Abstract

Background

Fibromyalgia (FM) is a clinically well‐defined chronic condition of unknown aetiology characterized by chronic widespread pain that often co‐exists with sleep disturbances, cognitive dysfunction and fatigue. Patients often report high disability levels and negative mood. Psychotherapies focus on reducing key symptoms, improving daily functioning, mood and sense of personal control over pain.

Objectives

To assess the benefits and harms of cognitive behavioural therapies (CBTs) for treating FM at end of treatment and at long‐term (at least six months) follow‐up.

Search methods

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 8), MEDLINE (1966 to 28 August 2013), PsycINFO (1966 to 28 August 2013) and SCOPUS (1980 to 28 August 2013). We searched http://www.clinicaltrials.gov (web site of the US National Institutes of Health) and the World Health Organization Clinical Trials Registry Platform (ICTRP) (http://www.who.int/ictrp/en/) for ongoing trials (last search 28 August,2013), and the reference lists of reviewed articles.

Selection criteria

We selected randomised controlled trials of CBTs with children, adolescents and adults diagnosed with FM.

Data collection and analysis

The data of all included studies were extracted and the risks of bias of the studies were assessed independently by two review authors. Discrepancies were resolved by discussion.

Main results

Twenty‐three studies with 24 study arms with CBTs were included. A total of 2031 patients were included; 1073 patients in CBT groups and 958 patients in control groups. Only two studies were without any risk of bias. The GRADE quality of evidence of the studies was low. CBTs were superior to controls in reducing pain at end of treatment by 0.5 points on a scale of 0 to 10 (standardised mean difference (SMD) ‐ 0.29; 95% confidence interval (CI) ‐0.49 to ‐0.17) and by 0.6 points at long‐term follow‐up (median 6 months) (SMD ‐0.40; 95% CI ‐0.62 to ‐0.17); in reducing negative mood at end of treatment by 0.7 points on a scale of 0 to 10 (SMD ‐ 0.33; 95% CI ‐0.49 to ‐0.17) and by 1.3 points at long‐term follow‐up (median 6 months) (SMD ‐0.43; 95% CI ‐0.75 to ‐0.11); and in reducing disability at end of treatment by 0.7 points on a scale of 0 to 10 (SMD ‐ 0.30; 95% CI ‐0.51 to ‐0.08) and at long‐term follow‐up (median 6 months) by 1.2 points (SMD ‐0.52; 95% CI ‐0.86 to ‐0.18). There was no statistically significant difference in dropout rates for any reasons between CBTs and controls (risk ratio (RR) 0.94; 95% CI 0.65 to 1.35).

Authors' conclusions

CBTs provided a small incremental benefit over control interventions in reducing pain, negative mood and disability at the end of treatment and at long‐term follow‐up. The dropout rates due to any reason did not differ between CBTs and controls.

Author(s)

Kathrin Bernardy, Petra Klose, Angela J Busch, Ernest HS Choy, Winfried Häuser

Abstract

Plain language summary

Cognitive behavioural therapies for fibromyalgia syndrome

Researchers in The Cochrane Collaboration conducted a review of research about the effects of cognitive‐behavioural therapies (CBTs) on fibromyalgia (FM). After searching for all relevant studies, they found 23 studies with up to 2031 people. Their findings are summarised below.

After about 12 weeks, children, adolescents and adults with FMS, who used CBTs compared to controls, were likely to report that CBT

‐ may reduce slightly pain, negative mood and disability at the end of the treatment;

‐ may reduce slightly pain, negative mood and disability six months after the end of treatment.

There was no difference between CBTs and controls in the number of people who withdrew from treatment.

We do not have precise information about side effects and complications of CBTs. Rare complications may include worsening of co‐existing mental disorders.

What is fibromyalgia and what are cognitive behavioural therapies?

People with FM suffer from chronic widespread pain, sleep problems and fatigue. There is no cure for FM at present, so treatments aim to relieve symptoms and to improve daily functioning.

Cognitive behavioural therapies (CBTs) are widely used psychological treatments for a wide range of health problems, including chronic pain. CBTs are effective in enhancing patients’ beliefs in their own abilities and developing ways to deal with health problems. The primary goals of CBTs are to change negative thoughts and feelings that individuals may have of their physical and mental problems and to change their behaviour accordingly. Patients learn skills (for example, relaxation, activity pacing) to help them to manage their pain better or develop different attitudes towards pain (for example, more acceptance), or both.

Best estimates of what happens to people with FMS when they use CBTs

Pain (higher scores mean worse or more severe pain):

‐ People who used CBTs rated their pain to be 0.5 points lower at the end of treatment (6.3% absolute improvement) and to be 0.6 points lower six months after the end of treatment on a scale of 0 to 10 (4.2% absolute improvement).

‐ People who used CBTs rates their pain to be 6.9 points on a scale of 0‐10.

‐ People who used a control treatment rated their pain to be 7.4 points on a scale of 0 to 10.

Negative mood (higher scores mean worse or more severe negative mood):

‐ People who used CBTs rated their depressed mood to be 0.7 points lower at the end of treatment (10.2% absolute improvement) and to be 1.3 points lower six months after the end of treatment on a scale of 0 to 10 (2.7% absolute improvement).

‐ People who used CBTs rated their negative mood to be 6.1 points on a scale of 0 to 10.

‐ People who had a control treatment rated their negative mood to be 6.8 points on a scale of 0 to 10.

Disability (higher scores mean more disability):

‐ People who used CBTs rated their disability to be 0.7 points lower at the end of treatment (7.2% absolute improvement) and to be 1.2 points lower six months after the end of treatment on a scale of 0 to 10 (11.7% absolute improvement).

‐ Peope who used CBTs rated their disability to be 2.0 points on a scale of 0 to 10.

‐ People who used a control treatment rated their disability to be 2.8 points on a scale of 0 to 10.

Withdrawing from treatment:

‐ The number of people who withdrew from CBTs compared to control interventions due to any reason was equal.

‐ 15 people out of 100 who used CBTs withdrew from treatment due to any reason;

‐ 15 people out of 100 who used control interventions withdrew from treatment due to any reason.

Author(s)

Kathrin Bernardy, Petra Klose, Angela J Busch, Ernest HS Choy, Winfried Häuser

Reviewer's Conclusions

Authors' conclusions 

Implications for practice 

Traditional cognitive behavioural therapy and operant therapy reduce the key symptoms of FM after six months. These types of therapies should be offered face‐to face. The limited data available on internet‐ or telephone‐based CBTs do not allow a recommendation to use this type of delivery. Treatment intensity should be between five and 25 hours. Evidence was not found for benefit of self management programs as single therapy.

Even if the assessment of adverse events in most CBTs studies was insufficient and two studies reported a dropout rate of up to 5% of patients in CBTs groups due to worsening of co‐morbid mental disorders, the risk‐benefit ratio of CBTs is more favourable than that of drugs which have been approved by the US Food and Drug Administration (FDA) for FM treatment. Adverse events and dropouts due to adverse events were higher in drug than in CBTs trials (see Häuser 2010; Sommer 2012b). In addition, the positive effects of CBTs, especially of operant therapy, increase within six months after the end of therapy, whereas the positive effects of drugs disappear within two weeks after the cessation of therapy (Saxe 2012).

In some countries (for example USA), CBTs might not be easily available for patients and might be expensive and not covered by insurance (Rheumatologist Los Angeles 2012). In contrast, aerobic exercise (for example walking) is available everywhere with very low costs because it can be carried out by the patient himself without professional guidance, or after a short education. We found that CBTs were not superior to other active treatments such as aerobic exercise in the reduction of FM symptoms. However, aerobic exercise of low to moderate intensity is effective in reducing FM key symptoms (pain, fatigue, negative mood) at end of treatment and long‐term follow‐up (Busch 2007; Winkelmann 2012), to the same amount as CBTs (Nüesch 2013). Therefore, aerobic exercise and not CBTs are the first non‐pharmacologic treatment option of choice for FM (Eich 2012). This conclusion is not based on the results of head‐to‐head comparisons of CBTs versus aerobic exercise but on the higher availability and lower costs of aerobic exercise compared to CBTs.

Implications for research 

The following research priorities would help to understand the effects of CBTs in FM according to EPICOT (Brown 2006), and to definitively convince patients, clinicians, researchers and payers of the benefits of CBTs in FM.

Evidence

No further small sample size studies with low to moderate methodology and treatment quality comparing CBTs with treatment as usual are needed. Large and high quality studies should compare CBTs with an adequate psychological placebo or best available drug therapy or aerobic exercise. Any new RCT needs to be designed and reported taking explicit account of the challenges identified and discussed in this review and in the ones of psychological therapies in chronic pain in children and adolescents (Eccleston 2012) and in adults (Williams 2012).

