Table 2.
Evidence-based framework for fibromyalgia online interventions.
| Intervention domain | Evidence level and rationale | Implementation in mobile health app | Digital enablement features | Evaluation metrics |
| Psychoeducational therapies (CBTa, ACTb, and PNEc) | Strong evidence from RCTsd and guidelines for reducing pain, distress, and maladaptive thoughts | Modular courses; microlearning sessions; quizzes; journaling; goal setting; and self-efficacy tracking | Chatbots or avatars for guidance; adaptive progression based on symptom and mood data; empathy-based conversational tone; and voice message transcription | Pain, FIQe, self-efficacy, catastrophizing, engagement rate, and module completion |
| Physical activity and graded exercise | Strong evidence for aerobic and resistance training improving function and mood | Video demonstrations; personalized exercise plans; daily movement reminders; wearable integration (steps, HRf, and HRVg) | AIh-driven motion feedback (computer vision); adaptive load progression; safety alerts; and gamification | Physical function (FIQ physical domain), fatigue, adherence (logged sessions), and HR and HRV trends |
| Mind-body techniques (mindfulness, Tai Chi, breathing, and relaxation) | Moderate evidence for improving sleep, mood, and QoLi | Audio-guided meditations, breathing animations, mindfulness timers, and relaxation music | Adaptive session lengths; stress biofeedback using HRV; sleep tracking linkage; and integration with smartwatches | Sleep quality, stress index, anxiety, HRV, and app usage continuity |
| Symptom tracking and patient-reported outcomes | Essential for personalization and clinical insight for HCPj | In-app FIQ, pain diaries, and fatigue and sleep trackers | Voice or video symptom entry; AI-based summary visualization; and adaptive dashboard | Data completeness, trend accuracy, and correlation with clinical outcomes |
| Personalization and adaptive design | Increasingly essential for engagement and relevance | Custom goal setting; phenotype-based pathways (eg, obesity-, menopause-, and PTSDk-related FMl) | Machine learning–based tailoring; predictive suggestions for pacing and exercise. Adapted avatars, eg, older people with obesity | User satisfaction, engagement over time, and adaptive accuracy |
| Behavior change and motivation | Crucial for long-term adherence | SMARTm goal planning, feedback loops, and progress visualization | Gamification, motivational messaging, positive reinforcement, and social comparison (optional) | Retention rate, adherence index, and self-efficacy gain |
| Communication and support | Improves adherence and patient safety | Chatbot or professional chat; asynchronous therapist feedback | Hybrid care integration (eg, AI triage + human follow-up); crisis escalation paths | Message frequency, satisfaction, and safety events |
| Data integration and clinical workflow | Enables clinical supervision and research | Clinician dashboard, FHIRn-based interoperability, and data export to EHRo | Sidecar EMR integration; secure teleconsultation channel | Clinical uptake, data completeness, and clinician feedback |
| Accessibility, UXp, and emotional design | Critical for usability and adherence in cognitive fatigue | Clean interface, large icons, voice navigation, and light and dark modes | Emotionally supportive design (colors, feedback tone), simplified onboarding, and language localization | SUSq score, accessibility compliance, and dropout rate |
| Privacy, certification, and ethics | Required for trust and scalability | CEr, FDAs, or DiGAt conformity, and transparent data policies | Privacy-by-design architecture; on-device data processing | Certification status, GDPRu or HIPAAv compliance, and user trust rating |
aCBT: cognitive behavioral therapy.
bACT: acceptance and commitment therapy.
cPNE: pain neuroscience education.
dRCT: randomized controlled trial.
eFIQ: Fibromyalgia Impact Questionnaire.
fHR: heart rate.
gHRV: heart rate variability.
hAI: artificial intelligence.
iQoL: quality of life.
jHCP: health care professional.
kPTSD: posttraumatic stress disorder.
lFM: fibromyalgia.
mSMART: specific, measurable, achievable, relevant, time-bound.
nFHIR: Fast Healthcare Interoperability Resources.
oEHR: electronic health record.
pUX: user experience.
qSUS: System Usability Scale.
rCE: Conformité Européenne.
sFDA: US Food and Drug Administration.
tDiGA: Digitale Gesundheitsanwendung.
uGDPR: General Data Protection Regulation.
vHIPAA: Health Insurance Portability and Accountability Act.