ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616000191493

Ethics application status

Approved

Date submitted

3/02/2016

Date registered

15/02/2016

Date last updated

15/02/2016

Type of registration

Retrospectively registered

Titles & IDs

Public title

Mindfulness-based Stress Release Program for university employees: a pilot, waitlist-controlled trial

Scientific title

Mindfulness-based Stress Release Program for university employees: a pilot, waitlist-controlled trial and implementation replication

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Psychological distress

Work engagement

Condition category

Condition code

Mental Health

Other mental health disorders

Mental Health

Anxiety

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention period is six weeks, involving one half-day introductory session, followed by five weekly 60-minute face-to-face sessions with a trained instructor. The active intervention is based on an established Stress Release Program developed by staff at Monash University, Melbourne (Hassed & Chambers, 2014). This program, delivered in the format of a small, interactive group, utilises cognitive strategies and reflective activities aimed to reduce stress, and improve wellbeing and resilience. Each session commences with a brief mindfulness practice, followed by an introduction to the session topic, an opportunity to reflect on the previous week’s practice, a theoretical component of the session. The main cognitive themes covered in the sessions include: perception and stress; reacting vs. responding to stress; presence of mind; the costs of automatic pilot and multitasking; listening; cultivating curiosity and openness; letting go and acceptance. Between sessions, participants are advised to practise formal mindfulness meditation at least 5 minutes per day and practise informal, mindfulness ‘pauses’ (15-30 seconds) as needed. There is also a homework task related to each weekly topic, which involves identifying unhelpful cognitive patterns in real time as often as possible as they go about their usual daily life. One instructor who has received direct training from the original facilitators will deliver the intervention. Participant compliance is encouraged at each instructional session, and a register of attendees at each session noted.

Hassed C & Chambers R (2014) Stress Release Program, accessed at http://www.monash.edu.au/counselling/stress-release-program.html on 30th May 2014

Intervention code [1]

Treatment: Other

Comparator / control treatment

Waitlist control group over a 6 week period.

Control group

Active

Outcomes

Primary outcome [1]

Psychological distress, as measured by a well validated and widely used self-report questionnaire, the Kessler Psychological Distress Scale (K10). This is a 10-item questionnaire intended to yield a global measure of distress based on questions about anxiety and depressive symptoms that a participant has experienced in the most recent 4 week period, and is the scale used by NSW Mental Health for standardized outcome measures. The K10 is scored using a five-level response scale based on the frequency of symptoms reported for each question. The maximum possible score of 50.

Timepoint [1]

6 weeks after the commencement of the intervention.

Primary outcome [2]

Work-specific measures of employee wellness and work-engagement. This will be measured by means of two questionnaires to evaluate a) University of Sydney specific workplace engagement and b) general engagement with the work content. The first questionnaire is adapted from a scale used by previous University of Sydney projects (The Voice Project, 2013). Only the relevant subscales will be used, the questions regarding Wellness and Work/life balance. The second questionnaire is a previously validated tool for assessing work engagement, the Utrecht Work Engagement Scale (Schaufeli & Bakker, 2003)

Timepoint [2]

6 weeks after the commencement of the intervention.

Secondary outcome [1]

N/A

Timepoint [1]

N/A

Eligibility

Key inclusion criteria

Adult (> 18 years old) employees at the University of Sydney willing to commit and consent to the full half day session and subsequent 5, weekly 60-minute sessions.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

As a naturalistic study there are no specific exclusion criteria

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

There is no allocation concealment to participants. Outcome measures are collected by self report and the investigators are blind to allocation

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Once the quota of 30 participants is enrolled in the program, the next 30 to register interest will then be invited to be placed on a waitlist to attend the next available mindfulness program in 3-4 months time. Whilst on the waitlist, participants in this group will be asked to fill out the same three short questionnaires regarding their level of stress, perceived wellbeing and workplace engagement, both at enrolment and then at 6 weeks follow-up.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

The key analyses will involve a) a within group quantitative analysis of scores for each of the 3 scales at follow-up ( 6 weeks) compared to baseline (prior to commencing the study) and b) between group comparison of the scores of each of the 3 scales at baseline and follow-up

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

24/10/2014

Date of last participant enrolment

Anticipated

Actual

20/02/2015

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2006 - The University Of Sydney

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Sydney

Address [1]

Healthy Sydney University
Charles Perkins Centre
University of Sydney
NSW, 2006

Country [1]

Australia

Primary sponsor type

University

Name

University of Syndey

Address

Healthy Sydney University
Charles Perkins Centre
University of Sydney
NSW, 2006

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee, University of Sydney

Ethics committee address [1]

Office of Research Integrity Research Portfolio 
THE UNIVERSITY OF SYDNEY
Level 2, Margaret Telfer Building (K07)  
The University of Sydney, NSW  2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

09/09/2014

Ethics approval number [1]

2014/649

Summary

Brief summary

Stress in the workplace is prevalent, with Australians reporting significantly lower overall workplace wellbeing in 2013 compared to previous years. Psychological injury is now the second most common cause of workplace compensation claims in Australia, and the direct cost to employers is estimated to be greater than $10 billion annual in terms of lost productivity. Thus, from an individual and public health perspective, there is an imperative to implement low risk, economically viable and effective programs to reduce workplace-stress and improve employee outcomes such as productivity, satisfaction and engagement.

Mindfulness-based programs have become increasingly popular as a means of targeting enhanced wellness at work as well as combatting negative consequences of excessive workplace stress. Mindfulness involves making a commitment to being fully conscious in the present moment without judgement, in an attitude of openness and acceptance. To date, reviews report a small to moderate effect for mindfulness in reducing multiple negative dimensions of psychological distress including anxiety, depression and appraised stress, although this is not specific for the workplace setting. Further research into the benefit of mindfulness programs in reducing workplace stress and quality of productivity is warranted.

This study aims to assess the effectiveness of structured, mindfulness-based program on decreasing work related stress and enhancing workplace wellbeing and engagement in fulltime university employees. Based on current available evidence, we hypothesise that mindfulness-based program participation will:
1. Improve employee work-related outcomes including workplace wellbeing and engagement
2. Reduce employee levels of stress, anxiety and improve mood

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/367421-Ethics_approval.pdf

Attachments [2]

/AnzctrAttachments/367421(v17-11-2014-21-37-49)-Utrecht Work Engagement Scale.docx

Attachments [3]

/AnzctrAttachments/367421-K10.docx

Attachments [4]

/AnzctrAttachments/367421-Usyd wellbeing & engagement questionnaire.docx

Contacts

Principal investigator

Name

Prof Nicholas Glozier

Address

Brain and Mind Centre
University of Sydney
94 Mallett Street
Camperdown
NSW 2050

Country

Australia

Phone

+61 2 9515 1596

Fax

nick.glozier@sydney.edu.au

Contact person for public queries

Name

Fiona Wolfenden

Address

Safety, Health and Wellbeing, Human Resources
Level 5, School of Information Technologies Building (J12)
The University of Sydney, NSW 2006

Country

Australia

Phone

+61 2 9351 4178

Fax

fiona.wolfenden@sydney.edu.au

Contact person for scientific queries

Name

Nicholas Glozier

Address

Brain and Mind Centre
University of Sydney
94 Mallett Street
Camperdown
NSW 2050

Country

Australia

Phone

+61 2 95151596

Fax

nick.glozier@sydney.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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