The Effectiveness of a Mindfulness Application on Perceived Stess

Sponsor
Erasmus Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT05246800
Collaborator
(none)
587
1
2
10.1
58.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Structured 8-week mHealth mindfulness program
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
587 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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 (Participant)
Primary Purpose:
Treatment
Official Title:
The Effectiveness of a Non-guided Mindfulness Application on Perceived Stress in a Non-clinical Dutch Population: a Randomized Controlled Trial
Actual Study Start Date :
Mar 1, 2018
Actual Primary Completion Date :
Oct 1, 2018
Actual Study Completion Date :
Jan 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental group

a structured 8-week mHealth mindfulness program.

Other: Structured 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.

No Intervention: Control group

The control group was suggested to read the information about stress and burnout on the website of the TV-programme.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion criteria:

18 years

Exclusion criteria:

There were no other eligibility criteria

Contacts and Locations

Locations

Site City State Country Postal Code
1 Erasmus University Medical Center Rotterdam Netherlands

Sponsors and Collaborators

  • Erasmus Medical Center

Investigators

  • Principal Investigator: Leonieke Kranenburg, Department of Psychiatry, section Medical Psychology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Leonieke Kranenburg, Principal Investigator, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT05246800
Other Study ID Numbers:
  • METC 2017-1117
First Posted:
Feb 18, 2022
Last Update Posted:
Feb 18, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 18, 2022