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

Not Applicable

Recruiting

• Conditions: F32.0; F32.1; F33.0; F33.1; Mild depressive episode; Moderate depressive episode; Recurrent depressive disorder, current episode mild; Recurrent depressive disorder, current episode moderate

• Registration Number: DRKS00033268
• Lead Sponsor: Sympatient GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 160

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

? 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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