Overview

This trial is active, not recruiting.

Conditions stress, complete psychological check up, sleep, cognition - other, personality
Treatments mindfulness intervention, music relaxation
Sponsor Region Skane
Start date October 2011
End date June 2012
Trial size 150 participants
Trial identifier NCT01457222, 2011/345

Summary

The purpose of this study is to determine whether mindfulness is useful as primary prevention for psychological health in highschool students, primarily related to stress, and whether mindfulness can improve cognitive function.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking single blind (investigator)
Primary purpose prevention
Arm
(Active Comparator)
Mindfulness intervention 10 minutes daily
mindfulness intervention Mindfulnesscenter, Web-based mindfulness intervention
Web-based guided mindfulness meditation 10 minutes daily
(Active Comparator)
Music intervention 10 minutes daily
music relaxation Music relaxation by Paxx
Music relaxation 10 minutes daily
(No Intervention)
No intervention - control group.

Primary Outcomes

Measure
Better mental health
time frame: Baseline to Eight weeks

Secondary Outcomes

Measure
Better sleep quality
time frame: Baseline to Eight weeks
Lower degree of perceived stress
time frame: Baseline to Eight weeks
Cognitive enhancement
time frame: Baseline to Eight weeks
Higher grades
time frame: Baseline to 6 months
Lower sick leave
time frame: Baseline to 6 months
Lower Neuroticism
time frame: Baseline to Eight weeks

Eligibility Criteria

Male or female participants from 15 years up to 20 years old.

Inclusion Criteria: - High school student from designated school Exclusion Criteria: - None Swedish-speaking

Additional Information

Official title Mindfulness as a Method of Improving Mental Health and Cognitive Results and Decreasing Stress in Secondary School Students; a Prospective Randomised Controlled Single-blinded Pilot Study
Description There is a general suspicion that stress and stress-related psychological disorders is growing in highschool students in Sweden. Mindfulness is a well researched therapeutical method for treating stress-related disorders. This study will first collect data on stress-related psychological symptoms by several well-validated surveys. The surveys will be made twice with 8 weeks in between to examine variability. After the second survey the population of highschool students will be randomly assigned to web-based mindfulness intervention, music relaxation intervention or control group. A third survey will be conducted after eight weeks of intervention and before and after an external stressor.
Trial information was received from ClinicalTrials.gov and was last updated in February 2012.
Information provided to ClinicalTrials.gov by Region Skane.