The Effectiveness of a Mindfulness Application on Perceived Stess
Primary Purpose
mHealth, Mindfulness, Stress
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Structured 8-week mHealth mindfulness program
Sponsored by
About this trial
This is an interventional treatment trial for mHealth
Eligibility Criteria
Inclusion criteria:
>18 years
Exclusion criteria:
There were no other eligibility criteria
Sites / Locations
- Erasmus University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
a structured 8-week mHealth mindfulness program.
The control group was suggested to read the information about stress and burnout on the website of the TV-programme.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05246800
First Posted
January 31, 2022
Last Updated
February 11, 2022
Sponsor
Erasmus Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05246800
Brief Title
The Effectiveness of a Mindfulness Application on Perceived Stess
Official Title
The Effectiveness of a Non-guided Mindfulness Application on Perceived Stress in a Non-clinical Dutch Population: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
January 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
mHealth, Mindfulness, Stress, Burnout
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
587 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
a structured 8-week mHealth mindfulness program.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group was suggested to read the information about stress and burnout on the website of the TV-programme.
Intervention Type
Other
Intervention Name(s)
Structured 8-week mHealth mindfulness program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in perceived stress levels between baseline, end of program and after six months
Description
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.
Time Frame
baseline (before randomization), at the end of the program (eight weeks after randomization) and six months after randomization
Secondary Outcome Measure Information:
Title
Change in burnout symptoms between baseline, end of program and after six months
Description
Measured with Visual analogue scale (VAS). Each symptom was rated on a 0-100 scale, with higher scores meaning higher difficulty.
Time Frame
baseline (before randomization), at the end of the program (eight weeks after randomization) and six months after randomization
Title
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
Description
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.
Time Frame
baseline (before randomization), at the end of the program (eight weeks after randomization) and six months after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
>18 years
Exclusion criteria:
There were no other eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonieke Kranenburg
Organizational Affiliation
Department of Psychiatry, section Medical Psychology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasmus University Medical Center
City
Rotterdam
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35302504
Citation
Kranenburg LW, Gillis J, Mayer B, Hoogendijk WJG. The Effectiveness of a Nonguided Mindfulness App on Perceived Stress in a Nonclinical Dutch Population: Randomized Controlled Trial. JMIR Ment Health. 2022 Mar 18;9(3):e32123. doi: 10.2196/32123.
Results Reference
derived
Learn more about this trial
The Effectiveness of a Mindfulness Application on Perceived Stess
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