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My7steps App Trial Study

My7steps App Trial Study - M7SA-TS

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00025530
Enrollment
260
Registered
2023-06-09
Start date
2023-06-27
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F32.0 F32.1 F33.0 F33.1

Interventions

Group 1: The study participants in the intervention group receive the web-based self-help intervention My7steps App, which guides the user through an intervention consisting of self-assessment, psycho

Sponsors

My7steps GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

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

MeasureTime 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

MeasureTime 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

Public ContactPelle Bernhold

Ipso gGmbH – International Psychosocial Organisation

studie@ipsocontext.org0049 30 55077203

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026