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Accepted for/Published in: JMIR Mental Health

Date Submitted: Aug 8, 2024
Date Accepted: Nov 6, 2024

The final, peer-reviewed published version of this preprint can be found here:

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

Macrynikola N, Chen K, Lane E, Nguyen N, Pinto J, Yen S, Torous J

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

JMIR Ment Health 2025;12:e65222

DOI: 10.2196/65222

PMID: 39879612

PMCID: 11822323

The Digital Clinic: Testing the Feasibility of an Innovative Digital Mental Health Care Delivery Model Designed to Increase Access to Care

  • Natalia Macrynikola; 
  • Kelly Chen; 
  • Erlend Lane; 
  • Nic Nguyen; 
  • Jen Pinto; 
  • Shirley Yen; 
  • John Torous

ABSTRACT

Background:

Background:

Mental health concerns have become increasingly prevalent yet care often remains inaccessible to many. While digital mental health interventions offer a promising solution, self-help and even coached apps have not fully addressed these challenges. There is now a growing interest in hybrid 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 and the quality of mental health services.

Objective:

Objective:

To assess the feasibility, acceptability, and potential efficacy of the Digital Clinic model, we conducted a non-randomized open trial with participants experiencing depression, anxiety, or both, at various levels of clinical severity.

Methods:

Methods:

Clinicians were trained in conducting brief transdiagnostic evidence-based treatment that is 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 depressive (PHQ-9), anxiety (GAD-7), and co-morbid depressive and anxiety (PHQ-ADS) symptoms, as well as rates of clinically meaningful change and remission. Secondary outcomes included change in functional impairment, self-efficacy in managing emotions, and flourishing.

Results:

Results:

Participants were 215 individuals, primarily White (70%) cisgender women (63%) with a mean age of 41 (SD = 14). Feasibility and acceptability was good to excellent across a range of domains. The program demonstrated potential efficacy: The average PHQ-9 score decreased from moderate/moderately severe at baseline (M = 13.39, SD = 4.53) to sub-clinical (M = 7.79, SD = 4.61) by the end of the intervention, t(127) = 12.50, p < .001, d = 1.11. Similarly, the average GAD-7 score decreased from moderate at baseline (M = 12.93, SD = 3.67) to sub-clinical (M = 7.35, SD = 4.19) by the end of the intervention, t(114) = 13, p <.001, d = 1.22. Participation in the program was also associated with high rates of clinically significant improvement and remission.

Conclusions:

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


 Citation

Please cite as:

Macrynikola N, Chen K, Lane E, Nguyen N, Pinto J, Yen S, Torous J

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

JMIR Ment Health 2025;12:e65222

DOI: 10.2196/65222

PMID: 39879612

PMCID: 11822323

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