Links between individual disease courses of patients with depressive disorders and self-monitoring data collected via smartphones and smartwatches: A one-year observational study

Links between individual disease courses of patients with depressive disorders and self-monitoring data collected via smartphones and smartwatches: A one-year observational study - MONDY

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00032618

Enrollment

Registered

2023-09-12

Start date

2023-09-27

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

F33

Interventions

Group 1: Participants will be asked a) to complete three in-person appointments at the study centre (at the beginning, after 6 months and after 12 months) and b) to collect daily self-report and senso

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Diagnosis of a recurrent major depression with two or more depressive episodes during the last ten years (SCID-I for DSM-5) - Currently residual symptoms of depression (BDI-2 sum score = 14) - Being in concurrent treatment for the depressive illness - Being able to provide informed consent - Usage of an own Android smartphone (or agreement to switch to an Android smartphone provided by the study centre) - In case of any lifetime substance abuse disorder: being in stable remission (min. 6 months)

Exclusion criteria

Exclusion criteria: - Acute risk of self-hazard/ suicidality (six months before inclusion) - Currently severe episode with psychotic symptoms (F33.3) - Lifetime diagnosis of any psychotic disorder (any diagnosis according to ICD-10 F2) - Lifetime diagnosis of any bipolar disorder (ICD-10 F31) - Lifetime diagnosis of any borderline personality disorder (screening for borderline personality disorder will be done using the McLean Screening Instrument for Borderline Personality Disorder (MSI-BPD), with a cut-off score of = 7) - Severe somatic illnesses requiring intensive treatment

Design outcomes

Primary

Measure	Time frame
Self-reported depressive symptom severity will be assessed daily and weekly by using a smartphone app. The daily self-reported depressive symptom severity will be assessed using the items of the Patient Health Questionnaire-2 (PHQ-2). A Visual Analogue Scale ranging from zero to ten will be used for the collection of daily answers. The weekly self-reported depressive symptom severity will be assessed using the Patient Health Questionnaire-9 (PHQ-9), using a Likert Scale ranging from zero to three as answering options.	—

Measure

Time frame

Self-reported depressive symptom severity will be assessed daily and weekly by using a smartphone app. The daily self-reported depressive symptom severity will be assessed using the items of the Patient Health Questionnaire-2 (PHQ-2). A Visual Analogue Scale ranging from zero to ten will be used for the collection of daily answers. The weekly self-reported depressive symptom severity will be assessed using the Patient Health Questionnaire-9 (PHQ-9), using a Likert Scale ranging from zero to three as answering options.

—

Secondary

Measure	Time frame
BDI-II (Beck's Depression Inventory) and MHSQ (Mental Health Self-Management Questionnaire) at inclusion, after six months, and after 12 months. SSAS (Situational Self-Awareness Scale) weekly.	—

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 5, 2026