Population (external validity)

Studies are needed in all age groups. Future studies should include more adolescents, men and seniors. Clinical studies in FM should be conducted with patient samples representative of clinical practice, including patients with co‐morbid anxiety and depressive disorders and inflammatory rheumatic diseases. Subgroup analyses should be performed for these subpopulations. Moreover, studies should include patients with different disease durations and different severity levels all over the world.

Intervention (treatment quality)

Standardised empirical protocols should be used. Therapists providing interventions in trials should have been trained in the use of the protocol. Therapist adherence to the protocol (treatment integrity) and patient adherence to behavioural skill training (treatment uptake) should be monitored (Kashikar‐Zuck 2010). Attendance rates should be reported. Future intervention studies should be designed to assess dose–response curves for improvement of FM symptoms and evaluate follow‐up periods following completion of the active intervention period. These studies should include ongoing, intermittent assessment of CBTs interventions and FM outcome measures to understand the stability of responses and program characteristics (intensity, duration, frequency) needed to maintain gains.

Comparisons

An attention control with the same amount of time spent with the patients by therapists with the same experience in psychotherapy as in the treatment groups is the gold standard to control for unspecific effects of psychological therapies (Kashikar‐Zuck 2010; Wampold 2005). Of note, the superiority of CBTs over controls which we found in this review is based on the comparison of CBTs with treatment as usual and waiting list control, which were inadequate according to the gold standard. A recent large trial with mindfulness‐based stress reduction (MBSR) failed to demonstrate a superiority of MBSR over an adequate 'psychological placebo' (Schmidt 2011). Whether CBTs add a relevant benefit over an adequate psychological placebo still needs to be determined. The significance of CBTs compared to other established FM therapies such as aerobic exercise and drugs recommended for FM (amitriptyline, duloxetine, milnacipran, pregabalin) still needs to be determined.

Outcomes

A core set of outcome measures for psychological trials in FM is needed. The set should include the key domains of FM developed through consensus among experts and FM patients (Mease 2009) and the suggestions of the Initiative of Methods, Measurement and Pain Assessment in Clinical trials (IMMPACT) (Dworkin 2008; Dworkin 2009). Key domains include pain, sleep problems and fatigue. Responder outcomes (for example number of patients with ≥ 50% pain reduction, number of patients with ≥ 14% in the FIQ‐total score) should be reported. There is increasing recognition that psychological treatments have the potential for negative outcomes for some patients (Kashikar‐Zuck 2010). Standards, in which potential negative outcomes should be routinely monitored, by which methods, still have to be defined by the research community. In addition, a discussion of what we think is feasible as the outcome of any type of therapy in FM is appropriate. Average effect sizes across trials are relatively small, as they are across pharmacological and physical treatments in FM (Nüesch 2013; Winkelmann 2012). This raises the issue of whether FM trials should still focus on mere symptom reduction. FM trials on psychological therapies, especially acceptance‐based CBTs, could provide a better answer on how to live more satisfactorily with FM symptoms (Williams 2012).

Disease‐relevant timelines

Follow‐up of all study participants (including members of the control group) should be for at least one year (Brachaniec 2009).

Study type and methodology (methodology quality)

The following requirements should be met for the 'green' criterion of the suggested Cochrane Collaboration traffic light system (Moore 2010a). Randomization should be performed by an adequate method. Treatment allocation should be undertaken independently. Investigators and assessment staff should be blinded to prevent inadvertent bias. Analysis should be performed by an ITT analysis based on baseline observation carried forward method. Patient‐associated barriers to participate in CBTs should be investigated.

Major tasks of future research are: a) the definition of subgroups (e.g. FM patients with and without major depression or post‐traumatic stress disorder, pain persistence and pain avoidance behaviour) with development of more tailored therapies to these subgroups (Lange 2010; Loevinger 2012; Lumley 2011; van Koulil 2011), b) the identification of common (e.g. therapeutic relationship) and specific (e.g. exposure) treatment mechanisms by more frequent measures than pre‐post assessment allowing examination of lagged relationships over time (Thurns 2011) c) the development of cost‐effective telephone or internet‐assisted therapies to overcome the costs of CBTs and limited availability of providers with specialized training (Kashikar‐Zuck 2010; McBeth 2012) and d) the application of new study designs beyond the "gold standard" of RCTs, e.g. clinical effectiveness trials where clinical effectiveness is "the product of efficacy, tolerability, utility, cost, and speed" (Moore 2010c).

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