Brief digital mindfulness and compassion training for healthcare professionals
| ISRCTN | ISRCTN94766568 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94766568 |
- Submission date
- 08/11/2023
- Registration date
- 09/11/2023
- Last edited
- 23/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
Several studies show that intense work schedules make healthcare professionals particularly vulnerable to emotional exhaustion and burnout. Self-compassion and mindfulness have often been found to be negatively correlated with burn-out, suggesting these behaviors may prevent burn-out and promote well-being. Scalable, digital app-based methods may have potential to enhance self-compassion and mindfulness in health-care professionals. In this study, we designed and implemented a scalable, digital app-based, brief mindfulness and compassion training program “WellMind” for healthcare professionals to investigate if this digital training may enhance self-compassion and mindfulness.
Who can participate?
Healthcare professionals aged 18-65 years can participate in this study.
What does the study involve?
The WellMind group participants received the digital app intervention and had periodic email contact from our research team during intervention, at about once every two weeks frequency, to ensure compliance and help troubleshoot any issues faced by the participants.
The no-contact control group had no interaction with the study research team nor any digital training resource provided to them between their pre and post assessment time points.
What are the possible benefits and risks of participating?
Possible benefits are improvement in mental health and risks of participating are minimal with some risk of loss of confidentiality although privacy and confidentiality is prioritized throughout the study.
Where is the study run from?
University of California San Diego (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?
Sanford Institute for Empathy and Compassion (USA)
Who is the main contact?
Jyoti Mishra, jymishra@ucsd.edu
Contact information
Public, Scientific, Principal Investigator
9500 Gilman Drive
La Jolla
92037
United States of America
 ORCID ID |
0000-0001-6612-4557 |
|---|---|
| Phone | +1 8582322855 |
| jymishra@ucsd.edu |
Study information
| Study design | Interventional cluster randomized |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Brief digital mindfulness and compassion training drives behavioral and neural plasticity in healthcare professionals |
| Study acronym | WellMind |
| Study hypothesis | The WellMind program will enhance mindfulness and compassion in healthcare professionals. |
| Ethics approval(s) |
Approved 29/01/2021, University of California San Diego Institutional Review Board (9500 Gilman Drive, San Diego, 92037, United States of America; +1 858-246-4777; hrpp@ucsd.edu), ref: 180140 |
| Condition | Mindfulness and compassion in healthcare professionals |
| Intervention | Participants were cluster randomized by their study batch to the WellMind or control group. This was done because individuals within each study batch (but not across batches) knew each other professionally and could reveal components of the study intervention to each other. The WellMind group participants received the digital app intervention and had periodic email contact from our research team during intervention, at about once every two weeks frequency, to ensure compliance and help troubleshoot any issues faced by the participants. The no-contact control group had no interaction with the study research team nor any digital training resource provided to them between their pre and post assessment time points. Digital WellMind intervention. The WellMind digital intervention was deployed on the BrainE© platform implemented in Unity and available on both iOS and Android phone devices. This digital program is HIPAA-compliant and secured by password-protection, and each user interacts via an alphanumeric study ID that is not linked to any personal health information. Participants accessed the app in their own free time and engaged in breath-focused mindfulness training with each session of 5-10 minutes duration for up to 60 sessions. The training was delivered in a game-like format and was performance-adaptive. Specifically, individuals were requested to close their eyes, pay attention to their breathing and tap the mobile screen after a specific number of breaths. The app monitored consistency of tap responses. If the user was distracted based on low consistency of breath monitoring taps, a gentle chime reminded the user to let go of the distraction and revert their attention back to mindful breathing. Initially, at level 1, participants tapped the screen after each breath. If they were able to do this consistently for three repeats of level 1 of 1 minute duration each, they graduated to level 2 and tracked two breaths at a time for 2 minutes, and so on. Thus, in the performance-adaptive task, the level reflected the number of minutes spent at that level and the number of breaths the participant was requested to repeatedly monitor. The max achievable level was level 10, i.e. monitoring 10 breaths at a time for up to 10 minutes. When the user graduated to the max level, they stayed at this level until end of all assigned sessions, i.e. 60 sessions. Also within the game-like format, when the participant opened their eyes at the end of a level, a peaceful nature scene would slowly unveil as a form of training reward. Overall, this digital meditative practice is considered closed-loop because of its performance-adaptive feature. Consistent attention to breathing is emphasized over say other types of breathing techniques like deep breathing. The moment-to-moment performance tracking further allows quantification of the attentive focus during each session that is not possible with traditional non-digital meditation. Finally, the training also introduced standard compassion cultivation instructions as audio and text prompts prior to the start of each session’s breath practice. Prompts were updated every 6 sessions, with a total of 10 prompts gradually increasing in complexity over 60 sessions. These prompts were designed per guidance from the Compassion Cultivation Training program, and included (i) settling the mind, (ii) compassion for a loved one, (iii) compassion for oneself, (iv) loving kindness for oneself, (v) embracing common humanity, (vi) embracing common humanity continued, (vii) cultivating compassion for oneself and others, (viii) cultivating compassion for others continued, (ix) active compassion, and (x) integrated compassion cultivation practice. Participants received in-app notifications, once a day, reminding them to complete their training. |
| Intervention type | Behavioural |
| Primary outcome measure | At baseline (T1), post-intervention completion (T2) (or 3 month no-contact period for the control group), and at follow-up (T3) (6 months following baseline) self-report scales measured: 1. Self-compassion: 12-item self-compassion scale, 2. Mindfulness: 14-item mindful attention awareness scale (MAAS). |
| Secondary outcome measures | 1. Maslach Burnout Inventory (MBI) at T1 and T2. 2. Objective neurophysiological assessment of interoceptive attention to breathing at T1 and T2. |
| Overall study start date | 29/01/2021 |
| Overall study end date | 31/12/2022 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 40; 2 clusters; 20 per arm |
| Total final enrolment | 43 |
| Participant inclusion criteria | Participants must be healthy adults and affiliated with the UC San Diego School of Medicine |
| Participant exclusion criteria | 1. Current clinical diagnosis or illness 2. Use of psychotropic medications |
| Recruitment start date | 01/02/2021 |
| Recruitment end date | 01/10/2022 |
Locations
Countries of recruitment
- United States of America
Study participating centre
La Jolla
92037
United States of America
Sponsor information
University/education
9500 Gilman Drive
La Jolla
92093
United States of America
| Phone | +1 (858) 534-2230 |
|---|---|
| empathyandcompassion@health.ucsd.edu | |
| Website | https://empathyandcompassion.ucsd.edu/ |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/03/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets analyzed in the current study will be stored in the publicly available DataDryad.org repository. doi:10.5061/dryad.0zpc8672x Please note that datadryad.org keeps this dataset URL private until the manuscript has been accepted. 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 does not have any personal health information for participants. The dataset is de-identified and there are no ethical or legal restrictions. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 14/11/2023 | No | No | ||
| Statistical Analysis Plan | 14/11/2023 | No | No | ||
| Results article | 22/01/2024 | 23/01/2024 | Yes | No |
Additional files
Editorial Notes
23/01/2024: Publication reference added.
14/11/2023: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed) as an additional file.
2. Uploaded SAP (not peer-reviewed) as an additional file.
09/11/2023: Trial's existence confirmed by UC San Diego
