CClinicalTrials.gg
Status unknownNCT01457222CHAMPSUpdated Feb 14, 2012

Cognition and Health in Adolescents, Mindfulness as Prevention of Stress.

An interventional study of Mindfulness intervention and Music relaxation in Stress, Complete Psychological Check Up and Sleep, sponsored by Region Skane. Status unknown at 1 site in Sweden. Open to participants aged 15 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-02-14.

Sponsored by Region Skane · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Feb 2012), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
15 Years to 20 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Stress
  • Complete Psychological Check Up
  • Sleep
  • Cognition - Other
  • Personality

Keywords

  • Mindfulness
  • Stress
  • Cognition
  • Psychological health
  • Primary prevention
03

In context

Lead sponsor

Region Skane is the lead sponsor of 372 studies on the registry; 113 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • High school student from designated school

Exclusion criteria

Exclusion Criteria:

  • None Swedish-speaking
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Investigator)
Enrollment
150 participants (estimated)

Study arms

  • Active comparator
    Mindfulness

    Mindfulness intervention 10 minutes daily

    Behavioral: Mindfulness intervention

  • Active comparator
    Music relaxation

    Music intervention 10 minutes daily

    Behavioral: Music relaxation

  • No intervention
    Business as usual

    No intervention - control group.

Interventions

  • BehavioralMindfulness intervention

    Web-based guided mindfulness meditation 10 minutes daily

    Also known as: Mindfulnesscenter, Web-based mindfulness intervention

  • BehavioralMusic relaxation

    Music relaxation 10 minutes daily

    Also known as: Music relaxation by Paxx

06

What researchers measure

Primary outcomes

  1. Better mental health

    Lower Global Severity Index (from SCL-90) intrapersonal change

    Time frame: Baseline to Eight weeks

Secondary outcomes

  1. Better sleep quality

    Lower result on Pittsburgh Sleep Quality Index

    Time frame: Baseline to Eight weeks

  2. Lower degree of perceived stress

    Lower result on Perceived Stress Scale

    Time frame: Baseline to Eight weeks

  3. Cognitive enhancement

    Shorter time on Trailmaking A and B as well as higher result on Symbol-Digit

    Time frame: Baseline to Eight weeks

  4. Higher grades

    Higher mean school grades

    Time frame: Baseline to 6 months

  5. Lower sick leave

    Less days of sick leave

    Time frame: Baseline to 6 months

  6. Lower Neuroticism

    Lower Neuroticism result on Eysenck's Personality Questionnaire

    Time frame: Baseline to Eight weeks

07

Study locations

1 site
  • Centrum för Primärvårdsforskning, Lunds Universitet
    Malmö, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01457222
Lead sponsor
Region Skane
Responsible party
Sponsor
First posted
Oct 21, 2011
Start date
Oct 2011
Primary completion
Jun 2012 (estimated)
Completion
Jun 2012 (estimated)
Last update
Feb 14, 2012

Study contacts

Jan Sundquist, Professor/MD
study chair · Centrum för Primärvårdsforskning

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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