Major Depressive DisorderNCT04972474
Exploring Engagement With Remote Symptom Tracking for Depression (RADAR: Engage)
A study testing Smartphone app in-app components in people with Major Depressive Disorder, run by King's College London at 1 site in United Kingdom.
Trial summary
The aim of this study is to understand how best to promote engagement with remote measurement technology (RMT) research in major depressive disorder, using the RADAR-MDD infrastructure as a case study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Smartphone app in-app components
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Apr 2021to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participation in the RADAR-MDD London site study
- Consent for future research contact given during participation in the RADAR-MDD study
- Willing and able to continue using an Android smartphone
- Willing and able to continue using a Fitbit device
- Capacity to give informed consent
Who cannot join
- Development of a comorbid psychiatric disorder since participation in the RADAR-MDD study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Department of Psychological Medicine, King's College London
London, SE5 8AF
Katie White, BSc, 07850 684847, katie.white@kcl.ac.uk
About this study
Official title: A Two-Armed Trial Exploring the Effects of In-App Components on User Engagement With a Symptom-Tracking System for Depression (RADAR: Engage)
The aim of this study is to understand how best to promote engagement with remote measurement technology (RMT) research in major depressive disorder, using the RADAR-MDD infrastructure as a case study. An adapted questionnaire app with insightful notifications and progress visualization will be compared against the app as usual, in terms of behavioural and experiential engagement.
Read the detailed description
Remote measurement technologies (RMTs) provide an opportunity for real-time, longitudinal health tracking through a combination of smartphone apps for symptom reporting (active RMT; aRMT) and mobile/wearable sensors for passive data collection (passive RMT; pRMT). The use of RMTs to track relapse and remission of symptoms in major depressive disorder (MDD) is thought to be more reflective of patient daily experience, in comparison to retrospective recall during clinic visits. The Remote Assessment of Disease and Relapse- Major Depressive Disorder (RADAR-MDD) study uses RMTs to identify predictors of MDD relapse. It collects multiparametric RMT data through the RADAR-base system over a two year follow-up period; aRMT data is collected via mood-tracking questionnaires in the active app, and pRMT data is collected via a fitness watch, the Fitbit Charge device. The promise of RADAR-MDD depends heavily on user engagement with the app. Currently, engagement with aRMT symptom tracking in the field is hugely heterogeneous and preliminary estimates of the RADAR-MDD study suggest around 50% completion of fortnightly questionnaires. There are several, in-app methods available to promote engagement with mHealth tools. Notifications with theoretically informed content can provide a trigger to perform a behaviour, and data visualisation of progress can prompt continued data input. It is unclear which combination of in-app features can promote engagement with the RADAR-base system, while minimising participant burden.
This study therefore aims to understand how best to promote engagement with RMT research, using the RADAR-MDD project as a case study. This protocol will outline a mixed-methods approach to exploring the impact of additional, in-app components on engagement with symptom tracking via the RADAR-Base infrastructure. First, a two-armed randomized controlled trial will compare the RADAR-MDD questionnaire app as usual with an adapted app with insightful notifications and progress visualization, aimed at promoting behavioural and experiential engagement. Engagement will be measured as a) provision of symptom tracking scores over the 12-week study period, and b) the degree to which participants feel experientially engaged with symptom tracking via the system. Second, qualitative interviews will reveal participant experiences of the techniques used.
The study has three main objectives:
To examine the impact of an adapted smartphone app on behavioural engagement with RMT symptom tracking, in comparison with the RADAR-MDD app as usual;
To examine the impact of an adapted smartphone app on experiential engagement with RMT symptom tracking, in comparison with the RADAR-MDD app as usual;
Qualitatively explore the views of participants on the use of an adapted smartphone app to increase engagement with the RADAR-Base system.
Findings in this field would go some way to providing scalable solutions for engagement in RMT studies, higher quality results and applications for implementation into clinical practice.
- Conditions
- Major Depressive Disorder
- Being tested
- Smartphone app in-app components
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone app in-app componentsOther
Insightful notification text, data visualisation, research team contact details.
| Study group | Role | What they receive |
|---|---|---|
| RADAR-MDD Questionnaire App as Usual | No intervention | The RADAR-MDD questionnaire app as usual asks participants to complete 3x active tasks per week, with one reminder notification at 9am on a day that a questionnaire is due. The notification reads 'Questionnaire Time. Won't usually take longer than 3 minutes'. The participant is not able to view any data progress, aside from through the Fitbit app, which was present in the original RADAR-MDD study. |
| RADAR-MDD Adapted Questionnaire App | Experimental | The following components are also present:
Notifications: The notification will alternate between the phrases 'Questionnaire Time. Symptom tracking might increase self-awareness of your emotions (Bakker \& Rickard, 2018)', 'Questionnaire Time. Symptom tracking is a technique often used in treatment to increase insight into your symptoms (Kramer et al., 2014)', and 'Questionnaire Time. Tracking your symptoms through a smartphone and Fitbit might help research to better understand health conditions'.
