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The Effects of Yoga on Student Mental Health

Primary Purpose

Mental Health, Public Health, Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Yoga group
yoga course
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mental Health focused on measuring mental health, public health, depression, anxiety, sleep problems, insomnia, yoga, students

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Oslo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group waitlist

Arm Description

The intervention group received a yoga course for 12 weeks, two times a week. Each yoga class was 1.25 hr in duration.

The control group were on a waitlist during the period of measurements, and received the same yoga course after all measurements had been completed.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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).

Full Information

First Posted
February 3, 2020
Last Updated
February 4, 2020
Sponsor
University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT04258540
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
December 16, 2016 (Actual)
Primary Completion Date
February 20, 2018 (Actual)
Study Completion Date
February 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health, Public Health, Depression, Anxiety, Sleep Problem, University Students
Keywords
mental health, public health, depression, anxiety, sleep problems, insomnia, yoga, students

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Randomisation by a simple online program.
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The intervention group received a yoga course for 12 weeks, two times a week. Each yoga class was 1.25 hr in duration.
Arm Title
Control group waitlist
Arm Type
Active Comparator
Arm Description
The control group were on a waitlist during the period of measurements, and received the same yoga course after all measurements had been completed.
Intervention Type
Behavioral
Intervention Name(s)
Yoga group
Other Intervention Name(s)
Intervention group
Intervention Description
The intervention group received yoga 2 times a week for 12 weeks (á 1.25 hr).
Intervention Type
Behavioral
Intervention Name(s)
yoga course
Intervention Description
yoga course
Primary Outcome Measure Information:
Title
Change in Psychological Distress
Description
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.
Time Frame
Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up)
Secondary Outcome Measure Information:
Title
Change in Heart Rate Variability (HRV)
Description
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.
Time Frame
Week 0 (baseline) and week 12 (post-intervention)
Title
Change in Mental Well-being
Description
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.
Time Frame
Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).
Title
Change in Life Satisfaction
Description
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.
Time Frame
week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).
Title
Change in Mindfulness
Description
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.
Time Frame
Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).
Title
Change in Sleep Problems
Description
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).
Time Frame
Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiril Elstad, MA (hon)
Organizational Affiliation
University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oslo
City
Oslo
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34040886
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.
Results Reference
derived

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The Effects of Yoga on Student Mental Health

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