The Effectiveness of a Mindfulness Application on Perceived Stess

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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mHealth, Mindfulness, Stress, Burnout

Intervention / Treatment
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* Other: Structured 8-week mHealth mindfulness program


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: >18 years Exclusion criteria: There were no other eligibility criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>a structured 8-week mHealth mindfulness program. | Other: Structured 8-week mHealth mindfulness program<br>* 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.<br>|
| No Intervention: Control group<br>The control group was suggested to read the information about stress and burnout on the website of the TV-programme. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in perceived stress levels between baseline, end of program and after six months | Measured 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. | baseline (before randomization), at the end of the program (eight weeks after randomization) and six months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in burnout symptoms between baseline, end of program and after six months | Measured with Visual analogue scale (VAS). Each symptom was rated on a 0-100 scale, with higher scores meaning higher difficulty. | baseline (before randomization), at the end of the program (eight weeks after randomization) and six months after randomization | 
| Change in Four dimensional symptoms: : Distress (16 items), Depression (6 items), Anxiety (12 items) and Somatization between baseline, end of program and after six months | Measured 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. | baseline (before randomization), at the end of the program (eight weeks after randomization) and six months after randomization |