Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06575582

Digital Navigators for Acceptance and Competence Development with Mental Health Apps

Led by Medizinische Hochschule Brandenburg Theodor Fontane · Updated on 2024-09-03

116

Participants Needed

6

Research Sites

6 weeks

Total Duration

On this page

Sponsors

M

Medizinische Hochschule Brandenburg Theodor Fontane

Lead Sponsor

H

Harvard Medical School (HMS and HSDM)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating how Digital Navigators (DN) can assist general practitioners, outpatient psychiatrists, psychologists, and their patients in using digital mental health apps (DiGAs) and integrating them into treatment. The study aims to understand the opportunities and barriers to implementing DNs, acceptance and expectations towards them, and their effects on patients' psychological health and digital literacy. Medical assistants and other medical team employees receive training to become Digital Navigators. These trained navigators support treatment teams in selecting and integrating suitable mental health apps and accompany patients for 12 weeks to help them find and use an appropriate app. The study includes a preliminary phase with interviews and focus groups, followed by DN training and a 12-week intervention period with 48 patients. Participants undergo assessments before and after the 12-week intervention to measure digital health literacy, acceptance and expectations of Digital Navigators, psychological health, and digital competence. Data collection involves interviews, focus groups, and validated scales to evaluate symptom severity and treatment effects. The study also evaluates implementation barriers and aims to establish accredited DN training for sustainable use.

CONDITIONS

Brief Title

Digital Navigators for Acceptance and Competence Development with Mental Health Apps

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Acute danger to self or others
  • Patients have received prompt (\u2264 3 weeks) qualified psychiatric or psychotherapeutic treatment
  • Severe organic brain diseases with cognitive deficits
  • Intellectual disability

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for eligibility assessment

Exploratory Preliminary Study

Duration - 3 months

Participants take part in interviews and focus groups to assess acceptance and expectations regarding digital navigators and digital health applications.

Multiple sessions including interviews and group discussions over 3 months

Training

Duration - 4 months

Medical assistants and staff members receive training to become Digital Navigators, learning how to support the integration of mental health apps.

Training sessions for staff over 4 months

Outpatient Treatment

Duration - 12 weeks

Digital Navigators support treatment teams and accompany patients to select and integrate suitable mental health apps into their care.

Support and follow-up visits with patients during the 12-week intervention period

Follow-up

Duration - Post-intervention assessments following the 12-week treatment

Evaluation of the intervention effects on digital health literacy, psychological health, and identification of implementation barriers after the 12-week support period.

1 to 2 visits for assessments after intervention completion

Trial Site Locations

Total: 6 locations

1

Praxis Brandenburg an der Havel

Brandenburg an der Havel, Brandenburg, Germany, 14776

Actively Recruiting

2

Praxis Eberswalde

Eberswalde, Brandenburg, Germany, 16225

Actively Recruiting

3

Psychiatrische Institutsambulanz (PIA) Fürstenwalde

Fürstenwalde, Brandenburg, Germany, 15517

Actively Recruiting

4

Praxis Fürstenwalde

Fürstenwalde, Brandenburg, Germany, 15518

Actively Recruiting

5

Psychiatrische Institutsambulanz (PIA) Rüdersdorf

Rüdersdorf, Brandenburg, Germany, 15562

Actively Recruiting

6

Psychiatrische Institutsambulanz (PIA) Strausberg

Strausberg, Brandenburg, Germany, 15344

Actively Recruiting

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Research Team

J

Julian Schwarz, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

3

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Published Research Related To This Trial

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).

Julian Schwarz, Kelly Chen, Hiwa Dashti...

https://pubmed.ncbi.nlm.nih.gov/40996088