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
BackgroundMental 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 growin...
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| Format: | Article |
| Language: | English |
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JMIR Publications
2025-01-01
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| Series: | JMIR Mental Health |
| Online Access: | https://mental.jmir.org/2025/1/e65222 |
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| author | Natalia Macrynikola Kelly Chen Erlend Lane Nic Nguyen Jennifer Pinto Shirley Yen John Torous |
| author_facet | Natalia Macrynikola Kelly Chen Erlend Lane Nic Nguyen Jennifer Pinto Shirley Yen John Torous |
| author_sort | Natalia Macrynikola |
| collection | DOAJ |
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BackgroundMental 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.
ObjectiveTo 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.
MethodsClinicians 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.
ResultsOf 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.
ConclusionsResults 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. |
| format | Article |
| id | doaj-art-c1d2aafea996459fb95bc6b88d92d27f |
| institution | Kabale University |
| issn | 2368-7959 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | JMIR Publications |
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| series | JMIR Mental Health |
| spelling | doaj-art-c1d2aafea996459fb95bc6b88d92d27f2025-01-29T19:30:45ZengJMIR PublicationsJMIR Mental Health2368-79592025-01-0112e6522210.2196/65222Testing 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 ClinicNatalia Macrynikolahttps://orcid.org/0000-0003-2988-5503Kelly Chenhttps://orcid.org/0009-0002-8071-6641Erlend Lanehttps://orcid.org/0009-0005-7120-2755Nic Nguyenhttps://orcid.org/0009-0007-5364-3682Jennifer Pintohttps://orcid.org/0009-0009-4024-4978Shirley Yenhttps://orcid.org/0000-0002-7194-1380John Toroushttps://orcid.org/0000-0002-5362-7937 BackgroundMental 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. ObjectiveTo 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. MethodsClinicians 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. ResultsOf 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. ConclusionsResults 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.https://mental.jmir.org/2025/1/e65222 |
| spellingShingle | Natalia Macrynikola Kelly Chen Erlend Lane Nic Nguyen Jennifer Pinto Shirley Yen John Torous 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 Mental Health |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://mental.jmir.org/2025/1/e65222 |
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