Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000952246
Ethics application status
Approved
Date submitted
8/10/2009
Date registered
5/11/2009
Date last updated
5/11/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Te Ira Tangata Study: In Maori who present to hospital with self harm is a complex package of interventions better than treatment as usual in preventing repetition of self harm twelve months after the index episode?
Scientific title
In Maori who present to hospital with self harm is a complex package of interventions better than treatment as usual in preventing repetition of self harm twelve months after the index episode?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Presentation to hospital with self harm 251980 0
Condition category
Condition code
Mental Health 252171 252171 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention package consists of the following elements delivered by Maori mental health workers, cultural workers and kaumatua which have some variation between cases depending on the clinical context:
i) patient support - usually in the two weeks post discharge two phone calls or face to face contacts to check the discharge paln from hospital is actually happening.
ii) problem solving therapy - four to six sessions of 30 to 60 minutes over four weeks
iii) a cultural assessment - focusing on sense of belonging and cultural identity
iv) a risk management programme for the clinicians
v) postcards in the year after the attempt posted monthly after the first month
vi) improved access to general practice
Intervention code [1] 241392 0
Treatment: Other
Comparator / control treatment
Treatment as usual differs on a case by case basis and is decided by the clinician who usually sees the patient. This may consist of admission to hospital, referral to a mental health crisis service, a community mental health service, their general practitioner or nothing plus a variety of less common interventions.
Control group
Active

Outcomes
Primary outcome [1] 253045 0
The proportion of participants scoring less than 9 on the Beck Hopelessness Scale at twelve months.
Timepoint [1] 253045 0
Three months and twelve months after the index presentation
Secondary outcome [1] 257860 0
Repetition of self harm assessed by hospital records, national minimum dataset and self report.
Timepoint [1] 257860 0
Three and twelve months after the index presentation.
Secondary outcome [2] 257861 0
Depression measured on the Hospital Anxiety and Depression Scale
Timepoint [2] 257861 0
Three and twelve months after the index presentation.
Secondary outcome [3] 257862 0
Anxiety measured on the Hospital Anxiety and Depression Scale
Timepoint [3] 257862 0
Three and twelve months after the index presentation.
Secondary outcome [4] 257863 0
Suicidality as measured on the Beck Suicide Ideation Scale
Timepoint [4] 257863 0
Three and twelve months after the index presentation.
Secondary outcome [5] 257864 0
Health care use assessed by hospital records, national minimum dataset and self report.
Timepoint [5] 257864 0
Three and twelve months after the index presentation.

Eligibility
Key inclusion criteria
Maori presenting to hospital with self harm
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under age
Out of area
Unable to consent (e.g. psychotic, cognitively impaired)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a Zelen trial so potential participants are randomised first and then approached to consent to whichever arm they have been allocated. Treatment allocation is determined by a remote computer at the Clinical Trials Research Unit at the University of Auckland.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Zelen trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
132
Accrual to date
Final
Recruitment outside Australia
Country [1] 2260 0
New Zealand
State/province [1] 2260 0

Funding & Sponsors
Funding source category [1] 243854 0
Government body
Name [1] 243854 0
New Zealand Ministry of Health
Country [1] 243854 0
New Zealand
Primary sponsor type
Government body
Name
New Zealand Ministry of Health
Address
1-3 The Terrace
Wellington
6011
Country
New Zealand
Secondary sponsor category [1] 237203 0
University
Name [1] 237203 0
The University of Auckland
Address [1] 237203 0
PB92109
Auckland 1142
Country [1] 237203 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243977 0
Multi Region Ethics Committee
Ethics committee address [1] 243977 0
Ministry of Health
1-3 The Terrace
Wellington
6011
Ethics committee country [1] 243977 0
New Zealand
Date submitted for ethics approval [1] 243977 0
Approval date [1] 243977 0
23/09/2009
Ethics approval number [1] 243977 0
MEC/09/06/067

Summary
Brief summary
Thye study is designed to answer the question "in Maori who present to hospital with self harm is a complex package of interventions delivered in a culturally acceptable way plus treatment as usual better than treatment as usual alone". The treatment package consists of several elements including patient support designed to stop patients slipping through the cracks in between hospital and community care; problem solving therapy; improved access to general practitioners; risk management for the self harm team; cultural assessment; regular postcards for a year. This is delivered in a culturally appropriate way using Maori clinicians and cultural workers with their unique networks to supplement problem solving.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30370 0
Address 30370 0
Country 30370 0
Phone 30370 0
Fax 30370 0
Email 30370 0
Contact person for public queries
Name 13617 0
Dr. Simon Hatcher
Address 13617 0
Department of Psychological Medicine
Faculty of medical and Health Sciences
The University of Auckland
PB92019
Auckland 1142
Country 13617 0
New Zealand
Phone 13617 0
+64 9 373 7599
Fax 13617 0
Email 13617 0
s.hatcher@auckland.ac.nz
Contact person for scientific queries
Name 4545 0
Dr. Simon Hatcher
Address 4545 0
Department of Psychological Medicine
Faculty of medical and Health Sciences
The University of Auckland
PB92019
Auckland 1142
Country 4545 0
New Zealand
Phone 4545 0
+64 9 373 7599
Fax 4545 0
Email 4545 0
s.hatcher@auckland.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTe Ira Tangata: A Zelen randomised controlled trial of a treatment package including problem solving therapy compared to treatment as usual in Maori who present to hospital after self harm.2011https://dx.doi.org/10.1186/1745-6215-12-117
N.B. These documents automatically identified may not have been verified by the study sponsor.