Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000743662
Ethics application status
Approved
Date submitted
14/11/2005
Date registered
15/11/2005
Date last updated
8/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Psychotherapeutic intervention for suicide attempters: A randomized controlled study
Scientific title
A randomized controlled study to evaluate the efficacy of modified dialectic behaviour therapy in preventing repetition of suicidal behaviour in individuals who have attempted suicide
Universal Trial Number (UTN)
Trial acronym
PISA Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicide attempts 895 0
Condition category
Condition code
Mental Health 963 963 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Modified version of dialectic bahaviour therapy not inclusive of group supervision (16 sessions, subject to continuation if needed).
Study participants will be followed-up over the period of 24 months and the recruitment into study is planned for six months.
Intervention code [1] 758 0
Treatment: Other
Comparator / control treatment
Treatment as usual (psychotherapy or/ and pharmacotherapy, not time limited).
Study participants will be followed-up over the period of 24 months and the recruitment into study is planned for six months.
Control group
Active

Outcomes
Primary outcome [1] 1277 0
Reduced rate of repetition of suicidal behaviour
Timepoint [1] 1277 0
Over the follow-up period of 24 months.
Secondary outcome [1] 2307 0
Remission in suicidal ideation, hopelessness, depression, anxiety and impulsiveness, and improved quality of life.
Timepoint [1] 2307 0
Over the 24-months follow-up period.

Eligibility
Key inclusion criteria
(a) suicide attempt within the last 14 days, (b) diagnosis: affective disorder, anxiety disorder, personality disorder, no diagnosis.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) current acute suicidality, (b) diagnosis: acute psychosis, intellectual impairment, substance abuse disorder, permanent physical disability.

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 opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random numbers
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
15/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1061 0
Self funded/Unfunded
Name [1] 1061 0
Australian Institute for Suicide Research and Prevention, Griffith University
Country [1] 1061 0
Australia
Primary sponsor type
University
Name
Australian Institute for Suicide Research and Prevention, Griffith University
Address
Country
Australia
Secondary sponsor category [1] 922 0
Hospital
Name [1] 922 0
In-kind contribution from Princess Alexandra Hospital Brisbane
Address [1] 922 0
Country [1] 922 0
Australia
Secondary sponsor category [2] 923 0
University
Name [2] 923 0
University of Queensland
Address [2] 923 0
Country [2] 923 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2364 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 2364 0
Ethics committee country [1] 2364 0
Australia
Date submitted for ethics approval [1] 2364 0
Approval date [1] 2364 0
Ethics approval number [1] 2364 0
Ethics committee name [2] 2365 0
Princess Alexandra Hospital Human Research Ethics Committee
Ethics committee address [2] 2365 0
Ethics committee country [2] 2365 0
Australia
Date submitted for ethics approval [2] 2365 0
Approval date [2] 2365 0
Ethics approval number [2] 2365 0

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

Contacts
Principal investigator
Name 36244 0
Address 36244 0
Country 36244 0
Phone 36244 0
Fax 36244 0
Email 36244 0
Contact person for public queries
Name 9947 0
Dr Karolina Krysinska
Address 9947 0
Australian Institute for Suicide Research and Prevention
Griffith University
Mt Gravatt Campus
Nathan QLD 4111
Country 9947 0
Australia
Phone 9947 0
+61 7 37353393
Fax 9947 0
+61 7 37353450
Email 9947 0
[email protected]
Contact person for scientific queries
Name 875 0
Professor Diego De Leo
Address 875 0
Australian Institute for Suicide Research and Prevention
Griffith University
Mt Gravatt Campus
Nathan QLD 4111
Country 875 0
Australia
Phone 875 0
+61 7 37353377
Fax 875 0
+61 7 37353450
Email 875 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.