Clinical trial NCT05246800: 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
Overall status: COMPLETED
Phase: NA
Conditions: mHealth
Mindfulness
Stress
Burnout
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 587
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria:

\>18 years

Exclusion criteria:

There were no other eligibility criteria

Primary outcomes:
measure: Change in perceived stress levels between baseline, end of program and after six months
timeFrame: baseline (before randomization), at the end of the program (eight weeks after randomization) and six months after randomization
Secondary outcomes:
measure: Change in burnout symptoms between baseline, end of program and after six months
timeFrame: baseline (before randomization), at the end of the program (eight weeks after randomization) and six months after randomization
measure: 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
timeFrame: baseline (before randomization), at the end of the program (eight weeks after randomization) and six months after randomization
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
Study officials:
affiliation: Department of Psychiatry, section Medical Psychology
name: Leonieke Kranenburg
role: PRINCIPAL_INVESTIGATOR
References:
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.