ClinicalTrials.gg
Active, not recruitingNCT03327714Updated Sep 3, 2026

Mindfulness as a Method of Improving the Well-being, Quality of Life and Health of Primary School Pupils

An interventional study of Mindfulness and compassion in Anxiety and Depression, sponsored by Lund University. Active, not recruiting at 1 site in Sweden. Open to participants aged 6 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.

Primary conditionDepressionRegistry: Anxiety DisordersReclassifiedWhy we changed it
Registry
Anxiety Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Depression
Why
  1. The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it.
  2. The study's listed conditions name Depression.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Lund University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Oct 2016, registered Sep 2017).

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Phase
Not applicable
Study type
Interventional
Enrollment
1,750
Allocation
Non-randomized
Ages
6 Years to 16 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 182 studies in Depression with a site in Sweden — 33 open to participants now, 46 under way, 1 of them phase 3. Depression · Sweden.

Planned enrollment
3rd of 155
1,750 · median 105
Started
2016
with 8 others
No phase
123 of 182
23 open now
Primary completion
2021-01
later than 0 of 45 live
Registered
68th of 182
by date

Among the 182 studies in Depression with a site in Sweden, this one is the 3rd largest by planned enrollment of the 155 interventional ones that give a count, is one of 9 that started in 2016, is one of 123 with no phase, reaches primary completion later than 0 of the 45 other live ones, and was the 68th registered.

Depression

8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.

Browse Depression studies →

Open to participants now

33 of the 182 studies in Depression with a site in Sweden are open now. Recruiting first, the newest first:

28 more — sign in →

All 33 open studies →

A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →

Who these studies take

Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.

This study: 6 Years to 16 Years · all sexes · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 182 studies in Depression with a site in Sweden, or all of them as a file.
02

Study summary

This study evaluates the short and long-term effect of 5-10 minutes daily mindfulness and compassion training in school among children aged between 6-16 years old. The mindfulness intervention will last for 10 weeks and the results will be compared to children who do not perform mindfulness in school. Due to practical reasons, the study is not randomized; classes are instead placed in the mindfulness or control group. Anxiety, mental, physical and social health, quality of life, and school performance will be evaluated via questionnaires and school registries, before and after the intervention and thereafter once a year until the end of ninth grade (age 16 years). Long term health (diagnoses, medical consumption, and drug prescriptions) and family income (proxy for socioeconomic status) will be followed in regional and national registries until 25 years of age.

The hypothesis of the study is that mindfulness can prevent mental disorders and anxiety, and increase well-being in children and adolescents. The primary aim is to subsequently evaluate if regular, daily, mindfulness and compassion training (5-10 minutes) prevents anxiety and mental disorders in children and adolescents. Secondary aims are to evaluate 1) the effect of mindfulness on daily life, quality of life, and health in school pupils; 2) the effect of mindfulness on school performance; 3) the effect of mindfulness and compassion on the class room environment; 4) the effect of potential individual, family, and school-level risk factors on mental health in children and adolescents; 5) the effect of mindfulness on these potential risk factors.

Sessions are led by school teachers who have been educated in mindfulness. Their own levels of stress and mindfulness will be evaluated by a questionnaire and compared to teachers in control classes both before and after the intervention. The teachers will also be interviewed to evaluate the effect of mindfulness on the class room environment.

In a sub-study, the effect of mindfulness on brain structure and function will be examined by magnetic resonance imaging in school pupils aged 15-16 year old. This will be preceded by a pilot study, in which feasibility of the method is tested in the target group.

To achieve sufficient statistical power, taking into account a cluster effect to adjust for grouping of the pupils, 1750 children and adolescents will be recruited. Written informed consent is a prerequisite for participation.

03

Conditions studied

  • Anxiety
  • Depression

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Keywords

  • mindfulness
  • children
  • anxiety
  • depression
  • mental disorder
  • risk factor
04

In context

Depression Reclassified

8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.

This study's planned enrollment of 1,750 is above the median of 81 across 7,066 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Lund University is the lead sponsor of 234 studies on the registry; 36 are open to participants now.

Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
6 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • School pupils in grade 0-9

Exclusion criteria

Exclusion Criteria:

  • No exclusion criteria
06

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,750 participants (estimated)

Study arms

  • Experimental
    Mindfulness and compassion

    Children aged between 6-16 years old will perform 5-10 minutes daily mindfulness and compassion training in school. The intervention will last for 10 weeks.

    Behavioral: Mindfulness and compassion

  • No intervention
    Control group

    The control group consists of children who do not perform mindfulness in school.

