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On a journey to feel a little better. Or BEDDA.

Development of a digital biomarker and intervention for subclinical depression: Study protocol for a longitudinal waitlist control study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN38841716
Enrollment
200
Registered
2022-08-20
Start date
2022-10-17
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Prevention of depression Mental and Behavioural Disorders

Interventions

Participants will be allocated using a computer algorithm script (Python) to either waitlist control or intervention group. Participants in the intervention group will start the intervention while par

Sponsors

ETH Zurich
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 years old and over 2. Residency in Switzerland 3. Understand of mid-level English or German (B1-B2)

Exclusion criteria

Exclusion criteria: 1. Current diagnosis with or in treatment for a mental health disease 2. Asthma, COPD, or any other lung or respiratory tract disease 3. Pregnancy 4. Scoring greater than 15 for symptom severity of depression and anxiety in the PHQ-9 and GAD-7 instruments, respectively 5. Positive response to the last question of the PHQ-9, accessing suicide ideation or self-harm

Design outcomes

Primary

MeasureTime frame
1. Depression severity measured using the nine-question version of the Patient Health Questionnaire (PHQ-9) at baseline, after 14 interactions, and at the end of the intervention (after 30 interactions). 2. One of three randomly selected symptoms of depression (mood, agitation, anhedonia) measured using the Multidimensional Mood State Questionnaire (MDMQ) on a daily basis 3. Physiological (such as heart-rate-variability) and behavioral (such as physical activity) outcomes measured using a Garmin Smartwatch Fitness Tracker in a sub sample of 25% of the participants

Secondary

MeasureTime frame
Anxiety severity measured using the seven-question version of the General Anxiety Disorder questionnaire (GAD-7) and stress using the short version of the Trier Inventory for Chronic Stress at baseline, after 14 interactions, and at the end of the intervention (after 30 interactions)

Countries

Switzerland

Contacts

Public ContactTobias Kowatsch
• tobias.kowatsch@unisg.ch+41 44 633 87 68

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026