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Acceptability of Health CareDigiNaviNCT06575582

Digital Navigators for Acceptance and Competence Development With Mental Health Apps

A study testing Support from Digital Navigators to Treatment Team, Support from Digital Navigators to Patients and Training for Digital Navigators in people with Acceptability of Health Care and Engagement, Patient, run by Medizinische Hochschule Brandenburg Theodor Fontane at 6 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Support from Digital Navigators to Treatment Team, Support from Digital Navigators to Patients and Training for Digital Navigators
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
6 sitesGermany
Study dates
15 Jul 2024to 31 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Germany6 sites

  • Praxis Brandenburg an der Havel

    Brandenburg an der Havel, Brandenburg, 14776

  • Praxis Eberswalde

    Eberswalde, Brandenburg, 16225

  • Psychiatrische Institutsambulanz (PIA) Fürstenwalde

    Fürstenwalde, Brandenburg, 15517

  • Praxis Fürstenwalde

    Fürstenwalde, Brandenburg, 15518

  • Psychiatrische Institutsambulanz (PIA) Rüdersdorf

    Rüdersdorf, Brandenburg, 15562

  • Psychiatrische Institutsambulanz (PIA) Strausberg

    Strausberg, Brandenburg, 15344

Other trials in Germany

About this study

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.

Read the 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.

Being tested
Support from Digital Navigators to Treatment Team, Support from Digital Navigators to Patients, Training for Digital Navigators
Keywords
digital health, ehealth, mhealth, mental health, health literacy
Medical subject headings
Patient Acceptance of Health Care, Patient Participation, Mental Disorders, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Support from Digital Navigators to Treatment TeamBehavioural

    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).

  • Support from Digital Navigators to PatientsBehavioural

    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.

  • Training for Digital NavigatorsBehavioural

    The training takes place in the six study centers and is preferably aimed at medical assistants.

Study groups in NCT06575582
Study groupRoleWhat they receive
Exploratory preliminary studyNo interventionGeneral practitioners (n = 10), outpatient psychiatrists and psychologists (n = 10) and their patients (n = 20) will be involved. First, partly structured interviews will be conducted with the general practitioners and the psychiatric/psychological professionals as well as the patients they treat in order to record their perspectives on digital health services and the role of digital navigators. In parallel, focus groups will be organized with all three main groups to understand their opinions, concerns and expectations regarding the use of digital health applications and digital navigators. The data collection for the preliminary study extends over a period of 3 months (October - December 2024).
TrainingExperimentalStaff members (n = 6) of participating study cites will be trained to become Digital Navigators. The recruitment and training of the digital navigators will take place over a period of 4 months (October 2024 to January 2025).
Receives: Behavioral: Training for Digital Navigators
Treatment team and patient supportExperimentalThe Digital Navigators support the treatment teams in the study centers in the selection and integration of suitable apps and digital health applications (DiGAs). The selected patients (n = 48, 8 per center) are accompanied and supported by the trained navigators for 12 weeks to find a suitable app for them and integrate it into their treatment. A total period of 3 months is planned for both the recruitment of patients and the implementation off the intervention (December 2024 to February 2025).
Receives: Behavioral: Support from Digital Navigators to Treatment Team; Behavioral: Support from Digital Navigators to Patients

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Digital health literacy (focus: digital information retrieval skills)

    Using the self-report rating inventory eHealth Literacy Scale (eHeals). Total score ranges from 8 to 40, with higher scores representing higher self-perceived eHealth literacy.

    Measured: Before (T0) and after completion of the 12-week intervention (T1)

  2. Digital health literacy (focus: digital interactive skills)

    Using a performance-based rating inventory Digital Health Literacy Index (DHLI). Total score ranges from 0 to 7, with higher scores representing a greater ability to operate digital devices and read and write in web-based modes.

    Measured: Before (T0) and after completion of the 12-week intervention (T1)

  3. Acceptance towards Digital Navigators

    Qualitative questions using semi-structured interviews

    Measured: Before the intervention (T0)

  4. Expectations towards Digital Navigators

    Qualitative questions using focus groups

    Measured: Before the intervention (T0)

  5. Expectations towards Digital Navigators

    Qualitative questions using semi-structured interviews

    Measured: Before the intervention (T0)

  6. Acceptance towards Digital Navigators

    Qualitative questions using focus groups

    Measured: Before the intervention (T0)

Secondary outcomes (13)

  1. Willingness and competence to change

    Using the self-report rating inventory "Readiness for Change". Total score ranges from 0 to 172, with higher scores representing higher self-perceived willingness and competence to change.

