negative CBT study – American ME and CFS Society

An analysis of Dutch hallmark studies confirms the outcome of the PACE trial: cognitive behaviour therapy with a graded activity protocol is not effective for chronic fatigue syndrome and Myalgic Encephalomyelitis

Abstract:

Myalgic Encephalomyelitis (ME) and Chronic Fatigue Syndrome (CFS) are considered to be enigmatic diseases. Several studies propose that the combination of cognitive behaviour therapy with a graded activity protocol (CBT+), justified by a so-called (bio)psychosocial (explanatory) model, is an effective treatment option for CFS (ME).

Objective :A critical review of five Dutch hallmark studies that allegedly support this claim.

Methods: An analysis of the five CBT+ studies with special attention to the patients studied, the criteria (subjective and objective measures and cut-off scores) used to select participants and to define improvement and recovery, the consistency of the definitions of caseness (being diagnosed as a CFS patient at entry) versus the definitions of improvement and recovery after CBT+, and the objective effects.

Results: The studies investigated suffer from various methodological flaws. Apart from these methodological shortcomings, the claim that CBT+ is an effective treatment option for CFS is not substantiated by the data reported. Some studies investigated CFS patients, other studies investigated CF patients, labelled as CFS patients, or combinations of CFS and CF patients. No study investigated the effect of CBT+ in a group of patients meeting the (original) diagnostic criteria for ME. The effects of CBT+ on subjective measures, for example fatigue and disability, if present, are insufficient to achieve normal values. Impressive recovery and improvement rates are based on very loose criteria for subjective measures. Cut-off scores for subjective measures used to define improvement and recovery in studies show overlap with cut-off scores for CFS caseness in one or more of the other studies. More importantly, looking at the objective measures, the proof of clinical improvement after CBT+ is lacking.

Conclusion: Solid evidence of effectiveness of CBT+ for CFS, let alone ME, is lacking in the five hallmark studies. The lack of objective improvement indicates CBT+ is ineffective. This finding confirms the outcome of the large-scale PACE-trial in the UK.

Source: Twisk FNM (2017) An analysis of Dutch hallmark studies confirms the outcome of the PACE trial: cognitive behaviour therapy with a graded activity protocol is not effective for chronic fatigue syndrome and Myalgic Encephalomyelitis. Gen Med Open, 2017 doi: 10.15761/GMO.1000117 (Full article)

Long-term follow-up after cognitive behaviour therapy for chronic fatigue syndrome

Abstract:

OBJECTIVE: Cognitive behaviour therapy (CBT) is an effective treatment for chronic fatigue syndrome (CFS). Main aim was to determine whether treatment effects were maintained up to 10years after treatment.

METHODS: Participants (n=583) of previously published studies on the effects of CBT for CFS were contacted for a long-term follow-up assessment. They completed questionnaires on main outcomes fatigue severity (CIS) and physical functioning (SF-36). The course of these outcomes since post-treatment assessment was examined using mixed model analyses.

RESULTS: Between 21 and 125months after finishing CBT, 511 persons (response rate 88%) completed a follow-up assessment. At follow-up, mean fatigue severity was significantly increased to 37.60 (SD=12.76) and mean physical functioning significantly decreased to 73.16 (SD=23.56) compared to post-treatment assessment. At follow-up still 37% of the participants had fatigue scores in the normal range and 70% were not impaired in physical functioning.

CONCLUSION: Positive effects of CBT for CFS on fatigue and physical functioning were partly sustained at long-term follow-up. However, a subgroup of patients once again reported severe fatigue, and compromised physical functioning. Further research should elucidate the reasons for this deterioration to facilitate the development of treatment strategies for relapse prevention.

Source: Janse A1, Nikolaus S2, Wiborg JF2, Heins M2, van der Meer JWM3, Bleijenberg G4, Tummers M5, Twisk J6, Knoop H7. Long-term follow-up after cognitive behaviour therapy for chronic fatigue syndrome. J Psychosom Res. 2017 Jun;97:45-51. doi: 10.1016/j.jpsychores.2017.03.016. Epub 2017 Mar 27. https://www.ncbi.nlm.nih.gov/pubmed/2860649

Cognitive behaviour therapy for chronic fatigue syndrome: Differences in treatment outcome between a tertiary treatment centre in the United Kingdom and the Netherlands

Abstract:

OBJECTIVE: Cognitive behaviour therapy (CBT) reduces fatigue and disability in chronic fatigue syndrome (CFS). However, outcomes vary between studies, possibly because of differences in patient characteristics, treatment protocols, diagnostic criteria and outcome measures. The objective was to compare outcomes after CBT in tertiary treatment centres in the Netherlands (NL) and the United Kingdom (UK), using different treatment protocols but identical outcome measures, while controlling for differences in patient characteristics and diagnostic criteria.

METHODS: Consecutively referred CFS patients who received CBT were included (NL: n=293, UK: n=163). Uncontrolled effect sizes for improvement in fatigue (Chalder Fatigue Questionnaire), physical functioning (SF-36 physical functioning subscale) and social functioning (Work and Social Adjustment Scale) were compared. Multiple regression analysis was used to examine whether patient differences explained outcome differences between centres.

RESULTS: Effect sizes differed between centres for fatigue (Cohen’s D NL=1.74, 95% CI=1.52-1.95; UK=0.99, CI=0.73-1.25), physical functioning (NL=0.99, CI=0.81-1.18; UK=0.33, CI=0.08-0.58) and social functioning (NL=1.47, CI=1.26-1.69; UK=0.61, CI=0.35-0.86). Patients in the UK had worse physical functioning at baseline and there were minor demographic differences. These could not explain differences in centre outcome.

CONCLUSION: Effectiveness of CBT differed between treatment centres. Differences in treatment protocols may explain this and should be investigated to help further improve outcomes.

Source: Worm-Smeitink M, Nikolaus S, Goldsmith K, Wiborg J, Ali S, Knoop H, Chalder T. Cognitive behaviour therapy for chronic fatigue syndrome: Differences in treatment outcome between a tertiary treatment centre in the United Kingdom and the Netherlands. J Psychosom Res. 2016 Aug;87:43-9. doi: 10.1016/j.jpsychores.2016.06.006. Epub 2016 Jun 11. https://www.ncbi.nlm.nih.gov/pubmed/27411751

The Cognitive Behavioral Treatment of Depression and Low Self-Esteem in the Context of Pediatric Chronic Fatigue Syndrome (CFS/ME): A Case Study

Abstract:

PROBLEM: Up to one in three young people with chronic fatigue syndrome (CFS/ME) also has depressive symptoms. It is not known how best to treat young people with this comorbidity.

METHOD: This case report seeks to describe and discuss the use of a cognitive behavioral approach for depression and low self-esteem in a 16-year-old girl with CFS/ME.

FINDINGS/CONCLUSION: Therapy was effective in remediating the young person’s mood difficulties, but appeared to exacerbate their CFS/ME symptoms. Therefore, it is crucial that CFS/ME and mood treatments are designed and trialed to ensure a complementary approach. Good communication and joint working between involved professionals is also important, and ideally, treatments for mood and for CFS/ME would be provided by the same team to facilitate this.

Source: Loades M. The Cognitive Behavioral Treatment of Depression and Low Self-Esteem in the Context of Pediatric Chronic Fatigue Syndrome (CFS/ME): A Case Study. J Child Adolesc Psychiatr Nurs. 2015 Nov;28(4):165-74. doi: 10.1111/jcap.12125. Epub 2015 Oct 16. https://www.ncbi.nlm.nih.gov/pubmed/26470755

Multidisciplinary rehabilitation treatment versus cognitive behavioural therapy for patients with chronic fatigue syndrome: a randomized controlled trial

Abstract:

OBJECTIVES: The aim of this trial was to evaluate the difference in treatment effect, at 26 and 52 weeks after the start of treatment, between cognitive behavioural therapy (CBT) and multidisciplinary rehabilitation treatment (MRT) for patients with chronic fatigue syndrome (CFS).

DESIGN: Multicentre, randomized controlled trial of patients with CFS. Participants were randomly assigned to MRT or CBT.

SETTING: Four rehabilitation centres in the Netherlands.

SUBJECTS: A total of 122 patients participated in the trial.

MAIN OUTCOME MEASURES: Primary outcomes were fatigue measured by the fatigue subscale of the Checklist Individual Strength and health-related quality of life measured by the Short-Form 36. Outcomes were assessed prior to treatment and at 26 and 52 weeks after treatment initiation.

