functioning in daily life was measured with the Physical Functioning > subscale > of the Rand-36 (Steward et al., 1998). > > Impact of the implementation interventions. > To determine the impact of the implementation, positive impact was > operationalized with five separate criteria that were formulated in > cooperation with the MHC project group members. These criteria were the > following: (a) Sufficient GPs (>=50%) are informed about the new treatment > setting for CFS; (b) the majority of CFS patients (>=50%) accept their > GP's > referral to the MHC; (c) sufficient CFS patients (>-150) are referred > during > the project; (d) a limited number of these referred patients (=<15%) are > falsely diagnosed as having CFS; (e) a limited number of referred patients > (=<30%) drop out of CBT. The number of 150 referred patients in the third > criterion was based on the calculation of the number of CFS patients > living > in the implementation region, assuming a prevalence of 180 adult CFS > patients > per 100,000 and an incidence of 60 per 100,000 per year (Afari & Buchwald, > 2003; Bazelmans et al., 1999). > > The measurements related to these criteria were completed as follows: (a) > One > year after starting the project, a short questionnaire was distributed > among > all GPs in the regions concerned, which investigated how many GPs were > informed about the new treatment setting and about how to diagnose CFS > (Scheeres, Wens- ing, & Bleijenberg, 2007); (b) on this questionnaire, GPs > were also asked to fill in the number of their CFS patients that did not > accept their referral to the MHC; (c) the number of CFS patients referred > to > the MHC was registered each week; (d) after the intake session, the > patient > filled in a questionnaire on the main complaints and criteria for CFS; and > (e) the number of patients that showed up at intake, did not show up at > intake, started treatment, did not start treatment, and that dropped out > during treatment were also registered each week, and dates of these events > were included. > > No show patients were patients who were referred to and registered at the > MHC > but who did not show up at intake. Not starting patients decided not to > start > treatment directly after the intake. Dropout patients were those who ended > treatment after at least 1 and maximum 11 treatment sessions. Completers > decided to stop treatment after 11 or more treatment sessions or finished > the > whole treatment. In cases of not starting and dropout, both patient and > therapist were asked to fill in a form about the reason for it. > Additionally, a structured telephone interview was held with 30 no show > and > not starting patients to further investigate these reasons. > > Problems during the implementation process. > These were measured and registered by a monthly diary that was kept by the > researcher and discussed with the project group every month. This diary > contained aspects like the weekly registration of the numbers of referred > and > treated patients, the mean waiting time between referral and intake, the > experiences of therapists and other people concerned with the project, and > unforeseen problems like trained therapists quitting the project or > organizational changes influencing the implementation process. > > > Analysis > > Treatment results. > The recovery rate was analyzed by calculating the percentage of patients > clinically significantly improved. Patients were defined as clinically > significantly improved at post-treatment if they had a reliable change > index >>1.96 on the CIS-20 Fatigue Severity subscale, a Fatigue Severity score >>=<35, > and a Rand-36 Physical Functioning score >=65 (Vercoulen et al., 1999). > For > missing data, the method of last observation carried forward was used, > indicating that intake measurements were used at post-treatment. > > Selection of the benchmark RCTs. > In the most recent systematic reviews concerning treatment for CFS (Afari > & > Buchwald, 2003; Chambers et al., 2006; Whiting et al., 2001), seven RCTs > investigating the effect of CBT for CFS have been included (Deale, > Chalder, > Marks, & Wessely, 1997; Lloyd et al., 1993; Prins et al., 2001; Ridsdale > et > al., 2001; Sharpe et al., 1996; Stulemeijer et al., 2005; Whitehead & > Campion, 2002). In this study, four of these RCTs (Deale et al., 1997; > Prins > et al., 2001; Sharpe et al., 1996; Stulemeijer et al., 2005) were included > to > create the benchmark. Our decisive criterion for including trials, in > addition to methodological criteria that the reviews already adjusted, was > homogeneity of the treatment manual (Streiner, 1991). In the RCTs of > Ridsdale > et al. (2001) and Lloyd et al. (1993), the therapy protocol counted only > six > to eight sessions in 6 to 12 weeks. This is about half as much as in the > other trials, which may partly explain why little effect was found. In the > RCT of Whitehead and Campion (2002), treatments were performed by GPs > instead > of behavioral therapists. Table 1 gives the characteristics of the trials > included