Implementation of a digital nurse to improve the use of digital health applications for older people with depressive disorders (DiGA4Aged) - A randomized proof of concept study.

Implementation of a digital nurse to improve the use of digital health applications for older people with depressive disorders (DiGA4Aged) - A randomized proof of concept study. - DiGA4Aged

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00033535

Enrollment

200

Registered

2024-02-02

Start date

2024-07-08

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F32.0 F33.0 F32.1 F33.1

Interventions

Group 1: Participants in the intervention group receive: a) The prescription of a depression-specific DiGA b) A brief explanation of the DiGA using the manufacturer's information videos. c) 8 weeks o

Twomey et al. 2017) is approved for mild, moderate and severe depressive disorders

both DiGAs are permanently approved. Therapeutically, both DiGAs use behavioral interventions and approaches, training and self-awareness and regulation exercises, which the individual goes through i

Eligibility

Sex/Gender

All

Age

60 Years to No maximum

Inclusion criteria

Inclusion criteria: Mild to moderate depressive disorder according to ICD-10 codes F32.0, F32.1, F33.0, F33.1; access to a digital device (desktop computer, tablet, smartphone) that allows the use of DiGA; consent to participate in all parts of the study and availability for the duration of the study; signed informed consent form

Exclusion criteria

Exclusion criteria: 1) Inability to give consent 2) Acute suicidal tendencies 3) Severe auditory and/or visual impairment 4) Lack of German language skills 5) Presence of dementia 6) Presence of bipolar disorder or schizophrenia or other severe psychiatric illness that prevents participation. 7) Advanced incurable illness 8) Participation in another treatment or intervention study 9) Current use of DiGA for depression

Design outcomes

Primary

Measure	Time frame
Is the patient using the DiGA after 8 weeks (T1)? (yes/no). The primary endpoint is assessed by telephone interviews or private contact (patient self-report).	—

Secondary

Measure	Time frame
1) Depressive symptoms (PHQ-9) (T0, T1, T2) 2) Treatment of depression through medication and other therapies (T0, T1, T2) 3) Usability of the DiGA (SUS, UEQ) (T1 and T2)	—

Countries

Germany

Contacts

Public ContactJan Dieris-Hirche

LWL-Universitätsklinikum Bochum, Klinik für Psychosomatische Medizin und Psychotherapie, Ruhr-Universität Bochum

jan.dieris-hirche@rub.de+49 234 5077 3135

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026