Fibromyalgia is defined as a syndrome characterized by moderate to severe symptoms, including widespread pain, fatigue, sleep disturbance, cognitive complaints, and an increase in somatic complaints [1]. Despite ongoing efforts to clarify the definition of fibromyalgia, accurately assessing its diagnosis, prevalence, management, and its personal and societal impacts remains challenging [2]. Fibromyalgia can be accompanied by psychiatric, rheumatological, gastrointestinal, or other comorbidities, which further complicate the management and contribute to its overall personal and societal burden [3].

Proposing a clear treatment strategy for fibromyalgia remains challenging. The focus is on nonpharmacological therapies, particularly physical interventions, psychological treatments, and mind-body approaches that aim to promote self-management. Patient education plays a crucial role in enhancing their understanding of the disease and fostering their active participation in its management. Pharmacological treatments have shown limited benefits [4-8]. Multimodal treatment programs are recommended for treatment-resistant fibromyalgia patients, as they combine different treatment modalities and offer group effects. However, such programs require significant resources that are not necessarily considered cost-effective.

Self-management programs play a crucial role in supporting individuals with chronic conditions [9] and are recommended by management fibromyalgia guidelines [4-7]. The fundamental concept of self-management emphasizes the active involvement of patients [9,10]. Self-management considers the multidimensional nature of the illness and combines multiple interventions such as psychological interventions, exercise, and nutritional aspects. It offers a relevant approach to address the challenges in fibromyalgia management and shows its efficiency to improve fibromyalgia patients’ well-being [11,12] and a reduced tendency of patients to seek repeated consultations with health care professionals. A plethora of these programs have shown an improvement in pain intensity, functionality, cognitive behavior, emotions, and quality of life (QoL). However, the quality of these studies is heterogeneous [13-17]. When programs are detailed, their references are often unclear, relying on peer opinions or interviews [18-24], or they may offer only one component, such as psychoeducation or exercises [25-28].

The digital transformation is continuously shaping the health care landscape. It encompasses various digital innovations such as online programs, apps, gaming, virtual reality, or, more recently, generative artificial intelligence (AI) and chatbots [29]. In a clinical context, mobile health (mHealth) apps have demonstrated several key functionalities, including diagnostics and clinical decision support, behavior change interventions, and the delivery of disease-related education and communication support. The latter 3 functionalities are particularly relevant for delivering self-management interventions, empowering patients to monitor and manage their own health conditions, and providing an additional avenue for health care professionals to support their patients’ well-being [30]. In 2019, a law was passed in Germany that digital health applications are reimbursable by health insurance companies under certain conditions. Currently, 8 digital health applications for musculoskeletal indications are registered; 2 of those are for chronic pain syndromes, including fibromyalgia [31]. There was a second acceleration of eHealth during the COVID-19 pandemic, notably concerning telemonitoring and video consultations. In the meantime, eHealth interventions have been shown to enhance patients’ QoL and treatment experiences [32,33].

Online programs and mobile apps have demonstrated promising benefits for individuals with chronic pain or musculoskeletal conditions [33,34]. The use of mHealth technologies offers an accessible and available 24/7 solution without geographical constraints, empowering patients to become more self-reliant in managing their chronic conditions [35,36]. Notwithstanding, there are several caveats and limitations in existing solutions. A substantial proportion of currently available online fibromyalgia programs are not evidence-based or lack proven, evidence-based content. They are usually not personalized and cannot be updated, as this would alter the certification status of the device. On the other hand, recent digital tools such as large language models (LLMs) and chatbots offer novel approaches that could address some of these limitations.

The objective of this work is to present an evidence-based framework and recommendations to guide the development of an mHealth self-management program for patients with fibromyalgia. A comprehensive literature review was conducted to evaluate the effectiveness of self-management interventions on symptoms in patients with fibromyalgia (phase 1). Where applicable, relevant practical characteristics of the interventions were also reported. In phase 2, existing therapeutic fibromyalgia apps and online programs were reviewed, and in phase 3, general aspects and user preferences were discussed in focus groups with patients. Finally, we aimed to identify strategies to optimize online self-management interventions and explore their potential for further improvement.

This study is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors.

In this part of the work, we investigated which type of self-management is integrated in existing apps for fibromyalgia and chronic pain syndromes (Table 1). Online fibromyalgia applications were identified via PubMed, Google, and the German Digitale Gesundheitsanwendung (DiGA) registry [76], as well as with ChatGPT (OpenAI). Available mobile apps targeting fibromyalgia self-management reveal a strong emphasis on psychoeducational content, particularly CBT, ACT, and pain neuroscience education. Out of the 12 reviewed apps, 10 integrate psychoeducational modules, often presented through structured lessons, interactive exercises, journaling tools, or virtual coaching. Physical activity interventions, such as aerobic or resistance exercise guidance, were integrated in 6 apps, typically via instructional videos, activity logging, or synchronization with wearable devices. Mind-body techniques, including guided meditation, breathing exercises, and mindfulness-based practices, were found in about 5 apps. This distribution highlights a predominant focus on psychological and cognitive strategies in current digital interventions, with fewer apps addressing physical or somatic components in depth.