in this study. > > Creation of the statistical benchmark and comparison of the treatment > effects. > Three of the four benchmark RCTs consisted of one intervention condition > tested against a control condition; one also had a support group condition > (Prins et al., 2001). For the purpose of this study, only the outcome data > of > the CBT conditions were used (since the implementation study also included > only a treatment group) to compose a benchmark indexing the mean change of > CBT under RCT conditions. The primary outcome measurements used in the > benchmark RCTs are shown in Table 1. Since the different outcome > measurements > could not be compared directly, uncontrolled effect sizes of all studies > were > calculated to standardize the treatment effects (Streiner, 1991). > Uncontrolled effect sizes obviously may inflate the effects of therapy as > compared with conventional controlled effect sizes, since they do not > control > for spontaneous recovery. However, for the purpose of just comparing > different study results, it provides a useful measure. The calculation of > the > composite benchmark thus involved two steps: First, uncontrolled pre-post > effect sizes were calculated as (M Start - M End)/SD Start (Cohen, 1988; > Westbrook & Kirk, 2004). Second, an average effect size was calculated, > taking into account the size of the patient group in the different trials > (Rosenthal & Rubin, 1982). When outcomes were reported at multiple time > points (e.g., post-treatment and follow-up), we coded the effect size > closest > to the time interval of the other studies, which was about 6 months. The > MHC's effect sizes for fatigue severity and physical functioning were > calculated by using the same formula (Westbrook & Kirk, 2004) and on the > basis of intention to treat, as was done in the RCTs. > > > Results > > Treatment Results > > Sample characteristics. > Table 2 provides the sample characteristics of the implementation study > and > the four benchmark studies. Of the 143 patients being referred to the MHC, > 18 > did not show up at intake and 13 appeared not to fulfill the criteria for > CFS > (Table 5). In 4 cases, the fatigue and/or impairments were not severe > enough, > 3 patients yet had a possible somatic explanation for their fatigue (2 for > obesity [BMI>40] and 1 for recently detected diabetes), 3 suffered > primarily > from depression, 1 was primarily addicted to alcohol, 1 had primarily pain > complaints, and in 2 cases the reason for rejecting the CFS diagnosis was > not > registered. The mean pretreatment score on CIS-20 Fatigue Severity was > 48.7 > (SD=7.1), on Rand-36 Physical Functioning 53.5 (SD=23.2), and on Rand-36 > Social Functioning 39.1 (SD 22.9). The mean total score on the Symptom > Checklist-90 (Arrindel & Etteme, 1986) was 162.4 (SD=39.1), and on the > Beck > Depression Inventory--Primary Care (Beck, Steer, & Garbon, 1988) 33 > patients > (30%) were indicated as having comorbid depressive disorder. Pain > medication > was used by 97 patients (87%) and antidepressants by 21 patients (19%). > Overall, patients attributed their fatigue more to physical than to > psychological causes. > > A remarkable difference did exist in CFS illness duration, which was > longer > in the MHC sample. Age, gender, and marital status were not statistically > different, except for the study of CBT for CFS in adolescents (Stulemeijer > et > al., 2005), of course. No significant differences were found on any > demographic characteristics or pretreatment illness scores between > patients > who did not start or did not finish CBT or who finished the treatment. > > MHC treatment results. > The mean number of treatment sessions of all 84 patients starting > treatment > was 14.5 (SD=5.6), varying from 3 to 31 treatment sessions. Table 3 shows > the > mean scores of Fatigue Severity and Physical Functioning at intake and > follow-up. Table 3 also shows the percentage of patients clinically > significantly improved after treatment at the MHC. > > Comparison of treatment effects. > The noncontrolled effect sizes of the implementation study and the > benchmark > studies are given in Table 4 and in Figures 1 and 2. The mean pre-post > treatment effect size of the four benchmark studies for fatigue was {1.02 > (Sharpe et al., 1996) + 2.05 (Deale et al., 1997) [3 x 1.25 (Prins et al., > 2001)] + 1.83 (Stulemeijer et al., 2005)}/6 =1.44 (95% confidence interval > [CI]=0.97, 1.89). This is somewhat higher than the effect size of fatigue > in > the MHC, which was 1.12 (95% CI = 0.85, 1.38). For physical functioning, > the > mean pre-post treatment effect size of the benchmark studies was {1.93 > (Deale > et al., 1997) + [3 x 0.71 (Prins et al., 2001)] 1.19 (Stulemeijer et al., > 2005)}/5=1.04 (95% CI=0.63, 1.44). This is again somewhat higher than the > effect size at the MHC for physical functioning, which was 0.64 (95% > CI=0.38, > 0.89). > > > Impact of the Implementation > > Table 5 provides the results on the research questions that defined the > overall impact of the implementation. It reveals