Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
ACTRN12618000008224
Ethics application status
Approved
Date submitted
7/12/2017
Date registered
10/01/2018
Date last updated
4/08/2022
Date data sharing statement initially provided
11/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Adapting Compassion Focused Therapy for Groups with Aboriginal and Torres Strait Islander Clients
Scientific title
A Pilot Study to Evaluate the Impact of Adapted Compassion Focused Therapy on Psychological Distress in Aboriginal and Torres Strait Islander Groups from 3 Different Services
Secondary ID [1] 293552 0
Nil known
Universal Trial Number (UTN)
U1111-1206-2676
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social and Emotional Wellbeing 305770 0
Psychological Distress 305778 0
Condition category
Condition code
Mental Health 304994 304994 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will take the form of a Compassion Focused Therapy (CFT) group based intervention to be know as “The Arts-based Compassion Skills program”, modeled on the work of Paul Gilbert, founder of CFT, Russell Kolts (author of CFT Made Simple) and the Centre for Clinical Interventions (WA) Building Self-Compassion program (modelled on CFT and the work of Kristin Neff, a leading researcher in the area). The total length of the groups will be approximately 18-24 hours. The length and frequency of each session will vary according to the group's specific needs e.g. at the Namatjira Drug and Alcohol Rehabilitation Centre, following feedback from the Learning Circle of Aboriginal staff we have found that 2 sessions/week over 3-4 weeks (up to 8x3hrs each) has worked better than 8 sessions spread over 8 weeks due to rapid turnover of clients. In other contexts (e.g. community groups), it may be that the 8 x 3 hr sessions over 8 weeks works best. Within these parameters, the length and frequency of sessions is agreed with each service, but and totals around 18-24hrs across 5-8 sessions.
Based on feedback from the Aboriginal health professionals group and the Advisory Group, we shall be making the following adaptations from standard protocols for CFT:
1. The program will be focused more broadly on self-care, not just self-compassion (e.g. engaging in self-appreciation, gratitude practices, savoring experience etc.)
2. It makes more use of art and music than standard CFT
3. It makes less use of written materials e.g. forms, writing tasks

Either Natalie Roxburgh or James Bennett-Levy (clinical psychologists) plus an Aboriginal group facilitator leads the sessions, assisted by Aboriginal health workers from the host organisations.

The key components of the program are:
1. Understanding Self-Compassion (e.g. what is it; Why is it important; Self-criticism vs. self-compassion. Why is it hard to be self-compassionate)
2. Barriers to Self-Compassion (e.g. positive beliefs about self-criticism; negative beliefs about self-compassion; kindness vs self-criticism experiment; compassion = courage)
3. Preparing for Self-Compassion (slowing down; soothing-rhythm breathing; attentional retraining; safe place imagery)
4. Compassionate Imagery via Arts Practice (giving compassion to another; creating an ideal compassionate image; building your own compassionate image, self-compassion break)
5. Self-Compassion Thinking (taking in the good, self-appreciation, savoring, gratitude,)
6. Self-Compassionate Behaviour (Taking care of ourselves - impact of the threat system e.g. avoidance, worry, procrastination, numbing through drugs/alcohol vs. engaging the caring/compassion system e.g. self-soothing activities; Taking care of others – acts of kindness, gratitude, appreciation)
7. Reviewing learning and planning for the future

The 5-8 sessions will comprise 1-7 above, with some adaptations and overlap across sessions.

The group-based interventions are conducted at either one of the three partnering organizations in the Northern Rivers region of NSW
o Namatjira Haven Drug and Alcohol Healing Centre - Alstonville
o Rekindling the Spirit - Lismore
o Bunjum Corporation - Ballina
Intervention code [1] 299797 0
Behaviour
Intervention code [2] 299887 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304160 0
Change in Psychological Distress as measured by the The Kessler Psychological Distress Scale (K6+1)
Timepoint [1] 304160 0
K6+1 Assessments will happen
1. Immediately pre-program
2. Immediately post-program
3. 2 month follow-up.
Primary outcome [2] 304161 0
Changes in Care and Compassion as measured by the the Care and Compassion Rating scale (CCRS) - a 3 item instrument developed by the researchers to measure the key outcome variables of care and compassion
Timepoint [2] 304161 0
1. Immediately pre-program
2. Immediately post-program
3. 2 month follow-up.
Primary outcome [3] 304162 0
Changes in self esteem as measured by The Rosenberg Self-esteem Scale
Timepoint [3] 304162 0
1. Immediately pre-program
2. Immediately post-program
3. 2 month follow-up.
Secondary outcome [1] 341124 0
Stacey Edwards was a university student who did the first qualitative interviews as part of her Masters thesis in 2017-18. Stacey interviewed 4 participants and 2 staff members in one of our sites - but not the other - in 2018.
Since early 2018, qualitative interviews have been conducted by an independent researcher (not Stacey). The semi-structured interviews are used to explore the participants’ subjective experience of CFT.
Timepoint [1] 341124 0
Within 4 months of completion of the program

Eligibility
Key inclusion criteria
Participants will be those Aboriginal clients of the three partnering organisations - Namatjira Haven Drug and Alcohol Rehab Centre, Bunjum Corporation and Rekindling the Spirit - who:
1. choose to be part of the groups
2. are referred as suitable by their services, and
3. who are assessed by the clinical psychologists/group leaders as being suitable (e.g. no serious mental illness, are suitable for group work etc.)

The groups will be be same sex groups due to the nature of the services and cultural appropriateness – Namatjira and Rekindling – all male;
Bunjum – all female or all male
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clients will not be included if they have serious mental illness (e.g. psychosis) or are actively suicidal, or are unlikely to function well in groups.

