NCT00192582

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 Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

May 22, 2007

Status Verified

May 1, 2007

First QC Date

September 12, 2005

Last Update Submit

May 20, 2007

Conditions

Keywords

Motivational interviewCare planRelapse preventionPsychoeducationIndigenous mental health

Outcome Measures

Primary Outcomes (1)

  • Health of Nations Outcome Scale (HONOS)

    Baseline, 6 months, 12 months, 18 months,

Secondary Outcomes (5)

  • Life Skills Profile 16 (LSP)

    Baseline, 6 months, 12 months, 18 months,

  • Severity of Dependence Scale (SDS)

    Baseline, 6 months, 12 months, 18 months,

  • Kessler 10 - client and carer

    Baseline, 6 months, 12 months, 18 months,

  • Partners in Health Scale (PIH) - modified

    Baseline, 6 months, 12 months, 18 months,

  • Semi structured interview with carer and client and Aboriginal Mental Health Worker

    Baseline, 6 months, 12 months, 18 months,

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menzies School of Health Research

Darwin, Northern Territory, 0810, Australia

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersPsychoses, Substance-InducedDepressionBipolar Disorder

Interventions

Motivational InterviewingEducational Status

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersPoisoningChemically-Induced DisordersSubstance-Related DisordersBehavioral SymptomsBehaviorBipolar and Related DisordersMood Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesSocioeconomic FactorsPopulation Characteristics

Study Officials

  • Tricia M Nagel, MBBS, FRANZCP

    Menzies School of Health Research, Australia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

July 1, 2005

Study Completion

August 1, 2007

Last Updated

May 22, 2007

Record last verified: 2007-05

Locations