The Effects of Yoga on Student Mental Health

Mental Health Clinical Trial

Official title:

The Effects of Yoga on Student Mental Health: A Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04258540
• Other study ID #: 2016/1751 C
• Status: Completed
• Phase: N/A
• Start date: December 16, 2016
• Est. completion date: February 20, 2018

Study information

• Verified date: February 2020
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators performed a randomised controlled trial with 202 healthy university students in the Oslo area, with 50:50 in a yoga intervention group and a waitlist control group. Measures included symptoms of depression and anxiety, sleep problems, heart rate variability (HRV), well-being and mindfulness at week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: February 20, 2018
• Est. primary completion date: February 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety
• Dyssomnias
• Mental Health
• Parasomnias
• Public Health
• Sleep Problem
• Sleep Wake Disorders
• University Students

Intervention

Behavioral:
• Yoga group
The intervention group received yoga 2 times a week for 12 weeks (á 1.25 hr).
• yoga course
yoga course

Locations

Country	Name	City	State
Norway	University of Oslo	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Psychological Distress	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.	Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up)
Secondary	Change in Heart Rate Variability (HRV)	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.	Week 0 (baseline) and week 12 (post-intervention)
Secondary	Change in Mental Well-being	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.	Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).
Secondary	Change in Life Satisfaction	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.	week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).
Secondary	Change in Mindfulness	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.	Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).
Secondary	Change in Sleep Problems	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).	Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).