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

NCT05085132 | Completed

• 1 other identifier: MINDFI01
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Burnout

Keywords

Mindfulness; Sleep quality; Well-being

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Depression, Anxiety, And Stress Scale -- Depression subscale (Lovibond and Lvibond, 1985)

  Week 0 (at the start of the intervention) and Week 5

• Depression, Anxiety, And Stress Scale -- Anxiety subscale (Lovibond and Lvibond, 1985)

  Week 0 (at the start of the intervention) and Week 5

• Maslach Burnout Inventory (Maslach et al., 1996)

  Week 0 (at the start of the intervention) and Week 5

• Five Factor Mindfulness Questionnaire (Baer et al., 2006)

  Week 0 (at the start of the intervention) and Week 5

• Brief Inventory of Thriving (Su et al., 2014)

  Week 0 (at the start of the intervention) and Week 5

Study Arms (2)

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.

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.

Behavioral: Mindfi app: Standard content without practice

Interventions

MindFi app: Standard content BEHAVIORAL

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

Mindfi app: Standard content without practice BEHAVIORAL

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.

Mindfi app: Standard content without practice

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently in full-time employment
• Fluent in English
• DASS-21 scores of at least 10 on the Stress subscale

You may not qualify if:

• Current diagnosis of a chronic psychological disorder, or sleep disorder
• Regularly practising meditation

Sponsors & Collaborators

• National University of Singapore: lead
• Jaedye Labs: collaborator

Study Sites (1)

National University Singapore

Singapore, 119077, Singapore

Location

MeSH Terms

Conditions

Burnout, Psychological; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Julian Lim, PhD

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 20, 2021
• Study Start: December 1, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, ANALYTIC CODE
• Time Frame: The data will become available after publication into perpetuity.
• Access Criteria: Researchers with a reasonable re-analysis plan will be eligible for data sharing

Locations

SG (1)