Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 18, 2024
Date Accepted: Jun 16, 2025
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Piloting Digital Navigators to Promote Acceptance and Engagement With Digital Mental Health Applications in German Outpatient Care: Protocol for a Mixed-Method Interventional Study
ABSTRACT
Background:
In Germany, patients often have to wait several months for a psychotherapeutic treatment. Digital therapeutics (DTx) offer a promising approach to providing timely mental health support. However, their use is still limited. Digital navigators (DNs) are specially trained advanced practice providers who support health care professionals (HCPs) and patients in the selection and use of DTx. This can improve digital health literacy, increase engagement and reduce the burden on HCPs.
Objective:
The DigiNavi study is the first pilot study to test the feasibility of implementing DNs in general practice and outpatient psychiatric care in Germany.
Methods:
I) In order to explore the acceptance and expectations of HCPs and patients towards DNs, a qualitative study will be conducted. II) The Harvard Digital Navigator Training will be adapted and advanced practice providers will be trained to become DNs at n=6 study sites. III) The DNs will guide a total of n=48 patients in the use of DTx for mental health. The patients’ digital health literacy and the severity of their psychological symptoms will be assessed quantitatively in a pre-post comparison. In addition, user experience and barriers to implementation will be explored qualitatively.
Results:
The study provides important insights into the acceptability and feasibility of human-facilitated competency development for mental health apps in multi-professional health care teams and their patients.
Conclusions:
The successful implementation of DNs can promote the use of DTx in Germany and thus enhance the provision of healthcare for individuals with mental health conditions. Clinical Trial: German Clinical Trials Registry (DRKS), registration number: DRKS00034327, https://drks.de/search/de/trial/DRKS00034327 ClinicalTrials.gov, registration number: NCT06575582, https://clinicaltrials.gov/study/NCT06575582?term=digital%20navigators&rank=1
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