Stress, EmotionalETSRNCT02947477
Emotion Tracking Study for Residents
A study testing EmoTrak in people with Stress, Emotional, run by University of California, San Francisco at 1 site in United States.
Trial summary
The proposed study will develop and pilot a fourteen-day assessment tailored for the high-demand schedule of residents through a smart phone intervention, EmoTrak.EmoTrak uses ecological measurement assessment (EMA), which solicits real-time user feedback at various time points across a series of days or weeks. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Emotional
- What is being tested?
- EmoTrak
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 17 Dec 2017
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Currently in Residency or Fellowship at UCSF
Who cannot join
- Not having an Iphone
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California
San Francisco, California, 94114
About this study
Official title: EmoTrak, Ecological Momentary Assessment of Emotion, Stress and Satisfaction Among Residents
The proposed study will develop and pilot a fourteen-day assessment tailored for the high-demand schedule of residents through a smart phone intervention, EmoTrak.EmoTrak uses ecological measurement assessment (EMA), which solicits real-time user feedback at various time points across a series of days or weeks.
Read the detailed description
The investigators will perform a randomized controlled trial that compares residents, using EmoTrak with a wait list control group. After two weeks, the active control group becomes the treatment group. All participants will be evaluated four times from at baseline to two months. The measures to explore for any pre and post change are stress reduction on the emotional exhaustion scale of the Maslach Burnout Inventory (MBI) and improved resilience on the Perceived Stress Scale (PSS).
- Conditions
- Stress, Emotional
- Being tested
- EmoTrak
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmoTrakBehavioural
Ecological Momentary Assessment of Emotion through Iphone App
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The EMA intervention uses twice-a-day interactive questions for emotion tracking including type of emotion, intensity of emotion, trigger to emotion and response to emotion through an Iphone app designed for the study. The study users receive individualized feedback about their daily reporting of emotions, sleep and stress.The study tracking is for 14 days. Receives: Behavioral: EmoTrak |
| Control | No intervention | The control arm does nothing for 14 days and then receives the 14 day emotion tracking listed above. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention of Participants Iphone App for Residents
Quantify amount of drop out through out the 14 day study and how many reports are responded two daily
Measured: 14 days
Acceptability of Iphone App for Residents Online Evaluation and Mini Interviews
Evaluate online questions and qualitative mini interviews about the usability of the app
Measured: 30 days
Secondary outcomes (3)
Real Time Assessment Comparison to Standardized Measures
Compare Pre, Post and Midway Assessments of Stress, Burnout and Emotion Awareness with daily, longitudinal measures to explore relationships between these sources of data.
Measured: 35 days
Ecological Assessment of Emotions Compared to Standardized Emotion Awareness Measures, PANAS
Comparing the daily reports of emotions in comparison to the PANAS scale of last week of experienced emotions
Measured: 14 days
Ecological Assessment of Stress Compared to Standardized Perceived Stress and Emotional Exhaustion from the Maslach Burnout Inventory
Comparing the daily reports of stress s in comparison to the week of stress as measured by PSS and MBI.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion17 Dec 2017
- Study completion17 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress, EmotionalStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eve Ekman, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947477
- Sponsor's protocol ID
- RAPFUNDEKMAN
- Acronym
- ETSR
- Status last verified
- Jan 2020
- First submitted
- 24 Oct 2016
- Last updated
- 18 Jan 2020
- Results posted
- No
- Individual data sharing
- No
Publications
Riess H, Kelley JM, Bailey RW, Dunn EJ, Phillips M. Empathy training for resident physicians: a randomized controlled trial of a neuroscience-informed curriculum. J Gen Intern Med. 2012 Oct;27(10):1280-6. doi: 10.1007/s11606-012-2063-z. Epub 2012 May 2.
PubMed 22549298
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EmoTrak, Ecological Momentary Assessment of Emotion, Stress and Satisfaction Among Residents
- ClinicalTrials.gov ID
- NCT02947477
- Acronym / sponsor ID
- ETSR / RAPFUNDEKMAN
- Conditions
- Stress, Emotional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 17 Dec 2017 (actual)
- Study completion
- 17 Dec 2017 (actual)
- First posted
- 28 Oct 2016 (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 proposed study will develop and pilot a fourteen-day assessment tailored for the high-demand schedule of residents through a smart phone intervention, EmoTrak.EmoTrak uses ecological measurement assessment (EMA), which solicits real-time user feedback at various time points across a series of days or weeks.
Detailed description
The investigators will perform a randomized controlled trial that compares residents, using EmoTrak with a wait list control group. After two weeks, the active control group becomes the treatment group. All participants will be evaluated four times from at baseline to two months. The measures to explore for any pre and post change are stress reduction on the emotional exhaustion scale of the Maslach Burnout Inventory (MBI) and improved resilience on the Perceived Stress Scale (PSS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: EmoTrakThe EMA intervention uses twice-a-day interactive questions for emotion tracking including type of emotion, intensity of emotion, trigger to emotion and response to emotion through an Iphone app designed for the study. The study users receive individualized feedback about their daily reporting of emotions, sleep and stress.The study tracking is for 14 days. |
| Control | No intervention | –The control arm does nothing for 14 days and then receives the 14 day emotion tracking listed above. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Currently in Residency or Fellowship at UCSF
Key exclusion criteria (1 listed)
- Not having an Iphone
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 |
|---|---|---|
| EmoTrakEcological Momentary Assessment of Emotion through Iphone App | Behavioural | Treatment |
Primary outcome
Retention of Participants Iphone App for Residents
Time frame: 14 days
Quantify amount of drop out through out the 14 day study and how many reports are responded two daily
Acceptability of Iphone App for Residents Online Evaluation and Mini Interviews
Time frame: 30 days
Evaluate online questions and qualitative mini interviews about the usability of the app
3 secondary outcomes
Real Time Assessment Comparison to Standardized Measures
Time frame: 35 days
Ecological Assessment of Emotions Compared to Standardized Emotion Awareness Measures, PANAS
Time frame: 14 days
Ecological Assessment of Stress Compared to Standardized Perceived Stress and Emotional Exhaustion from the Maslach Burnout Inventory
Time frame: 14 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 18 Jan 2020.
- Background: PubMed 22549298Riess H, Kelley JM, Bailey RW, Dunn EJ, Phillips M. Empathy training for resident physicians: a randomized controlled trial of a neuroscience-informed curriculum. J Gen Intern Med. 2012 Oct;27(10):1280-6. doi: 10.1007/s11606-012-2063-z. Epub 2012 May 2.
- Individual participant dataSharing planned: No
Related trials for Stress, Emotional
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
Recruiting
DBT-P Treatment Study
Emotion Dysregulation
Recruiting
The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
Caregiver Distress, Emotional Distress
Not yet recruitingObservational study
Caregiver and Child Anxiety, Relationships, and Daily Emotions ("CARE Study")
Anxiety
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.
Eve Ekman, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EmoTrak in people with Stress, Emotional, run by University of California, San Francisco 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 1 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 18 Jan 2020. 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?
Retention of Participants Iphone App for Residents (time frame: 14 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 NCT02947477, which also lists 1 linked publication.
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 18 Jan 2020.