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
The study is considered a pilot study and sample size was determined based on the availability of potential participants. No statistical calculations were used.

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
22/01/2018
Actual
22/01/2018
Date of last participant enrolment
Anticipated
1/03/2023
Actual
30/01/2018
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
26
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 18254 0
2478 - Ballina
Recruitment postcode(s) [2] 18255 0
2480 - Lismore
Recruitment postcode(s) [3] 18256 0
2477 - Alstonville

Funding & Sponsors
Funding source category [1] 298166 0
Government body
Name [1] 298166 0
North Coast Primary Health Network
Country [1] 298166 0
Australia
Primary sponsor type
Government body
Name
North Coast Primary Health Network
Address
106/108 Tamar St,
Ballina NSW 2478
Country
Australia
Secondary sponsor category [1] 297258 0
None
Name [1] 297258 0
Address [1] 297258 0
Country [1] 297258 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299184 0
AH&MRC ETHICS COMMITTEE
Ethics committee address [1] 299184 0
Level 3,
66 Wentworth Ave
Surry Hills, NSW, 2010
Ethics committee country [1] 299184 0
Australia
Date submitted for ethics approval [1] 299184 0
Approval date [1] 299184 0
30/08/2017
Ethics approval number [1] 299184 0
1246/17
Ethics committee name [2] 299185 0
Charles Sturt University Human Research Ethics Committee
Ethics committee address [2] 299185 0
OFFICE OF GOVERNANCE AND CORPORATE AFFAIRS GOVERNANCE SERVICES
Private Mail Bag 29
Panorama Avenue
Bathurst NSW 2795
Ethics committee country [2] 299185 0
Australia
Date submitted for ethics approval [2] 299185 0
Approval date [2] 299185 0
15/11/2017
Ethics approval number [2] 299185 0
H17171

Summary
Brief summary
New approaches to enhancing Aboriginal and/or Torres Strait Islander mental health are clearly needed. This study aims to development of a culturally relevant and appropriate model of mental health that addresses some of the core issues of disconnection, disrupted attachments and trauma experienced by so many Aboriginal people. We propose adapting compassion-focused therapy (CFT) so that it is culturally appropriate for Aboriginal clients; and will evaluate its effectiveness. As such, this is a pilot study. Our aims are as follows:

1. To develop an Aboriginal-adapted culturally appropriate form of CFT, based initially on feedback from an Aboriginal health professional group. It is anticipated that there will be some further modifications as necessary over the course of the project.
2. To determine if this Aboriginal-adapted form of CFT is viewed as an acceptable and promising approach by Aboriginal health professionals and Aboriginal clients.
3. To conduct a preliminary evaluation of the impact of CFT within the constraints of the timeline, the service contexts, the absence of available control groups and an acceptable evaluation design that meets AHRMC and other ethical guidelines

The participants will be clients of three different services: Namatjira Drug and Alcohol Rehabilitation Centre, Bunjum Corporation and Rekindling the Spirit. Different groups will be held in each of the services for their respective clients.. The clients of Namatjira Haven are in the early stages of drug or alcohol rehabilitation and are in-patients; The clients of the other two services live in the community, and may or may not have current mental health problems.
People who are assessed as having severe mental health problems (e.g. psychosis, current suicidal ideation) will not be included in the groups.
Trial website
Trial related presentations / publications
Public notes
Below is a list of the questions included in the semi structured interviews to be conducted as part of the evaluation process:
1. Generally speaking, what was it like for you to be part in the group program, GARIMALEH WERLU NA (Taking Care of Yourself)?

2. What was your understanding of self-compassion prior to attending the group?
• How has this change as a result of attending the program?
• How did it feel to learn about a new way of relating to yourself?

3. Can you tell me if you found the program to be helpful or not?
• What were the most helpful aspects of the program? And why?
• What aspects of the program were most difficult? And why?

4. Did you feel safe within the program? Can you tell me what contributed to your feelings of safety/insecurity?

5. What if any changes have you experienced as a result of attending the program?
• How has attending the program changed your relationship with yourself? With others?
• What will you take away from your time in the program and continue to practice?

6. As an aboriginal person, can you comment on whether the program felt culturally appropriate/relevant?
• Were there any aspects of the program that were culturally inappropriate/insensitive?
• Were there any aspects of the program that you felt were handled particularly well?

7. Do you have any final comments about the program that you would like to share?

Contacts
Principal investigator
Name 79570 0
Prof James Bennett-Levy
Address 79570 0
University Centre for Rural Health
61 Uralba St,
Lismore NSW 2480
Country 79570 0
Australia
Phone 79570 0
+61 2 6620 7570
Fax 79570 0
Email 79570 0
[email protected]
Contact person for public queries
Name 79571 0
James Bennett-Levy
Address 79571 0
University Centre for Rural Health
61 Uralba St,
Lismore NSW 2480
Country 79571 0
Australia
Phone 79571 0
+61 2 6620 7570
Fax 79571 0
Email 79571 0
[email protected]
Contact person for scientific queries
Name 79572 0
James Bennett-Levy
Address 79572 0
University Centre for Rural Health
61 Uralba St,
Lismore NSW 2480
Country 79572 0
Australia
Phone 79572 0
+61 2 6620 7570
Fax 79572 0
Email 79572 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
Protect privacy of individuals


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
695Ethical approval    374128-(Uploaded-11-12-2018-16-08-32)-Study-related document.pdf
696Ethical approval    374128-(Uploaded-11-12-2018-16-09-24)-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
No additional documents have been identified.