Cognition and Health in Adolescents, Mindfulness as Preve... | NCT01457222

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

NCT01457222

Sponsor

Region Skane

Status

Unknown status

Last Update Posted

Feb 14, 2012Estimated

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Stress
Complete Psychological Check Up
Sleep
Cognition - Other
Personality

Interventions

Mindfulness intervention
Music relaxation

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Jun 2012Estimated

Completion Date

Jun 2012Estimated

First Submitted Date

Oct 10, 2011

First Submission Date that Met QC Criteria

Oct 19, 2011

First Posted Date

Oct 21, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2012

Last Update Posted Date

Feb 14, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Mindfulness intervention	Behavioral	Web-based guided mindfulness meditation 10 minutes daily	Mindfulness

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Better sleep quality	Lower result on Pittsburgh Sleep Quality Index	Baseline to Eight weeks
Lower degree of perceived stress	Lower result on Perceived Stress Scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

High school student from designated school

Exclusion Criteria:

None Swedish-speaking

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jan Sundquist, Professor/MD	Centrum för Primärvårdsforskning	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centrum för Primärvårdsforskning, Lunds Universitet		Malmö			Sweden

Type	Date	Date Unknown
Release	Nov 3, 2017
Reset	Aug 9, 2018
Release	Dec 21, 2018
Reset	Mar 29, 2019
Release	Feb 16, 2023
Reset	Nov 29, 2023

Submission Tracking

Estimated Results First Submitted Date

Nov 3, 2017

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Nov 3, 2017			Aug 9, 2018
Dec 21, 2018

Condition Browse Module

MeSH Terms

ID	Term
D000092862	Psychological Well-Being

Ancestor Terms

ID	Term
D010549	Personal Satisfaction
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided