NCT01348893

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,693

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2010

Completed
1 year until next milestone

First Posted

Study publicly available on registry

May 6, 2011

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

7.8 years

First QC Date

April 29, 2010

Last Update Submit

March 18, 2019

Conditions

Adolescent Development

Keywords

Mental healthEducationMind Body Therapies

Outcome Measures

Primary Outcomes (2)

  • Change in self-reported negative affect and positive affect measured by the 30-item Positive and Negative Affect Schedule for Children (PANAS-C)

    Baseline; during intervention after 4 weeks, 8 weeks and 12 weeks; 1 week post-intervention

  • 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)

    Baseline; 1 week post-intervention

Secondary Outcomes (17)

  • Change in self-reported resilience (ability to adapt) as measured by the 25-item Resilience Scale (RS)

    Baseline, 1 week post-intervention

  • Change in self-reported life purpose/satisfaction and self-confidence during stress, as measured by the 32-item Inventory of Positive Psychological Attitudes (IPPA)

    Baseline, 1 week post-intervention

  • Change in self-reported mindfulness as measured by the 25-item Child Acceptance and Mindfulness Measure (CAMM)

    Baseline, 1 week post-intervention

  • 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)

    Baseline; during intervention after 4 weeks, 8 weeks and 12 weeks; 1 week post-intervention

  • 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)

    Baseline, 1 week post-intervention

  • +12 more secondary outcomes

Study Arms (2)

Physical education as usual

NO INTERVENTION

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.

Yoga during physical education

EXPERIMENTAL
Behavioral: Yoga

Interventions

YogaBEHAVIORAL

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.

Also known as: Kripalu Yoga In The Schools
Yoga during physical education

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Registered for physical education class

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Boston Latin Public School

Boston, Massachusetts, 02115, United States

Location

Monument Mountain Regional High School

Great Barrington, Massachusetts, 01230, United States

Location

Waltham Senior High School

Waltham, Massachusetts, 02452, United States

Location

Related Publications (3)

  • Noggle JJ, Steiner NJ, Minami T, Khalsa SB. Benefits of yoga for psychosocial well-being in a US high school curriculum: a preliminary randomized controlled trial. J Dev Behav Pediatr. 2012 Apr;33(3):193-201. doi: 10.1097/DBP.0b013e31824afdc4.

    PMID: 22343481RESULT

  • Khalsa SR, McCarthy KS, Sharpless BA, Barrett MS, Barber JP. Beliefs about the causes of depression and treatment preferences. J Clin Psychol. 2011 Jun;67(6):539-49. doi: 10.1002/jclp.20785. Epub 2011 Mar 1.

    PMID: 21365652RESULT

  • Conboy LA, Noggle JJ, Frey JL, Kudesia RS, Khalsa SB. Qualitative evaluation of a high school yoga program: feasibility and perceived benefits. Explore (NY). 2013 May-Jun;9(3):171-80. doi: 10.1016/j.explore.2013.02.001.

    PMID: 23643372DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Yoga

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Sat Bir S Khalsa, PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

April 29, 2010

First Posted

May 6, 2011

Study Start

August 1, 2008

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

March 19, 2019

Record last verified: 2019-03

Locations

US(3)