Trial of a digital depression management application: juli

ISRCTN	ISRCTN12329547
DOI	https://doi.org/10.1186/ISRCTN12329547
Secondary identifying numbers	2

Submission date: 26/05/2021
Registration date: 08/06/2021
Last edited: 12/07/2024

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Background and study aims
Each year, millions of people are diagnosed with depression and seek additional support from digital applications (apps). It can be overwhelming learning how to manage and unclear what can make symptoms better or worse. The digital health application juli aims to support people with depression with a number of evidence-based approaches including symptom tracking, medication reminders, journaling, data on sleep, activity, exercise, oxygen levels and heart rate, and recommendations about how to improve these.
However, it is still not certain how useful juli is compared to what people may do for themselves to help their depression. The aim of this study is to find out whether juli is effective at improving depression symptoms, compared to treatment as usual.

Who can participate?
People aged 18-65 years with depression

What does the study involve?
Participants will be randomly allocated to receive juli or a dummy version of juli. The participant will use the app for 8 weeks, and complete a depression symptoms questionnaire every 2 weeks (four in total). Participants will also be asked to complete a wellbeing questionnaire at 4 and 8 weeks and a user satisfaction questionnaire at 8 weeks. These are all standardised questionnaires, commonly used for research.
The full version of the app presents the participant with graphical displays of some data automatically generated from their phone and smartwatch. The types of data are: sleep (time in bed and time asleep), activity (steps and flights of stairs climbed), heart rate variability (variation in the time interval between heartbeats), workouts (periods of exercise, oxygen saturation and menstrual cycle). It also presents them with external data: weather, pollen count and air quality (provided via geolocation). It asks the participant to rate how they are feeling and answer questions about their mood on a daily basis. It allows them to set a medication reminder, and add notes to a journal. It presents them with correlations between these different types of data and helps them to identify things that make their mood better or worse. Participants allocated to the dummy version of the app will be asked to rate how they are feeling on a daily basis, but will not have access to the rest of the app.

What are the possible benefits and risks of participating?
Some people find it rewarding to take part in medical research and appreciate the additional monitoring. Using juli may improve participants' symptoms of depression, but this cannot be guaranteed.
It is also hoped that carrying out this study will help future guidance about when someone is likely to benefit from juli and how it can be improved. There may not be direct benefits of taking part. However, the study is designed to improve treatment and increase understanding of depression.

Where is the study run from?
University College London (UK)

When is the study starting and how long is it expected to run for?
December 2020 to August 2023

Who is funding the study?
Juli Health (USA)

Who is the main contact?
Joseph Hayes
joseph.hayes@ucl.ac.uk

Contact information

Dr Joseph Hayes
Scientific

6th Floor Maple House
149 Tottenham Court Road
London
W1T 7BN
United Kingdom

ORCID ID	0000-0003-2286-3862
Phone	+44 (0)20 7679 9736
Email	joseph.hayes@ucl.ac.uk

