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 details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00192582




Registration number
NCT00192582
Ethics application status
Date submitted
12/09/2005
Date registered
19/09/2005
Date last updated
22/05/2007

Titles & IDs
Public title
AIMHI NT Relapse Prevention Trial
Scientific title
Relapse Prevention Trial in Top End Aboriginal People With Chronic Mental Illness
Secondary ID [1] 0 0
283335
Secondary ID [2] 0 0
AIMHINTRPT
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 0 0
Schizoaffective Disorder 0 0
Psychoses, Substance Induced 0 0
Depression 0 0
Bipolar Disorder 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Mental Health 0 0 0 0
Psychosis and personality disorders
Mental Health 0 0 0 0
Schizophrenia
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Health of Nations Outcome Scale (HONOS)
Timepoint [1] 0 0
Baseline, 6 months, 12 months, 18 months,
Secondary outcome [1] 0 0
Life Skills Profile 16 (LSP)
Timepoint [1] 0 0
Baseline, 6 months, 12 months, 18 months,
Secondary outcome [2] 0 0
Severity of Dependence Scale (SDS)
Timepoint [2] 0 0
Baseline, 6 months, 12 months, 18 months,
Secondary outcome [3] 0 0
Kessler 10 - client and carer
Timepoint [3] 0 0
Baseline, 6 months, 12 months, 18 months,
Secondary outcome [4] 0 0
Partners in Health Scale (PIH) - modified
Timepoint [4] 0 0
Baseline, 6 months, 12 months, 18 months,
Secondary outcome [5] 0 0
Semi structured interview with carer and client and Aboriginal Mental Health Worker
Timepoint [5] 0 0
Baseline, 6 months, 12 months, 18 months,

Eligibility
Key inclusion criteria
* Participants will be recruited by Aboriginal Mental Health Workers - or nominated by mental health staff or the General Practitioner. The treating doctors or local mental health team will be notified of the nomination in each case and, if they have no concerns, the Aboriginal Mental Health Worker will arrange the information and consent session with the research team. The participants will be clients who have a primary chronic mental illness, are aged over 18 years, are able to give informed consent, and are current clients. The diagnoses for inclusion are Schizophrenia, Delusional disorder, Schizoaffective disorder, Drug-induced psychosis, Non-specific psychoses, and Affective disorders. The criteria for chronicity for the purposes of the project are defined by two or more episodes of illness severe enough to require medical intervention and treatment. The carer will be identified by discussion between the client and the Aboriginal Mental Health Worker or Health Worker.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People aged less than 18 years, and people with known Intellectual disability or organic brain disorders will be excluded. People with illnesses which have not recurred, or which are not likely to recur will be excluded.

-

Study design
Purpose of the study
Allocation to intervention
Randomised controlled 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
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2007
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 0 0
Menzies School of Health Research - Darwin
Recruitment postcode(s) [1] 0 0
0810 - Darwin

Funding & Sponsors
Primary sponsor type
Other
Name
Menzies School of Health Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Alcohol Education and rehabilitation Fund
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Cooperative Research Centre for Aboriginal Health
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Government body
Name [4] 0 0
Northern Territory Government of Australia
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
A new treatment for indigenous people with mental illness in remote communities has been developed. The study hypothesis is that this new treatment will result in better outcomes for clients and carers than the outcomes of clients and carers who do not receive the treatment. The treatment is a combination of a talking treatment and sharing of stories about mental health. The treatment will be delivered to the client with their chosen carer and with the local Aboriginal Mental Health Worker or Health Worker. The treatment will be given by the research team - a psychiatrist and an indigenous research officer. The trial will compare two groups of clients - a control group which is receiving 'treatment as usual', and the group which receives the new treatment. Measures of social functioning and symptoms of mental illness will be administered at base line and every six months for two years.
Trial website
https://clinicaltrials.gov/study/NCT00192582
Trial related presentations / publications
Nagel T, Robinson G, Condon J, Trauer T. Approach to treatment of mental illness and substance dependence in remote Indigenous communities: results of a mixed methods study. Aust J Rural Health. 2009 Aug;17(4):174-82. doi: 10.1111/j.1440-1584.2009.01060.x.
Public notes

Contacts
Principal investigator
Name 0 0
Tricia M Nagel, MBBS, FRANZCP
Address 0 0
Menzies School of Health Research, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00192582