that three of the five > subquestions (1, 2, and 5) got positive results and two (3 and 4) got > results > that did not meet the criteria for positive impact, the high percentage of > patients not starting and not finishing treatment being the most > problematic. > As can be seen in Table 6, of the 112 patients eligible for CBT, only 72 > finished treatment. In an additional analysis, we checked what > characteristics not starting patients and dropout patients had that were > different from completers. The results showed no differences between these > groups. > > Reasons for no show, not starting, and dropout. > The main reason for no show and not starting treatment, reported by 8 > patients, was having found another doctor or (alternative) therapist. > Seven > patients thought they had a medical reason for their fatigue and hence > thought they would not profit from psychological treatment. Another 7 > patients were of the opinion that the treatment did not suit them, mainly > because it would be too heavy. The other 8 patients had practical reasons. > The main reasons for dropout were the opinion that CBT was not the right > treatment for CFS (4 patients), experiencing too much pain or other > complaints during treatment (4 patients), and feeling sufficiently > recovered > after some sessions already (3 patients). > > > Problems During the Implementation Process > > Loss of trained therapists. > Within 1 year, four therapists dropped out of the project for several > reasons. Twice, an extra training had to be organized, and new therapists > had > to be found. Since this took several months, this loss of expertise led to > delays in the patient flow. > > Long waiting list. > During the 1st year, the waiting times before intake were increasing, and > during the 2nd year, they stayed on this level. The mean waiting time > before > intake was 7.3 weeks. Waiting time was significantly higher for not > starting > patients than for starting patients (M=9.5 weeks, SD=5.6; and M=6.8 weeks, > SD=5.1, respectively; t test p=.02). > > Limited use of the time reserved for CFS patients. > Therapists appeared not to use all the time reserved for CFS treatments. > The > problem was that beforehand it was said 1 day per therapist was reserved > for > CFS, in which they should be able to see 6 to 7 patients, but in practice > they saw only 3 to 6 patients per week. What we did not find out is > whether > this was because of inefficient use of time or just because of seeing more > of > the "usual" non-CFS patients at the expense of CFS. > > Long treatment duration. > Therapists appeared to have difficulties with ending a CFS treatment > within > the prescribed 16 sessions, which also hindered the patient flow. We had > not > expected that deviations in number of sessions would turn out to be so > large. > Generally in RCTs, and also in the present benchmark RCTs, this issue does > not become a problem. > > Extra analyses were performed to gain more insight into this problem. It > turned out that especially among beginning therapists some treatments were > long, up to a maximum of 31 sessions. None of the therapists with > experience > in CBT for CFS, having finished 5 or more treatments, used more than 19 > sessions for a treatment. Analyses on predictors of treatment success did > not > reveal any relations except for pretreatment fatigue severity. Neither > treatment duration nor number of sessions correlated with treatment > effect. > > > Discussion > > The treatment results of CBT for CFS in an MHC compared quite favorably > with > those of the benchmark RCTs. The effect on fatigue severity at the MHC was > comparable with that of previous RCT results, while the effect on physical > functioning was somewhat smaller at the MHC. Overall, apart from the high > levels of not starting and dropout patients, the impact of the > implementation > of CBT for CFS could be called successful. > > Because of the flexible prerequisites for client inclusion, the treatment > results are in fact quite remarkable. No strict minimum fatigue or > physical > impairment scores were required for participation, hence these complaints, > especially on physical functioning, were initially somewhat mild compared > with those in RCTs, providing a conservative test of pre-post comparisons. > Also, if the MHC will manage to reduce the numbers of not starting patents > in > future, the treatment effects might even increase. > > The most worrying aspect of the implementation was the relatively high > number > of patients not showing up at intake and deciding not to start treatment > after the intake (together more than 32% of all referrals). In the > benchmark > RCTs, the number of patients refusing to start CBT was generally much > lower. > Namely, 2 of 62 (3%) refused RCT participation and 0 of 30 refused CBT > after > randomization in Sharpe et al. (1996), and 7 of 67 (10%) refused RCT > participation and 0 of 30 refused CBT after randomization in Deale et al. > (1997). The study of Stulemeijer et al. (2005) did not report any > refusals. > Only Prins