Digital Navigators for Acceptance and Competence Development with Mental Health Apps
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedizinische Hochschule Brandenburg Theodor Fontane
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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 design
Design model
Crossover
Treatments tested in this trial
Support from Digital Navigators to Treatment Team
BehavioralThe 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 Patients
BehavioralThe 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 Navigators
BehavioralThe training takes place in the six study centers and is preferably aimed at medical assistants.
Treatment groups
116 Participants
are divided into 3 treatment groupsGroup A: Exploratory preliminary studyNo intervention 0 interventions
Group B: TrainingExperimental treatment 1 intervention
Group C: Treatment team and patient supportExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
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.
Time frame
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.
Time frame
Before (T0) and after completion of the 12-week intervention (T1)3
Acceptance towards Digital Navigators
Qualitative questions using semi-structured interviews
Time frame
Before the intervention (T0)4
Expectations towards Digital Navigators
Qualitative questions using focus groups
Time frame
Before the intervention (T0)Secondary outcomes
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.
Time frame
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.
Time frame
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.
Time frame
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.
Time frame
After completion of the 12-week intervention (T1)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Medizinische Hochschule Brandenburg Theodor Fontane
Lead sponsor
Harvard Medical School (HMS and HSDM)
Collaborator
Hannover Medical School
Collaborator
Source ClinicalTrials.gov