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

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05085132
• Other study ID #: MINDFI01
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: September 2022
• Source: National University, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Burnout
• Burnout, Psychological
• Stress

Intervention

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.
• 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.

Locations

Country	Name	City	State
Singapore	National University Singapore	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University, Singapore	Jaedye Labs

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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