Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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] 288505 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological distress 293499 0
Work engagement 293500 0
Condition category
Condition code
Mental Health 293778 293778 0 0
Other mental health disorders
Mental Health 293779 293779 0 0
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] 290596 0
Treatment: Other
Comparator / control treatment
Waitlist control group over a 6 week period.
Control group
Active

Outcomes
Primary outcome [1] 293579 0
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] 293579 0
6 weeks after the commencement of the intervention.
Primary outcome [2] 293580 0
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] 293580 0
6 weeks after the commencement of the intervention.
Secondary outcome [1] 320450 0
N/A
Timepoint [1] 320450 0
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
60
Accrual to date
Final
53
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 8932 0
2006 - The University Of Sydney

Funding & Sponsors
Funding source category [1] 290264 0
University
Name [1] 290264 0
University of Sydney
Country [1] 290264 0
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] 291559 0
None
Name [1] 291559 0
na
Address [1] 291559 0
NA
Country [1] 291559 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291960 0
Human Research Ethics Committee, University of Sydney
Ethics committee address [1] 291960 0
Ethics committee country [1] 291960 0
Australia
Date submitted for ethics approval [1] 291960 0
Approval date [1] 291960 0
09/09/2014
Ethics approval number [1] 291960 0
2014/649

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 241 241 0 0
/AnzctrAttachments/367421-Ethics_approval.pdf
Attachments [2] 242 242 0 0
/AnzctrAttachments/367421(v17-11-2014-21-37-49)-Utrecht Work Engagement Scale.docx
Attachments [3] 243 243 0 0
/AnzctrAttachments/367421-K10.docx
Attachments [4] 244 244 0 0
/AnzctrAttachments/367421-Usyd wellbeing & engagement questionnaire.docx

Contacts
Principal investigator
Name 52742 0
Prof Nicholas Glozier
Address 52742 0
Brain and Mind Centre
University of Sydney
94 Mallett Street
Camperdown
NSW 2050
Country 52742 0
Australia
Phone 52742 0
+61 2 9515 1596
Fax 52742 0
Email 52742 0
[email protected]
Contact person for public queries
Name 52743 0
Fiona Wolfenden
Address 52743 0
Safety, Health and Wellbeing, Human Resources
Level 5, School of Information Technologies Building (J12)
The University of Sydney, NSW 2006
Country 52743 0
Australia
Phone 52743 0
+61 2 9351 4178
Fax 52743 0
Email 52743 0
[email protected]
Contact person for scientific queries
Name 52744 0
Nicholas Glozier
Address 52744 0
Brain and Mind Centre
University of Sydney
94 Mallett Street
Camperdown
NSW 2050
Country 52744 0
Australia
Phone 52744 0
+61 2 95151596
Fax 52744 0
Email 52744 0
[email protected]

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.