ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

24/11/2024

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]

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

Psychological Distress

Condition category

Condition code

Mental Health

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]

Behaviour

Intervention code [2]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Change in Psychological Distress as measured by the The Kessler Psychological Distress Scale (K6+1)

Timepoint [1]

K6+1 Assessments will happen
1. Immediately pre-program
2. Immediately post-program
3. 2 month follow-up.

Primary outcome [2]

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]

1. Immediately pre-program
2. Immediately post-program
3. 2 month follow-up.

Primary outcome [3]

Changes in self esteem as measured by The Rosenberg Self-esteem Scale

Timepoint [3]

1. Immediately pre-program
2. Immediately post-program
3. 2 month follow-up.

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2478 - Ballina

Recruitment postcode(s) [2]

2480 - Lismore

Recruitment postcode(s) [3]

2477 - Alstonville

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

North Coast Primary Health Network

Address [1]

106/108 Tamar St,
Ballina NSW 2478

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

AH&MRC ETHICS COMMITTEE

Ethics committee address [1]

Level 3, 
66 Wentworth Ave
Surry Hills, NSW, 2010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

30/08/2017

Ethics approval number [1]

1246/17

Ethics committee name [2]

Charles Sturt University Human Research Ethics Committee

Ethics committee address [2]

OFFICE OF GOVERNANCE AND CORPORATE AFFAIRS GOVERNANCE SERVICES
Private Mail Bag 29 
Panorama Avenue 
Bathurst NSW 2795

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

15/11/2017

Ethics approval number [2]

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

Prof James Bennett-Levy

Address

University Centre for Rural Health
61 Uralba St,
Lismore NSW 2480

Country

Australia

Phone

+61 2 6620 7570

Fax

james.bl@sydney.edu.au

Contact person for public queries

Name

James Bennett-Levy

Address

University Centre for Rural Health
61 Uralba St,
Lismore NSW 2480

Country

Australia

Phone

+61 2 6620 7570

Fax

james.bl@sydney.edu.au

Contact person for scientific queries

Name

James Bennett-Levy

Address

University Centre for Rural Health
61 Uralba St,
Lismore NSW 2480

Country

Australia

Phone

+61 2 6620 7570

Fax

james.bl@sydney.edu.au

Data sharing statement

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

No/undecided IPD sharing reason/comment

Protect privacy of individuals

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
695	Ethical approval					374128-(Uploaded-11-12-2018-16-08-32)-Study-related document.pdf
696	Ethical 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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically