Mark A Lumley, Howard Schubiner, Nancy A Lockhart, Kelley M Kidwell, Steven E Harte, Daniel J Clauw, David A Williams

Patients with FM experience increased lifetime levels of psychosocial adversity, trauma, and emotional conflict. To address these risk factors, we developed Emotion Awareness and Expression Therapy (EAET) and tested its benefits against an active control condition, FM Education, and against the field's gold standard intervention for FM, cognitive-behavioral therapy (CBT) for symptom management. Adults with FM (n = 230) formed 40 treatment groups, which were randomized to EAET, CBT, or Education and given eight, 90-min sessions. Patient-reported outcomes were assessed at baseline, post-treatment, and 6-month follow-up (primary endpoint). Retention of patients to follow-up was excellent (90.4%). Intent-to-treat analyses indicated that, although EAET did not differ from FM Education on pain severity (primary outcome), EAET had significantly better outcomes than FM Education on overall symptoms, widespread pain, physical functioning, cognitive dysfunction, anxiety, depression, positive affect, and life satisfaction (between-condition d's ranging from 0.29 to 0.45 SD), and the percentage of patients improving "much/very much" (34.8% vs. 15.4%). EAET did not differ from CBT on the primary or most secondary outcomes, but compared to CBT, EAET led to significantly lower FM symptoms (d = 0.35) and widespread pain (d = 0.37), and a higher percentage of patients achieving 50% pain reduction (22.5% vs. 8.3%). In summary, an intervention targeting emotional awareness and expression related to psychosocial adversity and conflict was well-received, more effective than a basic educational intervention, and had some advantages over CBT on pain. We conclude that EAET should be considered as an additional treatment option for FM.