NCT04258540

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

1.2 years

First QC Date

February 3, 2020

Last Update Submit

February 4, 2020

Conditions

Mental HealthPublic HealthDepression, AnxietySleep ProblemUniversity Students

Keywords

mental healthpublic healthdepressionanxietysleep problemsinsomniayogastudents

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change in Heart Rate Variability (HRV)

    Week 0 (baseline) and week 12 (post-intervention)

  • Change in Mental Well-being

    Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).

  • Change in Life Satisfaction

    week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).

  • Change in Mindfulness

    Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).

  • Change in Sleep Problems

    Week 0 (baseline), week 12 (post-intervention) and week 24 (follow-up).

Study Arms (2)

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.

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.

Behavioral: yoga course

Interventions

Yoga groupBEHAVIORAL

The intervention group received yoga 2 times a week for 12 weeks (á 1.25 hr).

Also known as: Intervention group
Intervention group
yoga courseBEHAVIORAL

yoga course

Control group waitlist

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Living in the Oslo area

You may not qualify if:

  • No serious mental health diagnoses
  • No recent major life crisis
  • No systematic yoga practice during the prior six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oslo

Oslo, Norway

Location

Related Publications (1)

  • 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.

    PMID: 34040886DERIVED

MeSH Terms

Conditions

Psychological Well-BeingDepressionAnxiety DisordersParasomniasSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorBehavioral SymptomsMental DisordersSleep Wake DisordersNervous System DiseasesSleep Disorders, IntrinsicDyssomnias

Study Officials

  • Tiril Elstad, MA (hon)

    University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Randomisation by a simple online program.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 3, 2020

First Posted

February 6, 2020

Study Start

December 16, 2016

Primary Completion

February 20, 2018

Study Completion

February 20, 2018

Last Updated

February 6, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)