Mental Health IssueNCT04806542
Two-year Follow-up of a Mindfulness-based Intervention in Children.
A study testing TMR-group and Treatment as usual in people with Mental Health Issue, run by Göteborg University.
Trial summary
The primary aim of this study was to determine whether an 8-week mindfulness-based intervention, called Training for Mindfulness and Resilience (TMR), mitigates moderate mental health symptoms and increases resilience during a 2-year follow-up. Read more about this study
- Who is it for?
- Ages 9 to 14 years
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- TMR-group and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 29 Jan 2016to 20 Jun 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 9 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- F32.0 Mild depressive episode
- F32.1 Moderate depressive episode
- F41 Anxiety disorders
- F43 Reactions to stress
- F51 Nonorganic sleep disorders
- F93 Emotional disorders with onset specific to childhood
- F94.8 Other childhood disorders of social functioning
- F94.9 Other childhood disorder of social functioning, unspecified
Who cannot join
- Ongoing treatment for severe psychiatric disorders (F20-29, F31-F33.3)
- Cognitive disorders
- Difficulties in understanding Swedish
- Neuropsychiatric considerations and diagnosis
- Learning disabilities with difficulties in verbal understanding
- Ongoing parental conflict in conjunction with separation/divorce.
- Attending less than 5 of the 8 sessions of the TMR program.
About this study
Official title: A Mindfulness-based Intervention Improves Resilience, Anxiety, Anger and Disruptive Behaviour in Children With Mental Health Problems: A 2-year Follow-up Study
The primary aim of this study was to determine whether an 8-week mindfulness-based intervention, called Training for Mindfulness and Resilience (TMR), mitigates moderate mental health symptoms and increases resilience during a 2-year follow-up.
Methods
The participants were 34 schoolchildren in age range of 9-14 years, reporting moderate mental health problems. Participants were randomised into either TMR intervention group (N=22) or control group, receiving best current practice (N=12). The investigators used validated self-rating questionnaires to measure anxiety, depression, anger, disruptive behaviour, self-concept, resilience, stress and mindfulness before treatment with either TMR or control, as well as at 6 months, 1 year and 2 years after treatment period.
- Conditions
- Mental Health Issue
- Being tested
- TMR-group, Treatment as usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMR-groupBehavioural
A mindfulness-based 8 week program.
Treatment as usualBehavioural
Individual counselling.
| Study group | Role | What they receive |
|---|---|---|
| TMR-group | Experimental | 8-week program for schoolchildren called TMR (Training for Resilience and Mindfulness). Receives: Behavioral: TMR-group |
| Treatment as Usual | Active comparator | Individual counselling. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety, depression, anger, disruptive behaviour, self-concept according to Beck Youth Inventories.
The investigators used validated self-rating questionnaires called Beck Youth Inventories. Maximum score 300, minimum score 0. Higher values indicate worse outcome except on subscale measuring self-concept where higher score indicate better outcome .
Measured: Change from Baseline anxiety, depression, anger, disruptive behaviour and self-concept at 2 years.
Resilience.
The investigators used a validated self-rating questionnaire called Resilience Scale 10. Maximum score 40, minimum score 10. Higher values indicate better outcome.
Measured: Change from Baseline Resilience at 2 years.
Stress.
The investigators used a validated self-rating questionnaire called Stress in Children. Maximum score 92, minimum score 23. Higher values indicate better outcome.
Measured: Change from Baseline stress at 2 years.
Mindfulness.
The investigators used a validated self-rating questionnaire called Child and Adolescent Mindfulness Measure (CAMM). Maximum score 40, minimum score 0. Higher values indicate better outcome.
Measured: Change from Baseline mindfulness at 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start29 Jan 2016
- Primary completion20 Jun 2019
- Study completion20 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Study.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806542
- Sponsor's protocol ID
- TMR-study
- Status last verified
- Mar 2021
- First submitted
- 12 Mar 2021
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mindfulness-based Intervention Improves Resilience, Anxiety, Anger and Disruptive Behaviour in Children With Mental Health Problems: A 2-year Follow-up Study
- ClinicalTrials.gov ID
- NCT04806542
- Acronym / sponsor ID
- TMR-study
- Conditions
- Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 29 Jan 2016 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 19 Mar 2021 (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.
The primary aim of this study was to determine whether an 8-week mindfulness-based intervention, called Training for Mindfulness and Resilience (TMR), mitigates moderate mental health symptoms and increases resilience during a 2-year follow-up.
Methods
The participants were 34 schoolchildren in age range of 9-14 years, reporting moderate mental health problems. Participants were randomised into either TMR intervention group (N=22) or control group, receiving best current practice (N=12). The investigators used validated self-rating questionnaires to measure anxiety, depression, anger, disruptive behaviour, self-concept, resilience, stress and mindfulness before treatment with either TMR or control, as well as at 6 months, 1 year and 2 years after treatment period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Study.
| Arm | Type | Receives |
|---|---|---|
| TMR-group | Experimental | Behavioral: TMR-group8-week program for schoolchildren called TMR (Training for Resilience and Mindfulness). |
| Treatment as Usual | Active comparator | Behavioral: Treatment as usualIndividual counselling. |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- F32.0 Mild depressive episode
- F32.1 Moderate depressive episode
- F41 Anxiety disorders
- F43 Reactions to stress
- F51 Nonorganic sleep disorders
Key exclusion criteria (7 listed)
- Ongoing treatment for severe psychiatric disorders (F20-29, F31-F33.3)
- Cognitive disorders
- Difficulties in understanding Swedish
- Neuropsychiatric considerations and diagnosis
- Learning disabilities with difficulties in verbal understanding
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 |
|---|---|---|
| TMR-groupA mindfulness-based 8 week program. | Behavioural | TMR-group |
| Treatment as usualIndividual counselling. | Behavioural | Treatment as Usual |
Primary outcome
Anxiety, depression, anger, disruptive behaviour, self-concept according to Beck Youth Inventories.
Time frame: Change from Baseline anxiety, depression, anger, disruptive behaviour and self-concept at 2 years.
The investigators used validated self-rating questionnaires called Beck Youth Inventories. Maximum score 300, minimum score 0. Higher values indicate worse outcome except on subscale measuring self-concept where higher score indicate better outcome .
Resilience.
Time frame: Change from Baseline Resilience at 2 years.
The investigators used a validated self-rating questionnaire called Resilience Scale 10. Maximum score 40, minimum score 10. Higher values indicate better outcome.
Stress.
Time frame: Change from Baseline stress at 2 years.
The investigators used a validated self-rating questionnaire called Stress in Children. Maximum score 92, minimum score 23. Higher values indicate better outcome.
Mindfulness.
Time frame: Change from Baseline mindfulness at 2 years.
The investigators used a validated self-rating questionnaire called Child and Adolescent Mindfulness Measure (CAMM). Maximum score 40, minimum score 0. Higher values indicate better outcome.
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 19 Mar 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing TMR-group and Treatment as usual in people with Mental Health Issue, run by Göteborg University.
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 8 inclusion and 7 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 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Anxiety, depression, anger, disruptive behaviour, self-concept according to Beck Youth Inventories. (time frame: Change from Baseline anxiety, depression, anger, disruptive behaviour and self-concept at 2 years.). The study lists 4 primary outcomes in all. 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 19 Mar 2021.