Progress visualisation: Participants will be able to view their questionnaire completion progress as a visualisation through the app, in the form of a graph.
Additional components: An additional text on the home screen of the active app will read 'You can contact your research team between 9am-5pm Mon-Fri if you have questions, onradar-engage@kcl.ac.uk'. Receives: Other: Smartphone app in-app components |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioural engagement
Data completion of active symptom tracking (PHQ-8 scale). Value of 0-12.
Measured: Total completion at the 12-week end point
Secondary outcomes (4)
Experiential engagement (1)
User Engagement Scale for mHealth Technology. 30 items, 5-point likert scale. Minimum value 0, maximum value 150. Higher value relates to increased experiential engagement.
Measured: Baseline and 12-week point
Experiential engagement (2)
Emotional Self-Awareness Questionnaire. 33 items, 5-point likert scale. Minimum value 0, maximum value 165. Higher value relates to increased emotional awareness.
Measured: Baseline and 12-week point
System Usability
mHealth App Usability Questionnaire. 18 items, 7-point likert scale. Minimum value 0, maximum value 126. Higher value relates to increased app usability rating.
Measured: Baseline and 12-week point
Passive monitoring adherence
Fitbit device weartime
Measured: Continuously across a 12-week time period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start7 Apr 2021
- Primary completionAug 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomised to one of two arms, the app as usual or the adapted app.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katie White, BSc, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972474
- Sponsor's protocol ID
- RESCM-20/21-21083
- Status last verified
- May 2021
- First submitted
- 14 May 2021
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
White KM, Carr E, Leightley D, Matcham F, Conde P, Ranjan Y, Simblett S, Dawe-Lane E, Williams L, Henderson C, Hotopf M. Engagement With a Remote Symptom-Tracking Platform Among Participants With Major Depressive Disorder: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2024 Jan 19;12:e44214. doi: 10.2196/44214.
PubMed 38241070White KM, Matcham F, Leightley D, Carr E, Conde P, Dawe-Lane E, Ranjan Y, Simblett S, Henderson C, Hotopf M. Exploring the Effects of In-App Components on Engagement With a Symptom-Tracking Platform Among Participants With Major Depressive Disorder (RADAR-Engage): Protocol for a 2-Armed Randomized Controlled Trial. JMIR Res Protoc. 2021 Dec 21;10(12):e32653. doi: 10.2196/32653.
PubMed 34932005
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Armed Trial Exploring the Effects of In-App Components on User Engagement With a Symptom-Tracking System for Depression (RADAR: Engage)
- ClinicalTrials.gov ID
- NCT04972474
- Acronym / sponsor ID
- RESCM-20/21-21083
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to understand how best to promote engagement with remote measurement technology (RMT) research in major depressive disorder, using the RADAR-MDD infrastructure as a case study. An adapted questionnaire app with insightful notifications and progress visualization will be compared against the app as usual, in terms of behavioural and experiential engagement.
Detailed description
Remote measurement technologies (RMTs) provide an opportunity for real-time, longitudinal health tracking through a combination of smartphone apps for symptom reporting (active RMT; aRMT) and mobile/wearable sensors for passive data collection (passive RMT; pRMT). The use of RMTs to track relapse and remission of symptoms in major depressive disorder (MDD) is thought to be more reflective of patient daily experience, in comparison to retrospective recall during clinic visits. The Remote Assessment of Disease and Relapse- Major Depressive Disorder (RADAR-MDD) study uses RMTs to identify predictors of MDD relapse. It collects multiparametric RMT data through the RADAR-base system over a two year follow-up period; aRMT data is collected via mood-tracking questionnaires in the active app, and pRMT data is collected via a fitness watch, the Fitbit Charge device. The promise of RADAR-MDD depends heavily on user engagement with the app. Currently, engagement with aRMT symptom tracking in the field is hugely heterogeneous and preliminary estimates of the RADAR-MDD study suggest around 50% completion of fortnightly questionnaires. There are several, in-app methods available to promote engagement with mHealth tools. Notifications with theoretically informed content can provide a trigger to perform a behaviour, and data visualisation of progress can prompt continued data input. It is unclear which combination of in-app features can promote engagement with the RADAR-base system, while minimising participant burden.
