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Trial registered on ANZCTR


Registration number
ACTRN12623000083695p
Ethics application status
Submitted, not yet approved
Date submitted
14/12/2022
Date registered
25/01/2023
Date last updated
25/01/2023
Date data sharing statement initially provided
25/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Indigenous Model of Mental Health Care: an exploratory study of the therapeutic benefit of Aboriginal tradition healing combined with a trans-diagnostic CBT program for treating depression
Scientific title
Indigenous Model of Mental Health Care: an exploratory study of the therapeutic benefit of Aboriginal tradition healing combined with a trans-diagnostic CBT program for treating depression in Indigenous adults
Secondary ID [1] 308617 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 328507 0
Anxiety 328579 0
Substance use disorder 328580 0
Condition category
Condition code
Mental Health 325534 325534 0 0
Depression
Mental Health 325535 325535 0 0
Anxiety
Mental Health 325595 325595 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be delivered by qualified clinical psychologists and Aboriginal Traditional Healers. Treatment will consist of 10 - 12 sessions of transdiagnostic cognitive behavioural therapy (CBT) combined with traditional healing approaches.

Trans-diagnostic CBT targets common cognitive, emotional, physiological, or interpersonal processes that underlie and maintain mental disorders, such as poor emotional regulation, behavioural and emotional avoidance and inflexible thinking. It uses a streamlined set of CBT techniques to target multiple problems based on an individual case formulation. For example, the approach can draw on activity scheduling and cognitive restructuring to manage depression, whilst also drawing on exposure to manage anxiety responses associated with trauma reactions.

Aboriginal traditional healing aims to support the physical, social and emotional wellbeing of people. The traditional healers approach healing by observing, listening and touching. With massage and rubbing they release “blockages” from the body and apply various herbal tinctures and ointments where required. There is an understanding that the spirit can become dislodged through trauma, causing mental and physical disorders. Traditional Healers bring the spirit back into place.

The first one or two sessions will involve the assessment by the psychologist of the cognitive and behavioural factors maintaining the disorder, and assessment by the traditional healer of the spiritual and wellbeing needs of the individual. These treatment sessions could last up to 90-minutes. The psychologist and traditional healer will then develop a tailored treatment plan, in consultation with the participant. Changes in symptomatology may warrant adjustments or changes to the treatment plan. 10 - 12 sessions will be provided.

Transdiagnositc CBT Intervention Schedule:

Week 1: Overall assessment this includes clinical history and history enough information for a clinical formulation
Week 2: Feedback to the client, Psychoeducation about CBT. Commencement of Behavioural Activation and/or Relaxation Strategies. These are incorporated into in-between session practice.
Week 3-5: Review of Practice and techniques, commencement of identifying links between thoughts, beliefs, emotions and behaviours.
Week 6-8: Challenging thoughts, beliefs and behaviours (‘traps’) that are unhelpful and impact on negative emotions that are linked to depression and anxiety. During this process the client will become increasingly skilled at in identifying these traps and modifying these him or herself. Behavioural activation and relaxation is continues both in session and in between sessions.
Week 9-10/12: Consolation of cognitive and behavioural techniques, Relapse management planning.

Traditional healing sessions will occur concurrently with the transdiagnostic CBT sessions, and may occur before or after the sessions with the psychologist, depending on each participant's therapeutic treatment plan. The exact details of the traditional healing sessions will depend on the participants' needs, as assessed by the Traditional Healer. As outline above, Traditional healing aims to release blockages through massage and traditional bush medicines, and return the spirit to its rightful place. This traditional approach to healing is immersed in Aboriginal ways of being and cannot easily be explained through the scientific framework Western understanding demands. Nevertheless, increasingly across Australia, Aboriginal Traditional Healers are working alongside western doctors and other health professional to care for Aboriginal and Torres Strait Islander people.

Intervention code [1] 325064 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333375 0
Changes in depression scores as measured by the Beck Depression Inventory-II from baseline to end-of-treatment (approximately 3 months).
Timepoint [1] 333375 0
Baseline and end of treatment (10 - 12 weeks post commencement of the intervention)
Secondary outcome [1] 416837 0
Changes in depression scores as measured by the Beck Depression Inventory-II
Timepoint [1] 416837 0
Baseline and 6 months post commencement of the intervention
Secondary outcome [2] 416838 0
Depression and psychological distress will be assessed as a composite outcome measured by the adapted Patient Health Questionnaire-9 items (aPHQ-9)
Timepoint [2] 416838 0
Baseline, and 12 weeks and 6 months post commencement of the intervention
Secondary outcome [3] 416839 0
Changes in quality of life, measured using the Assessment of Quality of Life
Timepoint [3] 416839 0
Baseline, and 12 weeks and 6 months post commencement of the intervention
Secondary outcome [4] 416840 0
Changes in anxiety, measured using the Beck Anxiety Inventory
Timepoint [4] 416840 0
Baseline, and 12 weeks and 6 months post commencement of the intervention
Secondary outcome [5] 416841 0
Changes in substance use measured using the Alcohol, Smoking and Substance Involvement Screning Test
Timepoint [5] 416841 0
Baseline and 12 weeks and 6 months post commencement of the intervention
Secondary outcome [6] 416842 0
Attitudes and experiences of Aboriginal and Torres Strait Islander people receiving the Indigenous Model of Mental Health Care (IMMHC).
Timepoint [6] 416842 0
12 - 16 weeks post commencement of the intervention

Eligibility
Key inclusion criteria
Age 18 years or older;
Aboriginal and/or Torres Strait Islander identification;
Current diagnosis of depression (any sub-type), with or without other mood, anxiety or substance use disorder(s);
Able to provide written informed consent;
Sufficient English language proficiency to provide informed consent and complete study questionnaires
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive impairment as assessed by the recruiting psychologists;
At high-risk of suicide, assessed by the recruiting psychologists using the aPHQ-9;
Organic brain disorder;
Recent (< 6 weeks) changes in psychotropic medication;
Diagnosis of bipolar or psychotic disorder;
In the opinion of a clinical psychologist, presence of any other mental disorder (e.g. severe personality disorder) likely to interfere with participant’s ability to complete the study;
Any medical condition likely to prevent participation in the study for a minimum of 12 months.

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
For the quantitative data, descriptive statistics including means, standard deviations (SDs), frequencies and percentages will be used to present participants’ baseline characteristics. Mean changes over time in depression, quality of life, anxiety, and substance use will be evaluated using normal or binomial generalized estimating equation (GEE) models with exchangeable correlation matrix and robust Huber-White sandwich variance estimators. For all statistical tests, a = 0.05 will be used to define significance.
For the qualitative data, a thematic narrative analysis approach will be used. Here, the unit of analysis will be each narrator’s particiants’ understanding of how their experience of the IMMHC has impacted their mental health. Each interview will be ‘cleaned up’ (dysfluencies, break-offs, interviewer utterances, and other common features of interview conversations), and reordered into a chronological biographical account. Transcripts will be read and reread by interviewers to ensure familiarity with the data. The underlying assumptions and core elements in each account will be identified and named (coded). Particular cases will be selected to illustrate general patterns and the underlying assumptions and core elements in each case will be compared. This initial analysis will be shared with the broader research team to reach consensus on what constitutes major themes and subthemes in the data. An audit trail of the steps in the research process and data analysis will be kept to maximise inter-reliability.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2023
Actual
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
15/12/2023
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 23720 0
Toowoomba Hospital - Toowoomba
Recruitment postcode(s) [1] 39158 0
4350 - Toowoomba

Funding & Sponsors
Funding source category [1] 312857 0
Government body
Name [1] 312857 0
National Health and Medical Research Council
Country [1] 312857 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney NSW 2006, Australia
Country
Australia
Secondary sponsor category [1] 314510 0
None
Name [1] 314510 0
None
Address [1] 314510 0
None
Country [1] 314510 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312135 0
Darling Downs Health Human Research Ethics Committee
Ethics committee address [1] 312135 0
Ethics committee country [1] 312135 0
Australia
Date submitted for ethics approval [1] 312135 0
20/10/2022
Approval date [1] 312135 0
Ethics approval number [1] 312135 0

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

Contacts
Principal investigator
Name 123602 0
Prof Maree Toombs
Address 123602 0
University of Sydney
NSW 2006 Australia
Country 123602 0
Australia
Phone 123602 0
+61 417454065
Fax 123602 0
Email 123602 0
m.toombs@uq.edu.au
Contact person for public queries
Name 123603 0
Maree Toombs
Address 123603 0
University of Sydney
NSW 2006 Australia
Country 123603 0
Australia
Phone 123603 0
+61 417454065
Fax 123603 0
Email 123603 0
m.toombs@uq.edu.au
Contact person for scientific queries
Name 123604 0
Maree Toombs
Address 123604 0
University of Sydney
NSW 2006 Australia
Country 123604 0
Australia
Phone 123604 0
+61 417454065
Fax 123604 0
Email 123604 0
m.toombs@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data collected for this study will relate to the mental health and wellbeing of Aboriginal and Torres Strait Islander people, and will be inappropriate to be shared.


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.