Mental HealthNCT04258540
The Effects of Yoga on Student Mental Health
A study testing Yoga group and yoga course in people with Mental Health and Public Health, run by University of Oslo at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Public Health, Depression, Anxiety
- What is being tested?
- Yoga group and yoga course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteNorway
- Study dates
- 16 Dec 2016to 20 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Living in the Oslo area
Who cannot join
- No serious mental health diagnoses
- No recent major life crisis
- No systematic yoga practice during the prior six months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Yoga on Student Mental Health: A Randomised Controlled Trial
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).
Read the 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.
- Being tested
- Yoga group, yoga course
- Keywords
- mental health, public health, depression, anxiety, sleep problems, insomnia, yoga, students
- Medical subject headings
- Psychological Well-Being, Depression, Anxiety Disorders, Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga groupBehavioural
Also called Intervention group
The intervention group received yoga 2 times a week for 12 weeks (á 1.25 hr).
yoga courseBehavioural
yoga course
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group received a yoga course for 12 weeks, two times a week. Each yoga class was 1.25 hr in duration. Receives: Behavioral: Yoga group |
| Control group waitlist | Active comparator | The control group were on a waitlist during the period of measurements, and received the same yoga course after all measurements had been completed. Receives: Behavioral: yoga course |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up)
Secondary outcomes (5)
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.
Measured: Week 0 (baseline) and week 12 (post-intervention)
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.
Measured: Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).
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.
Measured: week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).
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.
Measured: Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).
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).
Measured: Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start16 Dec 2016
- Primary completion20 Feb 2018
- Study completion20 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tiril Elstad, University of Oslo
- Investigators
- Tiril Elstad, MA (hon), Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258540
- Sponsor's protocol ID
- 2016/1751 C
- Status last verified
- Feb 2020
- First submitted
- 3 Feb 2020
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34040886
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Yoga on Student Mental Health: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04258540
- Acronym / sponsor ID
- 2016/1751 C
- Keywords
- mental health, public health, depression, anxiety, sleep problems, insomnia, yoga, students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- 16 Dec 2016 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 20 Feb 2018 (actual)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Yoga groupThe intervention group received a yoga course for 12 weeks, two times a week. Each yoga class was 1.25 hr in duration. |
| Control group waitlist | Active comparator | Behavioral: yoga courseThe control group were on a waitlist during the period of measurements, and received the same yoga course after all measurements had been completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Living in the Oslo area
Key exclusion criteria (3 listed)
- No serious mental health diagnoses
- No recent major life crisis
- No systematic yoga practice during the prior six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga groupAlso: Intervention groupThe intervention group received yoga 2 times a week for 12 weeks (á 1.25 hr). | Behavioural | Intervention group |
| yoga courseyoga course | Behavioural | Control group waitlist |
Primary outcome
Change in Psychological Distress
Time frame: Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up)
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.
5 secondary outcomes
Change in Heart Rate Variability (HRV)
Time frame: Week 0 (baseline) and week 12 (post-intervention)
Change in Mental Well-being
Time frame: Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).
Change in Life Satisfaction
Time frame: week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).
Change in Mindfulness
Time frame: Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).
Change in Sleep Problems
Time frame: Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Derived from this study: PubMed 34040886Elstad 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiril Elstad, MA (hon) principal investigator
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga group and yoga course in people with Mental Health and Public Health, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Psychological Distress (time frame: Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04258540, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.