SchizophreniaNCT00192582
AIMHI NT Relapse Prevention Trial
A study testing Motivational Interview with care plan and education in people with Schizophrenia and Schizoaffective Disorder, run by Menzies School of Health Research at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Psychoses, Substance Induced
- What is being tested?
- Motivational Interview with care plan and education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 90 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2005to Aug 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
Australia1 site
Menzies School of Health Research
Darwin, Northern Territory, 0810
About this study
Official title: Relapse Prevention Trial in Top End Aboriginal People With Chronic Mental Illness
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.
Read the detailed description
A combined education and counselling treatment has been developed using a care plan and stories delivered via computer based animated software, with associated flip charts and information sheets. The new treatment will take about 60 minutes to administer and will be delivered on two occasions. It will include a discussion and assessment phase, setting of goals, and completion of a care plan. Three 5-minute stories will be shown during the session. Each story will have been adapted for use by the community Aboriginal Mental Health Workers prior to base line. The process for development of the stories in each community will involve showing the generic resources and any completed community specific resources - and allowing time for the stories to be adjusted by the community. The new community - specific resources will then be used in the treatment sessions - conducted by the chief investigator- a consultant psychiatrist with 15 years experience working with indigenous mental health clients and an indigenous research officer and Aboriginal Mental Health Worker (or Health Worker). The Aboriginal Mental Health Workers will receive training in the stories at two stages - through the consultation and workshop phase of the story development, and through the delivery phase with clients and carers. The stories and care planning intervention aim to promote change through encouraging clients in their own choices and their own control of their lives, and through setting goals to make changes if they choose. The intervention involves culturally appropriate sharing of information with clients and carers about illness and treatment. The information sharing is two way - as clients are invited to share their own stories during the process.
Overview
The project design is 2 years from base line to end. Base line measures of psychosocial functioning will be completed for clients and carers at commencement of the project. The measures will include self-completion and clinician completed scales. There will also be an interview - focusing on protective factors, precipitants of illness, symptoms, goals for change, and strategies for change. The new treatment will be delivered between base line and 6 weeks for group one, and in the six weeks following the six-month measures for group two. Follow up measures will be completed six months post new treatment, and every six months for 2 years post new treatment for group one. Follow up measures will be completed six months post new treatment for group two with 18 months follow up. Aboriginal Mental Health Workers will also have base line and follow up measures of knowledge and confidence in treatment - and qualitative information will be gathered about the client's progress and about the Aboriginal Mental Health Worker's experience of the new treatment.
Informed Consent
Patients, carers and Aboriginal Mental Health Workers will be given information about the project in written and spoken form, with the Aboriginal research officer, prior to obtaining their consent to participate.
Recruitment of participants Participants will be recruited by Aboriginal Mental Health Workers - or nominated by mental health staff or the General Practitioner. The treating doctors 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 psychoses. People with Intellectual disability or organic brain disorders will be excluded. 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.
Random allocation to two groups within communities The consenting clients and carers will be allocated within communities randomly to Group 1 (treatment group) and Group 2 (control group). The researchers will not direct the allocation or be involved in choosing the groups. The control group will still receive the new treatment - but they will receive the new treatment 6 months after Group 1.
Baseline measures
Baseline data will be collected on all consumers at base line - gender, age, place of residence, psychiatric and alcohol and other drug history, social history, family situation, strengths and skills. The number of people in the home and home stressors will also be recorded. A formal psychiatric diagnosis will be applied following review of history and previous diagnoses, and base line measures. Measures will be taken at base line and every six months up to 2 years. The new treatment will be given twice - once after the base line measures are completed and a follow up session 2 to 6 weeks later. The measures rate symptoms, social functioning. substance dependence and the client's knowledge of their illness. The following three brief base line and follow up measures will be used for clients in addition to the interview.
Client rated scales
Partners in Health Scale (PIH), Kessler 10, Severity of Dependence Scale,
Carer rated scales
The carer will be interviewed with the client. There will be two occasions when the carer is asked for a separate rating - their own K10 and their view of the client's substance misuse worry score.
