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Background Mobile health (mHealth) technologies have been used extensively in psychosis research. In contrast, their integration into real-world clinical care has been limited despite the broad availability of smartphone-based apps targeting mental health care. Most apps developed for treatment of individuals with psychosis have focused primarily on encouraging self-management skills of patients via practicing cognitive behavioral techniques learned during face-to-face clinical sessions (eg, challenging dysfunctional thoughts and relaxation exercises), reminders to engage in health-promoting activities (eg, exercising, sleeping, and socializing), or symptom monitoring. In contrast, few apps have sought to enhance the clinical encounter itself to improve shared decision-making (SDM) and therapeutic relationships with clinicians, which have been linked to positive clinical outcomes. Objective This qualitative study sought clinicians’ input to develop First Episode Digital Monitoring (FREEDoM), an app-based mHealth intervention. FREEDoM was designed to improve the quality, quantity, and timeliness of clinical and functional data available to clinicians treating patients experiencing first-episode psychosis (FEP) to enhance their therapeutic relationship and increase SDM. Methods Following the app’s initial development, semistructured qualitative interviews were conducted with 11 FEP treatment providers at 3 coordinated specialty care clinics to elicit input on the app’s design, the data report for clinicians, and planned usage procedures. We then generated a summary template and conducted matrix analysis to systematically categorize suggested adaptations to the evidence-based intervention using dimensions of the Framework for Reporting Adaptations and Modifications‐Enhanced (FRAME) and documented the rationale for adopting or rejecting suggestions. Results The clinicians provided 31 suggestions (18 adopted and 13 rejected). Suggestions to add or refine the content were most common (eg, adding questions in the app). Adaptations to context were most often related to plans for implementing the intervention, how the reported data were displayed to clinicians, and with whom the reports were shared. Reasons for suggestions primarily included factors related to health narratives and priorities of the patients (eg, focus on the functional impact of symptoms vs their severity), providers’ clinical judgment (eg, need for clinically relevant information), and organizations’ mission and culture. Reasons for rejecting suggestions included requests for data and procedures beyond the intervention’s scope, concerns regarding dilution of the intervention’s core components, and concerns about increasing patient burden while using the app. Conclusions FREEDoM focuses on a novel target for the deployment of mHealth technologies in the treatment of FEP patients—the enhancement of SDM and improvement of therapeutic relationships. This study illustrates the use of the FRAME, along with methods and tools for rapid qualitative analysis, to systematically track adaptations to the app as part of its development process. Such adaptations may contribute to enhanced acceptance of the intervention by clinicians and a higher likelihood of integration into clinical care. Trial Registration ClinicalTrials.gov NCT04248517; https://tinyurl.com/tjuyxvv6

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BACKGROUND Mobile health (mHealth) technologies have been used extensively in psychosis research. In contrast, their integration into clinical care has been sparse, despite substantial increase in the availability of smartphone-based apps targeting mental health care. One potential reason is that few of these apps have been developed with input from stakeholders (e.g., clinicians), the primary users of data from such applications, making their integration into routine clinical care challenging. OBJECTIVE This qualitative study sought clinicians’ input to inform the adaptation of FREEDoM, an app-based mHealth intervention designed to enhance treatment of patients with first-episode psychosis (FEP). METHODS The FREEDoM app was developed to enhance the quality, quantity, and timeliness of clinical and functional data available to clinicians and patients in order to enhance their therapeutic relationship and increase shared decision-making. Following the app’s initial development, semi-structured qualitative interviews were conducted with 11 FEP treatment providers at three sites to elicit input on the app. We then conducted summary template and matrix analysis to systematically categorize suggested adaptations using dimension of the Framework for Reporting Adaptations and Modifications to Evidence-based interventions (FRAME) and documented the rationale for adopting/rejecting suggestions. RESULTS The clinicians provided 31 suggestions (18 adopted, 13 rejected). Suggestions to add/refine content were most common (e.g., adding questions within the app). Adaptations to context were most often related to plans for implementing the intervention, how reported data were displayed to clinicians, and with whom reports were shared. Reasons for suggestions primarily included factors related to clients’ health narratives/priorities (e.g., symptom’s functional impact vs. their frequency/severity), providers’ clinical judgment (e.g., need for clinically relevant information), and organizations’ mission/culture. Reasons for rejecting suggestions included need for resources beyond intervention scope, concerns regarding dilution of the intervention core components, and increasing patient burden. CONCLUSIONS This study describes the development of the FREEDoM app, an innovative stakeholder-informed intervention designed to enhance treatment for individuals with FEP. Our study illustrates a pragmatic application of the FRAME and provides methods and tools for rapid analysis to track adaptations and related decision-making processes, potentially contributing to its acceptance and use in clinical care. CLINICALTRIAL Trial registration: ClinicalTrials.gov #NCT04248517, registered Jan. 30, 2020 https://clinicaltrials.gov/ct2/show/NCT04248517?term=using+mhealth&draw=2&rank=4