F32.0 F32.1 F33.0 F33.1
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| The strengthening of personal resilience through My7steps App is measured with the established 10-item Connor-Davidson Resilience Scale (CD-Risc-10). The scale measures characteristics such as resilience (e.g., commitment, challenging change, control), self-efficacy, goal and action orientation, tolerance of negative affect, patience, sense of humor in the face of stress, and tendency to recover from stress . The increase in the sense of coherence through My7steps App is recorded with the Sense of Coherence Scale in the Leipzig short form (SOC-L9). The scale's nine items measure the sense of coping with life demands according to the concept introduced by Antonovsky on a 7-point Likert scale with bipolar responses, with a higher score indicating a stronger sense of coherence as a coping resource. The one-dimensional instrument covers the three sub-components of comprehensibility, manageability and significance, but only the overall SOC value is used. The relevant outcomes at time t0 (pre) and t1 (post) are collected in standardized interviews by a medically/psychologically trained examiner. | — |
Countries
Germany
Contacts
Ipso gGmbH – International Psychosocial Organisation