Evaluation of a Yoga Program in Schools

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Kripalu Center for Yoga and Health
Information provided by (Responsible Party):
Sat Bir Khalsa, PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01348893
First received: April 29, 2010
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

The purpose of this preliminary study is to evaluate the effects of a yoga-based program on high school students' psychological health. Results will be used to generate specific hypotheses of how yoga may improve adolescent mental health.


Condition Intervention
Adolescent Development
Behavioral: Yoga

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of Yoga During School as a Behavioral Prevention Program for Adolescent Health

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Change in self-reported negative affect and positive affect measured by the 30-item Positive and Negative Affect Schedule for Children (PANAS-C) [ Time Frame: Baseline; during intervention after 4 weeks, 8 weeks and 12 weeks; 1 week post-intervention ] [ Designated as safety issue: No ]
  • Change in self-reported mood as measured by: the 30-item Profile of Mood States Short Form (POMS-SF, total and 6 sub-scales), or the 24-item Brunel University Mood Scale (BRUMS, total and 6 sub-scales) [ Time Frame: Baseline; 1 week post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in self-reported resilience (ability to adapt) as measured by the 25-item Resilience Scale (RS) [ Time Frame: Baseline, 1 week post-intervention ] [ Designated as safety issue: No ]
  • Change in self-reported life purpose/satisfaction and self-confidence during stress, as measured by the 32-item Inventory of Positive Psychological Attitudes (IPPA) [ Time Frame: Baseline, 1 week post-intervention ] [ Designated as safety issue: No ]
  • Change in self-reported mindfulness as measured by the 25-item Child Acceptance and Mindfulness Measure (CAMM) [ Time Frame: Baseline, 1 week post-intervention ] [ Designated as safety issue: No ]
  • Change in self-reported emotion regulation as measured by the 10-item Emotion Regulation Questionnaire (ERQ, 2 subscales), or the 36-item Difficulties in Emotion Regulation (DERS, 6 sub-scales) [ Time Frame: Baseline; during intervention after 4 weeks, 8 weeks and 12 weeks; 1 week post-intervention ] [ Designated as safety issue: No ]
  • Change in self-reported anger expression and control as measured by part 3 of the 35-item State-Trait Anger Expression Inventory (STAXI2-C/A) [ Time Frame: Baseline, 1 week post-intervention ] [ Designated as safety issue: No ]
  • Change in self-reported self-esteem as measured by the 10-item Rosenberg Self-Esteem Scale (RSES) [ Time Frame: Baseline, 1 week post-intervention ] [ Designated as safety issue: No ]
  • Feasibility and acceptance of the yoga program as measured by: student and parent forms of the 8-item Yoga Evaluation Questionnaire (YEQ), and 30-minute one-on-one qualitative interviews with students [ Time Frame: 1 week post-intervention ] [ Designated as safety issue: No ]
  • Change in parent-reported psychological difficulties (total plus 5 sub-scales) as measured by the 25-item Strength and Difficulties Questionnaire (SDQ), parent/teacher form [ Time Frame: Baseline, 1 week post-intervention ] [ Designated as safety issue: No ]
  • Change in self-reported stress levels as measured by the 10-item Perceived Stress Scale (PSS) [ Time Frame: Baseline, 1 week post-intervention ] [ Designated as safety issue: No ]
  • Change in self-reported sleep as measured by the 19-item Pittsburgh Sleep Quality Index (PSQI) or the 3-item Adolescent Sleep Quality (ASQ) scale [ Time Frame: Baseline, 1 week post-intervention ] [ Designated as safety issue: No ]
  • Change in self-reported bullying and victimization by bullying as measured by the 12-item Peer Relations Questionnaire (PRQ) [ Time Frame: Baseline, 1 week post-intervention ] [ Designated as safety issue: No ]
  • Change in self-reported physical activity and eating habits as measured by the 8-item Health Behaviors Survey (HBS) [ Time Frame: Baseline, 1 week post-intervention ] [ Designated as safety issue: No ]
  • Change in self-reported substance use risk factors as measured by the 45-item UPPS Impulsive Behavior Scale (UPPS), or the 10-item Brief Sensation Seeking Scale with Slater's Addition (BSSS+S2) [ Time Frame: Baseline, 1 week post-intervention ] [ Designated as safety issue: No ]
  • Change in attention as measured by: self-report using the 9-item inattention sub-scale of the ADHD Self-Report Scale (ASRS), and a 20-minute O-SPAN task for working memory capacity [ Time Frame: Baseline; during intervention after 4 weeks, 8 weeks and 12 weeks; 1 week post-intervention ] [ Designated as safety issue: No ]
  • Change in self-reported stress levels as measured by the 7-Item subscale of the Depression Anxiety Stress Scale (DASS) [ Time Frame: Baseline, 1 week post-intervention ] [ Designated as safety issue: No ]
  • Change in self-reported sensation seeking tendencies as measured by the 12 item Brief Sensation Seeking Scale and Slater's Addition (BSSS+SS2). [ Time Frame: Baseline, 1 week post-intervention ] [ Designated as safety issue: No ]
  • Change in self-reported sadness levels as measured by the 3-Item subscale of the Sadness Management Scale (SMS) [ Time Frame: Baseline, 1 week post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 1800
Study Start Date: August 2008
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Physical education as usual
High school physical education curriculum established by the school, including competitive sports, aerobic and anaerobic activities, balance and coordination skills. Yoga is not a component of the curriculum.
Experimental: Yoga during physical education Behavioral: Yoga
12 to 16 weeks of group yoga classes (approximately 32 classes per student), 30-45 minutes per class, 2-3 times per week, during physical education class. Yoga program includes physical postures and movement, breathing exercises, partner/group games, deep relaxation and meditative techniques.
Other Name: Kripalu Yoga In The Schools

