Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000114448
Ethics application status
Approved
Date submitted
13/01/2007
Date registered
8/02/2007
Date last updated
8/02/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Multisite Intervention Study on Suicidal Behaviours (SUPRE-MISS)
Scientific title
In suicide attempters, does a brief information intervention and follow-up contact compared with treatment as usual decrease mortality rate?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicidal behaviour (suicidal thoughts, attempted suicide, completed suicide) 1606 0
Condition category
Condition code
Mental Health 1710 1710 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Suicide attempters seen at emergency care settings, comparison of treatment as usual (TAU) versus brief intervention and contact (BIC). BIC: a one-hour individual information session as close to the time of discharge as possible (including information about suicidal behaviour as a sign of psychological/social distress, risk factors and protective factors for suicidal behaviour, basic epidemiology, repetition, contacts) PLUS after discharge phone calls or visits, as appropriate, according to a time line asking how the person feels and whether he or she needs any support and referral to an appropriate channel if needed. The time line of contacts is as follows: 1, 2, 4, 7, 11 weeks, 4, 6, 12, 18 months after discharge.
Intervention code [1] 1552 0
Other interventions
Comparator / control treatment
TAU: according to the norms prevailing in the respective emergency department in each site. The TAU group is followed up only at 18 months after discharge.
Control group
Active

Outcomes
Primary outcome [1] 2381 0
Completed suicide (mortality)
Timepoint [1] 2381 0
Assessed once the intervention (brief intervention and contact) has been completed at the 18-month follow-up.
Secondary outcome [1] 4136 0
Attempted suicide (morbidity; i.e. repeated suicide attempts), other variables such as hopelessness, wellbeing, need of support, assessed once the intervention has been completed at the 18-month follow-up.
Timepoint [1] 4136 0

Eligibility
Key inclusion criteria
All suicide attempters seen at the emergencey care settings.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Death in the ward, clinical conditions not allowing an interview, leaving against medical order, residence in a different catchment area, language problems.

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)
An allocation sequence based on a random number table was used to randomly assign all enrolled subjects to BIC or TAU; the allocation sequence was maintained in a separate location to ensure that clinicians responsible for assignment of subjects could not bias the assignment. Allocation was concealed done by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An allocation sequence based on a random number table was used to randomly assign all enrolled subjects to BIC or TAU. The random order generation was done by simple randomisation by using a randomisation table from a statistic book.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Single blind - the subjects were blinded and unaware of the intervention assignment.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1730
Accrual to date
Final
Recruitment outside Australia
Country [1] 471 0
Switzerland
State/province [1] 471 0

