Presence of an affective disorder (e.g., depressive or bipolar episode) according to the treating clinic
Conditions
Interventions
Group 1: The subject of the study is the prospective collection and analysis of actively assessed affective symptomatology and passively collected digital biomarkers via wearables (e.g., Apple Watch)
Sponsors
Klinik für Psychiatrie und Psychotherapie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Minimum age = 18 years - Presence of an affective disorder (e.g., depressive or bipolar episode) as diagnosed by the treating clinic - Outpatient connection to the PIA (at least presentation every 3 months) - Capacity to consent - Written informed consent - Technical requirement: possession of a compatible iPhone or suitable device for pairing with the Apple Watch - Willingness to use the wearable regularly and to participate in monthly clinical visits as well as weekly self-assessments
Exclusion criteria
Exclusion criteria: - Withdrawal of consent or termination of participation - Acute risk of harm to self or others (e.g., acute suicidality) - Inpatient psychiatric treatment during the study period - Severe cognitive impairment (e.g., dementia, severe intellectual disability) with relevant limitation of study participation - Insufficient German language skills for informed consent and completion of self-assessments - Severe psychotic symptoms or other clinical conditions that, in the judgment of the treating clinicians, preclude study participation - Lack of technical suitability (e.g., incompatible device) preventing study conduct
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| H1 (Feasibility): Digital biomarkers can be recorded on at least 80 days within a 3-month period, with a minimum of 18h/day (87.5%) of coverage each day, in the routine context of outpatient psychiatric care. | — |
Secondary
| Measure | Time frame |
|---|---|
| H2 (Clinical Validity, exploratory): There are associations between passively collected digital biomarkers (activity, sleep, heart rate, HRV) and the severity of depressive, manic, and psychotic symptoms over time. | — |
Countries
Germany
Contacts
Public ContactStefanie Schreiter
Klinik für Psychiatrie und Psychotherapie
Outcome results
None listed