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Effectiveness of an app-based intervention for the treatment of patients with a depressive disorder - A randomized controlled trial

Effectiveness of an app-based intervention for the treatment of patients with a depressive disorder - A randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00033268
Enrollment
160
Registered
2023-12-21
Start date
2024-01-18
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

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

Interventions

Group 1: Intervention group with immediate access to "Invirto - Die Therapie gegen Depression" (an app-based intervention for patients with depression) Group 2: Care as usual control group: care as us

Sponsors

Sympatient GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: ? Informed written consent to participate in the study ? PHQ-9 score of = 5 (Kroenke et al., 2001) ? Presence of a smartphone with internet access

Exclusion criteria

Exclusion criteria: ? Acute suicidal intentions ? Diagnosis of schizophrenic or bipolar disorder ? Diagnosis of a severe depressive disorder ? Contraindications for the use of Invirto - Die Therapie gegen Depression according to the instructions for use ? Change in medication for the treatment of depressive symptoms in the last four weeks ? Current participation in another intervention study in the field of psychotherapy ? Currently undergoing psychotherapeutic treatment at the start of the study

Design outcomes

Primary

MeasureTime frame
The primary endpoint is depressive symptoms after three months in the intervention group compared to the control group, taking into account the initial symptoms at Baseline. Depressive symptoms are recorded using the Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001)

Secondary

MeasureTime frame
- Depressive symptoms as rated by clinicans, Quick Inventory of Depressive Symptomatology (QIDS-C16; Rush et al., 2003) - Depression-related health literacy, Depression Literacy Scale (D-Lit; Freitag et al., 2018; Griffiths et al., 2004)

Countries

Germany

Contacts

Public ContactLena Jelinek

Universitätsklinikum Hamburg-Eppendorf

l.jelinek@uke.de+49 (0)40 7410-58087

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026