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

ISRCTN	ISRCTN38841716
DOI	https://doi.org/10.1186/ISRCTN38841716
Secondary identifying numbers	EK 2022-N-31

Submission date: 17/08/2022
Registration date: 20/08/2022
Last edited: 12/08/2024

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
In this study, we aim to improve the detection and prevention of subclinical depression in an individual who has not previously met the full criteria for major depression and who currently experiences depressive symptoms. Detection and prevention can offer help before the subclinical depression becomes a full-blown depressive episode. Improving this detection and prevention is important because more and more people are suffering from subclinical and clinical depression.

Who can participate?
Healthy individuals who are at least 18 years old and over with residency in Switzerland

What does the study involve?
This study aims to improve the prevention of depression in students and the general public by developing digital biomarkers and a digital intervention called BEDDA. Participants interact with the digital health app for 30 sessions. To receive compensation, participants must complete these 30 sessions in 45 days or less. The digital health app called BEDDA consists of a conversational agent (i.e., chatbot), a gamified slow-paced breathing training, and actionable advice integrable into everyday life.

What are the possible benefits and risks of participating?
Potential benefits include a reduction in symptoms of depression and anxiety and a stress reduction. Participants will learn a slow-paced breathing technique that may help them to calm down in stressful situations. To the best of our knowledge, the different components of BEDDA have not been associated with any health risks. For individuals excluded due to the severity of symptoms, we will provide information on how to find help from mental health services.

Where is the study run from?
Center for Digital Health Interventions (ETH Zurich) (Switzerland)

When is the study starting and how long is it expected to run for?
February 2021 to February 2026

Who is funding the study?
1. CSS health insurance (public health insurance Switzerland)
2. Center for Digital Health Interventions (ETH Zurich) (Switzerland)

Who is the main contact?
Mr Gisbert W. Teepe
gteepe@ethz.ch

Study website

Contact information

Mr Gisbert Teepe
Public

Weinbergstrasse 56/58
Zürich
8006
Switzerland

ORCID ID	0000-0002-2264-9797
Phone	+41 44 633 87 68
Email	gteepe@ethz.ch

Prof Tobias Kowatsch
Principal Investigator

Center for Digital Health Interventions
Weinbergstrasse 56/58
Zurich
8006
Switzerland

ORCID ID	0000-0001-5939-4145
Phone	+41 44 632 94 88
Email	tkowatsch@ethz.ch

Mr Yanick Lukic
Scientific

Center for Digital Health Interventions
Weinbergstrasse 56/58
Zürich
8006
Switzerland

ORCID ID	0000-0002-2576-6569
Phone	+41 44 633 87 68
Email	ylukic@ethz.ch

Study information

Study design	Single-centre interventional double-blinded waitlist-controlled field study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Participant information sheet	42247 Study_Consent_English_Smartwatch.pdf
Scientific title	Development of a digital biomarker and intervention for subclinical depression: Study protocol for a longitudinal waitlist control study
Study acronym	BEDDA
Study objectives	Due to the substantial number of voice features, formulating a hypothesis for investigating digital biomarkers for subclinical depression is difficult. However, related work reported differences in voice features depending on the severity of depression (Cummins et al., 2015; Low et al., 2020). Certain features (such as fundamental frequency, jitter, shimmer) extracted from voice and breathing should correlate higher with symptoms and severity of depression than other features (e.g., first and second formant variability), as this difference has been reported in Low et al. (2020). Similarly, we cannot predict feature importance for more elaborated machine learning models. For reported classification accuracy or predictive accuracy of existing work, we refer to the publications from Cummins et al. (2015) and Low et al. (2020). Regarding the investigation of efficacy, we can formulate the hypothesis. We hypothesize that the intervention group using the slow-paced breathing training "Breeze" will show significant improvements in symptoms and severity of depression compared to a waitlist control. --- Cummins, N., Scherer, S., Krajewski, J., Schnieder, S., Epps, J., & Quatieri, T. F. (2015). A review of depression and suicide risk assessment using speech analysis. In Speech Communication (Vol. 71, pp. 10–49). Elsevier B.V. https://doi.org/10.1016/j.specom.2015.03.004 Low, D. M., Bentley, K. H., & Ghosh, S. S. (2020). Automated assessment of psychiatric disorders using speech: A systematic review. In Laryngoscope Investigative Otolaryngology (Vol. 5, Issue 1, pp. 96–116). John Wiley and Sons Inc. https://doi.org/10.1002/lio2.354
Ethics approval(s)	Approved 23/06/2022, ETH Zurich Ethics Commission (ETH Zurich Prof. Dr. Detlef Günther, HG F 57, Rämistrasse 101, 8092 Zurich, Switerland; +41 44 63 28572; ethics@sl.ethz.ch), ref: EK 2022-N-31
Health condition(s) or problem(s) studied	Prevention of depression
Intervention	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 participants in the waitlist control group will wait until the intervention group has finished the intervention. Participants will interact with the digital intervention BEDDA consisting of a scripted conversational agent, a slow-paced breathing training called Breeze, and actionable advice for different symptoms. The intervention comprises 30 daily interactions the participants must complete in less than 45 days.
Intervention type	Behavioural
Primary outcome measure	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 outcome measures	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)
Overall study start date	01/02/2021
Completion date	01/02/2026

