Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000574549
Ethics application status
Approved
Date submitted
9/04/2015
Date registered
3/06/2015
Date last updated
28/11/2018
Date data sharing statement initially provided
28/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Resilience at Work (RAW) Mindfulness Program: The development and evaluation of an online mindfulness based training program aimed at enhancing psychological resilience and wellbeing among Emergency Workers
Scientific title
The Resilience at Work (RAW) Mindfulness Program. Evaluating the efficacy of an online mindfulness based cognitive therapy program aimed at enhancing psychological resilience and well-being among Emergency Workers.
Secondary ID [1] 286465 0
None
Universal Trial Number (UTN)
U1111-1168-9466
Trial acronym
RAW Mindfulness Program
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological resilience 294653 0
general well-being 294901 0
psychological symptoms of stress 294902 0
psychological symptoms of anxiety 294903 0
psychological symptoms of depression 294904 0
psychological symptoms associated with post traumatic stress 294905 0
alcohol usage 294906 0
Condition category
Condition code
Mental Health 294952 294952 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 294953 294953 0 0
Anxiety
Mental Health 294954 294954 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves a 6-8 week online mindfulness-based resilience program for emergency workers. The intervention will be delivered via IPADs and comprises 6 interactive online modules running for about 20 minutes each. Each week a new module will be made available online to participants. They will have the opportunity to opt-in for text-message reminders or email reminders to practice the skills in the program. The program will provide participants with quick access to a range of adaptive skills, which could enhance their ability to manage stress and cope with trauma more effectively. These core skills are derived from the principles underpinning a number of evidence based cognitive therapies including Acceptance and Commitment Therapy (ACT), Compassion focused Therapy (CFT) mindfulness based Cognitive Therapy (mBCT) and Mindfulness based Stress Reduction (MBSR). Adherence to the program will be assessed by the sum total number of sessions completed by each participant. This information will be collected by the backend IT programming system.
Intervention code [1] 291550 0
Prevention
Comparator / control treatment
The control treatment will involve providing control participants with online information regarding psychological health and well-being. This information will be delivered via IPAD.
Access to this resource is unlimited for the study duration. The online information will included basic mental health information on the following topics :

what is psychological health and well-being
Tips on looking after your psychological well-being
What is stress
Where to get more information
Who can help you to improve your psychological health and well-being
Control group
Active

Outcomes
Primary outcome [1] 294705 0
The primary outcome of this intervention is psychological resilience as measured by the Connors-Davidson Resilience Scale (CDRISC-10). Primary outcome 1 : Difference between intervention group and control group on the CDRISC-10 immediately post intervention and at 6-month follow-up..
Timepoint [1] 294705 0
While resilience outcomes will be measured at baseline, immediately post intervention and at 6 month follow-up, the primary time point will be immediately post intervention
Primary outcome [2] 294706 0
The second primary outcome is bounce-back resilience as measured by the Brief Resilience Scale (BRS) (Smith et al., 2008).
Timepoint [2] 294706 0
While resilience outcomes will be measured at baseline, immediately post intervention and at 6 month follow-up, the primary time point will be immediately post intervention
Secondary outcome [1] 313897 0
General well-being as measured by The WHO (Five) Well Being Index ( Bech P, Olsen LR, Kjoller M. Measuring well-being rather than the absence of distress symptoms: a comparison of the SF-36 Mental Health subscale and the WHO-Five Well-Being Scale. International Journal of Methods in Psychiatric Research. 2003; 12: 85–91.)
Timepoint [1] 313897 0
Time point: baseline, immediately post intervention and at 6 month follow up.
Secondary outcome [2] 314339 0
Psychological symptoms associated with Depression and Anxiety as measured by the Hospital Anxiety and Depression Scale (HADS). (Zigmond, A. S.; Snaith, R. P.. The hospital Anxiety and Depression Scale, Acta Psychiatrica Scandinavica, Vol 67(6), Jun 1983, 361-370).
Timepoint [2] 314339 0
baseline, immediately post intervention and at 6 month follow up.
Secondary outcome [3] 314340 0
Trauma outcomes including symptoms of post traumatic stress and post traumatic growth as measured by:
The Posttraumatic Stress Disorder Checklist for DSM V(PCL-5) (Weathers, F.W., Litz, B.T., Keane, T.M., Palmieri, P.A., Marx, B.P., & Schnurr, P.P. (2013). The PTSD Checklist for DSM-5 (PCL-5).
Trauma outcomes will also be measured by the Posttraumatic Growth Inventory (PTGI), (Cann, A., Calhoun, L. G., Tedeschi, R.G., et al., (2010) 'A short form of the Posttraumatic Growth Inventory', Anxiety, Stress & Coping, 23: 2, 127 — 137).
Timepoint [3] 314340 0
baseline, immediately post intervention and at 6 month follow up.
Secondary outcome [4] 314341 0
Alcohol usage as measured by The Alcohol Use Disorders Identification Test (AUDIT-C) (Bush, K., Kivlahan, D.R.,McDonell, M.B., et al., (1998). The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Alcohol Use Disorders Identification Test. Archives of International Med. 14;158(16):1789-95).
Timepoint [4] 314341 0
baseline, immediately post intervention and at 6 month follow up
Secondary outcome [5] 314923 0
Rumination and worry as measured by the Cognitive Fusion Questionnaire (CFQ) (Gillanders, D.T., Bolderston, H., Bond, F.W., et al., (2014). The Development and Initial Validation of the Cognitive Fusion Questionnaire. Behavior Therapy, 45 : 83 – 101.)
Timepoint [5] 314923 0
baseline, immediately post intervention and at 6 month follow up.
Secondary outcome [6] 314924 0
Perceived stress as measured by the Perceived Stress Scale (PSS) (Cohen, S., & Williamson, G. (1988). Perceived stress in a probability sample of the U.S. In S. Spacapam & S. Oskamp (Eds.), The social psychology of health: Claremont Symposium on Applied Social Psychology. Newbury Park, CA: Sage.)
Timepoint [6] 314924 0
baseline, immediately post intervention and at 6 month follow up.
Secondary outcome [7] 334665 0
Longer term changes to resilience as measured by the CDRISC-10 and BRS
Timepoint [7] 334665 0
6 months

Eligibility
Key inclusion criteria
Inclusion criteria
-Participant is currently employed as a permanent firefighter within FRNSW
-Participant is permanently based at a Primary Rescue Station
-Participant is not currently engaged in any regular individual psychological therapy i.e., weekly or fortnightly sessions with a Psychologist and/or Psychiatrist
-Good English comprehension
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- inability to provide informed consent

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
24 Fire stations will be randomly allocated to either an Intervention Group or Control Group. Allocation will not be concealed. Firefighters in each of the 24 station will be notified about the Resilience Program study in a brief introduction letter that will be circulated via email 3 weeks prior to recruitment. The letter will also invite participants to attend an information presentation about the program and the study which will be delivered by the Station's Peer Support Officer. The letter will stipulate that attendance at this introductory presentation and participation in the study is completely voluntary. The Peer Support System within the NSW Fire and Rescue is a successful and long running non-hierarchical support service for firefighters. During the presentation, the PEER support officer will reiterate that participation in the research is voluntary. Following this introductory presentation, male and female firefighters within the station will be given the opportunity to opt-in to participating in the study. Those firefighters who opt-in to participating in the study will then be provided with the Participant Information Sheet and Consent Form. The Participant Information Sheet will outline the aims of the study and will highlight that participation in the research study is entirely voluntary and that they will be able to receive the training at a later date without participating in the evaluation. The information sheet will also highlight that withdrawal from the study is possible at any time and under no circumstances will it incur any consequences from management at NSW Fire and Rescue.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The SAS "Registered Trademark" random number generator will be utilised to randomly assign fire stations to either the intervention group or the control group.
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 statistical software package STATA was utilised to perform a power calculation in order to establish the number of participants required to achieve this study's objectives.
The primary outcome of interest in this study is level of psychological resilience as measured by both the Connors-Davidson Resilience Scale (CDRS) and Brief Resilience Scale (BRS). Previous research has reported baseline levels of resilience as measured by the CDRS in similar trials to be 67.7 out of 100 with an increase of about 1 standard deviation (10 points) observed with resilience interventions (Steinhardt & Dolbier, 2008). Any increase in resilience of greater than 0.5 standard deviation in the intervention group would be considered a meaningful and clinically important effect. As the intervention is being delivered in fire stations, the potential clustering of resilience/psychological factors within fire stations needs to be accounted for in the power calculations. Pilot data collection has shown that we should be able to recruit at least 6 firefighters from each station will agree to be part of this study. Based on an average of 67.7 on the CDRS resilience scale and an intracluster correlation coefficient of 0.01, a total of 24 fire stations (clusters) including 144 firefighters would need to be recruited to this study to achieve 0.8 power of detecting a 5 point (0.5 standard deviation) improvement in the Connors-Davidson Resilience Scale (CDRS)with an alpha of 0.05 (two sided).

The statistical analysis for this project will be conducted using the statistical software package STATA. The RCT data will be analysed using both intention to treat analysis (ITT) and per protocol analysis. The primary outcome in both analyses will be a comparison of the resilience levels between the intervention group and the control. The per protocol analysis will also be contacted to examine the effect of completing different amounts of the intervention program.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2015
Actual
1/11/2015
Date of last participant enrolment
Anticipated
Actual
27/04/2016
Date of last data collection
Anticipated
12/05/2017
Actual
30/05/2017
Sample size
Target
144
Accrual to date
Final
143
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 291061 0
Government body
Name [1] 291061 0
New South Wales Health
Country [1] 291061 0
Australia
Primary sponsor type
Individual
Name
A/Prof Samuel Harvey
Address
School of Psychiatry
Faculty of Medicine
University of New South Wales
The Black Dog Institute
Hospital Road
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 289744 0
None
Name [1] 289744 0
Address [1] 289744 0
Country [1] 289744 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292647 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 292647 0
Ethics committee country [1] 292647 0
Australia
Date submitted for ethics approval [1] 292647 0
30/04/2015
Approval date [1] 292647 0
30/06/2015
Ethics approval number [1] 292647 0
HC15300

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56242 0
A/Prof Samuel Harvey
Address 56242 0
Workplace Mental Health Team School of Psychiatry Faculty of Medicine UNSW The Black Dog Institute Hospital Road, Randwick NSW 2031
Country 56242 0
Australia
Phone 56242 0
+612 9382 8356
Fax 56242 0
Email 56242 0
[email protected]
Contact person for public queries
Name 56243 0
Sadhbh Joyce
Address 56243 0
Psychologist/PhD Candidate
Workplace Mental Health Team
School of Psychiatry
Faculty of Medicine
UNSW
The Black Dog Institute
Hospital Road, Randwick NSW 2031
Country 56243 0
Australia
Phone 56243 0
+61401297711
Fax 56243 0
Email 56243 0
[email protected]
Contact person for scientific queries
Name 56244 0
Sadhbh Joyce
Address 56244 0
Psychologist/PhD Candidate
Workplace Mental Health Team
School of Psychiatry
Faculty of Medicine
UNSW
The Black Dog Institute
Hospital Road, Randwick NSW 2031
Country 56244 0
Australia
Phone 56244 0
+61401297711
Fax 56244 0
Email 56244 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.