Clinician rated scales Health of the Nation Outcome Scales, Life Skills Profile, Global Assessment of Functioning,
Clinical File Audit
A file audit at base line and at 12 months and 2 years will score the following:
Mental health assessment recorded in preceding 3 months Involvement of specialist mental health services in assessment and treatment planning Early warning signs recorded Causes of getting sick again noted Strategies to address causes of getting sick again incorporated in treatment plan Care Plan developed Care Plan goals reviewed Service contact, hospital admission, number of hospital days, and mental health act detention data will also be reviewed. This routinely collected data will be examined by the research team for number of attendances of the client at the health clinic, service events by the regional mental health service, and hospital admission and detention occasions in the 12 months prior to the project and for the 2 years duration of the project.
Interview - Qualitative data
A clinical assessment and a care plan will be completed. There will be a semi-structured discussion about the client's experience of mental illness, which will be recorded by written notes. The AMHW, carer, and indigenous research officer will be present. At any time the carer will only be present if the client gives consent to that. This interview will cover symptoms, treatment, and goals for change, barriers to change, and strategies for change. After the second new treatment the client and carer will be asked their opinion of the care package and whether they found it easy to use, interesting and acceptable, and whether they believed it had changed their knowledge or attitudes to illness in any way and if so - in what way.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Psychoses, Substance Induced, Depression, Bipolar Disorder
- Being tested
- Motivational Interview with care plan and education
- Keywords
- Motivational interview, Care plan, Relapse prevention, Psychoeducation, Indigenous mental health
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Psychoses, Substance-Induced, Depression, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interview with care plan and educationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Health of Nations Outcome Scale (HONOS)
Measured: Baseline, 6 months, 12 months, 18 months,
Secondary outcomes (5)
Life Skills Profile 16 (LSP)
Measured: Baseline, 6 months, 12 months, 18 months,
Severity of Dependence Scale (SDS)
Measured: Baseline, 6 months, 12 months, 18 months,
Kessler 10 - client and carer
Measured: Baseline, 6 months, 12 months, 18 months,
Partners in Health Scale (PIH) - modified
Measured: Baseline, 6 months, 12 months, 18 months,
Semi structured interview with carer and client and Aboriginal Mental Health Worker
Measured: Baseline, 6 months, 12 months, 18 months,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJul 2005
- Study completionAug 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- Menzies School of Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Alcohol Education and rehabilitation Fund, Cooperative Research Centre for Aboriginal Health, Northern Territory Government of Australia
- Investigators
- Tricia M Nagel, MBBS, FRANZCP, Principal investigator, Menzies School of Health Research, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192582
- Sponsor's protocol ID
- AIMHINTRPT
- Other IDs
- 283335
- Status last verified
- May 2007
- First submitted
- 12 Sep 2005
- Last updated
- 22 May 2007
- Results posted
- No
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.
PubMed 19664081
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relapse Prevention Trial in Top End Aboriginal People With Chronic Mental Illness
- ClinicalTrials.gov ID
- NCT00192582
- Acronym / sponsor ID
- AIMHINTRPT
- Conditions
- Schizophrenia, Schizoaffective Disorder, Psychoses, Substance Induced, Depression, Bipolar Disorder
- Keywords
- Motivational interview, Care plan, Relapse prevention, Psychoeducation, Indigenous mental health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants
- Lead sponsor
- Menzies School of Health ResearchUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Alcohol Education and rehabilitation Fund, Cooperative Research Centre for Aboriginal Health, Northern Territory Government of Australia
- Study start
- Jul 2005
- Study completion
- Aug 2007 (estimated)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A combined education and counselling treatment has been developed using a care plan and stories delivered via computer based animated software, with associated flip charts and information sheets. The new treatment will take about 60 minutes to administer and will be delivered on two occasions. It will include a discussion and assessment phase, setting of goals, and completion of a care plan. Three 5-minute stories will be shown during the session. Each story will have been adapted for use by the community Aboriginal Mental Health Workers prior to base line. The process for development of the stories in each community will involve showing the generic resources and any completed community specific resources - and allowing time for the stories to be adjusted by the community. The new community - specific resources will then be used in the treatment sessions - conducted by the chief investigator- a consultant psychiatrist with 15 years experience working with indigenous mental health clients and an indigenous research officer and Aboriginal Mental Health Worker (or Health Worker). The Aboriginal Mental Health Workers will receive training in the stories at two stages - through the consultation and workshop phase of the story development, and through the delivery phase with clients and carers. The stories and care planning intervention aim to promote change through encouraging clients in their own choices and their own control of their lives, and through setting goals to make changes if they choose. The intervention involves culturally appropriate sharing of information with clients and carers about illness and treatment. The information sharing is two way - as clients are invited to share their own stories during the process.