Mrs Bettina Dührkoop
Public

Juli Health
23 Beach Ave
Hull
MA 02045
United States of America

Phone	+44 (0)20 7679 9736
Email	bd@juli.co

Study information

Study design	Interventional placebo-controlled randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Internet/virtual
Study type	Treatment
Participant information sheet	ISRCTN12329547_PIS_V4.doc
Scientific title	Randomised control trial of a digital depression management application: juli
Study acronym	juli
Study hypothesis	Use of the juli app reduces depression symptoms at 8 weeks compared to attention placebo control.
Ethics approval(s)	Approved 07/06/2021, UCL Research Ethics Committee (Office of the Vice-Provost (Research), University College London, 2 Taviton St, London, WC1E 6BT, UK; +44 (0)20 7679 8717; ethics@ucl.ac.uk), ref: 19413/001
Condition	Depression
Intervention	Participants will be randomly allocated using an online tool to receive the juli app or treatment as usual plus an attention placebo control app. The participant will use the juli app for 8 weeks and complete a depression symptoms questionnaire every 2 weeks (four in total). Participants will also be asked to complete a wellbeing questionnaire at 4 and 8 weeks and a user satisfaction questionnaire at 8 weeks. These are all standardised questionnaires, commonly used for research (the 8-item Patient Health Questionnaire, the 12-item Short Form survey of health-related quality of life and the Mobile Health App Usability Questionnaire). The full version of the app presents the participant with graphical displays of some data automatically generated from their phone and smartwatch. The types of data are: 1. Sleep – time in bed and time asleep 2. Activity – steps and flights of stairs climbed 3. Heart rate variability – the variation in the time interval between heartbeats 4. Workouts – periods of exercise 5. Oxygen saturation 6. Menstrual cycle It also presents them with external data: weather, pollen count and air quality (provided via geolocation). It asks the participant to rate how they are feeling and answer questions about their mood on a daily basis. It allows them to set a medication reminder, and add notes to a journal. It presents them with correlations between these different types of data and helps them to identify things that make their mood better or worse. Participants allocated to the dummy version of the app will be asked to rate how they are feeling on a daily basis, but will not have access to the rest of the app.
Intervention type	Behavioural
Primary outcome measure	Depression symptoms measured using the eight-item Patient Health Questionnaire (PHQ-8) at 8 weeks
Secondary outcome measures	1. Depression symptoms measured using the PHQ-8 at 2, 4 and 6 weeks 2. Health-related quality of life measured using Short Form 12 (SF-12) Item at 4 and 8 weeks
Overall study start date	01/12/2020
Overall study end date	01/08/2023

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	476
Total final enrolment	456
Participant inclusion criteria	1. Depression with PHQ-8 score >4 at baseline 2. Age 18 to 65 years (inclusive) 3. English speakers 4. Have an iPhone
Participant exclusion criteria	1. PHQ-8 <5 at baseline 2. Children 3. Non-English speakers
Recruitment start date	21/06/2021
Recruitment end date	01/06/2023

Locations

Countries of recruitment

Afghanistan
Albania
Algeria
American Samoa
Andorra
Angola
Anguilla
Antarctica
Antigua and Barbuda
Argentina
Armenia
Aruba
Australia
Austria
Azerbaijan
Bahamas
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Belize
Benin
Bermuda
Bhutan
Bolivia
Bonaire Saint Eustatius and Saba
Bosnia and Herzegovina
Botswana
Bouvet Island
Brazil
British Indian Ocean Territory
Brunei Darussalam
Bulgaria
Burkina Faso
Burundi
Cabo Verde
Cambodia
Cameroon
Canada
Cayman Islands
Central African Republic
Chad
Chile
China
Christmas Island
Cocos (Keeling) Islands
Colombia
Comoros
Congo
Congo, Democratic Republic
Cook Islands
Costa Rica
Croatia
Cuba
Curaçao
Cyprus
Czech Republic
Côte d'Ivoire
Denmark
Djibouti
Dominica
Dominican Republic
Ecuador
Egypt
El Salvador
England
Equatorial Guinea
Eritrea
Estonia
Eswatini
Ethiopia
Falkland Islands
Faroe Islands
Fiji
Finland
France
French Guiana
French Polynesia
French Southern Territories
Gabon
Gambia
Georgia
Germany
Ghana
Gibraltar
Greece
Greenland
Grenada
Guadeloupe
Guam
Guatemala
Guernsey
Guinea
Guinea-Bissau
Guyana
Haiti
Heard Island and McDonald Islands
Holy See (Vatican City State)
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iran
Iraq
Ireland
Isle of Man
Israel
Italy
Jamaica
Japan
Jersey
Jordan
Kazakhstan
Kenya
Kiribati
Korea, North
Korea, South
Kosovo
Kuwait
Kyrgyzstan
Lao People's Democratic Republic
Latvia
Lebanon
Lesotho
Liberia
Libya
Liechtenstein
Lithuania
Luxembourg
Macao
Madagascar
Malawi
Malaysia
Maldives
Mali
Malta
Marshall Islands
Martinique
Mauritania
Mauritius
Mayotte
Mexico
Micronesia, Federated States of
Moldova
Monaco
Mongolia
Montenegro
Montserrat
Morocco
Mozambique
Myanmar
Namibia
Nauru
Nepal
Netherlands
New Caledonia
New Zealand
Nicaragua
Niger
Nigeria
Niue
Norfolk Island
North Macedonia
Northern Mariana Islands
Norway
Oman
Pakistan
Palau
Palestine, State of
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Pitcairn
Poland
Portugal
Puerto Rico
Qatar
Romania
Russian Federation
Rwanda
Réunion
Saint Barthélemy
Saint Helena, Ascension and Tristan da Cunha
Saint Kitts and Nevis
Saint Lucia
Saint Martin (French part)
Saint Pierre and Miquelon
Saint Vincent and the Grenadines
Samoa
San Marino
Sao Tome and Principe
Saudi Arabia
Senegal
Serbia
Seychelles
Sierra Leone
Singapore
Sint Maarten (Dutch part)
Slovakia
Slovenia
Solomon Islands
Somalia
South Africa
South Georgia and the South Sandwich Islands
South Sudan
Spain
Sri Lanka
Sudan
Suriname
Svalbard and Jan Mayen
Sweden
Switzerland
Syria
Taiwan
Tajikistan
Tanzania
Thailand
Timor-Leste
Togo
Tokelau
Tonga
Trinidad and Tobago
Tunisia
Turkmenistan
Turks and Caicos Islands
Tuvalu
Türkiye
Uganda
Ukraine
United Arab Emirates
United Kingdom
United States Minor Outlying Islands
United States of America
Uruguay
Uzbekistan
Vanuatu
Venezuela
Viet Nam
Virgin Islands, British
Virgin Islands, U.S.
Wallis and Futuna
Western Sahara
Yemen
Zambia
Zimbabwe
Åland Islands

