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Trial registered on ANZCTR


Registration number
ACTRN12609000317291
Ethics application status
Approved
Date submitted
24/03/2009
Date registered
21/05/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomised Control Trial of people with psychosis taking Risperdal Consta compared to people with psychosis taking Risperdal Consta and receiving Collaborative Therapy (a psychoeducational program) in a naturalistic setting
Scientific title
Do people with psychosis taking Risperdal Consta, who participate in Collaborative Therapy, compared to people with psychosis taking Risperdal Consta and treatment as usual, have improved treatment compliance?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychosis 4524 0
Condition category
Condition code
Mental Health 4812 4812 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Collaborative Therapy is an 8 session psychosocial program, which provides education and coping stratagies to enhance self management of mental illness. The program will be delivered individually (1 hour) or as a group (1.5 hours) weekly for 8 weeks. Participants will receive the program either individually or as a group if: 1, 2 or 3 participants are randomised per site, or if an individual is unable to participate in a group for mental health, religious or other reasons. The duration of the intervention is 8 weeks.
Intervention code [1] 4283 0
Other interventions
Comparator / control treatment
Participants receive risperdal consta as prescribed by the individuals treating doctor and treatment as usual which comprises of case management and/or General Practitioner support. Risperdal consta is an intramuscular injection usually given fortnightly. The duration of treatment and dose of the risperdal consta is determined by the treating team in the best interest of the participant.
Control group
Active

Outcomes
Primary outcome [1] 5671 0
Treatment compliance measured by an clinical file audit.
Timepoint [1] 5671 0
A 12 month period post baseline
Secondary outcome [1] 241558 0
Psychiatric Symptoms measured by Positive and Negative Symptom Scale (PANSS)Depression, Anxiety and Stress Scale (DASS)
Timepoint [1] 241558 0
Baseline, 3,6 9 and 12 month.
Secondary outcome [2] 241559 0
Side effect profile measured by Liverpool University neuroleptic side-effect rating scale (LUNSERS)
Timepoint [2] 241559 0
Baseline, 3,6 9 and 12 month.
Secondary outcome [3] 241560 0
Measure of Psychosocial Function using the
Occupational Self Assessment (OSA) and the
Personal Wellbeing Index (PWI)
Timepoint [3] 241560 0
Baseline, 3,6 9 and 12 month.
Secondary outcome [4] 241561 0
Service Utilisation using the Diagnostic Interview for Psychosis (DIP)service utilisation module.
Timepoint [4] 241561 0
baseline and 12 months only

Eligibility
Key inclusion criteria
Age 18 – 65 years
Currently taking Risperdal Consta (must have been on consta for a minimum of 6 weeks).
Able to converse in English without an interpreter
Absence of developmental disability or amnestic syndrome that would impair ability to learn from the intervention.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age under 18 years
Not taking Risperdal Consta
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)
Individuals will be randomised when a group of 6-12 consenting participants at a particular site have achieved therapeutic effect on Consta at 6 weeks, and each of the participants consent to participate in the study. The group of 6-12 participants will be randomised into two groups, one group of 3-6 to receive the control condition (Consta alone) and the other group of 3-6 to receive Consta and collaborative therapy. There will be a time window during which participants can be randomised, between 6 weeks since starting on Consta and 3 months since starting, when collaborative therapy will be commenced for the treatment group. Allocation is not concealed from the researcher running the group, however it is consealed from the researchers conducting the post group assessments. Method of allocation concealment: central randomisation by computer with allocation schedule in a password protected and encrypted file.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation tables are created by computer software. We use permuted blocks stratified by site. Randomisation is block simultaneous.
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
Recruiting
Date of first participant enrolment
Anticipated
2/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1570 0
3065

Funding & Sponsors
Funding source category [1] 4710 0
Commercial sector/Industry
Name [1] 4710 0
Janssen-Cilag
Country [1] 4710 0
Australia
Primary sponsor type
Individual
Name
Prof. David Castle
Address
St Vincent's Health Melbourne
Department of Psychiartry
PO Box 2900
Fitzroy
Victoria 3065
Country
Australia
Secondary sponsor category [1] 4256 0
Individual
Name [1] 4256 0
Monica Gilbert
Address [1] 4256 0
Frameworks for Health
St Vincent's Health Melbourne
PO Box 2900
Fitzroy
Victoria 3065
Country [1] 4256 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6745 0
St Vincent's Health Melbourne Research and Grants Unit
Ethics committee address [1] 6745 0
Ethics committee country [1] 6745 0
Australia
Date submitted for ethics approval [1] 6745 0
Approval date [1] 6745 0
22/11/2007
Ethics approval number [1] 6745 0
A 118/07
Ethics committee name [2] 6746 0
Peninsula Health Human Research Ethics Committee
Ethics committee address [2] 6746 0
Ethics committee country [2] 6746 0
Australia
Date submitted for ethics approval [2] 6746 0
Approval date [2] 6746 0
05/03/2008
Ethics approval number [2] 6746 0
2007-54

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

Contacts
Principal investigator
Name 29432 0
Address 29432 0
Country 29432 0
Phone 29432 0
Fax 29432 0
Email 29432 0
Contact person for public queries
Name 12679 0
Monica Gilbert
Address 12679 0
Frameworks for Health
St Vincent's Health Melbourne
PO Box 2900
Fitzroy
Victoria 3065
Country 12679 0
Australia
Phone 12679 0
+61 3 9288 2291
Fax 12679 0
+61 3 9288 2360
Email 12679 0
monica.gilbert@svhm.org.au
Contact person for scientific queries
Name 3607 0
Prof. David Castle
Address 3607 0
Department of Psychiatry
St Vincent's Health Melbourne
PO Box 2900
Fitzroy
Victoria 3065
Country 3607 0
Australia
Phone 3607 0
+61 3 9288 4145
Fax 3607 0
+61 3 9288 4147
Email 3607 0
david.castle@svhm.org.au

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.