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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04258540
Other study ID # 2016/1751 C
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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).
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