Self-Guided Digital Behavioral Therapy Improved Fibromyalgia Management and Pain

R. Michael Gendreau, MD, PhD

Credit: Linkedin

Digital acceptance and commitment therapy (ACT), a form of cognitive behavioral therapy (CBT), was safe and helped manage fibromyalgia in adult patients when compared with digital symptom tracking.¹

“Despite the proven benefits, real-world access to CBT and ACT is limited by a scarcity of trained therapists, few treatment centers, referral barriers, low insurance reimbursement, and prohibitive costs… A self-guided digital ACT therapy can substantially improve accessibility and enable and promote convenient ACT treatment engagement for patients, potentially enhancing its efficacy and complementing the patient’s overall fibromyalgia management in partnership with their health-care provider,” lead investigator R. Michael Gendreau, MD, PhD, president, Gendreau Consulting, and chief medical officer, Virios Therapeutics, and colleagues wrote.¹

Gendreau and colleagues conducted the 12-week PROSPER-FM trial (NCT05243511) evaluating a self-guided, smartphone-delivered digital ACT program for managing fibromyalgia in patients aged 22-75 years across 25 United States community sites. Participants were randomized to the digital ACT group or an active control group that offered daily symptom tracking and monitoring and access to health-related and fibromyalgia-related educational materials. Participants were informed they would be randomly assigned to 1 of 2 potentially effective therapies under evaluation, with research staff not masked except for a statistics group. The trial’s primary endpoint was patient global impression of change (PGIC) response rate at week 12.

The trial screened 590 people and enrolled 275 (257 women and 18 men) between February 2022 and February 2023. Of the enrolled participants 140 were randomly assigned to the digital ACT group and 135 to the active control group. The investigators found that at 12 weeks, 99 (71%) ACT participants reported improvement on PGIC compared with 30 (22%) active control participants, a 48·4% proportional difference (95% CI, 37·9–58·9; P<·0001). Participants in the digital ACT group were also more likely to be “much improved” or “better” (between-group difference in proportions, 21%; P<.0001), and a much smaller proportion of participants in this group reported worsening on PGIC (5% vs 24%; P <.0001).

Gendreau and colleagues concluded that “among adults with fibromyalgia, 12 weeks of treatment with the self-guided digital ACT app was safe and efficacious compared with an active control. Given the self-guided nature of the intervention and the strong safety profile, prescribing clinicians managing fibromyalgia patients could also prescribe digital ACT. 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.”¹

The digital ACT group also demonstrated superiority over the active control group on Revised Fibromyalgia Impact Questionnaire (FIQR) total score, with a between-group effect size of d=0·65 (least-squares mean difference, −8·04; standard error, 1·50; P<.0001). Digital ACT further demonstrated superiority to active control on Patient-Reported Outcomes Measurement Information System (PROMIS) scores, weekly pain intensity, and weekly pain interference. There were no adverse events related to the digital program reported.¹

“Many people with fibromyalgia can experience difficulties in carrying out remote sessions due to low education, difficulty using technology, and cognitive difficulties (often termed fibrofog). Despite the promising results obtained by Gendreau and colleagues, more studies should be conducted comparing interventions with ACT and other forms of intervention, such as physical exercise and ACT in conjunction with other interventions,” Guilherme Torres Vilarino, PhD, Sport and Exercise Psychology Laboratory, Department of Physical Education, Center for Health and Sports Sciences, Santa Catarina State University, Florianópolis, Brazil, wrote in a related editorial on the study.²

REFERENCES

• Gendreau RM, McCracken LM, Williams DA, et al. Self-guided digital behavioural therapy versus active control for fibromyalgia (PROSPER-FM): a phase 3, multicentre, randomised controlled trial. Lancet. 2024; 404(10450): 364-374. doi: 10.1016/S0140-6736(24)00909-7

• Vilarino GT. Self-guided digital acceptance and commitment therapy as a treatment option for fibromyalgia. Lancet. 2024; 404(10450): 315-317. doi: 10.1016/S0140-6736(24)01133-4