Digital Navigators for Acceptance and Competence Development with Mental Health Apps
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Support from Digital Navigators to Treatment Team, Support from Digital Navigators to Patients, Training for Digital Navigators.
- Who it may be relevant to
- Registry conditions: Acceptability of Health Care, Engagement, Patient, Nurse's Role, Mental Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this clinical trial is to learn if and how so called "Digital Navigators" (DN) can help general practitioners, outpatient psychiatrists and psychologists as well as their treated patients to use digital mental health apps (DiGAs) and integrate it into their treatment. The main questions it aims to answer are: * What are the chances and implementation barriers of DN? * What are the acceptance and expectations towards DN? * Do DN affect the psychological health of patients? * Do DN affect the digital health literacy and technical competence of participants? Employees of medical teams (e.g. medical assistants) receive training to become a DN. Afterwards patients are accompanied and supported by the DN for 12 weeks to select and use a suitable app for their mental disorder.
Detailed description
The study aims to promote the use of digital health applications (DiGAs) to improve mental health and provide timely treatment for underserved populations. Currently, DiGAs are only used by a small proportion of patients and practitioners in Germany. In order to solve this care problem, employees of medical teams, such as medical assistants, are to be trained as so-called 'digital navigators'. These digital navigators support stakeholders in the selection and use of mental health apps, impart the necessary digital skills, improve adherence and relieve the burden on those providing treatment.
As part of the pilot project, digital navigators will be implemented as an example in GP and outpatient psychiatric care in a rural region of Brandenburg. Firstly, a preliminary study will be conducted to determine the acceptance and expectations of the digital navigators using interviews and focus groups. The researchers then complete a training program at Harvard Medical School and adapt the 'Harvard Digital Navigator Training' to the German framework conditions. This adaptation process is supported by discussion groups with patients and practitioners.
In the next step, medical assistants in six study centres will receive the adapted training. A central tool available to them is the DiGAnavigator.de website, a guide for DiGAs. The digital navigators help with the integration of DiGAs into the treatment of 48 patients with mental illnesses and accompany them over a period of 12 weeks.
Finally, the implementation will be evaluated. The evaluation analyses the implementation hurdles and the effects on the eHealth literacy of patients and professionals. The eHealth Literacy Scale (eHeals) and the Digital Health Literacy Index (DHLI) will be used for this purpose. An accompanying process evaluation analyses the acceptance, effects and implementation barriers of the digital navigators. In addition, both patients and staff are surveyed regarding their digital and technical skills as well as their willingness and ability to change before and after the intervention. Furthermore, the severity of the patients' illness will be recorded and compared before and after the intervention using validated scales. To ensure sustainable implementation, the long-term aim is to provide accredited training to become a digital navigator.
Interventions
- Behavioral Support from Digital Navigators to Treatment Team
The trained professionals (the Digital Navigators) support the treatment teams in the study centers in the selection and integration of suitable apps and digital health applications (DiGAs). - Behavioral Support from Digital Navigators to Patients
The trained professionals (the Digital Navigators) accompany and support the selected patients to find a suitable app for them and integrate it into their treatment. - Behavioral Training for Digital Navigators
The training takes place in the six study centers and is preferably aimed at medical assistants.
Primary outcome measures
- Digital health literacy (focus: digital information retrieval skills) [Time frame: Before (T0) and after completion of the 12-week intervention (T1)]
- Digital health literacy (focus: digital interactive skills) [Time frame: Before (T0) and after completion of the 12-week intervention (T1)]
- Acceptance towards Digital Navigators [Time frame: Before the intervention (T0)]
- Expectations towards Digital Navigators [Time frame: Before the intervention (T0)]
- Expectations towards Digital Navigators [Time frame: Before the intervention (T0)]
- Acceptance towards Digital Navigators [Time frame: Before the intervention (T0)]
Secondary outcome measures (12)
- Willingness and competence to change [Time frame: Before (T0) and after completion of the 12-week intervention (T1)]
- Digital competence [Time frame: Before (T0) and after completion of the 12-week intervention (T1)]
- Technical competence [Time frame: Before (T0) and after completion of the 12-week intervention (T1)]
- Psychological Health of Patients (level of functioning) [Time frame: After completion of the 12-week intervention (T1)]
- Psychological Health of Patients (symptom severity, treatment response and the efficacy of treatment) [Time frame: Before (T0) and after completion of the 12-week intervention (T1)]
- Psychological Health of Patients (depressive symptoms; self-report) [Time frame: Before (T0) and after completion of the 12-week intervention (T1)]
- Psychological Health of Patients (depressive symptoms; clinician-administered) [Time frame: Before (T0) and after completion of the 12-week intervention (T1)]
- Psychological Health of Patients (anxiety) [Time frame: Before (T0) and after completion of the 12-week intervention (T1)]
- Psychological Health of Patients (insomnia) [Time frame: Before (T0) and after completion of the 12-week intervention (T1)]
- Identification of implementation barriers to the introduction of digital navigators [Time frame: After completion of the 12-week intervention (T1)]
- Identification of implementation barriers to the introduction of digital navigators [Time frame: After completion of the 12-week intervention (T1)]
- Use of Digital Health Applications and the effects of counseling and support by Digital Navigators [Time frame: After completion of the 12-week intervention (T1)]
Eligibility criteria
Inclusion criteria
- Main diagnosis according to ICD 10 F00-F69, F80-F99
- Capacity to consent is given
- Sufficient language skills for an interview in German
- Participants have access to modern digital hardware (smartphone)
- Basic knowledge of how to operate a smartphone
Exclusion criteria
- Acute danger to self or others
- Patients have received prompt (<= 3 weeks) qualified psychiatric or psychotherapeutic treatment
- Severe organic brain diseases with cognitive deficits
- Intellectual disability
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Germany · 6 centers
- Praxis Brandenburg an der Havel — Brandenburg an der Havel
- Praxis Eberswalde — Eberswalde
- Psychiatrische Institutsambulanz (PIA) Fürstenwalde — Fürstenwalde
- Praxis Fürstenwalde — Fürstenwalde
- Psychiatrische Institutsambulanz (PIA) Rüdersdorf — Rüdersdorf
- Psychiatrische Institutsambulanz (PIA) Strausberg — Strausberg
Publications
- Schwarz J, Chen K, Dashti H, Heinze M, Schonbeck J, Schubert D, Senst B, Speck J, Torous J, Wolff J, Uchtmann L, Meier-Diedrich E. Piloting Digital Navigators to Promote Acceptance and Engagement With Digital Mental Health Apps in German Outpatient Care: Protocol for a Multicenter, Single-Group, Observational, Mixed Methods Interventional Study (DigiNavi). JMIR Res Protoc. 2025 Sep 25;14:e67655. d PMID 40996088
Identifiers
NCT: NCT06575582 · 00034327