F32.0 F32.1 F33.0 F33.1 F43.2
Conditions
Interventions
Group 1: Study participants receive in the of the one-group pre-post design the web-based self-help intervention My7steps App (medical device), which guides users self-administratively through an inte
Sponsors
Ipso Healthcare GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Contacts
Public ContactPelle Bernhold
Ipso gGmbH
Outcome results
None listed