- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04258540
The Effects of Yoga on Student Mental Health
The Effects of Yoga on Student Mental Health: A Randomised Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Universities around the world are facing an epidemic of mental health problems among their students. The problem is truly a public health issue, affecting many and with serious consequences. Moreover, the global burden of disease-agenda calls for effective interventions with lasting effects that have the potential to improve the mental health of young adults. In this study the investigators aimed to determine whether yoga, a popular and widely available mind-body practice, can improve student mental health.
The participants were randomly assigned to a yoga group or waitlist control group in a 1:1 ratio by a simple online randomisation program. The intervention group was offered 24 yoga sessions over 12 weeks. Measurements were taken at week 0 (baseline), week 12 (post-intervention), and week 24 (follow-up). The primary outcome was psychological distress assessed by the HSCL-25 questionnaire. Analysis was performed based on the intention to treat-principle.
The methods were laid out in a protocol, previously published on the website of the study. (available at http://yogastudy.tilda.ws/). The planned analyses were very straightforward and included a description of the study participants, and simple analyses of each of the a priori selected outcome measures. We have not included or excluded any variables post-hoc.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oslo, Norway
- University of Oslo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Living in the Oslo area
Exclusion Criteria:
- No serious mental health diagnoses
- No recent major life crisis
- No systematic yoga practice during the prior six months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Intervention group
The intervention group received a yoga course for 12 weeks, two times a week.
Each yoga class was 1.25 hr in duration.
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The intervention group received yoga 2 times a week for 12 weeks (á 1.25 hr).
Other Names:
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ACTIVE_COMPARATOR: Control group waitlist
The control group were on a waitlist during the period of measurements, and received the same yoga course after all measurements had been completed.
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yoga course
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Psychological Distress
Time Frame: Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up)
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Measured with the Hopkins Symptom Checklist 25 (HSCL-25) questionnaire.
Consists of 25 items on symptoms of depression and anxiety, each rated on a 1 (not at all) to 4 (very much) scale.
Total scores range from 1 to 4, a higher score indicating more psychological distress.
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Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Heart Rate Variability (HRV)
Time Frame: Week 0 (baseline) and week 12 (post-intervention)
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Measured with nocturnal RMSSD (root mean square of successive differences), which is a validated measure of activity in the parasympathetic part of the autonomic nervous system.
In general, an increase in RMSSD is associated with increased parasympathetic system activity and less distress.
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Week 0 (baseline) and week 12 (post-intervention)
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Change in Mental Well-being
Time Frame: Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).
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Measured with the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS), a 14-item Warwick-Edinburgh Mental Well-Being Scale (WEMWBS).
This scale has five response categories (from "not at all" to "all the time") that are added together to produce a total score ranging from 14 to 70.
Higher scores indicate higher levels of mental well-being.
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Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).
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Change in Life Satisfaction
Time Frame: week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).
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Measured with the Satisfaction With Life Scale (SWLS), a 5-item questionnaire.
Items are scored on a 1- to 7-point Likert scale.
The total score is computed by adding all response values (ranging from 5 to 35), with higher scores indicating higher satisfaction.
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week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).
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Change in Mindfulness
Time Frame: Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).
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Mindful Attention Awareness Scale, MAAS, a 15-item scale.
The total score was computed by adding the score value on all individual items, producing a total score ranging from 15 to 75, with higher scores indicating higher levels of mindfulness.
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Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).
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Change in Sleep Problems
Time Frame: Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).
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The investigators used the Bergen Insomnia Scale (BIS), a 6-item scale.
Scores from 0 (no bad nights during the course of a week) to 7 (all nights) give a total score ranging from 0 to 42 (higher scores indicating more troubled sleep and daytime tiredness).
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Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tiril Elstad, MA (hon), University of Oslo
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/1751 C
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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