DepressionIHSNCT03972293
2018 Intern Health Study Micro-randomized Trial
A study testing Intern Health Study behavioral change mobile notification and Intern Health Study mobile app in people with Depression and Mood, run by University of Michigan at 1 site in United States.
Trial summary
The aim of this trial is to evaluate the efficacy of an intervention (delivered through a smartphone) for improving the mood, physical activity, and sleep of medical interns. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Depression, Mood, Sleep
- What is being tested?
- Intern Health Study behavioral change mobile notification and Intern Health Study mobile app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,134 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 1 Jul 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Medical intern during the 2018-2019 internship year
- iPhone user
- Affiliated with one of 47 recruitment institutions
- Downloaded app, completed consent, and filled out baseline survey prior to June 25th 2018
Who cannot join
- -None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 2018 Intern Health Study Micro-randomized Trial: Developing a Mobile Health App to Improve Mental Health and Maintain Healthy Behaviors During the Internship Year
The aim of this trial is to evaluate the efficacy of an intervention (delivered through a smartphone) for improving the mood, physical activity, and sleep of medical interns.
Read the detailed description
Due to their high stress workloads, medical interns suffer from depression at higher rates than the general population. Interns also tend to have lower sleep and decreased physical activity. The goal of this trial is to evaluate the efficacy of a mobile health intervention intending to help improve the mental health of medical interns. The intervention sends mobile phone notifications which aim to help interns improve their mood, maintain physical activity, and obtain adequate sleep during their internship year.
The primary aim of the study is to evaluate how notifications affect participants' weekly mood, as measured through a daily one question mood survey. The second primary aim of the study is to evaluate how notifications affect participants' long-term mental health, as measured by the Patient Health Questionnaire. The first secondary aim is to evaluate how mood notifications affect participants' weekly mood. The second secondary aim is to evaluate how activity notifications affect participants' weekly step count. The third secondary aim is to evaluate how sleep notifications affect participants' weekly sleep duration. In order to better optimize notification delivery, the final aim (exploratory) is to understand moderators of these effects. Moderators of interest are previous week's mood, previous week's step count, previous week's sleep duration, study week, sex, previous history of depression, and baseline neuroticism.
- Conditions
- Depression, Mood, Sleep, Physical Activity
- Being tested
- Intern Health Study behavioral change mobile notification, Intern Health Study mobile app
- Medical subject headings
- Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intern Health Study behavioral change mobile notificationBehavioural
The study's mobile app will be used to deliver intervention notifications. The intervention notifications appear on the participant's phone lock screen. The notifications have 3 categories: mood notifications, activity notifications, sleep notifications. Mood notifications aim to increase the participant's mood. Activity notifications aim to increase the participant's physical activity. Sleep notifications aim to increase the participant's sleep duration. To increase the category of interest, the notifications use two types of messages: life insights and tips. Life insights provide participants information on their historical data (for a given category) in order to help them self-monitor. Tips are non-data based notifications which provide general advice for improving the category of interest.
Intern Health Study mobile appBehavioural
The Intern Health Study mobile app is able to conduct a daily mood survey. It also aggregates and visualizes historical data on intern mood, activity, and sleep.
| Study group | Role | What they receive |
|---|---|---|
| Within-participant Micro-randomization | Experimental | Each week in the study, with probability .25 for each, a participant is randomized to receive either a week of mood notifications, activity notifications, sleep notifications, or no notifications.
If the participant is assigned to receive mood, activity, or sleep notifications on a given week, then, for every day of that week the participant is randomized to: send notification on that day (with probability .5), or to not send a notification on that day (with probability .5). Receives: Behavioral: Intern Health Study behavioral change mobile notification; Behavioral: Intern Health Study mobile app |
| No intervention | Experimental | Participants in this arm will not receive any notifications for the entire duration of the trial. Primary and secondary outcomes will still be collected on participants in arm 2 through the study app and Fitbit. Receives: Behavioral: Intern Health Study mobile app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily mood
Through the mobile app, participants enter a mood score (scale 1-10) every day of the study. 1 corresponds to lowest mood and 10 corresponds to highest mood
For interns randomized to arm 1, average daily moods scores on weeks when a specific category of notification is sent are compared to mood scores on weeks when no notifications are sent.
