Evaluation of a Yoga Program in Schools

March 18, 2019 updated by: Sat Bir Khalsa, PhD, Brigham and Women's Hospital

Evaluation of Yoga During School as a Behavioral Prevention Program for Adolescent Health

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1693

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Latin Public School
      • Great Barrington, Massachusetts, United States, 01230
        • Monument Mountain Regional High School
      • Waltham, Massachusetts, United States, 02452
        • Waltham Senior High School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Registered for physical education class

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Kripalu Yoga In The Schools

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
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)
Time Frame: Baseline; 1 week post-intervention
Baseline; 1 week post-intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in self-reported resilience (ability to adapt) as measured by the 25-item Resilience Scale (RS)
Time Frame: Baseline, 1 week post-intervention
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)
Time Frame: Baseline, 1 week post-intervention
Baseline, 1 week post-intervention
Change in self-reported mindfulness as measured by the 25-item Child Acceptance and Mindfulness Measure (CAMM)
Time Frame: Baseline, 1 week post-intervention
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)
Time Frame: Baseline; during intervention after 4 weeks, 8 weeks and 12 weeks; 1 week post-intervention
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)
Time Frame: Baseline, 1 week post-intervention
Baseline, 1 week post-intervention
Change in self-reported self-esteem as measured by the 10-item Rosenberg Self-Esteem Scale (RSES)
Time Frame: Baseline, 1 week post-intervention
Baseline, 1 week post-intervention
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
1 week post-intervention
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
Baseline, 1 week post-intervention
Change in self-reported stress levels as measured by the 10-item Perceived Stress Scale (PSS)
Time Frame: Baseline, 1 week post-intervention
Baseline, 1 week post-intervention
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
Baseline, 1 week post-intervention
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
Baseline, 1 week post-intervention
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
Baseline, 1 week post-intervention
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
Baseline, 1 week post-intervention
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
Baseline; during intervention after 4 weeks, 8 weeks and 12 weeks; 1 week post-intervention
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
Baseline, 1 week post-intervention
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
Baseline, 1 week post-intervention
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
Baseline, 1 week post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brigham and Women's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kripalu Center for Yoga and Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2007P002600A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings