mHealthNCT05246800
The Effectiveness of a Mindfulness Application on Perceived Stess
A study testing Structured 8-week mHealth mindfulness program in people with mHealth and Mindfulness, run by Erasmus Medical Center at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- mHealth, Mindfulness, Stress
- What is being tested?
- Structured 8-week mHealth mindfulness program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 587 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2018to 1 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 years
Who cannot join
- There were no other eligibility criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of a Non-guided Mindfulness Application on Perceived Stress in a Non-clinical Dutch Population: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- mHealth, Mindfulness, Stress, Burnout
- Being tested
- Structured 8-week mHealth mindfulness program
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured 8-week mHealth mindfulness programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | a structured 8-week mHealth mindfulness program. Receives: Other: Structured 8-week mHealth mindfulness program |
| Control group | No intervention | The control group was suggested to read the information about stress and burnout on the website of the TV-programme. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline (before randomization), at the end of the program (eight weeks after randomization) and six months after randomization
Secondary outcomes (2)
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.
Measured: baseline (before randomization), at the end of the program (eight weeks after randomization) and six months after randomization
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.
Measured: baseline (before randomization), at the end of the program (eight weeks after randomization) and six months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start1 Mar 2018
- Primary completion1 Oct 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for mHealthStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 587 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonieke Kranenburg, Erasmus Medical Center
- Investigators
- Leonieke Kranenburg, Principal investigator, Department of Psychiatry, section Medical Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246800
- Sponsor's protocol ID
- METC 2017-1117
- Status last verified
- Feb 2022
- First submitted
- 31 Jan 2022
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35302504
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Non-guided Mindfulness Application on Perceived Stress in a Non-clinical Dutch Population: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05246800
- Acronym / sponsor ID
- METC 2017-1117
- Conditions
- mHealth, Mindfulness, Stress, Burnout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 587 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Structured 8-week mHealth mindfulness programa structured 8-week mHealth mindfulness program. |
| Control group | No intervention | –The control group was suggested to read the information about stress and burnout on the website of the TV-programme. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- >18 years
Key exclusion criteria (1 listed)
- There were no other eligibility criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured 8-week mHealth mindfulness programThe 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. | Other | Experimental group |
Primary outcome
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.
2 secondary outcomes
Change in burnout symptoms 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
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
Time frame: baseline (before randomization), at the end of the program (eight weeks after randomization) and six months after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Derived from this study: PubMed 35302504Kranenburg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonieke Kranenburg principal investigator
Department of Psychiatry, section Medical Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured 8-week mHealth mindfulness program in people with mHealth and Mindfulness, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05246800, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.