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

February 13, 2012 updated by: Region Skane

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Malmö, Sweden
        • Centrum för Primärvårdsforskning, Lunds Universitet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • High school student from designated school

Exclusion Criteria:

  • None Swedish-speaking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mindfulness
Mindfulness intervention 10 minutes daily
Behavioral: Mindfulness intervention
Web-based guided mindfulness meditation 10 minutes daily
Other Names:
  • Mindfulnesscenter, Web-based mindfulness intervention
Active Comparator: Music relaxation
Music intervention 10 minutes daily
Behavioral: Music relaxation
Music relaxation 10 minutes daily
Other Names:
  • Music relaxation by Paxx
No Intervention: Business as usual
No intervention - control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Better mental health
Time Frame: Baseline to Eight weeks
Lower Global Severity Index (from SCL-90) intrapersonal change
Baseline to Eight weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Better sleep quality
Time Frame: Baseline to Eight weeks
Lower result on Pittsburgh Sleep Quality Index
Baseline to Eight weeks
Lower degree of perceived stress
Time Frame: Baseline to Eight weeks
Lower result on Perceived Stress Scale
Baseline to Eight weeks
Cognitive enhancement
Time Frame: Baseline to Eight weeks
Shorter time on Trailmaking A and B as well as higher result on Symbol-Digit
Baseline to Eight weeks
Higher grades
Time Frame: Baseline to 6 months
Higher mean school grades
Baseline to 6 months
Lower sick leave
Time Frame: Baseline to 6 months
Less days of sick leave
Baseline to 6 months
Lower Neuroticism
Time Frame: Baseline to Eight weeks
Lower Neuroticism result on Eysenck's Personality Questionnaire
Baseline to Eight weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Investigators

  • Study Chair: Jan Sundquist, Professor/MD, Centrum för Primärvårdsforskning

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

June 1, 2012

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

October 10, 2011

First Submitted That Met QC Criteria

October 19, 2011

First Posted (Estimate)

October 21, 2011

Study Record Updates

Last Update Posted (Estimate)

February 14, 2012

Last Update Submitted That Met QC Criteria

February 13, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2011/345

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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