Chronic orofacial pain (COP) is common [1], costly [2], and associated with substantial pain interference (ie, pain-related activity limitations) and emotional distress [3-5]. COP includes a group of conditions that involve pain in the hard and soft tissues of the head, face, and neck that last for more than 3 months [6]. Although the etiological aspects of COP are heterogeneous, COP conditions are unified by a psychosocial profile of substantial maladaptive coping (eg, pain-related fear, pain catastrophizing) [7-9], pain interference, and emotional distress (eg, depression, anxiety) [3,4,10-14], which worsen each other over time [15,16]. Treatments are typically biomedical [4], mostly ineffective [17], and often involve adverse side effects [18], misdiagnoses or incomplete diagnoses [17], and unnecessary/painful procedures (eg, tooth extractions, occlusal adjustment) that may lead to irreversible damage [4,19]. Such treatments do not typically address and often exacerbate activity limitations, maladaptive coping, and emotional distress [4,19]. These psychosocial factors are critical causative elements of COP but are mostly overlooked in COP treatment [20].

Psychosocial interventions such as cognitive behavioral therapy [21-28] and other behavioral programs [29-32] show promise in improving outcomes in individuals with COP [21-32]. However, the existing interventions are limited in several ways: these interventions (1) almost exclusively rely on talking, which is often painful for patients with COP and limits treatment engagement [20,33]; (2) are resource-intensive and require availability of trained providers, limiting accessibility, particularly for underserved communities [34]; (3) often involve costs, travel, and limited insurance coverage [35]; (4) carry a mental health stigma, which limits treatment-seeking and participation [36]; (5) tend to focus on an incomplete diagnosis and mostly temporomandibular disorder, limiting generalizability, and (6) are typically unimodal (eg, cognitive behavioral therapy alone), despite evidence that multimodal interventions work better for complex conditions like COP, which have high psychiatric comorbidity [24,37]. Talk-free asynchronous multimodal web-based platforms can bypass these limitations while maintaining effectiveness [38]. However, to our knowledge, no such interventions exist. Delivering COP interventions through a web-based platform holds potential to expand accessibility, increase scalability, and address this population’s largely unmet needs [20,39].

To this end, we will develop Face-Forward-Web, the first web-based platform adapted and refined via mixed methods for COP by using user-centered design principles [40-43]. Face-Forward-Web will be adapted from GetActive, a mind-body and activity intervention for individuals with chronic musculoskeletal pain [44]. Face-Forward-Web will be delivered via a talk-free asynchronous web platform and will address some of the unique and often unaddressed challenges faced by individuals with COP, including difficulty with talking due to pain [20,33], emotional distress [3,5,20], orofacial pain interference and pain intensity [8], and coping with unpredictable pain [20].

Our conceptual model (Figure 1) is informed by the fear-avoidance framework [45,46] and poses that improvement in pain interference, pain, and emotional distress after participation in Face-Forward-Web will be explained by improvement in the mechanistic targets of pain catastrophizing, fear of pain, and mindfulness. Our guiding hypothesis (to be tested in future work) is that the Face-Forward-Web intervention will be an effective, efficient, and scalable strategy to address the unmet needs and challenges of pain interference and distress among patients with COP.

This study aims to (1) develop Face-Forward-Web with the aid of live video focus groups with adults with COP and (2) optimize Face-Forward-Web and our study protocol through beta testing (n=up to 10) to refine the intervention followed by a feasibility trial (n=up to 20). The results will inform future efficacy research, evaluating Face-Forward-Web versus an active control web platform in improving pain interference, depression, and anxiety.

This study is funded by the National Institute of Dental and Craniofacial Research grant 1R21DE033502-01A1 to JG and AMV. Recruitment began in October 2024 for phase 1. Data collection for phase 1 was completed in March 2025. Primary data analysis for phase 1 is expected to conclude by fall 2025 and in 2026 for phase 2. As of August 2025, we have completed 4 planned focus groups with a total of 22 participants representing a variety of COP diagnoses, including temporomandibular joint dysfunction, trigeminal neuralgia, and burning mouth syndrome. The rapid data analysis is complete, and we are beginning thematic analysis. We are starting to create intervention content, informed by results from our focus groups. Once available, we will share the data and results in the Vivli global clinical research data sharing platform.

Pain interference and emotional distress are prevalent among people with COP [62] but are commonly neglected in current treatments [20,39]. Available psychosocial interventions such as cognitive behavioral therapy [21-28] and other behavioral programs [29-32] show promise in improving outcomes in individuals with COP [21-32] but are often not suitable for people with COP due to several limitations. Most notably, these interventions typically rely on verbal communication, which is often painful for this population due to facial pain symptoms, which can be exacerbated by talking. Additionally, such interventions can be associated with stigma and require extensive resources (eg, availability of a trained live clinician). Here, we describe a protocol to develop, test, and refine Face-Forward-Web, the first talk-free web-based intervention for adults with heterogeneous COP, tailored specifically to meet their needs and challenges. By teaching mind-body (eg, mindfulness, relaxation) and cognitive behavioral skills within a talk-free modality, this intervention holds potential to bypass barriers and address these commonly neglected needs [38].

We anticipate that the results of phase 1 will align with our preliminary work underscoring the need for a COP intervention that addresses psychosocial factors [20] and uses a web-based platform. We also anticipate findings to highlight specific elements of the intervention’s content, structure, and study procedures that can be tailored to maximize fit for this population’s needs. Assuming the successful integration of these findings, we hypothesize that phase 2 will demonstrate high levels of feasibility across domains (eg, user experience, acceptability, adherence) and no adverse events related to study participation.

We follow the NIH stage model [48] and prioritize establishing feasibility and iterative refinement of the intervention prior to efficacy testing. By integrating qualitative methods, our approach centers on participant needs and preferences, ensuring that the intervention is best positioned to support those impacted by COP. Once both phases are complete, these results will inform a future efficacy trial of Face-Forward-Web versus an active control platform.

Potential limitations should be considered. First, the study relies on participants’ self-reported diagnoses and symptoms. This limitation is partially mitigated by our recruitment methods, which include referrals from COP medical specialists and established advocacy groups. Second, our broad diagnostic inclusion criteria may reduce the specificity of the findings. However, our preliminary research suggests that individuals across diagnostic categories share more common needs than differences. This inclusive approach enhances the potential for generalizability to a broader population and may be considered a potential strength. Other strengths include the use of established feasibility benchmarks, validated measures, and following the NIH model for behavioral intervention development.

Our work has yielded a few lessons learned thus far. First, given our small budget, we have had to carefully prioritize spending and have chosen to focus on the remuneration of participants [70]. Additionally, for recruitment, we have found both professional networks (providers who treat COP) and community resources (Facial Pain Association) to be effective. However, meeting our goal of including the perspectives of diverse populations, including a variety of COP diagnoses, as well as racial, ethnic, and medically underserved areas [71] has required additional strategies such as direct engagement of referral providers.

In summary, this protocol describes the development, refinement, and feasibility testing of Face-Forward-Web, the first talk-free web platform for adults with heterogeneous COP, tailored specifically to their needs and challenges by using mixed methods. We will utilize the NIH stage model for behavioral intervention development [47,48], the Science of Behavioral Change framework [72], and a user-centered design process to maximize the intervention’s fit for this population’s needs [40,41]. Our results will establish feasibility and directly inform a subsequent efficacy trial.