Study participating centre

University College London

Division of Psychiatry
6th Floor Maple House
149 Tottenham Court Road
London
W1T 7BN
United Kingdom

Sponsor information

University College London
University/education

Division of Psychiatry
London
WC1E 6BT
England
United Kingdom

Phone	+44 (0)207 679 9253
Email	Glyn.lewis@ucl.ac.uk
Website	http://www.ucl.ac.uk/
"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Industry

Juli Health

No information available

Results and Publications

Intention to publish date	01/12/2023
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	When the study is completed, the results will be published in a peer-reviewed healthcare journal so healthcare professionals can see the results.
IPD sharing plan	Data will only be available to approved University College London researchers. The data will be available from Joseph Hayes (joseph.hayes@ucl.ac.uk). The data will be available following the publication of the trial and will include outcome measures and baseline characteristics. Participants have consented to: “I understand that other UCL authenticated researchers will have access to my anonymised data.” They may endorse: “If you would like your contact details to be retained so that you can be contacted in the future by UCL researchers who would like to invite you to participate in follow up studies to this project, or in future studies of a similar nature, please tick the appropriate box below.”

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	version V4		08/07/2021	No	Yes
Protocol file	version V2.0		08/07/2021	No	No
Preprint results		11/04/2023	06/07/2023	No	No
Statistical Analysis Plan	version 2.0		06/07/2023	No	No
Results article		07/06/2024	12/07/2024	Yes	No

Additional files

ISRCTN12329547_PIS_V4.doc: Uploaded 08/07/2021
ISRCTN12329547_PROTOCOL_V2.0.docx: Uploaded 08/07/2021
ISRCTN12329547_SAP_V2.0_2021.pdf

Editorial Notes

12/07/2024: Publication reference added.
06/07/2023: The following changes have been made:
1. SAP file uploaded.
2. Preprint reference added.
20/06/2023: Total final enrolment added.
17/06/2022: The following changes have been made:
1. The recruitment end date has been changed from 01/06/2022 to 01/06/2023.
2. The overall trial end date has been changed from 01/08/2022 to 01/08/2023 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 01/06/2023 to 01/12/2023.
08/07/2021: Uploaded protocol Version 2.0 (not peer reviewed). The participant information sheet has been uploaded.
08/06/2021: Trial's existence confirmed by UCL Research Ethics Committee.