Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000634673
Ethics application status
Approved
Date submitted
11/07/2005
Date registered
13/10/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
A patient preference trial of problem solving therapy following deliberate self harm
Scientific title
In a patient preference trial with people who attempt suicide does problem solving therapy compared to usual treatment reduce repetition, depression and suicidality one year after the index attempt.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Deliberate self harm/attempted suicide 762 0
Condition category
Condition code
Mental Health 838 838 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The group receiving the intervention get usual care plus the intervention (problem solving therapy-a brief psychological intervention of four to eight sessions delivered over four to eight weeks.)
Intervention code [1] 7 0
Treatment: Other
Comparator / control treatment
The control group is receiving the usual care that people get after they have self-harmed - that is a mixture of nothing, admission to a psychiatric unit, referral to mental health crisis teams and referral to community mental health services.
Control group
Active

Outcomes
Primary outcome [1] 1076 0
Reduction in repetition
Timepoint [1] 1076 0
At one year
Secondary outcome [1] 1996 0
Reduction in hopelessness and depression.
Timepoint [1] 1996 0
At one year.

Eligibility
Key inclusion criteria
Presentation to Emergency Departments of Waitemata Health in Auckland with deliberate self-harm; expressing a preference for problem solving therapy
Minimum age
16 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Psychotic or other cognitive difficulties; established diagnosis of borderline personality disorder.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Patient preference trial
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
15/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 101 0
New Zealand
State/province [1] 101 0

Funding & Sponsors
Funding source category [1] 926 0
Commercial sector/Industry
Name [1] 926 0
Accident Compensation Corporation, New Zealand
Country [1] 926 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 784 0
Commercial sector/Industry
Name [1] 784 0
ACC
Address [1] 784 0
Country [1] 784 0
New Zealand
Secondary sponsor category [2] 785 0
Government body
Name [2] 785 0
Waitemata Health
Address [2] 785 0
Country [2] 785 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2219 0
Waitemata Health
Ethics committee address [1] 2219 0
Auckland
Ethics committee country [1] 2219 0
New Zealand
Date submitted for ethics approval [1] 2219 0
Approval date [1] 2219 0
Ethics approval number [1] 2219 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35176 0
Address 35176 0
Country 35176 0
Phone 35176 0
Fax 35176 0
Email 35176 0
Contact person for public queries
Name 9196 0
Dr. Simon Hatcher
Address 9196 0
Department of Psychological Medicine
University of Auckland
Private Bag 92019
Grafton Auckland 1
Country 9196 0
New Zealand
Phone 9196 0
+64 9 3737599 (Ext. 86750)
Fax 9196 0
Email 9196 0
[email protected]
Contact person for scientific queries
Name 124 0
Dr. Simon Hatcher
Address 124 0
Department of Psychological Medicine
University of Auckland
Private Bag 92019
Grafton Auckland 1
Country 124 0
New Zealand
Phone 124 0
+64 9 3737599 (Ext. 86750)
Fax 124 0
Email 124 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
No additional documents have been identified.