A Phase 3 interventional study of Mindfulness-based stress reduction program and Usual care in Mental Health Wellness 1, sponsored by University of Alberta. Completed at 1 site in Canada. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2013-12-10.
Sponsored by University of Alberta · Phase 3, Interventional, and Treatment
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.
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.
University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Eight MBSR sessions of 2 hrs/week to be held during regular class time plus one 3-hour retreat
Also known as: MBSR
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.
Also known as: standard care
Behavioral Assessment System for Children - 2nd Edition
Time frame: change from baseline at 10 weeks after start of intervention (or control period)
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
this will occur only for intervention group
Time frame: 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)
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
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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University of Alberta