Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000210673
Ethics application status
Approved
Date submitted
22/08/2005
Date registered
25/08/2005
Date last updated
25/08/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing problem solving therapy, cognitive-behaviour therapy and treatment as usual, in clients with a past suicide attempt to decrease the likelihood of a future suicide attempt.
Scientific title
Comparing problem solving therapy, cognitive-behaviour therapy and treatment as usual, in clients with a past suicide attempt to decrease the likelihood of a future suicide attempt.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicide attempts 293 0
Condition category
Condition code
Mental Health 329 329 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Community mental health treatment (treatment is determined by team review meetings, treatment may include phone calls, home visits, and Psychiatric Registrar appointments,) treatment may last up to three months Vs One session of problem solving (then treatment as usual if required) Vs 6 sessions of Cognitive Behaviour therapy, one session per week (then treatment as usual if required).
Intervention code [1] 219 0
Behaviour
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 383 0
Decrease in suicide attempts
Timepoint [1] 383 0
At 2 months and 6 months follow-up
Primary outcome [2] 384 0
Decrease in suicidal ideation
Timepoint [2] 384 0
At 2 months and 6 months follow-up
Primary outcome [3] 385 0
Decrease in completed suicide
Timepoint [3] 385 0
At 2 months and 6 months follow-up
Primary outcome [4] 386 0
Decrease in representation rates to the Psychiatric Emergency Centre
Timepoint [4] 386 0
At 2 months and 6 months follow-up
Secondary outcome [1] 851 0
Increase in satisfaction with the Mental Health Service
Timepoint [1] 851 0
At two month and six month follow-up.
Secondary outcome [2] 852 0
Decrease in hopelessness
Timepoint [2] 852 0
At two month and six month follow-up.
Secondary outcome [3] 853 0
Increase in coping strategies
Timepoint [3] 853 0
At two month and six month follow-up.

Eligibility
Key inclusion criteria
Self-harm in context of wanting to end their life or seek escape from consious experience.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Recurrent DSH, chronic thoughts of self-harm or suicidal ideation, major diagnosis is personality disorder, suffering from a manic or psychotic illness, substance dependence.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 387 0
Government body
Name [1] 387 0
QLD Helalth
Country [1] 387 0
Australia
Primary sponsor type
Government body
Name
QLD Health
Address
Country
Australia
Secondary sponsor category [1] 319 0
None
Name [1] 319 0
nil
Address [1] 319 0
Country [1] 319 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36101 0
Address 36101 0
Country 36101 0
Phone 36101 0
Fax 36101 0
Email 36101 0
Contact person for public queries
Name 9408 0
Carmen Stewart
Address 9408 0
162 Alfred St
Fortitude Valley Brisbane QLD 4006
Country 9408 0
Australia
Phone 9408 0
+61 7 38341605
Fax 9408 0
+61 7 38341696
Email 9408 0
[email protected]
Contact person for scientific queries
Name 336 0
Carmen Stewart
Address 336 0
162 Alfred St
Fortitude Valley Brisbane QLD 4006
Country 336 0
Australia
Phone 336 0
+61 7 38341605
Fax 336 0
+61 7 38341696
Email 336 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.