Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000337673
Ethics application status
Approved
Date submitted
7/09/2005
Date registered
8/09/2005
Date last updated
30/01/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Problem solving therapy after attempted suicide
Scientific title
Does problem solving therapy after attempted suicide, compared to treatment as usual, reduce repetition, suicidality and depression after one year.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
People who attempt suicide/self harm and present to hospital emergency departments 430 0
Condition category
Condition code
Mental Health 500 500 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Problem solving therapy. Therapy is for four to eight sessions of one hour each for four to six weeks. Follow-up is for a year from the index episode. Recruitment into the study is planned for two years.
Intervention code [1] 386 0
Treatment: Other
Comparator / control treatment
Treatment as usual
Control group
Active

Outcomes
Primary outcome [1] 572 0
Repetition of self harm
Timepoint [1] 572 0
At one year
Secondary outcome [1] 1221 0
Depression and suicidality
Timepoint [1] 1221 0
At one year

Eligibility
Key inclusion criteria
Self harm presenting to hospital emergency department
Minimum age
16 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
At school or under 16; psychotic; established diagnosis of borderline personality disorder.

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)
Sequentially numbered sealed envelopes containing the treatment allocation opened when the patient is deemed eligible to enter the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generation by computer hardware (Hotbits); no restriction
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Modified Zelen design
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
10/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment outside Australia
Country [1] 176 0
New Zealand
State/province [1] 176 0

Funding & Sponsors
Funding source category [1] 563 0
Commercial sector/Industry
Name [1] 563 0
Accident Compensation Corporation
Country [1] 563 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bage 92019
Auckland 1
New Zealand
Country
New Zealand
Secondary sponsor category [1] 456 0
Government body
Name [1] 456 0
Waitemata Health DHB
Address [1] 456 0
Private Bag 93503
Takapuna
Auckland 9
Country [1] 456 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1585 0
Waitemata Health DHB
Ethics committee address [1] 1585 0
Ethics committee country [1] 1585 0
New Zealand
Date submitted for ethics approval [1] 1585 0
Approval date [1] 1585 0
Ethics approval number [1] 1585 0

Summary
Brief summary
The purpose of this study is to see whether problem solving therapy is better than usual care after someone presents to hospital with acute self-harm, (such as an overdose). The main outcome we are interested in is the repetition of self harm in the year after the first attempt. We are also interested to see whether people who receive problem solving therapy are less depressed and suicidal after a year.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36405 0
Address 36405 0
Country 36405 0
Phone 36405 0
Fax 36405 0
Email 36405 0
Contact person for public queries
Name 9575 0
Dr. Simon Hatcher
Address 9575 0
Department of Psychological Medicine
University of Auckland
Private Bag 92019
Auckland 1
Country 9575 0
New Zealand
Phone 9575 0
+64 9 3737599 ext. 86750
Fax 9575 0
Email 9575 0
[email protected]
Contact person for scientific queries
Name 503 0
Cynthia Sharon
Address 503 0
Department of Psychological Medicine
University of Auckland
Private Bag 92019
Auckland 1
Country 503 0
New Zealand
Phone 503 0
+64 9 3737599
Fax 503 0
Email 503 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.