Mindfulness-based Stress Reduction for Pediatric Mental Health

Mental Health Wellness 1 Clinical Trial

— MBSR  

Official title:

Mindfulness-based Stress Reduction for Pediatric Mental Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01307943
• Other study ID #: MBSR1
• Status: Completed
• Phase: Phase 3
• First received: February 25, 2011
• Last updated: December 9, 2013
• Start date: January 2011
• Est. completion date: April 2013

Study information

• Verified date: December 2013
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Health Wellness 1

Intervention

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
• 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.

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	CASA: Child, Adolescent and Family Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioral Assessment System for Children - 2nd Edition		change from baseline at 10 weeks after start of intervention (or control period)	No
Secondary	Child Acceptance and Mindfulness Measure (CAMM)		change from baseline at 10 weeks after start of intervention (or control period)	No
Secondary	EEG and fMRI		change from baseline at 10 weeks after start of intervention (or control period)	No
Secondary	Adverse events		at any stage during the study	Yes
Secondary	Qualitative interview	this will occur only for intervention group	12 weeks after start of intervention	No
Secondary	Emotion regulation in childhood and adolescence(ERQ-CA)		change from baseline at 10 weeks after start of intervention (or control period)	No
Secondary	Behavioral Assessment System for Children - 2nd Edition		change from baseline 3 months after intervention is complete and same time frame for control group	No
Secondary	Child Acceptance and Mindfulness Measure (CAMM)		change from baseline 3 months after intervention is complete and same time frame for control group	No
Secondary	Emotion regulation in childhood and adolescence(ERQ-CA)		change from baseline 3 months after intervention is complete and same time frame for control group	No
Secondary	Perceived Stress Scale (PSS)		change from baseline at 10 weeks after start of intervention (or control period)	No
Secondary	Perceived Stress Scale (PSS)		change from baseline 3 months after intervention is complete and same time frame for control group	No