    Measured: Before (T0) and after completion of the 12-week intervention (T1)

  2. Digital competence

    Using the self-report rating inventory ICT Self-Concept Scale. Total score ranges from 25 to 150, with higher scores representing higher self-perceived digital competence.

    Measured: Before (T0) and after completion of the 12-week intervention (T1)

  3. Technical competence

    Using the self-report rating inventory "Kurzskala Technikbereitschaft" (TB, technology commitment). Total score ranges from 12 to 60, with higher scores representing higher self-perceived technical competence.

    Measured: Before (T0) and after completion of the 12-week intervention (T1)

  4. Psychological Health of Patients (level of functioning)

    Using the self-report rating inventory Global Assessment of Functioning (GAF). Total score ranging from 0-100, with a higher score indicating a higher level of functioning.

    Measured: After completion of the 12-week intervention (T1)

  5. Psychological Health of Patients (symptom severity, treatment response and the efficacy of treatment)

    Using the self-report rating inventory Clinical Global Impression (CGI); Measuring three dimensions: severity of illness (score 1-7, with a higher score indicating a more severe illness), global improvement (score 1-7, with a higher score indicating a worsening of symptoms) and efficacy (measured with 4×4 rating scale (ranging from 01 - 16) that assesses the therapeutic effect of treatment and associated side effects; e.g. 01 = no side effects; vast improvement; 16 = severe side effects; unchanged or worse condition)

    Measured: Before (T0) and after completion of the 12-week intervention (T1)

  6. Psychological Health of Patients (depressive symptoms; self-report)

    Using the self-report rating inventory Beck's Depression Inventory (BDI); Total score 0-63, with higher scores representing more severe depressive symptoms.

    Measured: Before (T0) and after completion of the 12-week intervention (T1)

  7. Psychological Health of Patients (depressive symptoms; clinician-administered)

    Using the clinician-administered rating inventory Hamilton Depression Scale (HAMD); Total score 0-52, with higher scores representing more severe depressive symptoms.

    Measured: Before (T0) and after completion of the 12-week intervention (T1)

  8. Psychological Health of Patients (anxiety)

    Using the clinician-administered rating inventory Hamilton Anxiety Scale (HAMA); Total score 0-56, with higher scores representing more severe anxiety symptoms.

    Measured: Before (T0) and after completion of the 12-week intervention (T1)

  9. Psychological Health of Patients (insomnia)

    Using the self-report rating inventory Insomnia Severity Index (ISI); Total score 0-28, with higher scores representing more severe insomia symptoms.

    Measured: Before (T0) and after completion of the 12-week intervention (T1)

  10. Identification of implementation barriers to the introduction of digital navigators

    Qualitative questions using semi-structured interviews

    Measured: After completion of the 12-week intervention (T1)

  11. Identification of implementation barriers to the introduction of digital navigators

    Qualitative questions using focus groups

    Measured: After completion of the 12-week intervention (T1)

  12. Use of Digital Health Applications and the effects of counseling and support by Digital Navigators

    Qualitative questions using semi-structured interviews

    Measured: After completion of the 12-week intervention (T1)

  13. Use of Digital Health Applications and the effects of counseling and support by Digital Navigators

    Qualitative questions using focus groups

    Measured: After completion of the 12-week intervention (T1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2024
  2. Study start15 Jul 2024
  3. Primary completion31 May 2025
  4. Study completion31 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Crossover
Model description
The use of digital navigators in multi-professional treatment teams is a complex intervention.
Masking
None (open label)
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06575582
Sponsor's protocol ID
00034327
Acronym
DigiNavi
Status last verified
Aug 2025
First submitted
22 Aug 2024
Last updated
1 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We have decided not to make the individual participant data (IPD) publicly available in order to ensure the highest level of data protection and confidentiality. Although all data will be properly anonymized, we want to ensure that no conclusions can be drawn about individual participants, not even indirectly. The protection of study participants' personal data is a top priority for us. Therefore, for ethical and data protection reasons, it is more responsible not to make the IPD publicly accessible.

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. doi: 10.2196/67655.

    PubMed 40996088

Questions about this trial

What is this clinical trial studying?

A study testing Support from Digital Navigators to Treatment Team, Support from Digital Navigators to Patients and Training for Digital Navigators in people with Acceptability of Health Care and Engagement, Patient, run by Medizinische Hochschule Brandenburg Theodor Fontane at 6 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Digital health literacy (focus: digital information retrieval skills) (time frame: Before (T0) and after completion of the 12-week intervention (T1)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06575582, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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