Two applications, HelloBetter Chronic Pain and Stanza, are certified digital therapeutics. HelloBetter is DiGA-approved in Germany, meaning they are reimbursable by statutory health insurance and have met criteria for clinical evidence and data security. Stanza, developed in the United States, is US Food and Drug Administration–cleared as a prescription digital therapeutic, offering a 12-week ACT-based program with demonstrated clinical efficacy in reducing fibromyalgia symptoms [77]. The remaining apps, including Curable, MoreGoodDays, Manage My Pain, and FibroMapp, are publicly available but lack medical certification and are typically framed as wellness tools or digital companions rather than regulated treatments. Overall, while several apps offer well-designed psychoeducational modules and basic symptom tracking, fewer integrate evidence-based physical activity interventions or comprehensive mind-body components. Among the 12 fibromyalgia self-management apps analyzed, only 5 (42%) can be considered multicomponent, meaning they integrate at least 2 of the 3 core evidence-based intervention domains: psychoeducational therapies, physical activity, and mind-body techniques. Notably, the certified apps HelloBetter Chronic Pain, Selfapy Chronic Pain, and Stanza fall into this category, offering combinations of CBT or ACT, mindfulness, and, in some cases, activity planning. Noncertified apps such as MoreGoodDays and Curable also include psychoeducation and mind-body interventions, but vary in the depth and clinical rigor of their content. While most of the reviewed apps integrate evidence-based components aligned with current clinical guidelines, such as CBT, ACT, and mindfulness-based techniques, several also include strategies with limited or inconclusive evidence in fibromyalgia. For example, some noncertified apps incorporate generic meditation, unstructured journaling, expressive writing, or broad lifestyle advice without therapeutic framing or individual tailoring.

As previously reported, we investigated patient preferences for mobile app design through 2 online surveys (53 and 33 patients, respectively) and 3 focus groups comprising a rheumatologist, 1-6 fibromyalgia patients, with or without concomitant post-COVID-19 syndrome, as well as an app designer [78]. All patients in focus groups tested a self-developed app designed to assess fibromyalgia symptoms and to deliver an online therapeutic program containing CBT, mind-body techniques, and physical exercise instructions. This program was initially developed during the pandemic for fibromyalgia associated with postviral syndrome and was subsequently adapted as an experimental chronic pain companion (Pain Organiser and Companion System). The design and content of this app are described in detail elsewhere [78,79]. In the final focus group (n=1), the online program was connected to an LLM-based chatbot and tested by the patient (see Future Directions section).

Participants emphasized that simplicity, clarity, and accessibility are crucial for adherence, given common cognitive fatigue (“fibrofog”) and limited digital literacy. Users preferred short, well-structured modules, clear navigation, and scientifically validated content in plain, nontechnical language. Autonomy and empowerment emerged as central themes. Patients valued tools that visualize progress, such as symptom tracking and diaries, helping them recognize links between behavior and symptoms. Personalization was highly desired; users wanted adaptable exercises, favorite lists, and an interactive virtual coach or chatbot that responds to individual needs and previous activity. An empathic, motivating tone was considered essential. Participants appreciated friendly communication and multimedia content, particularly physiotherapy videos and mindfulness modules. Emotional design elements, positive wording, supportive colors, and encouraging feedback were viewed as vital for engagement and adherence. Reliability and trustworthiness were further priorities: users expected apps to be evidence-based, transparent, and secure, with clear data protection and professional validation. Barriers such as poor navigation, cognitive overload, or lack of emotional connection can significantly reduce adherence. The focus group highlighted that fibromyalgia mHealth apps offer the potential to serve as multicomponent platforms, covering the 3 key therapeutic domains discussed above: psychoeducation, mind-body techniques, and physical exercise guidance. Of note, instructions for physical exercises were appreciated by participants in the focus groups, ideally with more individualization (eg, for individuals with obesity).

There is proven evidence for psychoeducational interventions, mind-body therapies, and physical activities in fibromyalgia. All 3 are included in most of the current fibromyalgia mHealth applications on the market, several of those with proven efficacy in randomized controlled trials, although the underlying therapeutic content is not openly accessible [75]. CBT remained strongly recommended to assist patients with fibromyalgia in managing their pain, comorbidities, and lifestyle [49] and is the main approach used in existing fibromyalgia apps. Apart from CBT interventions, psychoeducation focuses on pain coping skills, mindfulness, lifestyle modification, and pain neuroscience education. The recommendations regarding mind-body therapies such as MMT, meditation, relaxation, or hypnosis are conflicting but safe and therefore might be integrated in apps as an adjunct. Certain interventions, such as stress reduction, breathing, and relaxation exercises, are notably suitable for integrating into apps as animation can be positive, such as a balloon for breathing exercises.

Half of the existing fibromyalgia apps integrate physical exercises into their program, but mostly only to a lower degree compared to CBT. The content of existing apps contrasts with technically more sophisticated physiotherapy or online rehabilitation apps; for example, integrating computer vision to instruct and monitor a wide range of exercises. In general, it can be postulated that true multicomponent apps integrating all 3 validated pillars of fibromyalgia self-management, psychoeducation, physical activity, and mind-body techniques, guided by clinical standards and codeveloped with patient input, would improve the effect.