RESULTS: A total of 114 participants completed the assessment at 26 weeks, and 112 completed the assessment at 52 weeks. MRT was significantly more effective than CBT in reducing fatigue at 52 weeks. The estimated difference in fatigue between the two treatments was -3.02 [95% confidence interval (CI) -8.07 to 2.03; P = 0.24] at 26 weeks and -5.69 (95% CI -10.62 to -0.76; P = 0.02) at 52 weeks. Patients showed an improvement in quality of life over time, but between-group differences were not significant.

CONCLUSION: This study provides evidence that MRT is more effective in reducing long-term fatigue severity than CBT in patients with CFS. Although implementation in comparable populations can be recommended based on clinical effectiveness, it is advisable to analyse the cost-effectiveness and replicate these findings in another multicentre trial.

Source: Vos-Vromans DC, Smeets RJ, Huijnen IP, Köke AJ, Hitters WM, Rijnders LJ, Pont M, Winkens B, Knottnerus JA. Multidisciplinary rehabilitation treatment versus cognitive behavioural therapy for patients with chronic fatigue syndrome: a randomized controlled trial. J Intern Med. 2016 Mar;279(3):268-82. doi: 10.1111/joim.12402. Epub 2015 Aug 26. https://www.ncbi.nlm.nih.gov/pubmed/26306716

The effect of counselling, graded exercise and usual care for people with chronic fatigue in primary care: a randomized trial

Abstract:

BACKGROUND: To evaluate the effectiveness of graded exercise therapy (GET), counselling (COUNS) and usual care plus a cognitive behaviour therapy (CBT) booklet (BUC) for people presenting with chronic fatigue in primary care.

METHOD: A randomized controlled trial in general practice. The main outcome measure was the change in the Chalder fatigue score between baseline and 6 months. Secondary outcomes included a measure of global outcome, including anxiety and depression, functional impairment and satisfaction.

RESULTS: The reduction in mean Chalder fatigue score at 6 months was 8.1 [95% confidence interval (CI) 6.6-10.4] for BUC, 10.1 (95% CI 7.5-12.6) for GET and 8.6 (95% CI 6.5-10.8) for COUNS. There were no significant differences in change scores between the three groups at the 6- or 12-month assessment. Dissatisfaction with care was high. In relation to the BUC group, the odds of dissatisfaction at the 12-month assessment were less for the GET [odds ratio (OR) 0.11, 95% CI 0.02-0.54, p=0.01] and COUNS groups (OR 0.13, 95% CI 0.03-0.53, p=0.004).

CONCLUSIONS: Our evidence suggests that fatigue presented to general practitioners (GPs) tends to remit over 6 months to a greater extent than found previously. Compared to BUC, those treated with graded exercise or counselling therapies were not significantly better with respect to the primary fatigue outcome, although they were less dissatisfied at 1 year. This evidence is generalizable nationally and internationally. We suggest that GPs ask patients to return at 6 months if their fatigue does not remit, when therapy options can be discussed further.

Source: Ridsdale L, Hurley M, King M, McCrone P, Donaldson N. The effect of counselling, graded exercise and usual care for people with chronic fatigue in primary care: a randomized trial. Psychol Med. 2012 Oct;42(10):2217-24. doi: 10.1017/S0033291712000256. Epub 2012 Feb 28. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3435871/ (Free article)

Childhood maltreatment and the response to cognitive behavior therapy for chronic fatigue syndrome

Abstract:

OBJECTIVE: To examine the relationship between a history of childhood maltreatment and the treatment response to cognitive behavior therapy for chronic fatigue syndrome (CFS).

METHODS: A cohort study in a tertiary care clinic with a referred sample of 216 adult patients meeting the Centers for Disease Control and Prevention criteria for CFS, and starting cognitive behavior therapy. Main outcome measures changes between pre- and post therapy in fatigue (Checklist Individual Strength fatigue subscale), disabilities (Sickness Impact Profile total score), physical functioning (short form 36 health survey subscale) and psychological distress (Symptom checklist 90 total score).

