ISRCTN ISRCTN16736293
DOI https://doi.org/10.1186/ISRCTN16736293
Submission date
27/11/2023
Registration date
01/12/2023
Last edited
17/12/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Medical scientists have dual commitments to clinical care and research efforts. Such commitments can create hectic and stressful work schedules, which may impact well-being and cognition. This study tests the hypothesis that mindfulness coaching plus wearable-based lifestyle monitoring can benefit such individuals.

Who can participate?
Physician Scientists affiliated with the UC San Diego Medical Scientist Training Program aged between 20 and 45 years old

What does the study involve?
The study involved mindfulness coaching plus wearable-based lifestyle monitoring. Mindfulness coaching will be provided in small group sessions led by two psychological health experts as coaches. The coaches lead three sessions (each lasting 1.5 hours) spread over one academic quarter for each small group. The group meetings will be held virtually to maximize accessibility and comfort for the participants and will be scheduled per the participants’ mutually preferred times. In each session, the coaches will conduct mindfulness exercises and lead an interactive discussion on health, well-being, resilience, leadership training, and self-compassion. Different mindfulness tools and perspectives will be suggested and discussed by the facilitators and by the participants themselves to address work-life challenges. The participants will be encouraged to share their sources of support (e.g., exploring sources of strength, stress management techniques, and spending time with loved ones). Focused mindfulness practice will be offered and taught at each session. At the end of each session, participants will be encouraged to prepare to share a tool or thought that was discussed at the next session. Intervention group participants will each be provided with a Garmin Vivosmart® 4 (a wearable device) to passively monitor and receive feedback on lifestyle factors (physical activity, heart rate, sleep quality and stress) via an app coupled to the Garmin for the duration of the intervention.

What are the possible benefits and risks of participating?
Benefits to participants may include improvements in well-being and/or cognition. This is a minimal-risk study.

Where is the study run from?
The University of California San Diego School of Medicine (USA)

When is the study starting and how long is it expected to run for?
January 2021 to December 2022

Who is funding the study?
National Institutes of Health (Grant: NIH/NIGMS 1T32GM121318-01) (USA)

Who is the main contact?
Jyoti Mishra, jymishra@ucsd.edu (USA)

Contact information

Dr Jyoti Mishra
Public, Scientific, Principal Investigator

9500 Gilman Drive MC0875
La Jolla
92037
United States of America

ORCiD logoORCID ID 0000-0001-6612-4557
Phone +1 8582322855
Email jymishra@ucsd.edu

Study information

Study designInterventional
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Internet/virtual, University/medical school/dental school
Study typePrevention
Participant information sheet 44648_PIS_22March2016.pdf
Scientific titleMindfulness coaching with digital lifestyle monitoring enhances selective attention in medical scientists
Study acronymWellMSTP
Study objectivesMindfulness coaching with digital lifestyle monitoring will enhance well-being and cognition and medical scientists
Ethics approval(s)

Approved 29/01/2021, University of California San Diego Institutional Review Board (9500 Gilman Drive, La Jolla, 92037, United States of America; +1 858-246-4777; hrpp@ucsd.edu), ref: 180140

Health condition(s) or problem(s) studiedWell-being
InterventionMindfulness Coaching
Participants will be randomized using a simple randomization method into the intervention or a waitlist control group. The intervention is a digital approach (delivered on Zoom) with group mindfulness sessions led by two psychological health faculty members as coaches. For these sessions, participants will be divided into sub-groups by career stage: pre-clinical medical scientist training program (MSTP) students, MSTP graduate students, or clinician/junior faculty. The coaches will lead three sessions (each 1.5 hours) spread over one academic quarter for each sub-group. The group meetings will be held virtually to maximize accessibility and comfort for the participants and will be scheduled per the participants’ mutually preferred times. In each session, the coaches will conduct mindfulness exercises and lead an interactive discussion on health, well-being, resilience, leadership training, and self-compassion. Participants will be asked to turn on their videos for the duration of the sessions and to share personal opinions and life experiences. In these sessions, the primary goal for the coaches will be to listen attentively and promote well-being. They will also aim to validate and acknowledge challenges that participants face as physician-scientists in training or as early career faculty. Different mindfulness tools and perspectives will be suggested and discussed by the facilitators and by the participants themselves to address work-life challenges. The participants will be encouraged to share their sources of support (e.g., exploring sources of strength, stress management techniques, and spending time with loved ones). Focused mindfulness practice will be offered and taught at each session. The participants will also discuss potential changes to the physician-scientist environment that would facilitate well-being if implemented. At the end of each session, participants will be encouraged to consider a tool or thought that was discussed to share at the next session. Intervention group participants will each be provided with a Garmin Vivosmart® 4 (a wearable device) to passively monitor and receive feedback on lifestyle factors (physical activity, heart rate, sleep quality, and stress) via an app coupled to the Garmin for the duration of the intervention.
Intervention typeBehavioural
Primary outcome measure1. Subjective well-being measured using a combination of the Mindful Attention Awareness Scale (MAAS), Short Warwick Edinburgh Mental Well-Being Scale (SWEMWBS), Self-Compassion Scale (SCS), and the Maslach Burnout Inventory (MBI) at baseline and post-intervention
2. Objective cognition measured using the BrainE neurocognitive platform at baseline and post-intervention

Secondary outcome measuresNeuroplasticity underlying cognition measured using electroencephalography (EEG) recordings synchronized to the BrainE neurocognitive platform assessments at baseline and post-intervention
Overall study start date01/01/2021
Completion date31/12/2022

Eligibility

Participant type(s)Healthy volunteer, Carer
Age groupAdult
Lower age limit20 Years
Upper age limit45 Years
SexBoth
Target number of participants43
Total final enrolment43
Key inclusion criteriaPhysician Scientists affiliated with the UC San Diego Medical Scientist Training Program
Key exclusion criteriaIndividuals not affiliated with the UCSD Medical Scientist Training Program
Date of first enrolment01/10/2021
Date of final enrolment01/12/2021

Locations

Countries of recruitment

  • United States of America

Study participating centre

University of California San Diego School of Medicine
9500 Gilman Drive
La Jolla
92037
United States of America

Sponsor information

University of California San Diego Medical Center
Hospital/treatment centre

9500 Gilman Drive
La Jolla
92037
United States of America

Phone +1 858-246-4777
Email irb@ucsd.edu
Website https://health.ucsd.edu/
ROR logo "ROR" https://ror.org/03aw5sn18

Funders

Funder type

Government

National Institutes of Health
Government organisation / National government
Alternative name(s)
Institutos Nacionales de la Salud, US National Institutes of Health, NIH
Location
United States of America

Results and Publications

Intention to publish date01/06/2025
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in publicly available repository
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planThe datasets generated during and/or analysed during the current study will be stored in a publically available repository, datadryad.org. The type of data stored includes all data outcome variables collected and analysed for the study. The data will be freely available for download post-publication of the research. Consent was obtained from participants for de-identified data sharing. The data will be de-identified and do not have any personal health information for participants. The data are de-identified with no ethical or legal restrictions.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet 22/03/2016 28/11/2023 No Yes

Additional files

44648_PIS_22March2016.pdf

Editorial Notes

17/12/2024: The intention to publish date was changed from 01/06/2024 to 01/06/2025.
28/11/2023: Study's existence confirmed by the Department of Health and Human Services, National Institutes of Health, National Institute of General Medical Sciences (USA).