This is the first randomized, controlled study to demonstrate the benefits of a primarily affectively oriented group intervention for fibromyalgia. We found that a relatively short-duration but intensive intervention (i.e., one individual session and three group sessions over 4 weeks) yielded substantial benefits within 6 weeks, and these benefits were maintained at the 6-month endpoint. It is noteworthy that long-term benefits were observed not only in subjective pain, but also in pressure pain threshold and physical functioning. Improvements in both pain and physical function at 6 months or beyond, using intent-to-treat analyses, have thus far been shown in only a handful of interventions for fibromyalgia55–59
To date, among non-pharmacological treatments for fibromyalgia, cognitive-behavioral therapy (CBT) has the strongest level of evidence supporting its use14
. ASA shares some aspects of CBT, particularly a shift in one’s perception that health is controlled by external factors, such as physicians, to internal control. However, CBT emphasizes modifying maladaptive thinking and behavioral responses to pain, and typically either avoids patients’ negative emotional experiences, or attempts to reduce negative emotions as directly as possible. In contrast, ASA emphasizes the value of approaching or confronting one’s stressful experiences, developing awareness of one’s emotions and motivations, and encouraging verbal rather than somatic expression27,28,60
Two prior fibromyalgia studies using written emotional disclosure asked patients to write about stressful experiences for three or four sessions, and improved pain and function were observed after 3 or 4 months, relative to controls36,37
. The between-group effect sizes on pain in these earlier studies, however, were only 0.22 and 0.49—substantially smaller than the effects noted in the current study (1.46 at 6 months). It is possible that the additional techniques—such as a clear statement of the key role played by emotions, more intensive and varied written emotional disclosure, inclusion of mindfulness exercises, and a group format—substantially increased the effect compared with expressive writing or mindfulness meditation alone36,37,40
There are a few noteworthy limitations of this study. First, the control group did not receive any active or placebo intervention, and therefore did not serve as a control for provider attention, peer-group interaction, personal time devoted to recovery, and other non-specific treatment effects. We did not monitor the interventions received by the control group. Second, perhaps due to our rather small sample size, randomization did not evenly distribute patients on some baseline measures. Covariance analyses and removal of baseline outliers, however, did not change the significance of any of our results, and the ASA group had ending values on significant outcomes that were superior to the controls, suggesting that the improvement in the ASA group extended beyond a regression to the mean.
Third, as in any clinical trial, a biased sample may have chosen to participate in this study. However, this sample of women with fibromyalgia was comparable to those reported in highly cited studies with respect to pain13
, physical function and fatigue55
, and comorbid affective disorder56
, and more than one-third of our participants had already tried pharmacological agents approved for the treatment of fibromyalgia in the US (e.g., pregabalin or duloxetine). Thus, the marked improvement seen in this study is unlikely to be explained by sampling bias leading to an easier-to-treat sample population. Nonetheless, it is likely that individuals who agreed to participate were at least open to the possibility that affective factors could be playing a role in their illness.
Despite our theoretical model, we do not know the mechanisms responsible for the benefits of the ASA intervention, because we did not assess treatment processes, such as changes in emotional awareness or expression. And despite limited sharing of personal information, aspects of the provider-patient relationship and the dynamics of group interactions may play significant roles in patient improvement. As mentioned above, there were no drop-outs from the intervention groups. In addition, attendance was nearly perfect, and the very few patients who missed a single session were contacted by the group leader with the homework assignments. Participants were asked to devote at least an hour per day to course homework and self-care activities, which may have significant benefit, as may behavioral and physical activation17,61
To address these limitations, we are currently planning a larger study that will not only assess the efficacy of this type of intervention in comparison to an active control group, but will allow for assessment of mediating and moderating variables to help determine mechanisms of action and subgroups of patients that respond best to this intervention.
In conclusion, an affective self-awareness intervention resulted in a sustained reduction in pain and improvement in physical functioning in a sample of women with fibromyalgia compared to wait-listed controls. A notable advantage of the ASA intervention used in this study is the relatively low amount of provider time needed to treat each individual and the relatively short duration protocol. Furthermore, this intervention does not require expensive equipment or pharmaceuticals and may prove to be a preferred adjunctive intervention for fibromyalgia in the primary care setting. Finally, although some practitioners suspect that patients with fibromyalgia are unwilling to consider a psychologically oriented, self-management approach, our experience found substantial interest in this intervention among patients, and attrition was very low. Individuals with fibromyalgia in this study appeared to accept the central messages of the intervention: that the experience of pain in fibromyalgia is real, that fibromyalgia pain is processed in the central nervous system, that unresolved emotional experiences can initiate and perpetuate physical symptoms, and that the mind-body link can be tapped to empower individuals with fibromyalgia to more effectively diminish pain and associated symptoms.