Yoga and mindfulness programming evaluation for middle school students

ISRCTN ISRCTN16686557
DOI https://doi.org/10.1186/ISRCTN16686557
Submission date
03/06/2020
Registration date
25/06/2020
Last edited
19/07/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Alessandra Bazzano
Scientific

Principal Investigator
1440 Canal St.
New Orleans
70112
United States of America

ORCiD logoORCID ID 0000-0002-8299-2626
Phone +1 (0)5049882338
Email abazzano@tulane.edu
Dr Alessandra Bazzano
Public

Principal Investigator
1440 Canal St.
New Orleans
70112
United States of America

ORCiD logoORCID ID 0000-0002-8299-2626
Phone +1 (0)5049882338
Email abazzano@tulane.edu

Study information

Study designSingle-center cluster randomized controlled trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)School
Study typePrevention
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleYoga and mindfulness programming evaluation for middle school students: a randomized controlled trial
Study acronymYMP
Study objectivesYoga and mindfulness programming reduces symptoms of depression and anxiety.
Ethics approval(s)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
Health condition(s) or problem(s) studiedPrevention of symptoms of anxiety and depression in early adolescents
InterventionThe 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 typeBehavioural
Primary outcome measure1. 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 measuresThere are no secondary outcome measures
Overall study start date01/09/2018
Completion date05/01/2019

Eligibility

Participant type(s)Healthy volunteer
Age groupChild
SexBoth
Target number of participants88
Total final enrolment86
Key inclusion criteriaStudents enrolled at the specific middle school where administrators evaluated their yoga and mindfulness programming
Key exclusion criteriaUnwilling to participate
Date of first enrolment10/01/2018
Date of final enrolment11/01/2018

Locations

Countries of recruitment

  • United States of America

Study participating centre

Tulane University
School of Public Health and Tropical Medicine
1440 Canal St.
New Orleans
70112
United States of America

Sponsor information

Tulane University
University/education

1440 Canal St.
New Orleans
70112
United States of America

Phone +1 (0)5049882338
Email abazzano@tulane.edu
Website https://tulane.edu/
ROR logo "ROR" https://ror.org/04vmvtb21

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date31/07/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in peer-reviewed journal. De-identified participant level data will be made available as required by WHO/ICMJE requirements.
IPD sharing planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 24/09/2022 19/07/2023 Yes No

Editorial Notes

19/07/2023: Publication reference added.
26/06/2020: Internal review.
23/06/2020: Trial's existence confirmed by Tulane University Human Subjects Protection Office Internal Review Board.