From a technical side, both web and native apps are viable platforms for integrating self-management tools and tracking disease activity in fibromyalgia. Native apps are particularly effective at incorporating wearable data directly from mobile devices, enabling continuous monitoring and data capture. Symptom tracking is typically based on patient-reported outcomes or symptom scores, including measures of pain, QoL, depression, anxiety, self-efficacy, acceptance, catastrophizing, fear-avoidance, physical function (eg, strength and disability), sleep quality, fatigue, and health care use indicators such as clinic visits, sick leave, and return-to-work patterns.

These apps often incorporate validated instruments such as the FIQ, the Symptom Severity Score, or the Widespread Pain Index to assess disease activity. Therapeutic content is typically delivered through text, animated videos, or voice formats, providing education, instructions, and exercises. In some cases, apps are integrated with connected devices, such as wearables that deliver millimeter wave stimulation [80]. Animation can be used to enhance certain exercises, such as balloons being used to synchronize breathing frequency and intensity.

Stand-alone apps, particularly those certified as digital therapeutics, often include a structured program guide to track patient progress. This is important for potential reimbursement by health insurers. Increasingly, mHealth apps also integrate chatbots that guide users through the program, enhance flexibility, and potentially improve adherence, one of the main challenges of these interventions. Successful therapeutic apps for this population require a balance between scientific rigor, user-friendly design, and emotionally intelligent interaction. A clinical and evidence-based framework for fibromyalgia interventions in apps can be found in Table 2. Textbox 1 presents practical recommendations for the corresponding app design and implementation roadmap.

The literature search was limited to PubMed and Cochrane databases, potentially introducing selection bias, and the cutoff at 2023 excluded recent studies or emerging interventions. Another limitation of this viewpoint concerns the transferability of conventional evidence-based therapies to digital formats. The effectiveness of individual therapeutic elements within apps remains largely untested, and user experience likely plays a decisive role. Adherence is particularly critical, as unguided online interventions often show low engagement. Psychiatric comorbidities, such as depression, trauma, and cognitive fatigue, further affect adherence and suggest that some users may benefit from guided or coach-assisted programs rather than fully automated ones. The human and group-based components of multimodal therapy are difficult to replicate digitally, raising questions about the optimal degree of human involvement in digital therapeutics. Device-based or biofeedback interventions were not included, as they require additional hardware not universally accessible; however, future versions may integrate smartwatch-based or wearable data.

Finally, personalization remains a key challenge. As fibromyalgia is heterogeneous, tailored approaches—whether based on symptom profiles or machine learning–derived phenotypes—are needed. Future studies should also account for contextual factors such as age, culture, digital literacy, and socioeconomic status, as well as identify which behavior change techniques drive engagement and outcomes. Guided and adaptive interventions appear more effective than static content, highlighting the importance of iterative, patient-centered design in future mHealth development.

As seen in other digital interventions, such as for depression, the inclusion of a channel for direct interaction with a health care professional or, potentially, a bot can increase effectiveness. Voice message transcription features can facilitate semiautomated, asynchronous communication. In this context, agentic AI trained on such interactions may provide supplementary or alternative support. Dashboards play a critical role in integrating fibromyalgia mHealth applications into the clinical workflow, enabling health care professionals to monitor their patients and app activity. Ideally, these dashboards should interface with electronic medical records through sidecar applications [81]. Personalization of content according to fibromyalgia subtypes should be encouraged. However, this increased individualization may make the creation of robust evidence or standardized certification more challenging. As a future perspective, new content formats could be developed and evaluated, such as therapeutic stories or short interventions. For example, therapeutic stories could resemble YouTube Shorts, with AI algorithms applied to tailor and deliver these formats accordingly. Other future digital directions for fibromyalgia apps will move beyond psychoeducation toward multimodal, personalized therapy ecosystems. Integration of exercise modules, CBT, and mindfulness into cohesive platforms is expected, with adaptive interfaces that adjust content to each user’s symptom patterns, motivation, and cognitive load. LLMs and AI-powered chatbots will evolve from static text-based assistants to emotionally intelligent digital companions that guide users through daily self-management, provide empathetic feedback, and interface with sensor data from wearables for sleep, mobility, or stress tracking. These systems could enhance adherence, detect flares early, and personalize pacing and exercise recommendations. Meanwhile, interoperability, data privacy, and regulatory validation will remain crucial to ensure clinical reliability and ethical use. Ultimately, the future of fibromyalgia apps lies in hybrid digital care, combining automated AI-driven support with human coaching and clinical oversight. By blending evidence-based therapy, personalization, and human empathy, next-generation digital therapeutics may finally bridge the gap between self-management and sustained symptom improvement.

Evidence-based foundations are needed to inform the development of effective digital therapeutic applications for fibromyalgia. To build impactful digital therapeutics, it is essential to integrate validated self-management strategies, engage key stakeholders, and consider social and cultural determinants. An iterative development process, guided by ongoing assessment of usability, effectiveness, equity, and safety, will ensure that mHealth tools align with both clinical goals and patient needs.