Overview
The project design is 2 years from base line to end. Base line measures of psychosocial functioning will be completed for clients and carers at commencement of the project. The measures will include self-completion and clinician completed scales. There will also be an interview - focusing on protective factors, precipitants of illness, symptoms, goals for change, and strategies for change. The new treatment will be delivered between base line and 6 weeks for group one, and in the six weeks following the six-month measures for group two. Follow up measures will be completed six months post new treatment, and every six months for 2 years post new treatment for group one. Follow up measures will be completed six months post new treatment for group two with 18 months follow up. Aboriginal Mental Health Workers will also have base line and follow up measures of knowledge and confidence in treatment - and qualitative information will be gathered about the client's progress and about the Aboriginal Mental Health Worker's experience of the new treatment.
Informed Consent
Patients, carers and Aboriginal Mental Health Workers will be given information about the project in written and spoken form, with the Aboriginal research officer, prior to obtaining their consent to participate.
Recruitment of participants Participants will be recruited by Aboriginal Mental Health Workers - or nominated by mental health staff or the General Practitioner. The treating doctors 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 psychoses. People with Intellectual disability or organic brain disorders will be excluded. 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.
Random allocation to two groups within communities The consenting clients and carers will be allocated within communities randomly to Group 1 (treatment group) and Group 2 (control group). The researchers will not direct the allocation or be involved in choosing the groups. The control group will still receive the new treatment - but they will receive the new treatment 6 months after Group 1.
Baseline measures
Baseline data will be collected on all consumers at base line - gender, age, place of residence, psychiatric and alcohol and other drug history, social history, family situation, strengths and skills. The number of people in the home and home stressors will also be recorded. A formal psychiatric diagnosis will be applied following review of history and previous diagnoses, and base line measures. Measures will be taken at base line and every six months up to 2 years. The new treatment will be given twice - once after the base line measures are completed and a follow up session 2 to 6 weeks later. The measures rate symptoms, social functioning. substance dependence and the client's knowledge of their illness. The following three brief base line and follow up measures will be used for clients in addition to the interview.
Client rated scales
Partners in Health Scale (PIH), Kessler 10, Severity of Dependence Scale,
Carer rated scales
The carer will be interviewed with the client. There will be two occasions when the carer is asked for a separate rating - their own K10 and their view of the client's substance misuse worry score.
Clinician rated scales Health of the Nation Outcome Scales, Life Skills Profile, Global Assessment of Functioning,
Clinical File Audit
A file audit at base line and at 12 months and 2 years will score the following:
Mental health assessment recorded in preceding 3 months Involvement of specialist mental health services in assessment and treatment planning Early warning signs recorded Causes of getting sick again noted Strategies to address causes of getting sick again incorporated in treatment plan Care Plan developed Care Plan goals reviewed Service contact, hospital admission, number of hospital days, and mental health act detention data will also be reviewed. This routinely collected data will be examined by the research team for number of attendances of the client at the health clinic, service events by the regional mental health service, and hospital admission and detention occasions in the 12 months prior to the project and for the 2 years duration of the project.
Interview - Qualitative data
A clinical assessment and a care plan will be completed. There will be a semi-structured discussion about the client's experience of mental illness, which will be recorded by written notes. The AMHW, carer, and indigenous research officer will be present. At any time the carer will only be present if the client gives consent to that. This interview will cover symptoms, treatment, and goals for change, barriers to change, and strategies for change. After the second new treatment the client and carer will be asked their opinion of the care package and whether they found it easy to use, interesting and acceptable, and whether they believed it had changed their knowledge or attitudes to illness in any way and if so - in what way.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interview with care plan and education | Behavioural | – |
Primary outcome
Health of Nations Outcome Scale (HONOS)
Time frame: Baseline, 6 months, 12 months, 18 months,
5 secondary outcomes
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,
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2007.
- Derived from this study: PubMed 19664081Nagel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tricia M Nagel, MBBS, FRANZCP principal investigator
Menzies School of Health Research, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interview with care plan and education in people with Schizophrenia and Schizoaffective Disorder, run by Menzies School of Health Research at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health of Nations Outcome Scale (HONOS) (time frame: Baseline, 6 months, 12 months, 18 months,). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00192582, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2007.