Measured: 7 days
Patient Health Questionnaire-9 (PHQ-9)
Four months into the study, all participants complete the Patient Health Questionnaire 9. High scores on the PHQ-9 correspond to a larger number of depressive symptoms.
PHQ-9 scores are compared between the two arms: receive notifications vs do not receive notifications.
Measured: 4 months
Secondary outcomes (2)
Average daily step count
Participant's daily step counts are recorded through a Fitbit. High step counts are considered a positive outcome as it indicates more physical activity.
For interns randomized to arm 1, average daily step counts on weeks when activity notifications are sent are compared to step counts on weeks when no notifications are sent.
Measured: 7 days
Average nightly sleep duration
Participant's nightly sleep duration (in minutes) is recorded through a Fitbit. High sleep duration is considered a positive outcome.
For interns randomized to arm 1, nightly sleep duration on weeks when sleep notifications are sent are compared to sleep duration on weeks when no notifications are sent.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start1 Apr 2018
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to two arms: 'receive notifications' or 'do not receive notifications'. The 'do not receive notifications' group will not receive any notifications for the entire study. The 'receive notifications' group will receive notifications according to a micro-randomized trial design. For the 'receive notifications' group, each participant-week is randomized between 4 different interventions (mood notifications, activity notifications, sleep notifications or no notifications). If the participant-week is randomized to a mood notification, activity notification, or sleep notification week, the participant will receive notifications of that category during that week. For mood notification, activity notification, and sleep notification weeks, each participant-day is also randomized between: send notification that day or do not send notification that day.
- Masking
- None (open label)
- Enrolment
- 2,134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Srijan Sen, University of Michigan
- Investigators
- Srijan Sen, M.D., Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972293
- Sponsor's protocol ID
- 0003302
- Acronym
- IHS
- Status last verified
- Aug 2019
- First submitted
- 30 May 2019
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified genomic and survey information (baseline survey, plus quarterly survey which contains the PHQ-9) will be shared with the National Institute for Mental Health (NIMH).
Publications
Klasnja P, Hekler EB, Shiffman S, Boruvka A, Almirall D, Tewari A, Murphy SA. Microrandomized trials: An experimental design for developing just-in-time adaptive interventions. Health Psychol. 2015 Dec;34S(0):1220-8. doi: 10.1037/hea0000305.
PubMed 26651463Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941NeCamp T, Sen S, Frank E, Walton MA, Ionides EL, Fang Y, Tewari A, Wu Z. Assessing Real-Time Moderation for Developing Adaptive Mobile Health Interventions for Medical Interns: Micro-Randomized Trial. J Med Internet Res. 2020 Mar 31;22(3):e15033. doi: 10.2196/15033.
PubMed 32229469
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2018 Intern Health Study Micro-randomized Trial: Developing a Mobile Health App to Improve Mental Health and Maintain Healthy Behaviors During the Internship Year
- ClinicalTrials.gov ID
- NCT03972293
- Acronym / sponsor ID
- IHS / 0003302
- Conditions
- Depression, Mood, Sleep, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,134 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 3 Jun 2019 (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 trial is to evaluate the efficacy of an intervention (delivered through a smartphone) for improving the mood, physical activity, and sleep of medical interns.
Detailed description
Due to their high stress workloads, medical interns suffer from depression at higher rates than the general population. Interns also tend to have lower sleep and decreased physical activity. The goal of this trial is to evaluate the efficacy of a mobile health intervention intending to help improve the mental health of medical interns. The intervention sends mobile phone notifications which aim to help interns improve their mood, maintain physical activity, and obtain adequate sleep during their internship year.
The primary aim of the study is to evaluate how notifications affect participants' weekly mood, as measured through a daily one question mood survey. The second primary aim of the study is to evaluate how notifications affect participants' long-term mental health, as measured by the Patient Health Questionnaire. The first secondary aim is to evaluate how mood notifications affect participants' weekly mood. The second secondary aim is to evaluate how activity notifications affect participants' weekly step count. The third secondary aim is to evaluate how sleep notifications affect participants' weekly sleep duration. In order to better optimize notification delivery, the final aim (exploratory) is to understand moderators of these effects. Moderators of interest are previous week's mood, previous week's step count, previous week's sleep duration, study week, sex, previous history of depression, and baseline neuroticism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized to two arms: 'receive notifications' or 'do not receive notifications'. The 'do not receive notifications' group will not receive any notifications for the entire study. The 'receive notifications' group will receive notifications according to a micro-randomized trial design. For the 'receive notifications' group, each participant-week is randomized between 4 different interventions (mood notifications, activity notifications, sleep notifications or no notifications). If the participant-week is randomized to a mood notification, activity notification, or sleep notification week, the participant will receive notifications of that category during that week. For mood notification, activity notification, and sleep notification weeks, each participant-day is also randomized between: send notification that day or do not send notification that day.
