Plain English Summary
Background and study aims
Anxiety and depression are mental disorders that cause excessive worry and sadness for people and get in the way of their daily lives. Young people are having anxiety and depression more than they used to in the past, and they need ways to help them feel better so that they can enjoy their lives and be successful at school and in life. Yoga is a way of moving and breathing to bring the body and mind together for relaxation. Mindfulness is a way of paying attention to the present moment in a purposeful way. Yoga and mindfulness are skills that can be taught to young people to help them cope with stress and difficult feelings. One way of providing yoga and mindfulness to young people is through activities at school. The aim of this study is to understand whether providing yoga and mindfulness at school to young people could help reduce their feelings of anxiety (worry) and depression (sadness).
Who can participate?
Students enrolled in the participating middle school
What does the study involve?
Participants are randomly allocated to either yoga and mindfulness activities in small groups or a waitlist control group. Activities include eight sessions of small group yoga and mindfulness (Monday, Tuesday, Thursday, or Friday) at the same time in the morning (8:05 to 9:05 AM during the school day). Symptoms of anxiety and depression are measured before the intervention, after completion of the intervention, and at the end of all the programming.
What are the possible benefits and risks of participating?
The benefits are to understand the usefulness of providing yoga and mindfulness programming to students based on whether their symptoms are affected by the programming. The risks are minimal and include potential breach of confidentiality in case any of the anonymized data may be sensitive.
Where is the study run from?
Tulane University (USA)
When is the study starting and how long is it expected to run for?
September 2018 to January 2019
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Alessandra Bazzano
abazzano@tulane.edu
Trial website
Contact information
Type
Scientific
Primary contact
Dr Alessandra Bazzano
ORCID ID
http://orcid.org/0000-0002-8299-2626
Contact details
Principal Investigator
1440 Canal St.
New Orleans
70112
United States of America
+1 (0)5049882338
abazzano@tulane.edu
Type
Public
Additional contact
Dr Alessandra Bazzano
ORCID ID
http://orcid.org/0000-0002-8299-2626
Contact details
Principal Investigator
1440 Canal St.
New Orleans
70112
United States of America
+1 (0)5049882338
abazzano@tulane.edu
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Yoga and mindfulness programming evaluation for middle school students: a randomized controlled trial
Acronym
YMP
Study hypothesis
Yoga and mindfulness programming reduces symptoms of depression and anxiety.
Ethics approval
Reviewed and deemed not human subjects research due to consisting of secondary analysis of de-identified data on 10/06/2019 by the Tulane University Human Subjects Protection Office Internal Review Board (Tulane University, HRPO 1440 Canal Street, Suite 1705, TW-8436 New Orleans, LA 70112, USA; +1 (0)504 988 2665; irbmain@tulane.edu), ref: 20191259
Study design
Single-center cluster randomized controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Schools
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Prevention of symptoms of anxiety and depression in early adolescents
Intervention
The school administration uses randomizer.org for group randomization with no blinding to either yoga and mindfulness activities in small groups or a waitlist control condition. Activities include eight sessions of small group yoga and mindfulness (Monday, Tuesday, Thursday, or Friday) and at the same time in the morning (8:05 to 9:05 AM during the school day). The total duration of the intervention and follow-up is September 2018 - March 2019.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Symptoms of anxiety measured using the Screen for Child Anxiety Related Disorders (SCARED) scale at baseline (prior to intervention) in September 2018, after completion of intervention in December 2018, and at the end of all the programming in March 2019
2. Symptoms of depression measured using the Patient Health Questionnaire revised for adolescents (PHQA) at baseline (prior to the intervention in September 2018), after completion of the intervention in December 2018, and at the end of all the programming in March 2019
Secondary outcome measures
There are no secondary outcome measures
Overall trial start date
01/09/2018
Overall trial end date
05/01/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Students enrolled at the specific middle school where administrators evaluated their yoga and mindfulness programming
Participant type
Healthy volunteer
Age group
Child
Gender
Both
Target number of participants
88
Total final enrolment
86
Participant exclusion criteria
Unwilling to participate
Recruitment start date
10/01/2018
Recruitment end date
11/01/2018
Locations
Countries of recruitment
United States of America
Trial participating centre
Tulane University
School of Public Health and Tropical Medicine
1440 Canal St.
New Orleans
70112
United States of America
Sponsor information
Organisation
Tulane University
Sponsor details
1440 Canal St.
New Orleans
70112
United States of America
+1 (0)5049882338
abazzano@tulane.edu
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in peer-reviewed journal. De-identified participant level data will be made available as required by WHO/ICMJE requirements.
IPD sharing statement
The participant-level data (original SCARED and PHQA forms used to collect data) are the property of the school, and access must be requested through email to the principal investigator Alessandra Bazzano (abazzano@tulane.edu) who will transfer the request to the school. The school wish to remain anonymous at this time to protect students’ privacy. All students involved in the study provided assent and their parents’ consented, with two students’ families opting out when provided informed consent and assent by the school.
Intention to publish date
31/07/2020
Participant level data
Available on request
Basic results (scientific)
Publication list