In the last decade, there has been burgeoning interest in the effectiveness of third-generation psychological therapies for managing fibromyalgia (FM) symptoms. The present study examined the effectiveness of acceptance and commitment therapy (ACT) on functional status as well as the role of pain acceptance as a mediator of treatment outcomes in FM patients. A total of 156 patients with FM were enrolled at primary health care centers in Zaragoza, Spain. The patients were randomly assigned to a group-based form of ACT (GACT), recommended pharmacological treatment (RPT; pregabalin + duloxetine), or wait list (WL). The primary end point was functional status (measured with the Fibromyalgia Impact Questionnaire, FIQ). Secondary end points included pain catastrophizing, pain acceptance, pain, anxiety, depression, and health-related quality of life. The differences between groups were calculated by linear mixed-effects (intention-to-treat approach) and mediational models through path analyses. Overall, GACT was statistically superior to both RPT and WL immediately after treatment, and improvements were maintained at 6months with medium effect sizes in most cases. Immediately after treatment, the number needed to treat for 20% improvement compared to RPT was 2 (95% confidence interval 1.2-2.0), for 50% improvement 46, and for achieving a status of no worse than mild impaired function (FIQ total score <39) also 46. Unexpectedly, 4 of the 5 tested path analyses did not show a mediation effect. Changes in pain acceptance only mediated the relationship between study condition and health-related quality of life. These findings are discussed in relation to previous psychological research on FM treatment.

Introduction: Help4Mood is an interactive system with an embodied virtual agent (avatar) to assist in self-monitoring of patients receiving treatment for depression. Help4Mood supports self-report and biometric monitoring and includes elements of cognitive behavioural therapy. We aimed to evaluate system use and acceptability, to explore likely recruitment and retention rates in a clinical trial and to obtain an estimate of potential treatment response with a view to conducting a future randomised controlled trial (RCT). Methods: We conducted a pilot RCT of Help4Mood in three centres, in Romania, Spain and Scotland, UK. Patients with diagnosed depression (major depressive disorder) and current mild/moderate depressive symptoms were randomised to use the system for four weeks in addition to treatment as usual (TAU) or to TAU alone. Results: Twenty-seven individuals were randomised and follow-up data were obtained from 21 participants (12/13 Help4Mood, 9/14 TAU). Half of participants randomised to Help4Mood used it regularly (more than 10 times); none used it every day. Acceptability varied between users. Some valued the emotional responsiveness of the system, while others found it too repetitive. Intention to treat analysis showed a small difference in change of Beck Depression Inventory II (BDI-2) scores (Help4Mood –5.7 points, TAU –4.2). Post-hoc on-treatment analysis suggested that participants who used Help4Mood regularly experienced a median change in BDI-2 of –8 points. Conclusion: Help4Mood is acceptable to some patients receiving treatment for depression although none used it as regularly as intended. Changes in depression symptoms in individuals who used the system regularly reached potentially meaningful levels.