Digital Health Navigators for the Integration of Digital Mental Health Applications in Ambulatory Care

A Prospective Feasibility Study

People wanting to start psychotherapeutic treatment in Germany have to wait several months (1). Digital health applications (Digitale Gesundheitsanwendungen, DiGAs) can bridge this period in an easily accessible way. Although since they were introduced in 2020, 30 DiGAs for mental health have become available and prescription numbers are rising, their actual use is less than expected (2). The reasons include lacking knowledge among treating professionals about integrating digital health applications and barriers to access or use in patients’ everyday lives (2, 3). Internationally, digital health navigators (DHNs) are used increasingly, which support medical teams as well as patients in selecting, using, and integrating digital health applications (4). The DigiNavi Study is the first to investigate the feasibility of using DHNs in Germany as well as exploratively patient related outcomes.

Methods

The study (07/2024–10/2025) was a multicenter, single-arm, interventional feasibility study carried out in three general practices and three institutional psychiatric outpatient clinics. It was retrospectively registered in the German Clinical Trials Register (DRKS00034327) and ClinicalTrials.gov (NCT06575582). One medical assistant per site was trained to become a DHN in 3×3 hours. The training included DiGAs, mental disorders, and motivational interviewing. The DHNs supported for three months each about eight patients and treating doctors in selecting and using a DiGA. Patients were contacted consecutively by the treating doctors, and those who met the inclusion and exclusion criteria were included. Support was given by means of regular check-ins (mostly on site or by telephone) and included organizational, technical, and motivational support. If signs of acute mental deterioration occurred, the DHNs informed the treating physicians. Patients with a mental disorder requiring treatment (ICD-10: F1, F3–F6 [mental and behavioral disorders due to psychoactive substance use, mood disorders, neurotic, stress-related, and somatoform disorders, behavioral syndromes associated with physiological disturbances and physical factors, disorders of adult personality and behavior] as well as F06.7 [mild cognitive disorder]) who had access to a digital device were included. Exclusion criteria were ongoing psychotherapy or changes in psychopharmacological treatment.

Before and after the intervention period we recorded as primary outcomes the digital health competency (German eHealth Literacy Scale [GR-eHEALS]; Digital Health Literacy Index [DHLI]), technical competency, (Information and Communication Technology (ICT); short scale technology commitment; Digital Use Survey), and readiness to change (Readiness for Change-Survey). Secondary outcomes were global clinical ratings (Global Assessment of Functioning [GAF]; Clinical Global Impression [CGI]) and disorder-specific symptoms (Beck Depression Inventory-II [BDI-II]; Hamilton Depression Rating Scale [HDRS]; Hamilton Anxiety Rating Scale [HAM-A]; Insomnia Severity Index [ISI]) and the quantitative measurement of using DiGAs (engagement).

The data were descriptively analyzed. We used multivariable linear regression to analyze associations between use of DiGAs, rates of checking in, and changes to the level of functioning as well as overall clinical severity.

Results

Of 53 patients included in the study, 42 participated in the follow-up survey. Over the three-months intervention period, a mean of 8.4 (SD 3.4) contacts occurred between study participants and DHNs, mostly lasting 10–20 minutes.

No clinically relevant changes were seen for the primary outcomes: ΔGR-eHEALS: −0.02; 95% confidence interval: [−0.19; 0.14]; ΔDHLI: –0.01 [−0.12; 0.11]; ΔShort-scale technology readiness: –0.18 [−0.56; 0.20]; ΔICT: 0.00 [−0.19; 0.18]; ΔDigital-Use-Survey: –0.01 [−0.07; 0.06]; ΔReadiness-to-change: –0.30 [−0.57; –0.02]. For secondary outcomes, improvements were seen for the global clinical endpoints (ΔGAF: +8.56 [5.47; 11.65]; ΔCGI: –0.83 [−1.17; –0.49]) and disorder-specific symptom measures (ΔBDI-II: –7.21 [−10.86; –3.57]; ΔHAM-A: –5.92 [−10.85; –0.98]; ΔHDRS: –7.11 [−9.98; –4.25]; ΔISI: –3.21 [−4.78; –1.65]; partly smaller case numbers). The use of DiGAs overall was moderate (frequency 2.6; intensity 2.3).

40 of 42 patients (95.2%) reported no need or only a very small need for technical support. More frequent check-ins were associated with greater use of DiGAs (Figure). In the multivariable regression analyses, use of DiGAs and frequency of check-ins were each associated with improved levels of functioning (GAF) and the overall clinical severity (CGI) (Table). No suicides or suicide attempts were documented during the study period.

Figure

Factors of influence on self-reported frequency and intensity of using a prescribed DiGA with support from digital health navigators.

Table

Multivariable linear regression measuring changed levels of functioning (?GAF) and overall clinical severity (?CGI) after 12 weeks (n = 42)

Discussion

The study investigated the feasibility of DHNs in outpatient general medical and psychiatric care in Germany. For the primary outcomes, no relevant changes were observed, which could indicate ceiling effects in high baseline values or lacking changes in the study context. Exploratory analyses show that more frequent check-ins were associated with greater use of DiGAs and greater improvements in the level of functioning and overall clinical severity. This is consistent with international evidence regarding improved adherence as a result of human support (5).

Because of the lack of a control group, these associations cannot unequivocally be separated from non-specific effects of regular contacts or regression to the mean. Furthermore, the mean improvement of the functioning level (ΔGAF ≈ 9 points) is below the threshold of about 10 points, which is often considered clinically significant. In view of the limited time involved (3×3 hours of training for the DHNs; about eight contacts of 10–20 minutes each per patient) the use of DHNs seems practical. Delegating support for DiGAs to trained medical assistants is a potentially resource-saving approach to supporting the use of digital applications.

Given the limited option to ascribe observed changes causally to the intervention, any additional benefit cannot be conclusively judged on the basis of the available data. Randomized trials are required to check effects for validity.

Ethics approval
The study was approved by the ethics committee of the Brandenburg Medical School Theodor Fontane (ref: 218062024-BO-E). It was also registered in the German Clinical Trials Register (DRKS00034327) and ClinicalTrials.gov (NCT06575582).

Funding
The DigiNavi Study was funded by the Federal Ministry of Health in Germany (2524FEP10A).

Laura Freisberg, Eva Meier-Diedrich, Julia Schönbeck, Darja Schubert, Jan Wolff, John Torous, Julian Schwarz

Conflict of interest statement
The authors declare that no conflict of interest exists.

Manuscript received on 14 January 2026, revised version accepted on 18 May 2026.

Translated from the original German by Birte Twisselmann, PhD.

Cite this as
Freisberg L, Meier-Diedrich E, Schönbeck J, Schubert D, Wolff J, Torous J, Schwarz J: Digital health navigators for the integration of digital mental health applications in ambulatory care: A prospective feasibility study. Dtsch Arztebl Int 2026; 123: 453–4;
DOI: 10.3238/arztebl.m2026.0091

References

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