An Efficacy Trial of the MindFi App for Stress, Well-being, and Sleep Quality in Working Adults

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 Overview

• Status: Completed
• Conditions: Stress; Burnout
• Intervention / Treatment: Behavioral: MindFi app: Standard content; Behavioral: Mindfi app: Standard content without practice

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 119077
    • National University Singapore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Currently in full-time employment
2. Fluent in English
3. DASS-21 scores of at least 10 on the Stress subscale

Exclusion Criteria:

1. Current diagnosis of a chronic psychological disorder, or sleep disorder
2. Regularly practising meditation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MindFi app: Standard content; 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.	Behavioral: MindFi app: Standard content; 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.
Sham Comparator: Mindfi app: Standard content without practice; 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.	Behavioral: Mindfi app: Standard content without practice; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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	Week 0 (at the start of the intervention) and Week 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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)	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)	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	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	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)	Week 0 (at the start of the intervention) and Week 5

Collaborators and Investigators

• Sponsor: National University, Singapore
• Collaborators: Jaedye Labs

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 20, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Mindfulness; Well-being; Sleep quality
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Burnout, Psychological
• Other Study ID Numbers: MINDFI01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified IPD will be shared with other researchers upon reasonable request, and after publication of the study results,
• IPD Sharing Time Frame: The data will become available after publication into perpetuity.
• IPD Sharing Access Criteria: Researchers with a reasonable re-analysis plan will be eligible for data sharing
• IPD Sharing Supporting Information Type: Informed Consent Form (ICF); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No