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The Effectiveness of a Mindfulness Application on Perceived Stess

The Effectiveness of a Non-guided Mindfulness Application on Perceived Stress in a Non-clinical Dutch Population: a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05246800
Enrollment
587
Registered
2022-02-18
Start date
2018-03-01
Completion date
2019-01-01
Last updated
2022-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burnout, mHealth, Mindfulness, Stress

Brief summary

Mindfulness has become increasingly popular and positive outcomes have been reported for mindfulness-based interventions (MBIs) in reducing stress. The aim of this study is to investigate if a non-guided mindfulness mobile phone application can decrease perceived stress in a non-clinical Dutch population over the course of eight weeks, with follow-up at six months.

Detailed description

Background: Mindfulness has become increasingly popular and positive outcomes have been reported for mindfulness-based interventions (MBIs) in reducing stress. These findings make room for innovative perspectives on how MBIs could be applied, for instance through mHealth. Objectives: The aim of this study is to investigate if a non-guided mindfulness mobile phone application can decrease perceived stress in a non-clinical Dutch population over the course of eight weeks, with follow-up at six months. Methods: A randomized controlled trial (RCT) was performed, comparing the experimental group that made use of a structured 8-week mHealth mindfulness program and a control group after 8 weeks, with follow-up after six months. Participants were recruited via a national television program. The primary outcome measure was perceived stress as measured by the Perceived Stress scale (PSS), secondary outcomes were symptoms of burnout (VAS) and psychological symptoms (measured by the four-dimensional symptom questionnaire ; 4DSQ at follow-up). Outcomes were analyzed using a multilevel regression model.

Interventions

OTHERStructured 8-week mHealth mindfulness program

The mindfulness application was developed by Minddistrict The content of the app was developed by professionals in the field of mental healthcare and based on the principles of MBSR and MBCT The app consisted of a structured program, with chapters on psycho-education on mindfulness and the importance of practicing; acting on auto-pilot, conscious attention; non-judgmental attention, awareness; doing versus being-modus; attention for breath and body, conscious response; acceptance; a mindful attitude towards thoughts; applying mindfulness in daily life and staying mindful.

Sponsors

Erasmus Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

A randomized controlled trial (RCT) was performed, comparing the experimental group that made use of a structured 8-week mHealth mindfulness program and a control group after 8 weeks, with follow-up after six months.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

\>18 years

Exclusion criteria

There were no other eligibility criteria

Design outcomes

Primary

MeasureTime frameDescription
Change in perceived stress levels between baseline, end of program and after six monthsbaseline (before randomization), at the end of the program (eight weeks after randomization) and six months after randomizationMeasured with Perceived stress scale (PSS). The 14 item Dutch version was used. All items are rated on a 4-point Likert scale, with higher scores meaning more perceived stress.

Secondary

MeasureTime frameDescription
Change in burnout symptoms between baseline, end of program and after six monthsbaseline (before randomization), at the end of the program (eight weeks after randomization) and six months after randomizationMeasured with Visual analogue scale (VAS). Each symptom was rated on a 0-100 scale, with higher scores meaning higher difficulty.
Change in Four dimensional symptoms: : Distress (16 items), Depression (6 items), Anxiety (12 items) and Somatization between baseline, end of program and after six monthsbaseline (before randomization), at the end of the program (eight weeks after randomization) and six months after randomizationMeasured with Four dimensional symptom questionnaire (4DSQ). The 4DSQ consists of 50 items rated on a 4-point Likert scale. The 50 items can be grouped into four dimensions: Distress (16 items), Depression (6 items), Anxiety (12 items) and Somatization (16 items). Sum scores are calculated for each dimension.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026