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AIMHI NT Relapse Prevention Trial

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ClinicalTrials.gov Identifier: NCT00192582
Recruitment Status : Unknown
Verified May 2007 by Menzies School of Health Research.
Recruitment status was:  Active, not recruiting
First Posted : September 19, 2005
Last Update Posted : May 22, 2007
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
Alcohol Education and rehabilitation Fund
Cooperative Research Centre for Aboriginal Health
Northern Territory Government of Australia
Information provided by:
Menzies School of Health Research

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Psychoses, Substance Induced Depression Bipolar Disorder Behavioral: Motivational Interview with care plan and education Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Relapse Prevention Trial in Top End Aboriginal People With Chronic Mental Illness
Study Start Date : July 2005
Estimated Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Health of Nations Outcome Scale (HONOS) [ Time Frame: Baseline, 6 months, 12 months, 18 months, ]

Secondary Outcome Measures :
  1. Life Skills Profile 16 (LSP) [ Time Frame: Baseline, 6 months, 12 months, 18 months, ]
  2. Severity of Dependence Scale (SDS) [ Time Frame: Baseline, 6 months, 12 months, 18 months, ]
  3. Kessler 10 - client and carer [ Time Frame: Baseline, 6 months, 12 months, 18 months, ]
  4. Partners in Health Scale (PIH) - modified [ Time Frame: Baseline, 6 months, 12 months, 18 months, ]
  5. Semi structured interview with carer and client and Aboriginal Mental Health Worker [ Time Frame: Baseline, 6 months, 12 months, 18 months, ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00192582


Locations
Australia, Northern Territory
Menzies School of Health Research
Darwin, Northern Territory, Australia, 0810
Sponsors and Collaborators
Menzies School of Health Research
National Health and Medical Research Council, Australia
Alcohol Education and rehabilitation Fund
Cooperative Research Centre for Aboriginal Health
Northern Territory Government of Australia
Investigators
Principal Investigator: Tricia M Nagel, MBBS, FRANZCP Menzies School of Health Research, Australia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00192582     History of Changes
Other Study ID Numbers: AIMHINTRPT
283335
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: May 22, 2007
Last Verified: May 2007

Keywords provided by Menzies School of Health Research:
Motivational interview
Care plan
Relapse prevention
Psychoeducation
Indigenous mental health

Additional relevant MeSH terms:
Disease
Schizophrenia
Bipolar Disorder
Recurrence
Psychotic Disorders
Psychoses, Substance-Induced
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders
Disease Attributes
Poisoning
Chemically-Induced Disorders
Substance-Related Disorders