Funding & Sponsors
Funding source category [1] 1855 0
Charities/Societies/Foundations
Name [1] 1855 0
World Health Organization
Country [1] 1855 0
Funding source category [2] 1856 0
Charities/Societies/Foundations
Name [2] 1856 0
Fundacao de Amparo a Pesquisa do Estado de Sao Paulo
Country [2] 1856 0
Brazil
Funding source category [3] 1857 0
Government body
Name [3] 1857 0
Medical Research Council
Country [3] 1857 0
South Africa
Funding source category [4] 1858 0
Government body
Name [4] 1858 0
Mental Health Research Centre
Country [4] 1858 0
Iran, Islamic Republic Of
Funding source category [5] 1859 0
Commercial sector/Industry
Name [5] 1859 0
Estonian Health Insurance Fund
Country [5] 1859 0
Estonia
Funding source category [6] 1860 0
Other
Name [6] 1860 0
Karolinska Institute
Country [6] 1860 0
Estonia
Primary sponsor type
Charities/Societies/Foundations
Name
World Health Organization
Address
Country
Secondary sponsor category [1] 1670 0
None
Name [1] 1670 0
Nil
Address [1] 1670 0
Country [1] 1670 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3462 0
Department of Psychiatry, FCM-UNICAMP-Faculdade de Ciencias Medicas, Comite de Etica em Pesquisa, UNICAMP
Ethics committee address [1] 3462 0
Ethics committee country [1] 3462 0
Brazil
Date submitted for ethics approval [1] 3462 0
Approval date [1] 3462 0
19/03/2002
Ethics approval number [1] 3462 0
WHO Registry No. M4/445/137/BRA
Ethics committee name [2] 3463 0
Research Centre of Clinical Epidemiology, Beijing Hui Long Guan Hospital-Medical Ethics Committee, Beijing Hui Long Guan Hospital
Ethics committee address [2] 3463 0
Ethics committee country [2] 3463 0
China
Date submitted for ethics approval [2] 3463 0
Approval date [2] 3463 0
10/10/2001
Ethics approval number [2] 3463 0
WHO Registry No. M4/445/137/CHN
Ethics committee name [3] 3464 0
Estonian-Swedish Institute of Suicidology-Tallinn Medical Research Ethics Committee
Ethics committee address [3] 3464 0
Ethics committee country [3] 3464 0
Estonia
Date submitted for ethics approval [3] 3464 0
Approval date [3] 3464 0
22/08/2001
Ethics approval number [3] 3464 0
WHO Registry No. M4/181/170
Ethics committee name [4] 3465 0
Voluntary Health Services, Chennai-Ethics Committee of the Voluntary Health Services
Ethics committee address [4] 3465 0
Ethics committee country [4] 3465 0
India
Date submitted for ethics approval [4] 3465 0
Approval date [4] 3465 0
11/10/2001
Ethics approval number [4] 3465 0
WHO Registry No. M4/181/171
Ethics committee name [5] 3466 0
Tehran Psychiatric Institute, Iran University of Medical Sciences and Health Services-Ethics Committee of Iran University of Medical Sciences
Ethics committee address [5] 3466 0
Ethics committee country [5] 3466 0
Iran, Islamic Republic Of
Date submitted for ethics approval [5] 3466 0
Approval date [5] 3466 0
03/09/2001
Ethics approval number [5] 3466 0
WHO Registry No. M4/181/173
Ethics committee name [6] 3467 0
Tehran Psychiatric Institute, Iran University of Medical Sciences and Health Services-National Committee in Medical Research
Ethics committee address [6] 3467 0
Ethics committee country [6] 3467 0
Iran, Islamic Republic Of
Date submitted for ethics approval [6] 3467 0
Approval date [6] 3467 0
20/10/2001
Ethics approval number [6] 3467 0
WHO Registry No. M4/181/173
Ethics committee name [7] 3468 0
Department of Medically Applied Psychology, Nelson R. Mandela School of Medicine, University of Natal-Sub-Committee of Research Ethics Committee, University of Natal
Ethics committee address [7] 3468 0
Ethics committee country [7] 3468 0
South Africa
Date submitted for ethics approval [7] 3468 0
Approval date [7] 3468 0
30/01/2002
Ethics approval number [7] 3468 0
WHO Registry No. M4/445/137/SOA
Ethics committee name [8] 3469 0
Department of Psychological Medicine, Faculty of Medicine-Ethical Review Committee, Faculty Board, Medical Faculty Colombo
Ethics committee address [8] 3469 0
Ethics committee country [8] 3469 0
Sri Lanka
Date submitted for ethics approval [8] 3469 0
Approval date [8] 3469 0
14/12/2001
Ethics approval number [8] 3469 0
WHO Registry No. M4/445/137SRL
Ethics committee name [9] 3470 0
Hanoi Medical University-Ethics Committee of National Committee, Ministry of Health, Social Republic of Viet Nam
Ethics committee address [9] 3470 0
Ethics committee country [9] 3470 0
Viet Nam
Date submitted for ethics approval [9] 3470 0
Approval date [9] 3470 0
15/08/2001
Ethics approval number [9] 3470 0
WHO Registry No. M4/181/172

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

Contacts
Principal investigator
Name 27486 0
Address 27486 0
Country 27486 0
Phone 27486 0
Fax 27486 0
Email 27486 0
Contact person for public queries
Name 10741 0
Alexandra Fleischmann
Address 10741 0
20. avenue Appia,
CH-1211 Geneva 27
Country 10741 0
Switzerland
Phone 10741 0
+41 22 7913444
Fax 10741 0
+41 22 7914160
Email 10741 0
[email protected]
Contact person for scientific queries
Name 1669 0
Alexandra Fleischmann
Address 1669 0
20. avenue Appia,
CH-1211 Geneva 27
Country 1669 0
Switzerland
Phone 1669 0
+41 22 7913444
Fax 1669 0
+41 22 7914160
Email 1669 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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