AIMHI NT Relapse Prevention Trial - Full Text View

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 Department of Health and Community Services, NT
Information provided by:	Menzies School of Health Research
ClinicalTrials.gov Identifier:	NCT00192582

Purpose

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	Intervention
Schizophrenia Schizoaffective Disorder Psychoses, Substance Induced Depression Bipolar Disorder	Behavioral: Motivational Interview with care plan and education

MedlinePlus related topics: Bipolar Disorder Depression Mental Health Psychotic Disorders Schizophrenia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title:	Relapse Prevention Trial in Top End Aboriginal People With Chronic Mental Illness

Further study details as provided by Menzies School of Health Research:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	90
Study Start Date:	July 2005
Estimated Study Completion Date:	August 2007

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

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Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

Department of Health and Community Services, NT

Investigators

Principal Investigator:

Tricia M Nagel, MBBS, FRANZCP

Menzies School of Health Research, Australia

More Information

Study ID Numbers:	AIMHINTRPT, 283335
Study First Received:	September 12, 2005
Last Updated:	May 20, 2007
ClinicalTrials.gov Identifier:	NCT00192582
Health Authority:	Australia: National Health and Medical Research Council

Keywords provided by Menzies School of Health Research:

Motivational interview
Care plan
Relapse prevention
Psychoeducation
Indigenous mental health

Study placed in the following topic categories:

Depression
Bipolar Disorder
Poisoning
Disorders of Environmental Origin
Depressive Disorder
Recurrence
Behavioral Symptoms
Schizophrenia

Affective Disorders, Psychotic
Psychoses, Substance-Induced
Mental Disorders
Substance-Related Disorders
Mood Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 16, 2009