Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000989246
Ethics application status
Approved
Date submitted
8/06/2018
Date registered
13/06/2018
Date last updated
5/02/2020
Date data sharing statement initially provided
30/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the utility of Compassionate Mind Training for ex-service personnel and their partners
Scientific title
Investigating the effect of Compassionate Mind Training for ex-service personnel and their partners on psychological distress, PTSD symptom severity, and relationship satisfaction.
Secondary ID [1] 295140 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-Traumatic Stress Disorder 308239 0
Depression 308304 0
Anxiety 308305 0
Stress 308306 0
Condition category
Condition code
Mental Health 307265 307265 0 0
Anxiety
Mental Health 307308 307308 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Compassionate Mind Training (CMT)

The intervention is Compassionate Mind Training which will be delivered in 2x 2hr weekly sessions for 6 weeks (a total of 12 2hr sessions). The intervention will be delivered 4 times during the period of August - December 2018 (a total of 40 participants). The mode of delivery will be face-to-face in a group setting with 10 participants in each group (5 ex-service personnel and 5 partners). The intervention will be delivered at Greenslopes Private Hospital, Newdegate Street, Greenslopes 4120.

The training will be facilitated by two clinical psychologists who are trained in the delivery of CMT. One clinical psychologist has 5 years of experience and the other clinical psychologist has 23 years of experience as a psychologist.

The CMT will cover topics such as:
Mindfulness and focused attention
Soothing rhythm breathing (SRB
Creating a safe place
Compassion focused imagery
Compassion as a flow
Developing the compassionate self
Developing an ideal compassionate other
Our different parts
Engaging with self-criticism using the compassionate self
Managing difficult emotions such as guilt and shame
Developing compassionate assertive communication skills

Each 2 hour CMT session will include:
5 minutes of mindfulness, 10 minutes of homework review, 45 minutes education lecture on the relevant topic, 45 minutes of practical exercises and discussion, 15 minutes of homework setting and wrap up.

The intervention is a standardised psychological treatment program and will not be changed, personalised or adapted to the particular group of participants. Its fidelity/adherence will not be assessed for this pilot study.
Intervention code [1] 301480 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306218 0
Change in psychological distress as measured by the "Depression Anxiety and Stress Scales-21" (DASS-21).
Timepoint [1] 306218 0
Baseline, 6 weeks (primary timepoint), and 12 weeks after intervention commencement
Primary outcome [2] 306219 0
Change in PTSD severity as measured by the "PTSD Checklist for DSM-V"
Timepoint [2] 306219 0
Baseline, 6 weeks (primary timepoint), and 12 weeks after intervention commencement
Primary outcome [3] 306220 0
Change in relationship satisfaction as measured by the "Relationship Assessment Scale"
Timepoint [3] 306220 0
Baseline, 6 weeks (primary timepoint), and 12 weeks after intervention commencement
Secondary outcome [1] 347906 0
Change in fear of compassion as measured by the "Fears of Compassion Scales"
Timepoint [1] 347906 0
Baseline, 6 weeks, and 12 weeks after intervention commencement
Secondary outcome [2] 347907 0
Change in quality of life as measured by the "Quality of Life Enjoyment and Satisfaction Questionnaire"
Timepoint [2] 347907 0
Baseline, 6 weeks, and 12 weeks after intervention commencement
Secondary outcome [3] 347908 0
Change in self-criticism as measured by the "Forms of Self-criticising/Attacking and Self-Reassuring Scale" and the "Depressive Experiences Questionnaire - Self-Criticism subscale"
Timepoint [3] 347908 0
Baseline, 6 weeks, and 12 weeks after intervention commencement
Secondary outcome [4] 347909 0
Change in social safeness as measured by the "Social Safeness and Pleasure Scale"
Timepoint [4] 347909 0
Baseline, 6 weeks, and 12 weeks after intervention commencement

Eligibility
Key inclusion criteria
• Ex-service personnel with a current partner
• Both ex-service personnel and partner able to commit to twice weekly attendance for 6 weeks
• Diagnosis of PTSD (ex-service personnel only)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Ex-service personnel or partner currently hospitalised as an in-patient for a psychological condition
• Ex-service personnel or partner currently engaged in another group therapy program
• Ex-service personnel or partner is unable to commit to twice weekly attendance for 6 weeks

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Efficacy
Statistical methods / analysis
Sample size determination
To ensure adequate statistical power (as calculated with G Power analysis; ß = .80, a = .05) approximately 40 participants will be recruited.

