Clinical trial NCT05085132: An Efficacy Trial of the MindFi App for Stress, Well-being, and Sleep Quality in Working Adults
Official title: An Efficacy Trial of the MindFi App for Stress, Well-being, and Sleep Quality in Working Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Burnout
Keywords: Mindfulness
Sleep quality
Well-being
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: Jaedye Labs
First posted: 2021-10-20
Enrollment: 192
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: WHO Well-Being Index (WHO, 1998)
timeFrame: Week 0 (at the start of the intervention) and Week 5
measure: Depression, Anxiety, And Stress Scale -- Stress subscale (Lovibond and Lovibond, 1985)
timeFrame: Week 0 (at the start of the intervention) and Week 5
measure: Change in Sleep Efficiency (Oura Ring)
timeFrame: Week 0 (at the start of the intervention) and Week 5
Secondary outcomes:
measure: Depression, Anxiety, And Stress Scale -- Depression subscale (Lovibond and Lvibond, 1985)
timeFrame: Week 0 (at the start of the intervention) and Week 5
measure: Depression, Anxiety, And Stress Scale -- Anxiety subscale (Lovibond and Lvibond, 1985)
timeFrame: Week 0 (at the start of the intervention) and Week 5
measure: Maslach Burnout Inventory (Maslach et al., 1996)
timeFrame: Week 0 (at the start of the intervention) and Week 5
measure: Five Factor Mindfulness Questionnaire (Baer et al., 2006)
timeFrame: Week 0 (at the start of the intervention) and Week 5
measure: Brief Inventory of Thriving (Su et al., 2014)
timeFrame: Week 0 (at the start of the intervention) and Week 5
measure: Resting heart rate during sleep (from Oura Ring)
timeFrame: Week 0 (at the start of the intervention) and Week 5
measure: Heart-rate variability during sleep (from Oura Ring)
timeFrame: Week 0 (at the start of the intervention) and Week 5
measure: Satisfaction with Life Scale (Diener et al., 1985)
timeFrame: Week 0 (at the start of the intervention) and Week 5
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Singapore
Study officials:
affiliation: National University of Singapore
name: Julian Lim, PhD
role: PRINCIPAL_INVESTIGATOR
References: