Clinical trial NCT04258540: The Effects of Yoga on Student Mental Health
Official title: The Effects of Yoga on Student Mental Health: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Public Health
Depression, Anxiety
Sleep Problem
University Students
Keywords: mental health
public health
depression
anxiety
sleep problems
insomnia
yoga
students
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Psychological Distress
timeFrame: Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up)
Secondary outcomes:
measure: Change in Heart Rate Variability (HRV)
timeFrame: Week 0 (baseline) and week 12 (post-intervention)
measure: Change in Mental Well-being
timeFrame: Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).
measure: Change in Life Satisfaction
timeFrame: week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).
measure: Change in Mindfulness
timeFrame: Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).
measure: Change in Sleep Problems
timeFrame: Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: University of Oslo
Study officials:
affiliation: University of Oslo
name: Tiril Elstad, MA (hon)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elstad T, Ulleberg P, Klonteig S, Hisdal J, Dyrdal GM, Bjorndal A. The effects of yoga on student mental health: a randomised controlled trial. Health Psychol Behav Med. 2020 Nov 11;8(1):573-586. doi: 10.1080/21642850.2020.1843466.