Data Analyses
Analyses will be conducted using the IBM Statistical Package for the Social Sciences (SPSS) version 24 (IBM Corp, 2016), and R (R Core Team, 2017). Prior to conducting the planned analyses, data will be screened for missing values, data entry errors, outliers, and violations of assumptions. Frequencies, descriptive statistics (e.g., means, standard deviations, skewness and kurtosis) and graphs of each variable will be produced to screen for data entry errors, outliers and relevant analyses’ assumptions such as normality. Following data screening and cleaning, frequencies and descriptive statistics of demographic and military service information variables will be conducted to enable thorough description of the sample.

One-way repeated measures analysis of variances (ANOVA) with post-hoc analysis will be conducted to compare participants’ scores on outcome measures across data collection time points. ANOVA assumptions will be checked prior to running analyses. Findings from this analysis may establish if 12 sessions of CMT has led to a significant change in outcomes (e.g., compassion, psychological symptoms, relationship satisfaction) and if these changes are maintained over time. Pearson’s correlations may also be conducted to examine the relationships between key outcome variables (e.g., identify if an increase in compassion is associated with a decrease in depression symptom severity).

To mitigate potential bias, the clinical psychologists who will be facilitating the CMT sessions will not be involved in data analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/07/2018
Actual
12/07/2018
Date of last participant enrolment
Anticipated
22/02/2019
Actual
13/08/2019
Date of last data collection
Anticipated
31/01/2020
Actual
2/01/2020
Sample size
Target
40
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11107 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [2] 11108 0
Toowong Private Hospital - Toowong
Recruitment postcode(s) [1] 22920 0
4120 - Greenslopes
Recruitment postcode(s) [2] 22921 0
4066 - Toowong

Funding & Sponsors
Funding source category [1] 299732 0
Commercial sector/Industry
Name [1] 299732 0
Medibank Health and Wellbeing Fund
Country [1] 299732 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Gallipoli Medical Research Foundation
Address
Greenslopes Private Hospital
Newdegate Street Greenslopes QLD 4120
Country
Australia
Secondary sponsor category [1] 299067 0
None
Name [1] 299067 0
Address [1] 299067 0
Country [1] 299067 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300622 0
Departments of Defence and Veterans' Affairs Human Research Ethics Committee
Ethics committee address [1] 300622 0
Ethics committee country [1] 300622 0
Australia
Date submitted for ethics approval [1] 300622 0
19/03/2018
Approval date [1] 300622 0
01/06/2018
Ethics approval number [1] 300622 0
046-18
Ethics committee name [2] 304457 0
Ramsay Health Care QLD HREC
Ethics committee address [2] 304457 0
Ethics committee country [2] 304457 0
Australia
Date submitted for ethics approval [2] 304457 0
12/06/2018
Approval date [2] 304457 0
21/06/2018
Ethics approval number [2] 304457 0
18/33

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

Contacts
Principal investigator
Name 84246 0
Dr Madeline Romaniuk
Address 84246 0
Gallipoli Medical Research Foundation
Greenslopes Private Hospital
Newdegate Street, Greenslopes
QLD 4120
Country 84246 0
Australia
Phone 84246 0
+61, 07, 33947578
Fax 84246 0
Email 84246 0
[email protected]
Contact person for public queries
Name 84247 0
Madeline Romaniuk
Address 84247 0
Gallipoli Medical Research Foundation
Greenslopes Private Hospital
Newdegate Street, Greenslopes
QLD 4120
Country 84247 0
Australia
Phone 84247 0
+61, 07, 33947578
Fax 84247 0
Email 84247 0
[email protected]
Contact person for scientific queries
Name 84248 0
Madeline Romaniuk
Address 84248 0
Gallipoli Medical Research Foundation
Greenslopes Private Hospital
Newdegate Street, Greenslopes
QLD 4120
Country 84248 0
Australia
Phone 84248 0
+61, 07, 33947578
Fax 84248 0
Email 84248 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
Due to confidentiality and ethical reasons we will not be making individual participant data available.


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.