StressCHAMPSNCT01457222
Cognition and Health in Adolescents, Mindfulness as Prevention of Stress.
A study testing Mindfulness intervention and Music relaxation in people with Stress and Complete Psychological Check Up, run by Region Skane at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 15 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Complete Psychological Check Up, Sleep
- What is being tested?
- Mindfulness intervention and Music relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2011to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- High school student from designated school
Who cannot join
- None Swedish-speaking
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Stress, Complete Psychological Check Up, Sleep, Cognition - Other, Personality
- Being tested
- Mindfulness intervention, Music relaxation
- Keywords
- Mindfulness, Stress, Cognition, Psychological health, Primary prevention
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness interventionBehavioural
Also called Mindfulnesscenter, Web-based mindfulness intervention
Web-based guided mindfulness meditation 10 minutes daily
Music relaxationBehavioural
Also called Music relaxation by Paxx
Music relaxation 10 minutes daily
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Active comparator | Mindfulness intervention 10 minutes daily Receives: Behavioral: Mindfulness intervention |
| Music relaxation | Active comparator | Music intervention 10 minutes daily Receives: Behavioral: Music relaxation |
| Business as usual | No intervention | No intervention - control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Better mental health
Lower Global Severity Index (from SCL-90) intrapersonal change
Measured: Baseline to Eight weeks
Secondary outcomes (6)
Better sleep quality
Lower result on Pittsburgh Sleep Quality Index
Measured: Baseline to Eight weeks
Lower degree of perceived stress
Lower result on Perceived Stress Scale
Measured: Baseline to Eight weeks
Cognitive enhancement
Shorter time on Trailmaking A and B as well as higher result on Symbol-Digit
Measured: Baseline to Eight weeks
Higher grades
Higher mean school grades
Measured: Baseline to 6 months
Lower sick leave
Less days of sick leave
Measured: Baseline to 6 months
Lower Neuroticism
Lower Neuroticism result on Eysenck's Personality Questionnaire
Measured: Baseline to Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Sundquist, Professor/MD, Study chair, Centrum för Primärvårdsforskning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457222
- Sponsor's protocol ID
- 2011/345
- Acronym
- CHAMPS
- Status last verified
- Feb 2012
- First submitted
- 10 Oct 2011
- Last updated
- 14 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01457222
- Acronym / sponsor ID
- CHAMPS / 2011/345
- Conditions
- Stress, Complete Psychological Check Up, Sleep, Cognition - Other, Personality
- Keywords
- Mindfulness, Stress, Cognition, Psychological health, Primary prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 21 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Active comparator | Behavioral: Mindfulness interventionMindfulness intervention 10 minutes daily |
| Music relaxation | Active comparator | Behavioral: Music relaxationMusic intervention 10 minutes daily |
| Business as usual | No intervention | –No intervention - control group. |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- High school student from designated school
Key exclusion criteria (1 listed)
- None Swedish-speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness interventionAlso: Mindfulnesscenter, Web-based mindfulness interventionWeb-based guided mindfulness meditation 10 minutes daily | Behavioural | Mindfulness |
| Music relaxationAlso: Music relaxation by PaxxMusic relaxation 10 minutes daily | Behavioural | Music relaxation |
Primary outcome
Better mental health
Time frame: Baseline to Eight weeks
Lower Global Severity Index (from SCL-90) intrapersonal change
6 secondary outcomes
Better sleep quality
Time frame: Baseline to Eight weeks
Lower degree of perceived stress
Time frame: Baseline to Eight weeks
Cognitive enhancement
Time frame: Baseline to Eight weeks
Higher grades
Time frame: Baseline to 6 months
Lower sick leave
Time frame: Baseline to 6 months
Lower Neuroticism
Time frame: Baseline to Eight weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Sundquist, Professor/MD study chair
Centrum för Primärvårdsforskning
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness intervention and Music relaxation in people with Stress and Complete Psychological Check Up, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Better mental health (time frame: Baseline to Eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2012.