et al. (2001) had relatively higher refusal rates, namely 99 of > 476 (21%) refusals to participate in the RCT and 10 of 92 (11%) refusals > for > CBT after randomization. Probably, Sharpe et al.'s and Deale et al.'s > studies > had lower refusal rates because they offered therapy from experienced > "expert" therapists, which was not the case in the trial of Prins et al. > (2001) or in the present implementation study. One explanation might be > that > apparent experience of the therapist stimulates patients to start with > CBT. > However, the higher refusal rate after intake in the present study (25%) > in > comparison with the rate after randomization (11%) in the study of Prins > et > al. (2001) cannot be explained by a difference in therapist expertise. In > the > MHC, patients could have been motivated better during the intake session. > The > most reported reasons for not starting treatment were "I think this > treatment > does not fit me" and "I think there is a medical reason for my fatigue." > With > the right and well-timed information about the treatment, at least part of > those patients could presumably have been convinced to at least try the > treatment with CBT. Looking back, we conclude that motivating CFS patients > during the first contacts got too little attention in training and > supervision. MHC therapists are not accustomed to motivating patients for > psychological treatment. We recommend paying attention to this point, in > training as well as in supervision, in future implementation projects. > > In the present MHC benchmark study, a clear connection could be seen > between > waiting time and the high rate of "lost" patients. The loss of trained > therapists and the shortcoming of the MHC to quickly find new ones, the > limited use by therapists of their time reserved for CFS patients, and the > long duration of treatments were all partly responsible for the > increasingly > long waiting times. > > These long waiting times for their turn appeared to facilitate patients to > quit; they gave the patients reason and opportunity to look further for > other > treatments. Future implementation projects of CBT for CFS should therefore > take care to minimize the waiting times. > > Regarding the selection of benchmark studies, the question may arise > whether > including the Stulemeijer study (2005) was sensible, since it is a study > of > adolescents. Our reason to include it was that Stulemeijer et al.'s study > used the same and most recent version of the Dutch protocol (Bazelmans et > al., 2006), also used in this implementation study. Yet, an adolescent > study > population of course has a lower age and shorter illness duration than > adult > populations do, which probably makes it incorrect to compare these > studies. > However, it has been demonstrated before that neither age nor illness > duration influences effects of CBT for CFS (Deale et al., 1997). > > Concerning the MHC population characteristics, only illness duration was > different, namely longer, compared with illness duration in the three > benchmark RCTs of adults. This is quite remarkable; one might just expect > that specialized hospital settings attract patients with a severe, > complex, > and longer duration of fatigue. Possibly there was a "reservoir" of CFS > patients with long illness duration in the MHC region that could have > developed during the many years that no effective treatment was available. > Since this reservoir might now have dwindled, CFS patients being referred > today and in the coming years probably will have shorter illness duration. > > The present study fulfills most of the Shadish et al. (2000) criteria for > clinical representativeness. Two criteria were not met, namely the > monitoring > and the therapist pretherapy training criteria. However, training > therapists > inexperienced with CFS is quite common and also endorsed by us because > treating a somatic complaint with CBT is new for most therapists working > in > an MHC. The monitoring mainly included supervising therapists, which is > like > pretherapy training, is quite useful, and always accompanies a training of > CBT for CFS. Only the monitoring aspects like measuring treatment results, > registering the reasons for dropout, and reporting problems during the > implementation process contradicted full clinical representativeness. > Overall, though, from our point of view the MHC setting is clearly > clinically > representative. This means that this study demonstrated that CBT for CFS > is > also effective after implementing it in the clinical practice of an MHC. > > The results of the present study contradict the results of Quarmby et > al.'s > (2006), who found a discrepancy in treatment effect between their RCT and > clinical results. However, those effect differences might be explained by > the > fact that their RCT was extremely effective, which was the result of > including only one specialized therapist who was very experienced with > CFS. > > The question arises whether the treatment results will also remain > sufficient > in the long term. Given the rather high turnover of therapists and other > related persons, the treatment program might lose some of its strengths > and > effectiveness. Secondly, during this project the MHC knew an external > researcher would evaluate it. In fact, this makes the study less > representative for clinical practice, although this is not a criterion > that > Shadish et al. (2000) defined. It might be interesting to perform a longer > lasting but much less confrontational and less visible study to > investigate > the "lifetime" and development of a CBT for CFS implementation project > after > the 1st years of the research period have passed. > > To conclude, the results of this study suggest that implementing CBT for > CFS > in an MHC can be successful and that treatment results were comparable > with > RCT results. The positive outcome should facilitate the decision for > healthcare providers to adopt CBT for CFS in their institution so that > more > CFS patients can recover after years of illness. > > > Tables > > Table 1. Comparison of Study Characteristics of an Implementation Study > and Benchmark Randomized Controlled Trials > --------------------------------------------------------------------------------------------------------------------------------------- > Characteristic Implementation Sharpe et al. > Deale et al. Prins et al. Stulemeijer et al. > study (1996) > (1997) (2001) (2005) > --------------------------------------------------------------------------------------------------------------------------------------- > Treatment protocol > No. of performed 18 16 13 > 16 10 > sessions > Duration 6 to 8 months 5 months 4 > to 6 months 6 to 8 months 5 months > Therapists 9 nonexperienced 3 experienced 1 > experienced 13 nonexperienced 2 experienced > therapists therapists > therapist therapist therapists > Sample size > No. of patients 112 30 30 > 92 36 > Not starting 28 0 0 > 10 4 > Dropout 12 0 3 > 23 3 > Inclusion criteria CDC criteria for CFS Oxford criteria for > CDC criteria for CFS CDC criteria for CFS CDC criteria for CFS > CFS > Assessment scales > Fatigue Severity CIS-20 (8-56) Likert scale (0-10) > Chalder et al. CIS-20 (8-56) CIS-20 (8-56) > > (1993) fatigue > > scale (0-11) > Inclusion cutoff>27 No inclusion cutoff > Inclusion cutoff>=40 Inclusion cutoff>40 Inclusion cutoff>40 > Physical SF-36 (0-100) Karnofski (0-100; > SF-36 (0-100) SIP (0-5799) SF-36 (0-100) > Functioning Grieco & Long, 1984) > Inclusion cutoff <70 Inclusion cutoff<80 > Inclusion cutoff<83 Inclusion cutoff>800 Inclusion cutoff<65 > on either physical or > social functioning > --------------------------------------------------------------------------------------------------------------------------------------- > Note. CDC = Centers for Disease Control; CFS = chronic fatigue syndrome; > CIS-20 = Checklist Individual Strength; SF-36 = Short Form > (Physical Functioning Scale) of the Rand-36; SIP = Sickness Impact > Profile. > > > Table 2. Comparison of the Implementation Sample With the Benchmark > Randomized Controlled Trials Samples > --------------------------------------------------------------------------------------------------------------------------------------- > Characteristic Implementation Sharpe et al. > Deale et al. Prins et al. Stulemeijer et al. > study (1996) > (1997) (2001) (2005) > (N=112) (N=30) > (N=30) (N=92) (N=36) > --------------------------------------------------------------------------------------------------------------------------------------- > Years of illness 5.5 (4.9) 2.8 (0.8) > 3.4 (2.1) 4.9 (4.8) 1.4 > duration, M (SD) > Age in years, M (SD) 39 (10.2) 34 (9.1) > 31(9.0) 36 (9.4) 16 (1.3) > Gender (men/women) 34%/66% 40%/60% > 30%/70% 24%/76% 11%/89% > Marital status (married 72% 63% > 57%a 70% -- > or cohabiting) > Unemployed or not 53% 87% > 63% 46% 89%b > attending school > --------------------------------------------------------------------------------------------------------------------------------------- > Note. Marital status was not recorded for Stulemeijer et al. (2005) > because participants were adolescents. > a This percentage was not presented directly in the article, but was > derived from data indicating that 43% of participants were single. > b Including partial nonattendance. > > > Table 3. Percentages of Recovered Patients and Mean Fatigue Severity and > Physical Functioning Scores Before and After Treatment > --------------------------------------------------------------------------------------------------------------------------------------- > Patient group Patients clinically Fatigue Severity > Fatigue Severity SF-36 score at SF-36 score at > significantly score at intake > score at intake follow-up > improved > follow-up > n % M SD M > SD M SD M SD > Finished treatments, 46 54.8 48.5 7.1 > 29.3 14.0 52.8 21.2 73.6 22.9 > including dropout > (N=84) > Intention to treat 46 41.1 48.7 7.1 > 35.4 15.3 53.5 23.2 69.1 25.6 > (N=112) > --------------------------------------------------------------------------------------------------------------------------------------- > Note. SF-36=Short