Self-guided digital behavioural therapy versus active control for fibromyalgia (PROSPER-FM): a phase 3, multicentre,...

Area of Science:

• Digital health interventions
• Behavioral medicine
• Chronic pain management

Background:

• Fibromyalgia management guidelines recommend cognitive behavioral therapies like Acceptance and Commitment Therapy (ACT).
• Existing ACT programs are often inaccessible to patients.
• There is a need for accessible digital interventions for fibromyalgia.

Purpose of the Study:

• To evaluate the effectiveness of a 12-week, self-guided, smartphone-delivered digital ACT program.
• To assess the impact of digital ACT on fibromyalgia management.
• To determine the safety and efficacy of this digital intervention.

Main Methods:

• A randomized clinical trial (PROSPER-FM) involving 275 adult fibromyalgia patients.
• Participants were assigned to either a digital ACT group or an active control group (symptom tracking and educational materials).
• The primary endpoint was patient global impression of change (PGIC) at 12 weeks, analyzed by intention to treat.

Main Results:

• 71% of participants in the digital ACT group reported improvement in PGIC at 12 weeks, compared to 22% in the active control group.
• This represents a significant difference in improvement proportions (48.4%, p<0.0001).
• No device-related safety events were reported during the trial.

Conclusions:

• Smartphone-delivered digital ACT is a safe and effective intervention for managing fibromyalgia in adults.
• This digital approach offers a more accessible alternative to traditional ACT programs.
• Digital ACT shows promise for improving patient-reported outcomes in fibromyalgia.