StressNCT05085132
An Efficacy Trial of the MindFi App for Stress, Well-being, and Sleep Quality in Working Adults
A study testing MindFi app: Standard content and Mindfi app: Standard content without practice in people with Stress and Burnout, run by National University of Singapore at 1 site in Singapore.
Trial summary
90% of Asian workers report high levels of stress in an "always-on" culture. Stress and burnout are risk factors that account for 10-20% of health expenditure and threaten work longevity in the world's fastest growing economies. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- What is being tested?
- MindFi app: Standard content and Mindfi app: Standard content without practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Dec 2021to 31 May 2022
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Currently in full-time employment
- Fluent in English
- DASS-21 scores of at least 10 on the Stress subscale
Who cannot join
- Current diagnosis of a chronic psychological disorder, or sleep disorder
- Regularly practising meditation
Trial locations and contacts
1 site in 1 country.
About this study
90% of Asian workers report high levels of stress in an "always-on" culture. Stress and burnout are risk factors that account for 10-20% of health expenditure and threaten work longevity in the world's fastest growing economies. Traditional face-to-face sources of mental care such as counseling and psychotherapy are effective as a countermeasure to stress, but not always accessible or acceptable for those with busy lifestyles. Because of this, there is an urgent need for on-demand, scalable interventions to reduce stress and improve mental and physical well being. Technology-based solutions are increasingly being proposed to fill this need.
MindFi is a smartphone app that uses mindfulness exercises to help users cope with work stress and increase productivity. Since 2017, it has been featured by Apple, BBC, and Bloomberg and is being used at corporates such as Bain, Bloomberg, Cigna, and Zendesk. MindFi users contribute behavioral and self-report data, which are then used to generate individual recommendations for relevant, evidence-based exercises. These include mental care techniques such as mindfulness meditation, therapeutic journaling, psychosocial support and educational wellbeing quizzes.
In this study, the investigators will recruit 200 participants in a randomized controlled design, with 100 receiving access to content of the MindFi app, and 100 receiving access to a version containing music tracks for relaxation. Each intervention will last 4 weeks. Participants will use these apps for a period of 5 weeks (for a minimum of 10 minutes per day). Pre- and post-intervention, the investigators will measure self-reported ratings on a number of psychological variables, and will track sleep quality objectively for a one-week period.
- Being tested
- MindFi app: Standard content, Mindfi app: Standard content without practice
- Keywords
- Mindfulness, Sleep quality, Well-being
- Medical subject headings
- Burnout, Psychological, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindFi app: Standard contentBehavioural
Digital wellness training in this study will be delivered via the MindFi app, designed by Jaedye Labs. Content includes learning, assesesment, and practice tracks A core component of the exercises in this app is mindfulness training; however, the app also incorporates other exercises drawn from positive psychology such as journaling and diaphragmatic breathing. The app goes beyond traditional guided meditation through content that reinforces the principles and attitudes taught during in-person training, and also seeks to maximize user experience by using interactive tasks and progress charts.
Mindfi app: Standard content without practiceBehavioural
In this condition, participants will receive a version of the MindFi app that does NOT contain the practice tracks, only the learning and assessment tracks.
