Depressive DisorderNCT02499094
Modeling and Predicting Real World Behavior Using Mobile Sensor Data on Patients With Major Depressive Disorder
A study testing Behavioral-data driven support in people with Depressive Disorder, run by Ginger.io.
Trial summary
The purpose of this study is to validate the effectiveness of using an integrated mobile sensing platform to deliver large-scale data-driven interventions to patients with depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Behavioral-data driven support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,004 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Jul 2015
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently suffering from depression (as measured by a PHQ-9 score of 10 or more at the time of screening)
- Own an iPhone or Android smartphone with a mobile voice calling plan with a US carrier
- Fluency in English
Who cannot join
- Participants with visual or hearing impairment
- Recent history of pregnancy (currently pregnant or those who have given birth within the past four months at the time of screening)
- Recent loss of a loved one (within the past two months at the time of screening)
- Unable or unwilling to accept End User License Agreement, or to provide information regarding their demographic characteristics and mental health history
About this study
Official title: Modeling and Predicting Real World Behavior Using Mobile Sensor Data on Patients With Major Depressive Disorder: Protocol for a Randomized Controlled Study
The purpose of this study is to validate the effectiveness of using an integrated mobile sensing platform to deliver large-scale data-driven interventions to patients with depression.
Read the detailed description
This study is a smartphone-based, randomized, single-blind, controlled parallel-
design study with two intervention arms and one control arm. The two intervention arms
will receive in-app messages and phone-based support, which will be triggered by
participant's self-reported surveys and passive behavioral data gathered through a
smartphone app. The study will include a nationwide sample of adult (18 years or older)
smartphone users, who are currently experiencing depressive symptoms. The primary
outcome will be decrease in depression symptom severity, as measured by the 9-item
Patient Health Questionnaire, over 6 months.
- Conditions
- Depressive Disorder
- Being tested
- Behavioral-data driven support
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral-data driven supportOther
Phone-based support (e.g. triaging of the situation, emotional support, and guidance on next steps for the patient) and in-app support (health education content based on cognitive behavioral therapies, mindfulness, and behavioral activation)
| Study group | Role | What they receive |
|---|---|---|
| Intervention A- Heuristic based | Experimental | Behavioral-data driven support, both mobile phone application and phone-based, informed by their self-reported symptom assessment as well as simple heuristic-based behavioral measures Receives: Other: Behavioral-data driven support |
| Intervention B- Machine Learning Based | Experimental | Behavioral-data driven support, both mobile phone application and phone-based, informed by their self-reported symptom assessment as well as machine learning model-based behavioral measures Receives: Other: Behavioral-data driven support |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression symptom severity
Change in the 9-item Patient Health Questionnaire (PHQ-9) score from baseline
Measured: 6 months
Secondary outcomes (1)
Change in patient activation
Change in the 13-item Patient Activation Measure score from baseline
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startDec 2014
- Primary completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,004 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ginger.io
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Gourab De, Ginger.io
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02499094
- Sponsor's protocol ID
- GIO-001
- Status last verified
- Jul 2015
- First submitted
- 14 Jul 2015
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modeling and Predicting Real World Behavior Using Mobile Sensor Data on Patients With Major Depressive Disorder: Protocol for a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02499094
- Acronym / sponsor ID
- GIO-001
- Conditions
- Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,004 participants (actual)
- Lead sponsor
- Ginger.ioIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Jul 2015 (actual)
- First posted
- 15 Jul 2015 (estimated)
- 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 purpose of this study is to validate the effectiveness of using an integrated mobile sensing platform to deliver large-scale data-driven interventions to patients with depression.
Detailed description
This study is a smartphone-based, randomized, single-blind, controlled parallel-
design study with two intervention arms and one control arm. The two intervention arms
will receive in-app messages and phone-based support, which will be triggered by
participant's self-reported surveys and passive behavioral data gathered through a
smartphone app. The study will include a nationwide sample of adult (18 years or older)
smartphone users, who are currently experiencing depressive symptoms. The primary
outcome will be decrease in depression symptom severity, as measured by the 9-item
Patient Health Questionnaire, over 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention A- Heuristic based | Experimental | Other: Behavioral-data driven supportBehavioral-data driven support, both mobile phone application and phone-based, informed by their self-reported symptom assessment as well as simple heuristic-based behavioral measures |
| Intervention B- Machine Learning Based | Experimental | Other: Behavioral-data driven supportBehavioral-data driven support, both mobile phone application and phone-based, informed by their self-reported symptom assessment as well as machine learning model-based behavioral measures |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Currently suffering from depression (as measured by a PHQ-9 score of 10 or more at the time of screening)
- Own an iPhone or Android smartphone with a mobile voice calling plan with a US carrier
- Fluency in English
Key exclusion criteria (4 listed)
- Participants with visual or hearing impairment
- Recent history of pregnancy (currently pregnant or those who have given birth within the past four months at the time of screening)
- Recent loss of a loved one (within the past two months at the time of screening)
- Unable or unwilling to accept End User License Agreement, or to provide information regarding their demographic characteristics and mental health history
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 |
|---|---|---|
| Behavioral-data driven supportPhone-based support (e.g. triaging of the situation, emotional support, and guidance on next steps for the patient) and in-app support (health education content based on cognitive behavioral therapies, mindfulness, and behavioral activation) | Other | Intervention A- Heuristic based, Intervention B- Machine Learning Based |
Primary outcome
Change in depression symptom severity
Time frame: 6 months
Change in the 9-item Patient Health Questionnaire (PHQ-9) score from baseline
1 secondary outcome
Change in patient activation
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral-data driven support in people with Depressive Disorder, run by Ginger.io.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 15 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression symptom severity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2015.