CBT for Fibromyalgia: Acceptance and Commitment Therapy Is Safe, Efficacious

Among adults with fibromyalgia, digital acceptance and commitment therapy (ACT) vs digital symptom tracking is safe and efficacious in managing symptoms and improving overall patient outcomes, according to study results published in The Lancet.

Researchers conducted a phase 3, multicenter, randomized controlled trial (PROSPER-FM; ClincalTrials.gov Identifier: NCT05243511) between February 2022 and May 2023 at 25 US community sites to assess the safety and efficacy of a 12-week, self-guided, smartphone-delivered digital ACT program (Stanza) designed for the management of fibromyalgia. Adults aged 22 to 75 with fibromyalgia were eligible for inclusion and randomly assigned 1:1 to the digital ACT group or an active control group, which was provided with daily symptom tracking, monitoring, and access to educational materials related to health and fibromyalgia. The primary outcome was patient global impression of change (PGIC) response rate at week 12.  The key secondary outcome was change in the revised Fibromyalgia Impact Questionnaire (FIQ-R) total score from baseline to 12 weeks. Safety outcomes were based on monitoring and assessment of adverse events (AEs). Statistical analyses were conducted using SAS version 9.4.

A total of 275 participants were randomly assigned to treatment, of whom 140 (median age, 49.0; women, 94%; White, 84%) were assigned to the digital ACT group and 135 (median age, 49.0; women, 93%; White, 83%) to the symptom tracking active control group.

Participants in the digital ACT and active control groups completed an average of 54.6 and 58.8 therapy sessions, respectively. A total of 42 sessions and more were completed by 72% and 87% of participants in the digital ACT and active control groups, respectively.

At 12 weeks, a greater proportion of participants in the digital ACT vs active control group reported minimal improvement and better (71% vs 22%; P <.0001). Similarly, the second responder analysis based on much improved and better favored the intervention group, with a between-group difference in proportions of 21% (P <.0001).

A response of minimally worse or much worse was reported by 5% and 24% of digital ACT and active control group participants, respectively, at 12 weeks (P <.0001). No participant responded with very much worse.

Response rate on FIQ-R total score was 45% and 23% in the digital ACT and active control groups, respectively (P <.0001). Superiority of digital ACT was demonstrated in all FIQ-R domains, including function, overall impact, and symptoms.

At week 12, significant between-group differences on change from baseline favoring digital ACT treatment were observed for weekly pain intensity and weekly pain interference.  

No device-related AEs were reported in either treatment group. Infection and infestations were the most frequently reported AEs by both the digital ACT (28%) and active control (25%) groups, followed by psychiatric disorder-related events, which were reported by 14% of participants in both groups. All AEs were classified as mild or moderate and no AEs led to deaths, serious AEs, or study discontinuations.

Study limitations include the reduced generalizability of results, small sample sizes, selection bias, and the lack of long-term benefit data.

“Further research is needed to assess treatment effectiveness in a real-world setting, long-term clinical effectiveness, patient characteristics and engagement that predict positive outcomes, and the overall cost-effectiveness of the treatment,” the researchers concluded.

Disclosure: This research was supported by Swing Therapeutics. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.