| Study group | Role | What they receive |
|---|---|---|
| MindFi app: Standard content | Experimental | Participants will receive full access to the MindFi app, containing learning tracks, practice tracks, and assessments. Participants will be instructed to use a practice track for a minimum of 10 minutes a day, and may use other exercises or tracks if desired. The intervention will last 4 weeks. Receives: Behavioral: MindFi app: Standard content |
| Mindfi app: Standard content without practice | Sham comparator | Participants will receive full access to the MindFi app, containing learning tracks, music tracks, and assessments. Participants will be instructed to use a music track for a minimum of 10 minutes a day, and may use other exercises or tracks if desired. The intervention will last 4 weeks. Receives: Behavioral: Mindfi app: Standard content without practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
WHO Well-Being Index (WHO, 1998)
Change in self-reported mental well being (min score: 0; max score: 25; greater increases in this score represent a better outcome)
Measured: Week 0 (at the start of the intervention) and Week 5
Depression, Anxiety, And Stress Scale -- Stress subscale (Lovibond and Lovibond, 1985)
Change in self-report measure of stress (min score: 0; max score: 21; greater reductions in this score represent a better outcome)
Measured: Week 0 (at the start of the intervention) and Week 5
Change in Sleep Efficiency (Oura Ring)
(Latency + wake time)/Time in bed, as calculated by the Oura app
Measured: Week 0 (at the start of the intervention) and Week 5
Secondary outcomes (8)
Depression, Anxiety, And Stress Scale -- Depression subscale (Lovibond and Lvibond, 1985)
Change in Self-report measure of depression (min score: 0; max score: 21; greater reductions in this score represent a better outcome)
Measured: Week 0 (at the start of the intervention) and Week 5
Depression, Anxiety, And Stress Scale -- Anxiety subscale (Lovibond and Lvibond, 1985)
Change in Self-report measure of anxiety (min score: 0; max score: 21; greater reductions in this score represent a better outcome)
Measured: Week 0 (at the start of the intervention) and Week 5
Maslach Burnout Inventory (Maslach et al., 1996)
Change in self-report measure of burnout
3 subscales:
- Emotional exhaustion (min score: 0; max score: 54; greater reductions in this score represent a better outcome)
- Depersonalization (min score: 0; max score: 30; greater reductions in this score represent a better outcome)
- Personal achievement (min score: 0; max score: 48; greater increases in this score represent a better outcome)
Measured: Week 0 (at the start of the intervention) and Week 5
Five Factor Mindfulness Questionnaire (Baer et al., 2006)
Change in Self-report measure of trait mindfulness (min score: 39; max score: 195; greater increases in this score represent a better outcome)
Measured: Week 0 (at the start of the intervention) and Week 5
Brief Inventory of Thriving (Su et al., 2014)
Change in Self-report measure of eudaimonic well-being (min score: 10; max score: 50; greater increases in this score represent a better outcome)
Measured: Week 0 (at the start of the intervention) and Week 5
Resting heart rate during sleep (from Oura Ring)
Objective measure of resting heart rate
Measured: Week 0 (at the start of the intervention) and Week 5
Heart-rate variability during sleep (from Oura Ring)
Objective measure of heart rate variability
Measured: Week 0 (at the start of the intervention) and Week 5
Satisfaction with Life Scale (Diener et al., 1985)
Self-report measure of hedonic well being (min score: 5; max score: 35; greater increases in this score represent a better outcome)
Measured: Week 0 (at the start of the intervention) and Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start1 Dec 2021
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe 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 will be randomized in a 1:1 allocation to use the MindFi app or receive a dummy version of the app (containing music tracks for relaxation).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Jaedye Labs
- Responsible party
- Principal investigator, Julian Lim, National University of Singapore
- Investigators
- Julian Lim, PhD, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085132
- Sponsor's protocol ID
- MINDFI01
- Status last verified
- Sep 2022
- First submitted
- 22 Sep 2021
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD will be shared with other researchers upon reasonable request, and after publication of the study results,
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficacy Trial of the MindFi App for Stress, Well-being, and Sleep Quality in Working Adults
- ClinicalTrials.gov ID
- NCT05085132
- Acronym / sponsor ID
- MINDFI01
- Keywords
- Mindfulness, Sleep quality, Well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Jaedye Labs
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 20 Oct 2021 (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.
90% of Asian workers report high levels of stress in an "always-on" culture. Stress and burnout are risk factors that account for 10-20% of health expenditure and threaten work longevity in the world's fastest growing economies. Traditional face-to-face sources of mental care such as counseling and psychotherapy are effective as a countermeasure to stress, but not always accessible or acceptable for those with busy lifestyles. Because of this, there is an urgent need for on-demand, scalable interventions to reduce stress and improve mental and physical well being. Technology-based solutions are increasingly being proposed to fill this need.
MindFi is a smartphone app that uses mindfulness exercises to help users cope with work stress and increase productivity. Since 2017, it has been featured by Apple, BBC, and Bloomberg and is being used at corporates such as Bain, Bloomberg, Cigna, and Zendesk. MindFi users contribute behavioral and self-report data, which are then used to generate individual recommendations for relevant, evidence-based exercises. These include mental care techniques such as mindfulness meditation, therapeutic journaling, psychosocial support and educational wellbeing quizzes.
