Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000641291
Ethics application status
Approved
Date submitted
26/07/2009
Date registered
30/07/2009
Date last updated
4/11/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
In people who present to hospital after self harm does a package of measures including problem solving therapy plus treatment as usual result in better outcomes than treatment as usual.
Scientific title
In people who present to hospital after self harm does a complex intervention that includes problem solving therapy, postcards, risk management, cultural assessment, patient support and improved general practitioner (GP) access plus treatment as usual lead to better outcomes at one year than treatment as usual.
Universal Trial Number (UTN)
Trial acronym
ACCESS study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Self harm 237363 0
Condition category
Condition code
Mental Health 239684 239684 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Problem solving therapy (4-6 sessions lasting about 45 minutes each); Improved access to GP (by providing participants with a voucher to access their GP without cost); Risk management (using the principles of aviation risk management which include checklists, crew resource management techniques and continuous identification and management of adverse events); Cultural assessment (assessment of identity and sense of belonging and prompting for this as a potential problem in the problem solving therapy); Postcards (eight postcards sent to the particpants over a year saying "hope you are well"); Patient support (minimum of two phone calls over two weeks to make sure participants receive the treatment they are supposed to have and to co-ordinate intervention).
Intervention code [1] 237018 0
Treatment: Other
Comparator / control treatment
Standard treatment (treatment as usual) - which is hard to specify as it is very variable. It includes intervention from mental health crisis teams, referral to community mental health centres, private provision of therapy, contact with alcohol and drug services and general practitioner follow up.
Control group
Active

Outcomes
Primary outcome [1] 240457 0
Repetition of self harm at one year assessed by inspection of national hospital records from the New Zealand Ministry of Health Information Directorate.
Timepoint [1] 240457 0
Three months and one year after index presentation
Secondary outcome [1] 244991 0
Change in self perceived hopelessness as assessed by the Beck Hopelessness Scale
Timepoint [1] 244991 0
Three months and one year after index presentation

Eligibility
Key inclusion criteria
Presenting to hospital with intentional self harm
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
At school and 17 or under
Unable to give informed consent

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)
Potential particpants are registered and then randomised by a remote computer programme run by the Clinical Trials Unit at the University of Auckland.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation by computerised sequence generation.
Stratified allocation by centre, past history of self harm and Maori/non-Maori
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
3/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
900
Accrual to date
Final
Recruitment outside Australia
Country [1] 1920 0
New Zealand
State/province [1] 1920 0

Funding & Sponsors
Funding source category [1] 237401 0
Government body
Name [1] 237401 0
New Zealand Ministry of Health
Country [1] 237401 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Uniservices
Private Bag 92019
Auckland Mail Centre
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 236898 0
None
Name [1] 236898 0
Address [1] 236898 0
Country [1] 236898 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239533 0
Central Regional Ethics Committee
Ethics committee address [1] 239533 0
PO Box 5013
Wellington
Ethics committee country [1] 239533 0
New Zealand
Date submitted for ethics approval [1] 239533 0
Approval date [1] 239533 0
01/07/2009
Ethics approval number [1] 239533 0
CEN/09/04/011

Summary
Brief summary
The hypothesis is that the package of interventions will improve outcomes including repetition and other measures of distress at three months and one year.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29968 0
Address 29968 0
Country 29968 0
Phone 29968 0
Fax 29968 0
Email 29968 0
Contact person for public queries
Name 13215 0
Cynthia Sharon
Address 13215 0
Department of Psychological Medicine
University of Auckland
PB 92019
Auckland 1142
Country 13215 0
New Zealand
Phone 13215 0
+64 9 373 7599
Fax 13215 0
Email 13215 0
[email protected]
Contact person for scientific queries
Name 4143 0
Dr. Simon Hatcher
Address 4143 0
Department of Psychological Medicine
University of Auckland
PB 92019
Auckland 1142
Country 4143 0
New Zealand
Phone 4143 0
+64 9 373 7599
Fax 4143 0
Email 4143 0
[email protected]

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
EmbaseThe ACCESS study a Zelen randomised controlled trial of a treatment package including problem solving therapy compared to treatment as usual in people who present to hospital after self-harm: Study protocol for a randomised controlled trial.2011https://dx.doi.org/10.1186/1745-6215-12-135
EmbaseThe ACCESS study: Zelen randomised controlled trial of a package of care for people presenting to hospital after self-harm.2015https://dx.doi.org/10.1192/bjp.bp.113.135780
N.B. These documents automatically identified may not have been verified by the study sponsor.