Digital Navigators for Acceptance and Competence Development with Mental Health Apps
NCT Number: NCT06575582
Acronym: DigiNavi
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acceptability of Health Care|Engagement, Patient|Nurse's Role|Mental Disorder
Sponsor: Medizinische Hochschule Brandenburg Theodor Fontane
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 116
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-07-15
Completion Date: 2025-07-14

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. 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.

Primary Outcome Measures: 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., Before (T0) and after completion of the 12-week intervention (T1)|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., Before (T0) and after completion of the 12-week intervention (T1)|Acceptance towards Digital Navigators, Qualitative questions using semi-structured interviews, Before the intervention (T0)|Expectations towards Digital Navigators, Qualitative questions using focus groups, Before the intervention (T0)|Expectations towards Digital Navigators, Qualitative questions using semi-structured interviews, Before the intervention (T0)|Acceptance towards Digital Navigators, Qualitative questions using focus groups, Before the intervention (T0)
Secondary Outcome Measures: 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., Before (T0) and after completion of the 12-week intervention (T1)|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., Before (T0) and after completion of the 12-week intervention (T1)|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., Before (T0) and after completion of the 12-week intervention (T1)|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., After completion of the 12-week intervention (T1)|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), Before (T0) and after completion of the 12-week intervention (T1)|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., Before (T0) and after completion of the 12-week intervention (T1)|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., Before (T0) and after completion of the 12-week intervention (T1)|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., Before (T0) and after completion of the 12-week intervention (T1)|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., Before (T0) and after completion of the 12-week intervention (T1)|Identification of implementation barriers to the introduction of digital navigators, Qualitative questions using semi-structured interviews, After completion of the 12-week intervention (T1)|Identification of implementation barriers to the introduction of digital navigators, Qualitative questions using focus groups, After completion of the 12-week intervention (T1)|Use of Digital Health Applications and the effects of counseling and support by Digital Navigators, Qualitative questions using semi-structured interviews, After completion of the 12-week intervention (T1)|Use of Digital Health Applications and the effects of counseling and support by Digital Navigators, Qualitative questions using focus groups, After completion of the 12-week intervention (T1)