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Trial registered on ANZCTR


Registration number
ACTRN12617001479392
Ethics application status
Approved
Date submitted
16/10/2017
Date registered
19/10/2017
Date last updated
7/05/2019
Date data sharing statement initially provided
7/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Mindful Self-Care and Resiliency (MSCR): A pilot trial of a brief mindfulness intervention to promote occupational resilience in rural general practitioners
Scientific title
Mindful Self-Care and Resiliency (MSCR): A pilot trial of a brief mindfulness intervention to promote occupational resilience in rural general practitioners
Secondary ID [1] 293139 0
Nil
Universal Trial Number (UTN)
U1111-1203-7779
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
burnout 305113 0
stress 305114 0
Condition category
Condition code
Mental Health 304435 304435 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 304447 304447 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mindful Self-Care and Resiliency Intervention is a brief psychosocial intervention that integrates key principles and practices of mindfulness-based therapy with compassion fatigue prevention education. The program was developed by researchers from Curtin University based on principles from Gentry and colleagues (1998) and Segal and colleagues (2002). The MSCR intervention consists of a full-day educational workshop divided into four sessions of about 1.5 hours each. This is followed by three sessions (one session per week) over the next 3-week period. These sessions will be 1.5 hours in duration and provided in-person. All intervention groups will be facilitated by a clinical psychologist with extensive experience in running the intervention. A train-the-trainer model will be utilised whereby the facilitator will then provide a training session to the designated trainer who will then sit in on an entire intervention group. A central aim of the five mindfulness sessions (Session themes: Autopilot, Staying Present; Allowing / Letting Be; Thoughts as Thoughts; Review) is to learn mindfulness-based skills and practices to support Compassion Fatigue resiliency. Mindfulness sessions are adapted from an abbreviated protocol described by MacKenzie et al. (2006), based on Segal et al. (2002). Both formal (e.g., body and breath; body scan; mindful movement and stretching; sitting with the breath, body and thoughts) and informal practices (e.g., breathing space, mindful eating) as described by Williams and Penman (2011) will be included (about 10 to 25 minutes duration), and assigned as home-based practice exercises using a CD where applicable.
Intervention code [1] 299392 0
Prevention
Intervention code [2] 299400 0
Behaviour
Comparator / control treatment
No control comparison group (open trial).
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303666 0
Burnout. Burnout will be assessed using the Short Burnout Measure (2005) - a short ten-item version of the widely used 21 item scale. Data from 2 national samples (Israeli Jewish and Arab) and 3 occupational samples attest to the validity and reliability of the BMS.
Timepoint [1] 303666 0
Pre, post (primary timepoint), one-month, six month and 12 month follow-up
Primary outcome [2] 303667 0
Stress. Stress will be measured using the Depression and Anxiety Stress Scale (DASS-21). This measure is widely used and well validated.
Timepoint [2] 303667 0
Pre, post (primary timepoint), one-month, six month and 12 month follow-up
Primary outcome [3] 303668 0
Resilience. Resilience will be measured he Connor-Davidson Resilience Scale [CD-RISC10] short form of the original 25-item tool developed as a survey based measure of stress, coping ability or resilience. A 5-point response scale asks participants to rate how much they feel a series of statements applied to them over the previous month. Higher scores reflect greater resilience.
Timepoint [3] 303668 0
Pre, post (primary timepoint), one-month, six month and 12 month follow-up
Secondary outcome [1] 339815 0
Compassion satisfaction will be measured using the Compassion satisfaction sub-scale of the The Professional Quality of Life Scale version 5 [ProQol5]
Timepoint [1] 339815 0
Pre, post, one-month, three-month and 6 month follow-up
Secondary outcome [2] 339816 0
Well-being will be measured using the WHO (Five) Well-being Index - a short instrument measuring subjective quality of life based on positive mood, vitality and general interest.
Timepoint [2] 339816 0
Pre, post, one-month, three-month and 6 month follow-up

Eligibility
Key inclusion criteria
General Practitioners working in either a full-time or part-time capacity within the health services of Emerald Queensland
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Not applicable

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/05/2018
Actual
1/05/2018
Date of last participant enrolment
Anticipated
3/06/2019
Actual
1/08/2018
Date of last data collection
Anticipated
2/12/2019
Actual
1/10/2018
Sample size
Target
60
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 297765 0
Government body
Name [1] 297765 0
Central Queensland Hospital and Health Service
Country [1] 297765 0
Australia
Primary sponsor type
University
Name
Central Queensland University
Address
Bruce Hwy, Rockhampton City QLD 4702
Country
Australia
Secondary sponsor category [1] 296804 0
None
Name [1] 296804 0
Address [1] 296804 0
Country [1] 296804 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298827 0
Central Queensland University Ethics Committee
Ethics committee address [1] 298827 0
Ethics committee country [1] 298827 0
Australia
Date submitted for ethics approval [1] 298827 0
01/11/2017
Approval date [1] 298827 0
06/12/2017
Ethics approval number [1] 298827 0

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

Contacts
Principal investigator
Name 78362 0
Prof Desley Hegney
Address 78362 0
Central Queensland University, Building/Level 21, 160 Ann Street, Brisbane, Qld., 4000
Country 78362 0
Australia
Phone 78362 0
+61 7 30234286
Fax 78362 0
Email 78362 0
[email protected]
Contact person for public queries
Name 78363 0
Desley Hegney
Address 78363 0
Central Queensland University, Building/Level 21, 160 Ann Street, Brisbane, Qld., 4000
Country 78363 0
Australia
Phone 78363 0
+61 7 30234286
Fax 78363 0
Email 78363 0
[email protected]
Contact person for scientific queries
Name 78364 0
Clare Rees
Address 78364 0
Curtin University, Kent Street, Bentley, Perth, WA 6845
Country 78364 0
Australia
Phone 78364 0
+61 8 9266 3442
Fax 78364 0
Email 78364 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This was not something that the participants consented to on the ethics consent form


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1284Study protocol    https://bmjopen.bmj.com/content/8/6/e021027 373826-(Uploaded-04-02-2019-16-45-02)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMindful Self-Care and Resiliency (MSCR): Protocol for a pilot trial of a brief mindfulness intervention to promote occupational resilience in rural general practitioners.2018https://dx.doi.org/10.1136/bmjopen-2017-021027
N.B. These documents automatically identified may not have been verified by the study sponsor.