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

Stress Clinical Trial

— CHAMPS  

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01457222
• Other study ID #: 2011/345
• Status: Unknown status
• Phase: N/A
• First received: October 10, 2011
• Last updated: February 13, 2012
• Start date: October 2011
• Est. completion date: June 2012

Study information

• Verified date: February 2012
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 150
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 20 Years

Eligibility

Inclusion Criteria:

• High school student from designated school

Exclusion Criteria:

• None Swedish-speaking

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Mindfulness intervention
Web-based guided mindfulness meditation 10 minutes daily
• Music relaxation
Music relaxation 10 minutes daily

Locations

Country	Name	City	State
Sweden	Centrum för Primärvårdsforskning, Lunds Universitet	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Better mental health	Lower Global Severity Index (from SCL-90) intrapersonal change	Baseline to Eight weeks
Secondary	Better sleep quality	Lower result on Pittsburgh Sleep Quality Index	Baseline to Eight weeks
Secondary	Lower degree of perceived stress	Lower result on Perceived Stress Scale	Baseline to Eight weeks
Secondary	Cognitive enhancement	Shorter time on Trailmaking A and B as well as higher result on Symbol-Digit	Baseline to Eight weeks
Secondary	Higher grades	Higher mean school grades	Baseline to 6 months
Secondary	Lower sick leave	Less days of sick leave	Baseline to 6 months
Secondary	Lower Neuroticism	Lower Neuroticism result on Eysenck's Personality Questionnaire	Baseline to Eight weeks