Detailed Description:

Specific Aims:

  1. To evaluate the hypothesis that 12 weeks of yoga during physical education will be acceptable by and feasible with high school students. To test Specific Aim 1, outcomes assessed at both Monument Mountain Regional High School and Waltham High School include: feasibility and acceptance.
  2. To evaluate the hypothesis that yoga will improve self-and parent-reported psychosocial well-being including affect, mood, stress and anxiety in high school students, relative to control students taking regular physical education. To test Specific Aim 2, both primary outcomes (affect and mood) will be assessed at both schools. Additional psychosocial well-being outcomes assessed at Monument Mountain Regional High School include: life purpose/satisfaction and self-confidence during stress; self-esteem; parent-reported psychological difficulties; perceived stress; and sleep quality. Additional psychosocial well-being outcomes assessed at Waltham High School include: self-esteem; parent-reported psychological difficulties; and sleep quality.
  3. To evaluate the hypothesis that yoga will improve self- and parent-reported self-regulatory skills including resilience, mindfulness, emotion regulation, anger expression, self-esteem and self-confidence relative to physical education controls. Self-regulation outcomes assessed at Monument Mountain Regional High School include: resilience; mindfulness; emotion regulation; control of anger expression; bullying; health behaviors; substance use risk factors; and attention. Self-regulation outcomes assessed at Waltham High School include: resilience; mindfulness; emotion regulation; control of anger expression; substance use risk factors; and attention.
  Eligibility

Ages Eligible for Study:   14 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Registered for physical education class
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01348893

Locations
United States, Massachusetts
Boston Latin Public School
Boston, Massachusetts, United States, 02115
Monument Mountain Regional High School
Great Barrington, Massachusetts, United States, 01230
Waltham Senior High School
Waltham, Massachusetts, United States, 02452
Sponsors and Collaborators
Brigham and Women's Hospital
Kripalu Center for Yoga and Health
Investigators
Principal Investigator: Sat Bir S Khalsa, PhD Brigham and Women's Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sat Bir Khalsa, PhD, Assistant Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01348893     History of Changes
Other Study ID Numbers: 2007P002600A
Study First Received: April 29, 2010
Last Updated: May 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Mental health
Education
Mind Body Therapies

ClinicalTrials.gov processed this record on July 29, 2014