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	200
Key inclusion criteria	1. Aged 18 years old and over 2. Residency in Switzerland 3. Understand of mid-level English or German (B1-B2)
Key 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
Date of first enrolment	17/10/2022
Date of final enrolment	31/10/2023

Locations

Countries of recruitment

Switzerland

Study participating centre

Center for Digital Health Interventions

ETH Zurich
Weinbergstrasse 56/58
Zurich
8006
Switzerland

Sponsor information

ETH Zurich
University/education

Ethics Comitee
Rämistrasse 101
Zurich
8092
Switzerland

Phone	+41 44 63 28572
Email	ethics@sl.ethz.ch
Website	https://www.ethz.ch/en.html
"ROR"	https://ror.org/05a28rw58

Funders

Funder type

University/education

CSS Health Insurance

No information available

Eidgenössische Technische Hochschule Zürich
Private sector organisation / Universities (academic only)

Alternative name(s): ETH Zurich, ETH Zürich, Federal Institute of Technology Zurich, ETH Zürich (Eidgenössische Technische Hochschule Zürich), Eidgenössische Technische Hochschule Zürich (Switzerland), Eidgenössische Technische Hochschule Zürich (ETH), ethzurich, ETH
Location: Switzerland

Results and Publications

Intention to publish date	01/02/2027
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal
IPD sharing plan	The data-sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet		19/08/2022	No	Yes
Participant information sheet		19/08/2022	No	Yes
Participant information sheet		19/08/2022	No	Yes
Protocol article	22/06/2023	23/06/2023	Yes	No

Additional files

42247 Study_Consent_English_Smartwatch.pdf
42247 Study_Consent_English_No_Smartwatch.pdf
42247 PIS debrief_English.pdf

Editorial Notes

12/08/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2023 to 31/10/2023.
2. The overall end date was changed from 30/12/2024 to 01/02/2026.
3. The intention to publish date was changed from 01/04/2025 to 01/02/2027.
4. The plain English summary was updated to reflect these changes.
22/01/2024: The following changes were made to the trial record:
1. The overall end date was changed from 30/09/2023 to 30/12/2024.
2. The intention to publish date was changed from 31/12/2023 to 01/04/2025.
3. The plain English summary was updated to reflect these changes.
23/06/2023: Publication reference added.
06/03/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/03/2023 to 30/09/2023.
2. The overall end date was changed from 30/04/2023 to 30/09/2023.
3. The intention to publish date was changed from 30/11/2023 to 31/12/2023.
4. The plain English summary was updated to reflect these changes.
11/10/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 25/09/2022 to 17/10/2022.
2. The recruitment end date was changed from 30/10/2022 to 30/03/2023.
3. The overall end date was changed from 30/11/2022 to 30/04/2023.
4. The plain English summary was updated to reflect these changes.
19/08/2022: Trial's existence was confirmed by ETH Zurich Ethics Commission.