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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01307943
First Posted: March 3, 2011
Last Update Posted: December 10, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
CASA: Child, Adolescent and Family Mental Health
Information provided by (Responsible Party):
Sunita Vohra, University of Alberta
  Purpose
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.

Condition Intervention Phase
Mental Health Wellness 1 Other: Mindfulness-based stress reduction program Other: Usual care Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mindfulness-based Stress Reduction for Pediatric Mental Health

Resource links provided by NLM:


Further study details as provided by Sunita Vohra, University of Alberta:

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

Secondary Outcome Measures:
  • Child Acceptance and Mindfulness Measure (CAMM) [ Time Frame: 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) ]
  • Adverse events [ Time Frame: at any stage during the study ]
  • Qualitative interview [ Time Frame: 12 weeks after start of intervention ]
    this will occur only for intervention group

  • Emotion regulation in childhood and adolescence(ERQ-CA) [ Time Frame: 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 ]
  • Child Acceptance and Mindfulness Measure (CAMM) [ Time Frame: 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 ]
  • Perceived Stress Scale (PSS) [ Time Frame: 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 ]

Enrollment: 85
Study Start Date: January 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: standard care

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01307943


Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada
Sponsors and Collaborators
University of Alberta
CASA: Child, Adolescent and Family Mental Health
Investigators
Principal Investigator: Sunita Vohra, MD, MSc University of Alberta
  More Information

Responsible Party: Sunita Vohra, Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT01307943     History of Changes
Other Study ID Numbers: MBSR1
First Submitted: February 25, 2011
First Posted: March 3, 2011
Last Update Posted: December 10, 2013
Last Verified: December 2013

Keywords provided by Sunita Vohra, University of Alberta:
MBSR
adolescent
mental health