Form (Physical Functioning Scale) of the Rand-36. > > > Table 4. Mean Scores at Intake and Follow-Up and Effect Sizes of the Four > Benchmark Studies and the Implementation Study > --------------------------------------------------------------------------------------------------------------------------------------- > Subscale Sharpe et Deale et Prins et > al. Stulemeijer Statistical Implementation > al. (1996) al. (1997) (2001) > et al. (2005) benchmark study > --------------------------------------------------------------------------------------------------------------------------------------- > Fatigue Severity > Intake score, M (SD) 7.8 (1.5) 10.2 (1.3) 52.2 > (3.9) 52.5 (3.8) 48.7 (7.1) > Follow-up score, M (SD) 4.7 (4.1)a 4.1 (4.0) 42.0 > (10.9) 30.2 (16.8) 35.4 (15.3) > Pooled SD 3.1 3.0 8.2 > 12.2 11.9 > Effect size 1.02 2.05 1.25 > 1.83 1.44 1.12 > Confidence interval 0.47, 1.54 1.40, 2.65 0.93, > 1.56 1.21, 2.41 0.97, 1.89 0.85, 1.38 > Physical Functioning > Intake score, M (SD) 71 (3.3) 25.5 (18.9) 1,752 > (611) 42.1 (16.5) 53.5 (23.2) > Follow-up score, M (SD) -- 71.6 (28.0) 1,285 > (703) 69.4 (28.0) 69.1 (25.6) > Pooled SD -- 23.9 659 > 23.0 24.2 > Effect size -- 1.93 0.71 > 1.19 1.04 0.64 > Confidence interval -- 1.29, 2.51 0.41, > 1.00 0.62, 1.71 0.63, 1.44 0.38, 0.89 > --------------------------------------------------------------------------------------------------------------------------------------- > Note. Sharpe et al.'s (1996) article did not give follow-up data for the > Karnofski scale, hence this study was not included > in the analysis of the benchmark effect size of physical functioning. > a The follow-up SD was not given in Sharpe et al.'s article; it was > estimated based on the assumption that an SD at follow- > up is in general about 2.8 times higher an SD at intake. > > > Table 5. Operationalization of Positive Impact of the Implementation and > Formulation of the Related Subquestions and Their Results > --------------------------------------------------------------------------------------------------------------------------------------- > Subquestions related to criteria for Results of the subquestions > successful implementation > --------------------------------------------------------------------------------------------------------------------------------------- > 1. How many GPs were after 1.5 years familiar 1. Of the 452 questionnaires > that were sent to all GPs, 301 were completed and returned, > with the new treatment setting for CFS? implying a response rate > of 67%. Of these 301, 212 GPs (70%) remembered to have > been informed by us about > CFS and knew about the new treatment possibility. > 2. How many CFS patients did not accept a 2. Thirty of all 212 > informed GPs (14%) reported to have met 1 or more patients that > referral to the MHC? did not want a referral to > the MHC. In total, this concerned 41 patients, which is > 22% of the 184 (143+41) > patients that were proposed a referral to the MHC by their GP. > 3. How many CFS patients were referred for 3. During the 20-month > inclusion period, 143 patients were referred for CBT. The > CBT? number of patients > referred per month varied from 3 to 13. > 4. How many patients were diagnosed 4. From the 143 referred > patients, 125 actually appeared at intake; the other 18 did no > incorrectly or unjustly as having CFS? show up at intake. Of > these 125 patients, 13 (10.4%) turned out to be referred > unjustly because they did > not meet the CDC-94 criteria for CFS. > 5. How many patients finished treatment and 5. From the 112 patients > that showed up at intake and appeared to have CFS, 72 finished > what were reasons for not finishing treatment, implying a > total dropout rate of 36%. Reasons for not finishing treatment > treatment? are described in the text > of this article. > --------------------------------------------------------------------------------------------------------------------------------------- > Note. GP = general practitioner; CFS = chronic fatigue syndrome; MHC = > mental health center; CBT = cognitive behavioral therapy; CDC= > Centers for Disease Control. > > > Table 6. Sample and Subsample Sizes of Chronic Fatigue Syndrome > (CFS) Patients Referred to the Mental Health Center (MHC) > --------------------------------------------------------------------- > Sample or subsample N or n % Remaining > patients > --------------------------------------------------------------------- > Patients referred to the MHC 143 > No show patients not showing up 18 12.6% 125 > at intake (% of the 143 referrals) > Non-CFS patients, referred unjustly 13 10.4% 112 > (% of the 125 intakes) > Patients that after intake decided to 28 25.0% 84 > not start treatment (% of the 112 > CFS patients after intake) > Patients dropping out during 12 14.3% 72 > treatment (% of the 84 started > treatments) > Patients finishing treatment 72 > --------------------------------------------------------------------- > > > Figure captions > > Figure 1. 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