Trial Review

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
ACTRN12611001219976
Ethics application status
Approved
Date submitted
27/11/2011
Date registered
28/11/2011
Date last updated
2/06/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Controlled Trial of a Traditional and Modified Healing Program for Enhancing Social Emotional Well-Being in Indigenous Australians
Scientific title
Randomised Controlled Trial of a Traditional and Modified Healing Program for Enhancing Social Emotional Well-Being in Indigenous Australians
Secondary ID [1] 273473 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social emotional well-being 279263 0
Condition category
Condition code
Mental Health 279461 279461 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two arms to this trial. Arm 1: Healing Program. Arm 2: Healing Program/CBT. Therapy is administered once-weekly over 5 weeks in a 3-hour group format, augmented with 3-once weekly one-on-one 1-hour sessions with a counsellor. Healing Program includes education about traditional indigenous knowledge and rituals, awareness raising of problems in communities and the historical context in which they have developed, and traditional practices to address current problems. The duration of the study for any participant will conclude after the 6-month follow-up assessment, resulting in participation duration of 8 months.
Intervention code [1] 283791 0
Behaviour
Comparator / control treatment
The Healing Program/Cognitive Behaviour Therapy condition is identical to the Healing Program and with additional elements.Therapy is administered once-weekly over 5 weeks in a 3-hour group format, augmented with 3-once weekly one-on-one 1-hour sessions with a counsellor. Healing Program includes education about traditional indigenous knowledge and rituals, awareness raising of problems in communities and the historical context in which they have developed, and traditional practices to address current problems. In addition, individual therapy involves recounting one's family history, and personal life and providing a narrative of positive and negative experiences. Specific skills are reviewed on managing grief responses. The duration of the study for any participant will conclude after the 6-month follow-up assessment, resulting in participation duration of 8 months.
Control group
Active

Outcomes
Primary outcome [1] 286022 0
Social Emotional Well Being as measured by items from the Strengths and Difficulties Questionnaire, Physician Depression Questionnaire, and Alcohol Use Disorder Identification Test.
Timepoint [1] 286022 0
Pretreatment, posttreatment, 6-Month Follow-up
Secondary outcome [1] 295012 0
Alocohol use as measured by the AUDIT
Timepoint [1] 295012 0
Pretreatment, posttreatment, 6-Month Follow-up

Eligibility
Key inclusion criteria
(1) Adult Indigenous Australian living in Broken Hill, Wilcannia, or Menindee.
(2) Willingness to participate in Healing Program
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe suicidal intent, psychotic

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be treatment seeking adults who respond to public invitations in Broken Hill, Wilcannia, and Menindee. Participants will be randomly allocated according to a random numbers system administered by an individual who is independent of the study and who works at a site that is distant from the treatment center.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be conducted by a process of minmization stratified on gender, locality, and severity of Social and Emotional Well-Being levels.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284266 0
Government body
Name [1] 284266 0
Australian Research Council
Country [1] 284266 0
Australia
Primary sponsor type
University
Name
Unversity of New South Wales
Address
School of Psychology, University of New South Wales, Anzac Parade, Kensington, Sydney, NSW, 2052
Country
Australia
Secondary sponsor category [1] 283218 0
Other Collaborative groups
Name [1] 283218 0
Maari Ma Health Aboriginal Corporation
Address [1] 283218 0
Shop 2, 443 Argent Street
Broken Hill, NSW, 2880
Country [1] 283218 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286227 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 286227 0
HREC
University of New South Wales
Sydney NSW 2052
Ethics committee country [1] 286227 0
Australia
Date submitted for ethics approval [1] 286227 0
Approval date [1] 286227 0
24/07/2007
Ethics approval number [1] 286227 0
HREC 07093
Ethics committee name [2] 291108 0
Aboriginal Health & Medical Research Council
Ethics committee address [2] 291108 0
Level 3, 66 Wentworth Ave
Surry Hills, NSW, 2010
Ethics committee country [2] 291108 0
Australia
Date submitted for ethics approval [2] 291108 0
05/04/2014
Approval date [2] 291108 0
Ethics approval number [2] 291108 0
1015/14

Summary
Brief summary
This study will randomly allocate participants to either (a) Healing Program, or (b) Healing Program + Cognitive Behaviour Therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33443 0
Prof Richard Bryant
Address 33443 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 33443 0
Australia
Phone 33443 0
61293853640
Fax 33443 0
61293853641
Email 33443 0
[email protected]
Contact person for public queries
Name 16690 0
Professor Richard Bryant
Address 16690 0
School of Psychology
University of New South Wales
Sydney, NSW, 2052
Country 16690 0
Australia
Phone 16690 0
61-2-93853640
Fax 16690 0
61-2-93853641
Email 16690 0
[email protected]
Contact person for scientific queries
Name 7618 0
Professor Richard Bryant
Address 7618 0
School of Psychology
University of New South Wales
Sydney, NSW, 2052
Country 7618 0
Australia
Phone 7618 0
61-2-93853640
Fax 7618 0
61-2-93853641
Email 7618 0
[email protected]

No information has been provided regarding IPD availability


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.