The Effectiveness of a Mindfulness Application on Perceived Stess

Not Applicable

Completed

• Conditions: Burnout; Stress; Mindfulness; mHealth
• Interventions: Other: Structured 8-week mHealth mindfulness program

• Registration Number: NCT05246800
• Lead Sponsor: Erasmus Medical Center

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.

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2018-10-01
• Study Completion: 2019-01-01
• Study First Submitted: 2022-01-31
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-11
• Last Update Submitted: 2022-02-11
• Study First Posted: 2022-02-18
• Last Update Posted: 2022-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 587

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Structured 8-week mHealth mindfulness program	a structured 8-week mHealth mindfulness program.

Primary Outcome Measures

Name	Time	Method
Change in perceived stress levels 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	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 Outcome Measures

Name	Time	Method
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	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.
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	Measured with Visual analogue scale (VAS). Each symptom was rated on a 0-100 scale, with higher scores meaning higher difficulty.

Trial Locations

Locations (1)

Erasmus University Medical Center; 🇳🇱 Rotterdam, Netherlands