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Trial registered on ANZCTR


Registration number
ACTRN12605000659606
Ethics application status
Approved
Date submitted
10/10/2005
Date registered
19/10/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Trialling CBT for Psychosis in Ordinary Mental Health Services
Scientific title
Applicability of Cognitive Behavior Therapy to Unselected Mental Health Service Clients With Psychotic Disorders
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe persistent psychotic disorders (schizophrenia, schizoaffective disorder, mood disorder with psychotic features, and delusional disorder) 794 0
Condition category
Condition code
Mental Health 868 868 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to either the therapy group, where participants will receive Recovery Therapy (a variant of Cognitive Behaviour Therapy for psychosis) in addition to standard case management, or to the control group where participants will be monitored over a similar period while receiving standard case management.

Those participants randomised to the therapy group will receive a Recovery Therapy intervention which involves the implementation, as needed by the client, of one or more of the following elements:
1. Introduction or enhancement of techniques for better coping with persisting positive symptoms
2. Adoption of a more adaptive explanatory model of their disorder by clients
3. Strengthening of positive beliefs of self within a reality framework
4. Implementation of practical strategies for relapse prevention
5. Progress in resolution of personal/emotional issues impeding adaptation

The duration of the intervention will be 12 to 24 sessions of therapy over a maximum 12 month period.
Intervention code [1] 707 0
Behaviour
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1112 0
To determine the applicability of cognitive behaviour therapy for psychosis in the "real world" setting of ordinary mental health services. Therapy efficacy will be assessed by a variety of clinical measures including PANSS.
Timepoint [1] 1112 0
At intake; following completion of therapy; and at 9-months follow-up. The TAU group will receive identical assessment measures at intake; another 8 months after randomisation (the expected mean length of therapy); and then again at 9-months follow-up.
Primary outcome [2] 1113 0
To determine the applicability of cognitive behaviour therapy for psychosis in the "real world" setting of ordinary mental health services. Therapy efficacy will be assessed by a variety of clinical measures including Readmissions.
Timepoint [2] 1113 0
At intake; following completion of therapy; and at 9-months follow-up. The TAU group will receive identical assessment measures at intake; another 8 months after randomisation (the expected mean length of therapy); and then again at 9-months follow-up.
Primary outcome [3] 1114 0
To determine the applicability of cognitive behaviour therapy for psychosis in the "real world" setting of ordinary mental health services. Therapy efficacy will be assessed by a variety of clinical measures including Insight.
Timepoint [3] 1114 0
At intake; following completion of therapy; and at 9-months follow-up. The TAU group will receive identical assessment measures at intake; another 8 months after randomisation (the expected mean length of therapy); and then again at 9-months follow-up.
Primary outcome [4] 1115 0
To determine the applicability of cognitive behaviour therapy for psychosis in the "real world" setting of ordinary mental health services. Therapy efficacy will be assessed by a variety of clinical measures including Depression.
Timepoint [4] 1115 0
At intake; following completion of therapy; and at 9-months follow-up. The TAU group will receive identical assessment measures at intake; another 8 months after randomisation (the expected mean length of therapy); and then again at 9-months follow-up.
Secondary outcome [1] 2058 0
To establish rates of uptake of Recovery Therapy amongst clients at a community mental health service: The proportions of new patients to the services who agree to participate in the therapy trial, and dropout rates at different choice points will be determined at the end of treatment.
Timepoint [1] 2058 0
Secondary outcome [2] 2059 0
To establish effectiveness of therapy in clients who received a defined length of therapeutic contact (12-24 sessions).
Timepoint [2] 2059 0
The outcomes of those treated according to the therapy protocol will be examined by comparing groups at baseline, post-treatment and 9-month follow-up.
Secondary outcome [3] 2060 0
To identify factors predicting uptake and effectiveness.
Timepoint [3] 2060 0

Eligibility
Key inclusion criteria
Acceptance by the participating Community Mental Health Services for case management;A preliminary DSM-IV diagnosis of schizophrenia, schizoaffective disorder, mood disorder with psychotic features, or delusional disorder;A recovery "need" in one of the areas addressed by the therapy elements (see Intervention/s above).
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A preliminary DSM-IV diagnosis of brief psychotic disorder, drug-induced psychosis, mood disorder without hallucinations or delusions, or any other disorder (eg. personality disorder,PTSD) even where psychotic features are/have been present;Non-English speaking; Comorbid intellectual 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was conducted by a coin toss (by a RA), monitored by a witness independent of the trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 957 0
Charities/Societies/Foundations
Name [1] 957 0
William Buckland Foundation
Address [1] 957 0
Country [1] 957 0
Australia
Primary sponsor type
Government body
Name
Melbourne Health
Address
Country
Australia
Secondary sponsor category [1] 824 0
University
Name [1] 824 0
LaTrobe University
Address [1] 824 0
Country [1] 824 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2257 0
North Western Mental Health Research and Ethics Committee
Ethics committee address [1] 2257 0
Ethics committee country [1] 2257 0
Australia
Date submitted for ethics approval [1] 2257 0
Approval date [1] 2257 0
Ethics approval number [1] 2257 0
Ethics committee name [2] 2258 0
LaTrobe University Human Ethics Committee
Ethics committee address [2] 2258 0
Ethics committee country [2] 2258 0
Australia
Date submitted for ethics approval [2] 2258 0
Approval date [2] 2258 0
Ethics approval number [2] 2258 0

Summary
Brief summary
This project will systematically apply a specialist version of Cognitive Behaviour Therapy (CBT), known as Recovery Therapy, to a random sample of patients with psychotic disorders. Previously, the therapy has been developed and efficacy established, but the extent of applicability to (unselected) mental health service patients is unknown. The main aim is to establish the extent to which this therapy is acceptable and effective for mental health service clients. A secondary aim is to develop guidelines for the conduct of such therapy in public mental health settings.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35537 0
Address 35537 0
Country 35537 0
Phone 35537 0
Fax 35537 0
Email 35537 0
Contact person for public queries
Name 9896 0
Mr John Farhall
Address 9896 0
Academic Unit
Whittlesea Community Mental Health Service
c/o The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country 9896 0
Australia
Phone 9896 0
+61 3 94098779
Fax 9896 0
+61 3 94089508
Email 9896 0
john.farhall@mh.org.au
Contact person for scientific queries
Name 824 0
Mr John Farhall
Address 824 0
Academic Unit
Whittlesea Community Mental Health Service
c/o The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country 824 0
Australia
Phone 824 0
+61 3 94098779
Fax 824 0
+61 3 94089508
Email 824 0
john.farhall@mh.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary