Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000249055
Ethics application status
Approved
Date submitted
29/01/2010
Date registered
24/03/2010
Date last updated
24/03/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomised Control Trial of a Group Based Intervention and Relapse Prevention Package for Substance Misuse and Psychosis.
Scientific title
A randomised control trial of a group based intervention and relapse prevention package for substance misuse and psychosis.
Secondary ID [1] 1540 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychosis 256711 0
Substance Use 256712 0
Condition category
Condition code
Mental Health 256868 256868 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of an 8 session intergated program for those with co-occurring psychosis and substance use. It is delevered in a group format for two hours over 8 weeks by qualified and trained mental health professionals.
Intervention code [1] 255942 0
Behaviour
Comparator / control treatment
Control consisted of treatment as usual, which is case management through area community mental health services.
Control group
Active

Outcomes
Primary outcome [1] 257736 0
Decreased substance dependence. The Opiate Treatment Index, the Alcohol Use Disorders Identification test (AUDIT), the Drug Abuse Screening Test (DAST), and the Severity of Substance Use are administered to all participants accross all time points.
Timepoint [1] 257736 0
3, 6, 9, 12 months and 5 years post intervention
Primary outcome [2] 257737 0
Decreased impact of psychopathology. The World health organisation Quality of Life Questionnaire, the Life Skills profile, the Global Assessment of Functioning and the Brief Psychiatric Rating Scale are used for all participants.
Timepoint [2] 257737 0
3, 6, 9, 12 months and 5 years post intervention
Secondary outcome [1] 263107 0
Increased community service utilisation. the Diagnostic Interview for Psychosis: Service Utilisation (DIP-Part 3) is administered to all participants.
Timepoint [1] 263107 0
3, 6, 9, 12 months and 5 years post intervention

Eligibility
Key inclusion criteria
Current Diagnosistic and Statistical Manual, Fourth Edition Revised (DSM-IV) diagnosis of schizophrenia or affective psychosis
Concurrent DSM-IV diagnosis of problematic substance use or dependence
Age 18yrs or over
Able to converse in English without an interpreter
Ability to engage in a one and a half hour group, with a mid-group break.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Age under 16 years
Unable to converse in English without an interpreter
Presence of developmental disability or amnestic syndrome that would impair ability to learn from the intervention.

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)
Subject provide informed consent, are assessed at baseline, by a trained research clinician. Participants are then randomly assigned to control or treatment, by an independant person (statistician), through a central computer randomisation, using block simultaneous randomisation stratified by site, upon sufficient numbers at each site for group to be formed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number sequences, from www.randomization.com.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/01/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2618 0
3021

Funding & Sponsors
Funding source category [1] 256437 0
Charities/Societies/Foundations
Name [1] 256437 0
National Health and Medical Research Council (NH&MRC)
Country [1] 256437 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Frameworks For health
Address
Frameworks For Health
55 Victoria Parade Fitzroy,
Victoria 3065
Country
Australia
Secondary sponsor category [1] 255738 0
Hospital
Name [1] 255738 0
St. Vincent's Health Melbourne
Address [1] 255738 0
55 Victoria Parade Fitzroy,
Victoria 3065
Country [1] 255738 0
Australia
Other collaborator category [1] 1093 0
University
Name [1] 1093 0
Swinburne University Of technology
Address [1] 1093 0
PO Box 218
HAWTHORN VIC 3122
Country [1] 1093 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258490 0
St.Vincent's Health Melbourne HREC-A
Ethics committee address [1] 258490 0
Ethics committee country [1] 258490 0
Australia
Date submitted for ethics approval [1] 258490 0
Approval date [1] 258490 0
21/10/2002
Ethics approval number [1] 258490 0
1/02/0114
Ethics committee name [2] 258491 0
Northwestern mental health
Ethics committee address [2] 258491 0
Ethics committee country [2] 258491 0
Australia
Date submitted for ethics approval [2] 258491 0
Approval date [2] 258491 0
25/10/2002
Ethics approval number [2] 258491 0
E/02/038

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

Contacts
Principal investigator
Name 30788 0
Address 30788 0
Country 30788 0
Phone 30788 0
Fax 30788 0
Email 30788 0
Contact person for public queries
Name 14035 0
Brendan Pawsey
Address 14035 0
Level, 8 Aikenhead Building
55 Victoria Parade Fitzroy
Victoria 3065
Country 14035 0
Australia
Phone 14035 0
+61 39 2882327
Fax 14035 0
Email 14035 0
[email protected]
Contact person for scientific queries
Name 4963 0
Ben Williams
Address 4963 0
Swinburne University of Technology
PO Box 218
HAWTHORN VIC 3122
Country 4963 0
Australia
Phone 4963 0
+61 3 9214 8059
Fax 4963 0
Email 4963 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.