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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT01457222
Other study ID # 2011/345
Secondary ID
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
Health authority
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

Study Design


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
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