medwireNews: A 12-week self-guided, smartphone-delivered, digital acceptance and commitment therapy (ACT) program offers a “safe and effective” nonpharmacological intervention for adults with fibromyalgia, suggest the PROSPERFM trial investigators.
Lesley Arnold (University of Cincinnati, Ohio, USA) and team report that “[a]nalysis of the intention-to-treat population supports the clinical benefits of digital ACT [a form of cognitive behavioural therapy (CBT)] compared with an active control and showed statistical superiority in improvement of patients’ wellbeing, lowering the severity of fibromyalgia, and reducing the impact of fibromyalgia-associated symptoms, such as pain, fatigue, sleep problems, and depression.”
The phase 3 trial, conducted at 25 US community sites between February 2022 and February 2023, involved 275 adult patients with fibromyalgia aged 22–75 years (mean 49 years), of whom 93% were women and 83% were White.
A total of 140 participants were randomly assigned to the digital ACT program that “includes acceptance, mindfulness, and valuesbased behaviour change skills,” note the researchers.
The digital ACT app featured eight structured chapters with 42 daily sessions. Each session included a lesson on an ACT skill, an audio awareness activity, a journaling activity, and a self-guided exercise activity to aid physical functioning. Participants spent approximately 15–20 minutes completing each session, with new ones becoming available only after finishing the previous lesson.
Following the completion of all sessions, a reinforcement phase began, aimed at strengthening and integrating the lessons learned into daily life.
The remaining 135 participants received the symptom-tracking active control app which included educational materials on fibromyalgia and general health, as well as daily questions for tracking symptoms and functionality, with progress charts available for regular review.
The results published in The Lancet show that 71% of participants in the digital ACT group reported experiencing at least a minimal improvement on the patient global impression of change (PGIC) scale at week 12, compared with 22% of controls, a significant difference.
In addition, patients given digital ACT were significantly more likely to experience “much improved or better” on the PGIC than controls (25.9 vs 4.5%), and significantly less likely to report being “minimally worse or much worse” (24.0 vs 5.0%).
Digital ACT also showed superiority over the active control strategy in a continuous analysis of PGIC.
Analysis of the secondary endpoints showed that a significantly greater proportion of patients in the digital ACT than control group reported improvements in functional impairment on the Fibromyalgia Impact Questionnaire Revised (FIQ-R) total score, at 45% and 23%, respectively.
Additionally, “significant benefits [emerged] early in treatment between weeks 2 and 7 on nearly all measures,” the researchers say, with significant effect sizes by week 12 observed in the four FIQ-R domains of function, overall impact, symptoms, and a 20% or greater improvement.
Participants in the digital ACT group demonstrated significant improvements in fibromyalgia-associated symptoms including fatigue, sleep disturbance, pain intensity, pain interference, and depression compared with the active control group.
Moreover, patients using the digital ACT app experienced fewer adverse events and had a lower dropout rate than participants of previously reported phase 3 clinical trials of fibromyalgia medications, Arnold et al say.
The researchers observe that the digital ACT app offers patients greater flexibility and convenience than other non-drug fibromyalgia interventions, but does require greater self-discipline to integrate into daily living.
They therefore conclude that “[g]iven the selfguided nature of the intervention and the strong safety profile, prescribing clinicians managing fibromyalgia patients could also prescribe digital ACT.”
In a related comment, Guilherme Torres Vilarino (Santa Catarina State University, Florianópolis, Brazil) highlights that these results “are essential for professionals who care for patients with fibromyalgia as they present a new viable treatment alternative.”
He emphasizes the importance of multidisciplinary treatment for fibromyalgia patients and suggests that “alternative treatments that can facilitate improved access are essential,” especially since psychological therapies like CBT are often inaccessible to those with fibromyalgia despite their frequent psychological comorbidities.
medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2024 Springer Healthcare Ltd, part of the Springer Nature Group.
Lancet 2024; doi:10.1016/S0140-6736(24)00909-7
Lancet 2024; doi:10.1016/S0140-6736(24)01133-4
