Testing the Feasibility, Acceptability, and Potential Efficacy of an Innovative Digital Mental Health Care Delivery Model Designed to Increase Access to Care: Open Trial of the Digital Clinic.

Background: Mental health concerns have become increasingly prevalent; however, care remains inaccessible to many. While digital mental health interventions offer a promising solution, self-help and even coached apps have not fully addressed the challenge. There is now a growing interest in hybrid, or blended, care approaches that use apps as tools to augment, rather than to entirely guide, care. The Digital Clinic is one such model, designed to increase access to high-quality mental health services.

Objective: To assess the feasibility, acceptability, and potential efficacy of the Digital Clinic model, this study aims to conduct a nonrandomized open trial with participants experiencing depression, anxiety, or both, at various levels of clinical severity.

Methods: Clinicians were trained in conducting brief transdiagnostic evidence-based treatment augmented by a mental health app (mindLAMP); digital navigators were trained in supporting participants' app engagement and digital literacy while also sharing app data with both patients and clinicians. Feasibility and acceptability of this 8-week program were assessed against a range of benchmarks. Potential efficacy was assessed by calculating pre-post change in symptoms of depression (Patient Health Questionnaire-9; PHQ-9), anxiety (7-item Generalized Anxiety Disorder; GAD-7), and comorbid depression and anxiety (Patient Health Questionnaire Anxiety and Depression Scale; PHQ-ADS), as well as rates of clinically meaningful improvement and remission. Secondary outcomes included change in functional impairment, self-efficacy in managing emotions, and flourishing.

Results: Of the 258 enrolled participants, 215 (83.3%) completed the 8-week program. Most were White (n=151, 70.2%) and identified as cisgender women (n=136, 63.3%), with a mean age of 41 (SD 14) years. Feasibility and acceptability were good to excellent across a range of domains. The program demonstrated potential efficacy: the average PHQ-9 score was moderate to moderately severe at baseline (mean 13.39, SD 4.53) and decreased to subclinical (mean 7.79, SD 4.61) by the end of the intervention (t₁₂₆=12.50, P<.001, Cohen d=1.11). Similarly, the average GAD-7 score decreased from moderate at baseline (mean 12.93, SD 3.67) to subclinical (mean 7.35, SD 4.19) by the end of the intervention (t₁₁₃=13, P<.001, Cohen d=1.22). Participation in the program was also associated with high rates of clinically significant improvement and remission.

Conclusions: Results suggest that the Digital Clinic model is feasible, acceptable, and potentially efficacious, warranting a future randomized controlled trial to establish the efficacy of this innovative model of care.