Clinical trial NCT01307943: Mindfulness-based Stress Reduction for Pediatric Mental Health
Official title: Mindfulness-based Stress Reduction for Pediatric Mental Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mental Health Wellness 1
Keywords: MBSR
adolescent
mental health
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: CASA: Child, Adolescent and Family Mental Health
First posted: 2011-03-03
Enrollment: 85
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Behavioral Assessment System for Children - 2nd Edition
timeFrame: change from baseline at 10 weeks after start of intervention (or control period)
Secondary outcomes:
measure: Child Acceptance and Mindfulness Measure (CAMM)
timeFrame: change from baseline at 10 weeks after start of intervention (or control period)
measure: EEG and fMRI
timeFrame: change from baseline at 10 weeks after start of intervention (or control period)
measure: Adverse events
timeFrame: at any stage during the study
measure: Qualitative interview
timeFrame: 12 weeks after start of intervention
measure: Emotion regulation in childhood and adolescence(ERQ-CA)
timeFrame: change from baseline at 10 weeks after start of intervention (or control period)
measure: Behavioral Assessment System for Children - 2nd Edition
timeFrame: change from baseline 3 months after intervention is complete and same time frame for control group
measure: Child Acceptance and Mindfulness Measure (CAMM)
timeFrame: change from baseline 3 months after intervention is complete and same time frame for control group
measure: Emotion regulation in childhood and adolescence(ERQ-CA)
timeFrame: change from baseline 3 months after intervention is complete and same time frame for control group
measure: Perceived Stress Scale (PSS)
timeFrame: change from baseline at 10 weeks after start of intervention (or control period)
measure: Perceived Stress Scale (PSS)
timeFrame: change from baseline 3 months after intervention is complete and same time frame for control group
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Sunita Vohra, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.