JMIR Publications

ABSTRACT

Background:

In Germany, patients often have to wait several months for a psychotherapeutic treatment. Digital therapeutics (DTx) offer a promising approach for timely mental health support, but their use remains limited. Digital navigators (DNs) are specially trained medical assistants who support other health care professionals (HCPs) in selecting and using 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:

This mixed-method study takes place at 6 study sites (3 psychiatric outpatient clinics, 3 general practices) in Germany. In the pre-study, patients and HCPs participate in semi-structured interviews and focus groups concerning their acceptance and expectations of DNs. The Harvard Digital Navigator Training (HDNT) will be adapted and medical assistants will be trained as DNs. During the intervention, n=8 patients per site (n=48) diagnosed with a mental disorder are recruited via convenience sampling and supported by DNs in using a DTx for mental health for 3 months. Patients’ (n=48) and HCPs’ (n=18) digital health literacy, digital and technical literacy, readiness and ability to change and clinical symptom severity will be assessed before and after 3 months DTx’ prescription and support by DNs. Quantitative data will be analysed using a pre-post design. Finally, qualitative interviews will be conducted with HCPs, patients, and DNs to explore their experiences with DNs including perceived implementation barriers.

Results:

The pre-study, including n=40 participants, was conducted from August to October 2024. The HDNT adaptation and DN training were conducted from October to December 2024. Recruitment and quantitative baseline data collection started December 2024, enrolling n = 48 participants by the end of February. The intervention study is ongoing and scheduled to end May 2025. Results dissemination and the development of strategies for the long-term implementation of DNs into the German health care system are planned until September 2025. It is hypothesised that the provision of support by the DNs will enhance patients' and practitioners' digital health literacy, digital and technical literacy, and readiness and ability to change. In addition, patients' mental health is expected to improve after the end of the intervention.

Conclusions:

This is the first study to examine the feasibility and effects of DNs in German health care. The study will provide significant insights into the acceptability and feasibility of human-facilitated competency development for mental health apps in multi-professional health care teams and their patients. The successful implementation of DNs can promote the use of DTx in Germany and thus enhance access to and the provision of health care for individuals affected by a mental disorder. Clinical Trial: German Clinical Trial Register: DRKS00034327, https://drks.de/search/en/trial/DRKS00034327; ClinicalTrials.gov: NCT06575582, https://clinicaltrials.gov/study/NCT06575582