RESULTS: At baseline, patients with a history of childhood maltreatment had significantly more limitations and a higher level of psychological distress, but were not more severely fatigued. Change scores on the outcome measures after cognitive behavior therapy did not differ significantly between patients with or without a history of childhood maltreatment, or between the different types of childhood maltreatment. However, patients with a history of childhood maltreatment still experienced more limitations and a higher level of psychological distress after CBT.

CONCLUSIONS: A history of childhood maltreatment was not related to the treatment response of cognitive behavior therapy for CFS. In patients with a history of childhood maltreatment CFS symptoms can be treated with CBT just as well as those without.

Source: Heins MJ, Knoop H, Lobbestael J, Bleijenberg G. Childhood maltreatment and the response to cognitive behavior therapy for chronic fatigue syndrome. J Psychosom Res. 2011 Dec;71(6):404-10. doi: 10.1016/j.jpsychores.2011.05.005. Epub 2011 Jun 30. https://www.ncbi.nlm.nih.gov/pubmed/22118383

Effectiveness of stepped care for chronic fatigue syndrome: a randomized noninferiority trial

Abstract:

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 effectiveness 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.

Source: Tummers M, Knoop H, Bleijenberg G. Effectiveness of stepped care for chronic fatigue syndrome: a randomized noninferiority trial. J Consult Clin Psychol. 2010 Oct;78(5):724-31. doi: 10.1037/a0020052. https://www.ncbi.nlm.nih.gov/pubmed/20873907

How does cognitive behaviour therapy reduce fatigue in patients with chronic fatigue syndrome? The role of physical activity

Abstract:

BACKGROUND: Cognitive behaviour therapy (CBT) is known to reduce fatigue severity in chronic fatigue syndrome (CFS). How this change in symptomatology is accomplished is not yet understood. The purpose of the present study was to determine whether the effect of CBT on fatigue is mediated by an increase in physical activity.

METHOD: Three randomized controlled trials were reanalysed, previously conducted to evaluate the efficacy of CBT for CFS. In all samples, actigraphy was used to assess the level of physical activity prior and subsequent to treatment or a control group period. The mediation hypothesis was analysed according to guidelines of Baron & Kenny [Journal of Personality and Social Psychology (1986)51, 1173-1182]. A non-parametric bootstrap approach was used to test statistical significance of the mediation effect.

RESULTS: Although CBT effectively reduced fatigue, it did not change the level of physical activity. Furthermore, changes in physical activity were not related to changes in fatigue. Across the samples, the mean mediation effect of physical activity averaged about 1% of the total treatment effect. This effect did not yield significance in any of the samples.

CONCLUSIONS: The effect of CBT on fatigue in CFS is not mediated by a persistent increase in physical activity.

Source: Wiborg JF, Knoop H, Stulemeijer M, Prins JB, Bleijenberg G. How does cognitive behaviour therapy reduce fatigue in patients with chronic fatigue syndrome? The role of physical activity. Psychol Med. 2010 Aug;40(8):1281-7. doi: 10.1017/S0033291709992212. Epub 2010 Jan 5. https://www.ncbi.nlm.nih.gov/pubmed/20047707

Cognitive-behavior therapy in chronic fatigue syndrome: is improvement related to increased physical activity?

Abstract:

This multiple case study of cognitive-behavioral treatment (CBT) for chronic fatigue syndrome (CFS) compared self-report and behavioral outcomes. Eleven relatively high-functioning participants with CFS received 6-32 sessions of outpatient graded-activity oriented CBT.

Self-report outcomes included measures of fatigue impact, physical function, depression, anxiety, and global change. Behavioral outcomes included actigraphy and the 6-minute walking test. Global change ratings were very much improved (n=2), much improved (n=2), improved (n=5), and no change (n=2).

Of those reporting improvement, clinically significant actigraphy increases (n=3) and decreases (n=4) were found, as well as no significant change (n=2). The nature of clinical improvement in CBT trials for high-functioning CFS patients may be more ambiguous than that postulated by the cognitive-behavioral model.

Source: Friedberg F, Sohl S. Cognitive-behavior therapy in chronic fatigue syndrome: is improvement related to increased physical activity? J Clin Psychol. 2009 Apr;65(4):423-42. doi: 10.1002/jclp.20551. https://www.ncbi.nlm.nih.gov/pubmed/19213007