Mindfulness-based Stress Reduction for Pediatric Mental Health

NCT ID: NCT01307943

Last Updated: 2013-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-04-30

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.

Conditions

Mental Health Wellness 1

Keywords

MBSR; adolescent; mental health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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").

Group Type: EXPERIMENTAL

Mindfulness-based stress reduction program

Intervention Type: OTHER

Eight MBSR sessions of 2 hrs/week to be held during regular class time plus one 3-hour retreat

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.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

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.

Interventions

Mindfulness-based stress reduction program

Eight MBSR sessions of 2 hrs/week to be held during regular class time plus one 3-hour retreat

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

MBSR; standard care

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CASA: Child, Adolescent and Family Mental Health

UNKNOWN

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Sunita Vohra

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sunita Vohra, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta

Edmonton, Alberta, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 32677243 (View on PubMed)

Other Identifiers

MBSR1

Identifier Type: -

Identifier Source: org_study_id