MindfulnessGIKNCT03141229

Health, Integration, Concentration: Mindfulness in Schools

A study testing Mindfulness based stress reduction in people with Mindfulness and Child Development, run by Universität Duisburg-Essen at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Mindfulness training for teacher and children of primary schools. Blinded and controlled study design. Burnout as primary outcome for teacher and classroom behavior for children. Read more about this study

Who is it for?: Ages 8 years and older
Conditions the study is for: Mindfulness, Child Development, Burnout Syndrome
What is being tested?: Mindfulness based stress reduction
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 1 siteGermany
Study dates: Dec 2016to Mar 2019
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 8 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

reading ability
positive declaration of consent

Who cannot join

Trial locations and contacts

1 site in 1 country.

Germany1 site

Schulamt Stadt Solingen
Solingen, North Rhine-Westphalia, 42697

Other trials in Germany

About this study

Official title: Gesundheit, Integration, Konzentration: Achtsamkeitsbasierte Stabilisierung Von LehrerInnen Und SchülerInnen

Mindfulness training for teacher and children of primary schools. Blinded and controlled study design. Burnout as primary outcome for teacher and classroom behavior for children.

Conditions: Mindfulness, Child Development, Burnout Syndrome
Being tested: Mindfulness based stress reduction
Keywords: MBSR, Children, Teacher, School, Burnout, Classroom behavior
Medical subject headings: Burnout, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mindfulness based stress reductionBehavioural
Also called MBSR

Study groups in NCT03141229
Study group	Role	What they receive
Intervention	Experimental	One school semester MBSR training for teacher; followed by one school semester mindfulness training for children and one school semester follow-up period. Receives: Behavioral: Mindfulness based stress reduction
Waitlist	Other	One school semester waitlist; followed by one school semester MBSR training for teacher and one school semester MBSR training for children. Receives: Behavioral: Mindfulness based stress reduction

What is being measured

The primary outcome is the main question the study is designed to answer.

Burnout (Teacher) assessed with the Burnout-Screening-Scale
Burnout-Screening-Scale (Change from baseline)
Measured: Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
Classroom climate pupils
Emotional and social school experience questionnaire (Change from baseline)
Measured: Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)

Secondary outcomes (4)

Stress and Anxiety (Teacher) assessed with the Stress and Anxiety Inventory
Stress and Anxiety Inventory for teacher (Change from baseline)
Measured: Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
Mindfulness (Teacher) assessed with the Freiburg Mindfulness Inventory
Freiburg Mindfulness Inventory (Change from baseline)
Measured: Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
Concentration (pupils) assessed with a d2-Concentration assessment tool
d2-Concentration assessment tool (Change from baseline)
Measured: Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
Health-related Quality of Life (pupils) assessed with the Kidscreen-10
Kidscreen-10 (Change from baseline)
Measured: Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2016Mar 2019

First posted5 May 2017
Study startDec 2016
Primary completionAug 2018
Study completionMar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for MindfulnessStudies of the same condition, open and under way.
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: Parallel groups
Model description: Note: Either teacher and pupils are included in this study. We anticipate a number of 100 teacher and 500 pupils participating. Data from teacher and pupils will be analyzed separately.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03141229
Sponsor's protocol ID: 16-6998-BO
Acronym: GIK
Status last verified: Mar 2020
First submitted: 9 Feb 2017
Last updated: 24 Mar 2020
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
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Pilot MBSR for People With HS
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Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
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Recruiting
Evaluating Operation Calm With Children, Parents, and Clinicians
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A Comparison of Heart Rate Variability Biofeedback, Mindfulness, and Psychoeducation-based Interventions on Clinical Recovery Outcomes in Patients Undergoing Total Knee Arthroplasty
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All Mindfulness trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Gesundheit, Integration, Konzentration: Achtsamkeitsbasierte Stabilisierung Von LehrerInnen Und SchülerInnen
ClinicalTrials.gov ID: NCT03141229
Acronym / sponsor ID: GIK / 16-6998-BO
Conditions: Mindfulness, Child Development, Burnout Syndrome
Keywords: MBSR, Children, Teacher, School, Burnout, Classroom behavior
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Universität Duisburg-EssenUniversity, hospital or other
Collaborators: Ministerium für Schule und Weiterbildung, Land Nordrhein-Westfalen, Ministerium für Gesundheit, Emanzipation, Pflege und Alter, Land Nordrhein-Westfalen
Study start: Dec 2016
Primary completion: Aug 2018 (actual)
Study completion: Mar 2019 (actual)
First posted: 5 May 2017 (actual)
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.

Mindfulness training for teacher and children of primary schools. Blinded and controlled study design. Burnout as primary outcome for teacher and classroom behavior for children.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: Note: Either teacher and pupils are included in this study. We anticipate a number of 100 teacher and 500 pupils participating. Data from teacher and pupils will be analyzed separately.

Arm	Type	Receives
Intervention	Experimental	Behavioral: Mindfulness based stress reductionOne school semester MBSR training for teacher; followed by one school semester mindfulness training for children and one school semester follow-up period.
Waitlist	Other	Behavioral: Mindfulness based stress reductionOne school semester waitlist; followed by one school semester MBSR training for teacher and one school semester MBSR training for children.

Who may qualify

Ages: 8 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

reading ability
positive declaration of consent

Key exclusion criteria (1 listed)

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 based stress reductionAlso: MBSR	Behavioural	Intervention, Waitlist

Primary outcome

Burnout (Teacher) assessed with the Burnout-Screening-Scale
Time frame: Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
Burnout-Screening-Scale (Change from baseline)
Classroom climate pupils
Time frame: Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
Emotional and social school experience questionnaire (Change from baseline)

4 secondary outcomes

Stress and Anxiety (Teacher) assessed with the Stress and Anxiety Inventory
Time frame: Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
Mindfulness (Teacher) assessed with the Freiburg Mindfulness Inventory
Time frame: Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
Concentration (pupils) assessed with a d2-Concentration assessment tool
Time frame: Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
Health-related Quality of Life (pupils) assessed with the Kidscreen-10
Time frame: Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
Individual participant dataSharing planned: No

Related trials for Mindfulness

Recruiting
The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
Caregiver Distress, Emotional Distress
Active, not recruiting
Pilot MBSR for People With HS
Hidradenitis Suppurativa (HS)
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
Recruiting
Evaluating Operation Calm With Children, Parents, and Clinicians
Preoperative Anxiety Experienced by the Pediatric Patient, Dental Anxiety in Children
Recruiting
A Comparison of Heart Rate Variability Biofeedback, Mindfulness, and Psychoeducation-based Interventions on Clinical Recovery Outcomes in Patients Undergoing Total Knee Arthroplasty
Pain (Knee), Pain and Anxiety

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.

Gustav Dobos, MD principal investigator

Universität Duisburg-Essen, Medizinische Fakultät, Klinik für Naturheilkunde und Integrative Medizin

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 based stress reduction in people with Mindfulness and Child Development, run by Universität Duisburg-Essen at 1 site in Germany.

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 2 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: finished, as of the sponsor's last update on 24 Mar 2020. 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 Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Burnout (Teacher) assessed with the Burnout-Screening-Scale (time frame: Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03141229.

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 24 Mar 2020.