My7steps App Pilot Study

Phase 4

• Conditions: F32.0; F32.1; F33.1; F33.0; F43.2; Adjustment disorders; Mild depressive episode; Moderate depressive episode; Recurrent depressive disorder, current episode moderate; Recurrent depressive disorder, current episode mild

• Registration Number: DRKS00027925
• Lead Sponsor: Ipso Healthcare GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-04-06
• Study Start: 2022-04-13
• Results First Posted: 2023-07-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

Legally valid patient consent has been obtained - Ability to speak and understand German, English, Arabic, or Farsi/Dari.
- Age = 18 years - Patients living in Germany - Psychotherapeutic diagnosis of one of the following indications:
• F32.0 Mild depressive episode
• F32.1 Moderate depressive episode
• F33.0 Recurrent depressive disorder, currently mild episode
• F33.1 Recurrent depressive disorder, present moderate episode
• F43.2 Adjustment disorder

Exclusion Criteria

- Patients whose informed consent has not been obtained
- Patients participating in other interventional studies
- Individuals who are in a dependent/employee relationship with the sponsor or investigator.
- Subjects in institutionalization due to court or regulatory order.
- Patients with suicidality, major depression, addictive disorder, schizophrenic symptoms, psychotic symptoms, delusional disorder, brain organic disorder (e.g. delirium, dementia).

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of the study is to examine whether the care of patients from the spectrum of depressive disorders is improved by the web application My7steps App. This should be reflected in a reduction of depressive symptomatology measured with the Patient Health Questionnaire (PHQ-9). Survey of relevant outcome measures at time t0 (pre) and t1 (post) is conducted in standardized interviews by a medically/psychologically trained investigator.

Secondary Outcome Measures

Name	Time	Method
Secondary objectives relate to strengthening personal resilience and reducing disease-related problems in everyday life through the My7steps App. Personal resilience is measured using the Connor-Davidson Resilience Scale (CD-RISC-10), and impairment of daily functioning due to the disease is measured using the Daily Functionality Impairment Scale (DFI). Survey of relevant outcome measures at time t0 (pre) and t1 (post) is conducted in standardized interviews by a medically/psychologically trained investigator.