NCT01457222

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 21, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

February 14, 2012

Status Verified

February 1, 2012

Enrollment Period

8 months

First QC Date

October 10, 2011

Last Update Submit

February 13, 2012

Conditions

StressComplete Psychological Check UpSleepCognition - OtherPersonality

Keywords

MindfulnessStressCognitionPsychological healthPrimary prevention

Outcome Measures

Primary Outcomes (1)

  • Better mental health

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

    Baseline to Eight weeks

Secondary Outcomes (6)

  • Better sleep quality

    Baseline to Eight weeks

  • Lower degree of perceived stress

    Baseline to Eight weeks

  • Cognitive enhancement

    Baseline to Eight weeks

  • Higher grades

    Baseline to 6 months

  • Lower sick leave

    Baseline to 6 months

  • +1 more secondary outcomes

Study Arms (3)

Mindfulness

ACTIVE COMPARATOR

Mindfulness intervention 10 minutes daily

Behavioral: Mindfulness intervention

Music relaxation

ACTIVE COMPARATOR

Music intervention 10 minutes daily

Behavioral: Music relaxation

Business as usual

NO INTERVENTION

No intervention - control group.

Interventions

Mindfulness interventionBEHAVIORAL

Web-based guided mindfulness meditation 10 minutes daily

Also known as: Mindfulnesscenter, Web-based mindfulness intervention
Mindfulness
Music relaxationBEHAVIORAL

Music relaxation 10 minutes daily

Also known as: Music relaxation by Paxx
Music relaxation

Eligibility Criteria

Age15 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • High school student from designated school

You may not qualify if:

  • None Swedish-speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centrum för Primärvårdsforskning, Lunds Universitet

Malmo, Sweden

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Jan Sundquist, Professor/MD

    Centrum för Primärvårdsforskning

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2011

First Posted

October 21, 2011

Study Start

October 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

February 14, 2012

Record last verified: 2012-02

Locations

SE(1)