Mindfulness-based Stress Reduction for Pediatric Mental Health (MBSR)

December 9, 2013 updated by: Sunita Vohra, University of Alberta
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • University of Alberta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Mindfulness Based Stress Reduction
Eight 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").
Other: Mindfulness-based stress reduction program
Eight MBSR sessions of 2 hrs/week to be held during regular class time plus one 3-hour retreat
Other Names:
  • MBSR
ACTIVE_COMPARATOR: Usual Care
The 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.
Other: Usual 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.
Other Names:
  • standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Behavioral Assessment System for Children - 2nd Edition
Time Frame: change from baseline at 10 weeks after start of intervention (or control period)
change from baseline at 10 weeks after start of intervention (or control period)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child Acceptance and Mindfulness Measure (CAMM)
Time Frame: change from baseline at 10 weeks after start of intervention (or control period)
change from baseline at 10 weeks after start of intervention (or control period)
EEG and fMRI
Time Frame: change from baseline at 10 weeks after start of intervention (or control period)
change from baseline at 10 weeks after start of intervention (or control period)
Adverse events
Time Frame: at any stage during the study
at any stage during the study
Qualitative interview
Time Frame: 12 weeks after start of intervention
this will occur only for intervention group
12 weeks after start of intervention
Emotion regulation in childhood and adolescence(ERQ-CA)
Time Frame: change from baseline at 10 weeks after start of intervention (or control period)
change from baseline at 10 weeks after start of intervention (or control period)
Behavioral Assessment System for Children - 2nd Edition
Time Frame: change from baseline 3 months after intervention is complete and same time frame for control group
change from baseline 3 months after intervention is complete and same time frame for control group
Child Acceptance and Mindfulness Measure (CAMM)
Time Frame: change from baseline 3 months after intervention is complete and same time frame for control group
change from baseline 3 months after intervention is complete and same time frame for control group
Emotion regulation in childhood and adolescence(ERQ-CA)
Time Frame: change from baseline 3 months after intervention is complete and same time frame for control group
change from baseline 3 months after intervention is complete and same time frame for control group
Perceived Stress Scale (PSS)
Time Frame: change from baseline at 10 weeks after start of intervention (or control period)
change from baseline at 10 weeks after start of intervention (or control period)
Perceived Stress Scale (PSS)
Time Frame: change from baseline 3 months after intervention is complete and same time frame for control group
change from baseline 3 months after intervention is complete and same time frame for control group

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

CASA: Child, Adolescent and Family Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

April 1, 2013

Study Registration Dates

First Submitted

February 25, 2011

First Submitted That Met QC Criteria

March 2, 2011

First Posted (ESTIMATE)

March 3, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 10, 2013

Last Update Submitted That Met QC Criteria

December 9, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MBSR1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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