Clinical Trials Directory

Trials / Completed

CompletedNCT01307943

Mindfulness-based Stress Reduction for Pediatric Mental Health

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
85 (actual)
Sponsor
University of Alberta · Academic / Other
Sex
All
Age
12 Years – 18 Years
Healthy volunteers
Not accepted

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. 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.

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.

Conditions

Interventions

TypeNameDescription
OTHERMindfulness-based stress reduction programEight MBSR sessions of 2 hrs/week to be held during regular class time plus one 3-hour retreat
OTHERUsual careThe 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.

Timeline

Start date
2011-01-01
Primary completion
2013-04-01
Completion
2013-04-01
First posted
2011-03-03
Last updated
2013-12-10

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT01307943. Inclusion in this directory is not an endorsement.