The Effectiveness of a Non-guided Mindfulness Application on Perceived Stress in a Non-clinical Dutch Population: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- mHealth
- Sponsor
- Erasmus Medical Center
- Enrollment
- 587
- Locations
- 1
- Primary Endpoint
- Change in perceived stress levels between baseline, end of program and after six months
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Leonieke Kranenburg
Principal Investigator
Erasmus Medical Center
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in perceived stress levels between baseline, end of program and after six months
Time Frame: baseline (before randomization), at the end of the program (eight weeks after randomization) and six months after randomization
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.
Secondary Outcomes
- 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(baseline (before randomization), at the end of the program (eight weeks after randomization) and six months after randomization)
- Change in burnout symptoms between baseline, end of program and after six months(baseline (before randomization), at the end of the program (eight weeks after randomization) and six months after randomization)