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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05246800
Other study ID # METC 2017-1117
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2018
Est. completion date January 1, 2019

Study information

Verified date February 2022
Source Erasmus Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 587
Est. completion date January 1, 2019
Est. primary completion date October 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: >18 years Exclusion criteria: There were no other eligibility criteria

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Netherlands Erasmus University Medical Center Rotterdam

Sponsors (1)

Lead Sponsor Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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