The Effectiveness of a Mindfulness Application on Perceived Stess

NCT05246800 | Completed

• 1 other identifier: METC 2017-1117
• Study Type: interventional
• Target: 587
• Locations: 1 country
• Sites: 1

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.

Conditions

mHealth; Mindfulness; Stress; Burnout

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

a structured 8-week mHealth mindfulness program.

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.

Interventions

Structured 8-week mHealth mindfulness program OTHER

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.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years

You may not qualify if:

• There were no other eligibility criteria

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus University Medical Center

Rotterdam, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 35302504 DERIVED

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Leonieke Kranenburg

  Department of Psychiatry, section Medical Psychology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 18, 2022
• Study Start: March 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: January 1, 2019
• Last Updated: February 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)