My7steps App Trial Study

Phase 4

• 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: DRKS00025530
• Lead Sponsor: My7steps GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-09
• Study Completion: 2024-05-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 253

Inclusion Criteria

1. There is legal consent to participate
2. The ability to speak and understand German, English or Farsi/Dari
3. Between 18 and 65 years old
4. Living in Germany
5. Diagnosis of any of the following ICD-10 indications: F32.0, F32.1, F33.0, F33.1

Exclusion Criteria

Affected persons who do not meet the inclusion criteria are to be excluded from the study. In addition, people who meet the following criteria are excluded:
1. There has been a change in medication within the last 4 weeks
2. Participates in other interventional studies
3. Is in a dependent or employment relationship with the sponsor or investigator
4. Is housed in an institution due to a court or official order
5. Suicidal tendencies, diagnosed severe depression, addiction, psychotic symptoms or organic brain disorders (e.g. delirium, dementia) are present

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of the clinical study is the severity of the depressive symptoms. This is recorded using the well-established Patient Health Questionnaire (PHQ), which is used worldwide. The PHQ is based on a psychiatric classification system, the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). The PHQ-9 is the depression module validated for use in primary care, recommended for all ages 16 and older, and can be used for both longitudinal and cross-sectional studies. In addition, the PHQ-9 has also proven itself as a telephone interview. The relevant outcomes at time t0 (pre) and t1 (post) are collected in standardized interviews by a medically/psychologically trained examiner.