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

Primary Purpose

Stress, Burnout

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
MindFi app: Standard content
Mindfi app: Standard content without practice
Sponsored by
National University of Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress focused on measuring Mindfulness, Sleep quality, Well-being

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National University Singapore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

MindFi app: Standard content

Mindfi app: Standard content without practice

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)
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)
Change in Sleep Efficiency (Oura Ring)
(Latency + wake time)/Time in bed, as calculated by the Oura app

Secondary Outcome Measures

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)
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)
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)
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)
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)
Resting heart rate during sleep (from Oura Ring)
Objective measure of resting heart rate
Heart-rate variability during sleep (from Oura Ring)
Objective measure of heart rate variability
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)

Full Information

First Posted
September 22, 2021
Last Updated
September 26, 2022
Sponsor
National University of Singapore
Collaborators
Jaedye Labs
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1. Study Identification

Unique Protocol Identification Number
NCT05085132
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Singapore
Collaborators
Jaedye Labs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Burnout
Keywords
Mindfulness, Sleep quality, Well-being

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MindFi app: Standard content
Arm Type
Experimental
Arm Description
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.
Arm Title
Mindfi app: Standard content without practice
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MindFi app: Standard content
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfi app: Standard content without practice
Intervention Description
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.
Primary Outcome Measure Information:
Title
WHO Well-Being Index (WHO, 1998)
Description
Change in self-reported mental well being (min score: 0; max score: 25; greater increases in this score represent a better outcome)
Time Frame
Week 0 (at the start of the intervention) and Week 5
Title
Depression, Anxiety, And Stress Scale -- Stress subscale (Lovibond and Lovibond, 1985)
Description
Change in self-report measure of stress (min score: 0; max score: 21; greater reductions in this score represent a better outcome)
Time Frame
Week 0 (at the start of the intervention) and Week 5
Title
Change in Sleep Efficiency (Oura Ring)
Description
(Latency + wake time)/Time in bed, as calculated by the Oura app
Time Frame
Week 0 (at the start of the intervention) and Week 5
Secondary Outcome Measure Information:
Title
Depression, Anxiety, And Stress Scale -- Depression subscale (Lovibond and Lvibond, 1985)
Description
Change in Self-report measure of depression (min score: 0; max score: 21; greater reductions in this score represent a better outcome)
Time Frame
Week 0 (at the start of the intervention) and Week 5
Title
Depression, Anxiety, And Stress Scale -- Anxiety subscale (Lovibond and Lvibond, 1985)
Description
Change in Self-report measure of anxiety (min score: 0; max score: 21; greater reductions in this score represent a better outcome)
Time Frame
Week 0 (at the start of the intervention) and Week 5
Title
Maslach Burnout Inventory (Maslach et al., 1996)
Description
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)
Time Frame
Week 0 (at the start of the intervention) and Week 5
Title
Five Factor Mindfulness Questionnaire (Baer et al., 2006)
Description
Change in Self-report measure of trait mindfulness (min score: 39; max score: 195; greater increases in this score represent a better outcome)
Time Frame
Week 0 (at the start of the intervention) and Week 5
Title
Brief Inventory of Thriving (Su et al., 2014)
Description
Change in Self-report measure of eudaimonic well-being (min score: 10; max score: 50; greater increases in this score represent a better outcome)
Time Frame
Week 0 (at the start of the intervention) and Week 5
Title
Resting heart rate during sleep (from Oura Ring)
Description
Objective measure of resting heart rate
Time Frame
Week 0 (at the start of the intervention) and Week 5
Title
Heart-rate variability during sleep (from Oura Ring)
Description
Objective measure of heart rate variability
Time Frame
Week 0 (at the start of the intervention) and Week 5
Title
Satisfaction with Life Scale (Diener et al., 1985)
Description
Self-report measure of hedonic well being (min score: 5; max score: 35; greater increases in this score represent a better outcome)
Time Frame
Week 0 (at the start of the intervention) and Week 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Currently in full-time employment Fluent in English DASS-21 scores of at least 10 on the Stress subscale Exclusion Criteria: Current diagnosis of a chronic psychological disorder, or sleep disorder Regularly practising meditation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julian Lim, PhD
Organizational Affiliation
National University of Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Singapore
City
Singapore
ZIP/Postal Code
119077
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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