ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

U1111-1203-7779

Trial acronym

Linked study record

Health condition

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

burnout

stress

Condition category

Condition code

Mental Health

Studies of normal psychology, cognitive function and behaviour

Public Health

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]

Prevention

Intervention code [2]

Behaviour

Comparator / control treatment

No control comparison group (open trial).

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Pre, post (primary timepoint), one-month, six month and 12 month follow-up

Primary outcome [2]

Stress. Stress will be measured using the Depression and Anxiety Stress Scale (DASS-21). This measure is widely used and well validated.

Timepoint [2]

Pre, post (primary timepoint), one-month, six month and 12 month follow-up

Primary outcome [3]

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]

Pre, post (primary timepoint), one-month, six month and 12 month follow-up

Secondary outcome [1]

Compassion satisfaction will be measured using the Compassion satisfaction sub-scale of the The Professional Quality of Life Scale version 5 [ProQol5]

Timepoint [1]

Pre, post, one-month, three-month and 6 month follow-up

Secondary outcome [2]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Central Queensland Hospital and Health Service

Address [1]

33 Charlotte Street
Brisbane Queensland 4000 Australia

Country [1]

Australia

Primary sponsor type

University

Name

Central Queensland University

Address

Bruce Hwy, Rockhampton City QLD 4702

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Queensland University Ethics Committee

Ethics committee address [1]

Bruce Hwy, Rockhampton City QLD 4702

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/11/2017

Approval date [1]

06/12/2017

Ethics approval number [1]

Summary

Brief summary

The aim of this research trial is to investigate whether the Mindful Selfcare and Resiliency intervention is effective in reducing burnout, secondary traumatic stress, and symptoms of general psychological distress in General Practitioners working in a rural health service in Queensland, Australia. Secondary aims are to determine whether the intervention increases protective factors for occupational stress, including compassion satisfaction, self-compassion and resilience. 
Our primary hypothesis is that GPs completing the MSCR intervention will show significant reductions in symptoms of burnout, secondary traumatic stress and general psychological distress from pre to post intervention and from pre intervention to follow-up. A secondary hypothesis is that GPs completing the MSCR intervention would show significant improvements in compassion satisfaction, self-compassion and resilience from pre-post intervention and from pre-intervention to follow-up.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Desley Hegney

Address

Central Queensland University, Building/Level 21, 160 Ann Street, Brisbane, Qld., 4000

Country

Australia

Phone

+61 7 30234286

Fax

d.hegney@cqu.edu.au

Contact person for public queries

Name

Desley Hegney

Address

Central Queensland University, Building/Level 21, 160 Ann Street, Brisbane, Qld., 4000

Country

Australia

Phone

+61 7 30234286

Fax

d.hegney@cqu.edu.au

Contact person for scientific queries

Name

Clare Rees

Address

Curtin University, Kent Street, Bentley, Perth, WA 6845

Country

Australia

Phone

+61 8 9266 3442

Fax

c.rees@curtin.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
1284	Study 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

Source	Title	Year of Publication	DOI
Embase	Mindful Self-Care and Resiliency (MSCR): Protocol for a pilot trial of a brief mindfulness intervention to promote occupational resilience in rural general practitioners.	2018	https://dx.doi.org/10.1136/bmjopen-2017-021027

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically