Mental Health Clinical Trial
Official title:
The Effects of Yoga on Student Mental Health: A Randomised Controlled Trial
Verified date | February 2020 |
Source | University of Oslo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
Norway | University of Oslo | Oslo |
Lead Sponsor | Collaborator |
---|---|
University of Oslo |
Norway,
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). |
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