Interventions

  • BehavioralMindfulness and compassion
07

What researchers measure

Primary outcomes

  1. Effect of mindfulness on change in anxiety and depression in children, grade 3-9, as measured by the Beck Depression Inventory for Youth and the Beck Anxiety Inventory for Youth.

    The primary aim is to evaluate if regular, daily, mindfulness and compassion practice (5-10 minutes) for 10 weeks prevents anxiety and depression in children, grade 3-9. Results will be compared within respective group (change from baseline) and between mindfulness and control group.

    Time frame: Change from baseline depression and anxiety levels at 10 weeks

Secondary outcomes

  1. Effect of mindfulness on changes in daily life as measured by questions about school and leisure time (adapted from the Scania Public Health Survey).

    To evaluate the effect of regular mindfulness on daily life in children, grade 0-9, as measured by a number of questions about school and leisure time (adapted from the Scania Public Health Survey).

    Time frame: Change from baseline daily life status at 10 weeks

  2. Effect of regular mindfulness practice on school performance (data collected from school registers)

    To evaluate the effect of regular mindfulness on grades and attendance. The report cards will be collected before the Swedish summer holidays commence in June

    Time frame: Grade 0 (pupils aged 6-7 years) and will continue on a yearly basis until grade 9 (pupils aged 15-16).

  3. Effect of mindfulness on change in class room environment (evaluated by questionnaires, weekly schedule, and interviews with teachers).

    To evaluate the effect of regular mindfulness on class room environment (evaluated by questionnaires, weekly schedule, and interviews with teachers).

    Time frame: Change from baseline class room environment at 10 weeks

  4. Effect of risk factors on mental health: longitudinal follow-up study.

    To evaluate the association between, and effect of, potential individual, family, and school-level factors on mental health in children and adolescents. First results are obtained at baseline via questionnaires, the next 10 weeks later. Thereafter yearly until ninth grade (questionnaires) and until 25 years of age (diagnoses via registers)

    Time frame: Baseline, 10 weeks, 52 weeks. Thereafter yearly until 25 years of age.

  5. Effect of mindfulness on risk factors: longitudinal follow-up study.

    The effect of mindfulness on potential individual, family, and school-level risk factors. First evaluation after 10 weeks. Thereafter yearly until ninth grade (questionnaires) and 25 years of age (diagnoses via registers).

    Time frame: 10 weeks, 52 weeks. Thereafter yearly until 25 years of age.

  6. Effect of mindfulness on changes in quality of life as measured by questions adapted from the Scania Public Health Survey and Living Conditions Surveys (ULF/SILC)

    To evaluate the effect of regular mindfulness on quality of life in children, grade 0-9, as measured by questions adapted from the Scania Public Health Survey and Living Conditions Surveys (ULF/SILC)

    Time frame: Change from baseline quality of life at 10 weeks

  7. Effect of mindfulness on changes in health as measured by questions about school and leisure time (adapted from the Scania Public Health Survey).

    To evaluate the effect of regular mindfulness on health in children, grade 0-9, as measured by a number of questions about general health (adapted from the Scania Public Health Survey)

    Time frame: Change from baseline health at 10 weeks

  8. Long-term effect of mindfulness practice on anxiety, depression, daily life, quality of life and health as measured by the BDI Youth, the Scania Public Health Survey and Living Conditions Surveys (ULF/SILC) and registries: longitudinal follow-up study

    Long-term follow-up of outcomes # 1, 2, 7 and 8 via questionnaires once a year until ninth grade, and health until 25 years of age (diagnoses via registers)

    Time frame: 52 weeks and thereafter yearly until 25 years of age.

08

Study locations

1 site
  • Center for Primary Health Care Research
    Malmö, 20502, Sweden
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2016 to primary completion in Jan 2021, 51 months.

Of 3,471 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 51 months is above that.

Counting every sponsor, half of 3,569 studies reached it within 21 months; a quarter within 9 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 29, 2017
First posted
Oct 31, 2017
StartActual
Oct 12, 2016
Primary completionActual
Jan 30, 2021
CompletionEst.
Jun 30, 2039
Last update
Sep 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03327714
Lead sponsor
Lund University
Collaborators
Region Skane
Responsible party
Sponsor
First posted
Oct 31, 2017
Start date
Oct 12, 2016
Primary completion
Jan 30, 2021
Completion
Jun 30, 2039 (estimated)
Last update
Sep 3, 2026

Study contacts

Jan Sundquist, PhD, MD
principal investigator · Center for Primary Health Care Research, Institution of Clinical Sciences, Malmö, Sweden
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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