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Mental Health Wellness 1Phase 3MBSRNCT01307943

Mindfulness-based Stress Reduction for Pediatric Mental Health

A Phase 3 study testing Mindfulness-based stress reduction program in people with Mental Health Wellness 1, run by University of Alberta at 1 site in Canada.

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-based stress reduction (MBSR) is a group program in which participants are taught to be mindful or present-focused. MBSR programs consist of instruction in a variety of mindfulness meditations including body scan, sitting meditation, mindful yoga, and discussion of these practices. Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Mental Health Wellness 1
What is being tested?
Mindfulness-based stress reduction program
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteCanada
Study dates
Jan 2011to Apr 2013
Phase
Phase 3
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 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • between the ages of 12 and 18
  • residents of study site
  • communication and comprehension of English
  • not currently abusing substances

Who cannot join

  • participants diagnosed with psychosis, as meditation has rarely been associated with precipitation of psychosis and/or psychotic episodes in individuals with pre-existing schizophrenia or significant thought disorders

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Alberta

    Edmonton, Alberta

Other trials in Canada

About this study

Mindfulness-based stress reduction (MBSR) is a group program in which participants are taught to be mindful or present-focused. MBSR programs consist of instruction in a variety of mindfulness meditations including body scan, sitting meditation, mindful yoga, and discussion of these practices. Our study purpose is to develop and conduct a pilot mixed-methods randomized controlled trial (RCT), combining clinical outcomes, qualitative interviews, and brain imaging to assess the impact of the intervention on children with mental health challenges.

Read the detailed description

This study will be a 2 arm controlled clinical trial (CCT) comparing usual care to usual care plus MBSR. Participants will be residents of a local inpatient treatment facility for adolescents with serious mental health issues. Outcomes the investigators will measure include mental health status as well as mindfulness. The investigators will also conduct qualitative interviews to assess the personal impact of the intervention on the patients and their families. In order to map and measure cognitive changes during MBSR the investigators will conduct brain imaging using functional magnetic resonance imaging (fMRI) and Event-Related Potential (ERP) recordings. Through this study the investigators will determine if MBSR is helpful to our population.

Being tested
Mindfulness-based stress reduction program, Usual care
Keywords
MBSR, adolescent, mental health
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-based stress reduction programOther

    Also called MBSR

    Eight MBSR sessions of 2 hrs/week to be held during regular class time plus one 3-hour retreat

  • Usual careOther

    Also called standard care

    The site provides family centered treatment where adolescents take part in therapy from Sunday evening until Friday afternoon. In addition to a structured day and evening schedule, standard treatment includes: Daily group therapy; ii) Medications; iii) Schooling by Edmonton Public School Board teachers; iv) Physical education and recreation; and v) Weekly Multiple Family Therapy.

Study groups in NCT01307943
Study groupRoleWhat they receive
Mindfulness Based Stress ReductionExperimentalEight MBSR sessions of 2 hrs/week to be held during regular class time plus one 3-hour retreat at the completion of the eight sessions to review and consolidate experience with the various mindfulness practices. The MBSR concepts and techniques will emphasize portability. Participants will be encouraged to find moments throughout their day in which to practice the techniques. The language used to describe mindfulness practices will be accessible to youth. Mindfulness concepts will be linked with tag phrases like "breathing break," "autopilot," and "choice points." Homework will emphasize experiential, concrete tasks ("notice five new things today"; "eat one meal mindfully this week").
Receives: Other: Mindfulness-based stress reduction program
Usual CareActive comparatorThe control group will be youth receiving therapies and programs already used at the site. The site provides family centered treatment where adolescents take part in therapy from Sunday evening until Friday afternoon. In addition to a structured day and evening schedule, standard treatment includes: Daily group therapy; ii) Medications; iii) Schooling by Edmonton Public School Board teachers; iv) Physical education and recreation; and v) Weekly Multiple Family Therapy.
Receives: Other: Usual care

What is being measured

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

  1. Behavioral Assessment System for Children - 2nd Edition

    Measured: change from baseline at 10 weeks after start of intervention (or control period)

Secondary outcomes (10)

  1. Child Acceptance and Mindfulness Measure (CAMM)

    Measured: change from baseline at 10 weeks after start of intervention (or control period)

  2. EEG and fMRI

    Measured: change from baseline at 10 weeks after start of intervention (or control period)

  3. Adverse events

    Measured: at any stage during the study

  4. Qualitative interview

    this will occur only for intervention group

    Measured: 12 weeks after start of intervention

  5. Emotion regulation in childhood and adolescence(ERQ-CA)

    Measured: change from baseline at 10 weeks after start of intervention (or control period)

  6. Behavioral Assessment System for Children - 2nd Edition

    Measured: change from baseline 3 months after intervention is complete and same time frame for control group

  7. Child Acceptance and Mindfulness Measure (CAMM)

    Measured: change from baseline 3 months after intervention is complete and same time frame for control group

  8. Emotion regulation in childhood and adolescence(ERQ-CA)

    Measured: change from baseline 3 months after intervention is complete and same time frame for control group

  9. Perceived Stress Scale (PSS)

    Measured: change from baseline at 10 weeks after start of intervention (or control period)

  10. Perceived Stress Scale (PSS)

    Measured: change from baseline 3 months after intervention is complete and same time frame for control group

Timeline

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

  1. First posted3 Mar 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionApr 2013
  4. Study completionApr 2013

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01307943
Sponsor's protocol ID
MBSR1
Acronym
MBSR
Status last verified
Dec 2013
First submitted
25 Feb 2011
Last updated
10 Dec 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Vohra S, Punja S, Sibinga E, Baydala L, Wikman E, Singhal A, Dolcos F, Van Vliet KJ. Mindfulness-based stress reduction for mental health in youth: a cluster randomized controlled trial. Child Adolesc Ment Health. 2019 Feb;24(1):29-35. doi: 10.1111/camh.12302. Epub 2018 Oct 15.

    PubMed 32677243

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mindfulness-based stress reduction program in people with Mental Health Wellness 1, run by University of Alberta at 1 site in Canada.

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 4 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 10 Dec 2013. 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 Canada. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Behavioral Assessment System for Children - 2nd Edition (time frame: change from baseline at 10 weeks after start of intervention (or control period)). 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 NCT01307943, which also lists 1 linked publication.

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 10 Dec 2013.

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