| Arm | Type | Receives |
|---|---|---|
| Within-participant Micro-randomization | Experimental | Behavioral: Intern Health Study behavioral change mobile notification, Behavioral: Intern Health Study mobile appEach week in the study, with probability .25 for each, a participant is randomized to receive either a week of mood notifications, activity notifications, sleep notifications, or no notifications. If the participant is assigned to receive mood, activity, or sleep notifications on a given week, then, for every day of that week the participant is randomized to: send notification on that day (with probability .5), or to not send a notification on that day (with probability .5). |
| No intervention | Experimental | Behavioral: Intern Health Study mobile appParticipants in this arm will not receive any notifications for the entire duration of the trial. Primary and secondary outcomes will still be collected on participants in arm 2 through the study app and Fitbit. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Medical intern during the 2018-2019 internship year
- iPhone user
- Affiliated with one of 47 recruitment institutions
- Downloaded app, completed consent, and filled out baseline survey prior to June 25th 2018
Key exclusion criteria (1 listed)
- -None
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 |
|---|---|---|
| Intern Health Study behavioral change mobile notificationThe study's mobile app will be used to deliver intervention notifications. The intervention notifications appear on the participant's phone lock screen. The notifications have 3 categories: mood notifications, activity notifications, sleep notifications. Mood notifications aim to increase the participant's mood. Activity notifications aim to increase the participant's physical activity. Sleep notifications aim to increase the participant's sleep duration. To increase the category of interest, the notifications use two types of messages: life insights and tips. Life insights provide participants information on their historical data (for a given category) in order to help them self-monitor. Tips are non-data based notifications which provide general advice for improving the category of interest. | Behavioural | Within-participant Micro-randomization |
| Intern Health Study mobile appThe Intern Health Study mobile app is able to conduct a daily mood survey. It also aggregates and visualizes historical data on intern mood, activity, and sleep. | Behavioural | No intervention, Within-participant Micro-randomization |
Primary outcome
Average daily mood
Time frame: 7 days
Through the mobile app, participants enter a mood score (scale 1-10) every day of the study. 1 corresponds to lowest mood and 10 corresponds to highest mood For interns randomized to arm 1, average daily moods scores on weeks when a specific category of notification is sent are compared to mood scores on weeks when no notifications are sent.
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 4 months
Four months into the study, all participants complete the Patient Health Questionnaire 9. High scores on the PHQ-9 correspond to a larger number of depressive symptoms. PHQ-9 scores are compared between the two arms: receive notifications vs do not receive notifications.
2 secondary outcomes
Average daily step count
Time frame: 7 days
Average nightly sleep duration
Time frame: 7 days
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 13 Aug 2019.
- Background: PubMed 26651463Klasnja P, Hekler EB, Shiffman S, Boruvka A, Almirall D, Tewari A, Murphy SA. Microrandomized trials: An experimental design for developing just-in-time adaptive interventions. Health Psychol. 2015 Dec;34S(0):1220-8. doi: 10.1037/hea0000305.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Derived from this study: PubMed 32229469NeCamp T, Sen S, Frank E, Walton MA, Ionides EL, Fang Y, Tewari A, Wu Z. Assessing Real-Time Moderation for Developing Adaptive Mobile Health Interventions for Medical Interns: Micro-Randomized Trial. J Med Internet Res. 2020 Mar 31;22(3):e15033. doi: 10.2196/15033.
- Intern Health Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified genomic and survey information (baseline survey, plus quarterly survey which contains the PHQ-9) will be shared with the National Institute for Mental Health (NIMH).
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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.
Srijan Sen, M.D., Ph.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intern Health Study behavioral change mobile notification and Intern Health Study mobile app in people with Depression and Mood, run by University of Michigan at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 13 Aug 2019. 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 States. 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?
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?
Average daily mood (time frame: 7 days). The study lists 2 primary outcomes in all. 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 NCT03972293, which also lists 3 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 13 Aug 2019.