In this study, the investigators will recruit 200 participants in a randomized controlled design, with 100 receiving access to content of the MindFi app, and 100 receiving access to a version containing music tracks for relaxation. Each intervention will last 4 weeks. Participants will use these apps for a period of 5 weeks (for a minimum of 10 minutes per day). Pre- and post-intervention, the investigators will measure self-reported ratings on a number of psychological variables, and will track sleep quality objectively for a one-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 allocation to use the MindFi app or receive a dummy version of the app (containing music tracks for relaxation).
| Arm | Type | Receives |
|---|---|---|
| MindFi app: Standard content | Experimental | Behavioral: MindFi app: Standard contentParticipants will receive full access to the MindFi app, containing learning tracks, practice tracks, and assessments. Participants will be instructed to use a practice track for a minimum of 10 minutes a day, and may use other exercises or tracks if desired. The intervention will last 4 weeks. |
| Mindfi app: Standard content without practice | Sham comparator | Behavioral: Mindfi app: Standard content without practiceParticipants will receive full access to the MindFi app, containing learning tracks, music tracks, and assessments. Participants will be instructed to use a music track for a minimum of 10 minutes a day, and may use other exercises or tracks if desired. The intervention will last 4 weeks. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Currently in full-time employment
- Fluent in English
- DASS-21 scores of at least 10 on the Stress subscale
Key exclusion criteria (2 listed)
- Current diagnosis of a chronic psychological disorder, or sleep disorder
- Regularly practising meditation
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 |
|---|---|---|
| MindFi app: Standard contentDigital wellness training in this study will be delivered via the MindFi app, designed by Jaedye Labs. Content includes learning, assesesment, and practice tracks A core component of the exercises in this app is mindfulness training; however, the app also incorporates other exercises drawn from positive psychology such as journaling and diaphragmatic breathing. The app goes beyond traditional guided meditation through content that reinforces the principles and attitudes taught during in-person training, and also seeks to maximize user experience by using interactive tasks and progress charts. | Behavioural | MindFi app: Standard content |
| Mindfi app: Standard content without practiceIn this condition, participants will receive a version of the MindFi app that does NOT contain the practice tracks, only the learning and assessment tracks. | Behavioural | Mindfi app: Standard content without practice |
Primary outcome
WHO Well-Being Index (WHO, 1998)
Time frame: Week 0 (at the start of the intervention) and Week 5
Change in self-reported mental well being (min score: 0; max score: 25; greater increases in this score represent a better outcome)
Depression, Anxiety, And Stress Scale -- Stress subscale (Lovibond and Lovibond, 1985)
Time frame: Week 0 (at the start of the intervention) and Week 5
Change in self-report measure of stress (min score: 0; max score: 21; greater reductions in this score represent a better outcome)
Change in Sleep Efficiency (Oura Ring)
Time frame: Week 0 (at the start of the intervention) and Week 5
(Latency + wake time)/Time in bed, as calculated by the Oura app
8 secondary outcomes
Depression, Anxiety, And Stress Scale -- Depression subscale (Lovibond and Lvibond, 1985)
Time frame: Week 0 (at the start of the intervention) and Week 5
Depression, Anxiety, And Stress Scale -- Anxiety subscale (Lovibond and Lvibond, 1985)
Time frame: Week 0 (at the start of the intervention) and Week 5
Maslach Burnout Inventory (Maslach et al., 1996)
Time frame: Week 0 (at the start of the intervention) and Week 5
Five Factor Mindfulness Questionnaire (Baer et al., 2006)
Time frame: Week 0 (at the start of the intervention) and Week 5
Brief Inventory of Thriving (Su et al., 2014)
Time frame: Week 0 (at the start of the intervention) and Week 5
Resting heart rate during sleep (from Oura Ring)
Time frame: Week 0 (at the start of the intervention) and Week 5
Heart-rate variability during sleep (from Oura Ring)
Time frame: Week 0 (at the start of the intervention) and Week 5
Satisfaction with Life Scale (Diener et al., 1985)
Time frame: Week 0 (at the start of the intervention) and Week 5
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 28 Sep 2022.
- Individual participant dataSharing planned: Yes. De-identified IPD will be shared with other researchers upon reasonable request, and after publication of the study results,
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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.
Julian Lim, PhD principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MindFi app: Standard content and Mindfi app: Standard content without practice in people with Stress and Burnout, run by National University of Singapore at 1 site in Singapore.
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 2 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 28 Sep 2022. 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 Singapore. 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. Some participants in this study may receive a placebo. 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?
WHO Well-Being Index (WHO, 1998) (time frame: Week 0 (at the start of the intervention) and Week 5). The study lists 3 primary outcomes in all. 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 28 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.