This study therefore aims to understand how best to promote engagement with RMT research, using the RADAR-MDD project as a case study. This protocol will outline a mixed-methods approach to exploring the impact of additional, in-app components on engagement with symptom tracking via the RADAR-Base infrastructure. First, a two-armed randomized controlled trial will compare the RADAR-MDD questionnaire app as usual with an adapted app with insightful notifications and progress visualization, aimed at promoting behavioural and experiential engagement. Engagement will be measured as a) provision of symptom tracking scores over the 12-week study period, and b) the degree to which participants feel experientially engaged with symptom tracking via the system. Second, qualitative interviews will reveal participant experiences of the techniques used.
The study has three main objectives:
To examine the impact of an adapted smartphone app on behavioural engagement with RMT symptom tracking, in comparison with the RADAR-MDD app as usual;
To examine the impact of an adapted smartphone app on experiential engagement with RMT symptom tracking, in comparison with the RADAR-MDD app as usual;
Qualitatively explore the views of participants on the use of an adapted smartphone app to increase engagement with the RADAR-Base system.
Findings in this field would go some way to providing scalable solutions for engagement in RMT studies, higher quality results and applications for implementation into clinical practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomised to one of two arms, the app as usual or the adapted app.
| Arm | Type | Receives |
|---|---|---|
| RADAR-MDD Questionnaire App as Usual | No intervention | –The RADAR-MDD questionnaire app as usual asks participants to complete 3x active tasks per week, with one reminder notification at 9am on a day that a questionnaire is due. The notification reads 'Questionnaire Time. Won't usually take longer than 3 minutes'. The participant is not able to view any data progress, aside from through the Fitbit app, which was present in the original RADAR-MDD study. |
| RADAR-MDD Adapted Questionnaire App | Experimental | Other: Smartphone app in-app componentsThe following components are also present: Notifications: The notification will alternate between the phrases 'Questionnaire Time. Symptom tracking might increase self-awareness of your emotions (Bakker \& Rickard, 2018)', 'Questionnaire Time. Symptom tracking is a technique often used in treatment to increase insight into your symptoms (Kramer et al., 2014)', and 'Questionnaire Time. Tracking your symptoms through a smartphone and Fitbit might help research to better understand health conditions'. Progress visualisation: Participants will be able to view their questionnaire completion progress as a visualisation through the app, in the form of a graph. Additional components: An additional text on the home screen of the active app will read 'You can contact your research team between 9am-5pm Mon-Fri if you have questions, onradar-engage@kcl.ac.uk'. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participation in the RADAR-MDD London site study
- Consent for future research contact given during participation in the RADAR-MDD study
- Willing and able to continue using an Android smartphone
- Willing and able to continue using a Fitbit device
- Capacity to give informed consent
Key exclusion criteria (1 listed)
- Development of a comorbid psychiatric disorder since participation in the RADAR-MDD study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone app in-app componentsInsightful notification text, data visualisation, research team contact details. | Other | RADAR-MDD Adapted Questionnaire App |
Primary outcome
Behavioural engagement
Time frame: Total completion at the 12-week end point
Data completion of active symptom tracking (PHQ-8 scale). Value of 0-12.
4 secondary outcomes
Experiential engagement (1)
Time frame: Baseline and 12-week point
Experiential engagement (2)
Time frame: Baseline and 12-week point
System Usability
Time frame: Baseline and 12-week point
Passive monitoring adherence
Time frame: Continuously across a 12-week time period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Derived from this study: PubMed 38241070White KM, Carr E, Leightley D, Matcham F, Conde P, Ranjan Y, Simblett S, Dawe-Lane E, Williams L, Henderson C, Hotopf M. Engagement With a Remote Symptom-Tracking Platform Among Participants With Major Depressive Disorder: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2024 Jan 19;12:e44214. doi: 10.2196/44214.
- Derived from this study: PubMed 34932005White KM, Matcham F, Leightley D, Carr E, Conde P, Dawe-Lane E, Ranjan Y, Simblett S, Henderson C, Hotopf M. Exploring the Effects of In-App Components on Engagement With a Symptom-Tracking Platform Among Participants With Major Depressive Disorder (RADAR-Engage): Protocol for a 2-Armed Randomized Controlled Trial. JMIR Res Protoc. 2021 Dec 21;10(12):e32653. doi: 10.2196/32653.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katie White, BSc principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone app in-app components in people with Major Depressive Disorder, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katie White, BSc (07850 684847, katie.white@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioural engagement (time frame: Total completion at the 12-week end point). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04972474, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.