Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00239122




Registration number
NCT00239122
Ethics application status
Date submitted
12/10/2005
Date registered
14/10/2005
Date last updated
14/10/2005

Titles & IDs
Public title
Recovery Therapy Trial
Scientific title
Applicability of CBT to Unselected Mental Health Service Clients With Psychotic Disorders
Secondary ID [1] 0 0
E00013
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 0 0
Psychotic Disorders 0 0
Mood Disorders 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Schizophrenia
Mental Health 0 0 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Recovery Therapy (Cognitive Behaviour Therapy for psychosis)

Behaviour: Recovery Therapy (Cognitive Behaviour Therapy for psychosis)
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine the applicability of cognitive behaviour therapy for psychosis in the "real world" setting of ordinary mental health services
Timepoint [1] 0 0
Secondary outcome [1] 0 0
To establish rates of uptake of Recovery Therapy amongst clients at a community mental health service
Timepoint [1] 0 0
Secondary outcome [2] 0 0
To establish effectiveness of therapy in clients who received a defined length of therapeutic contact (12-24 sessions)
Timepoint [2] 0 0
Secondary outcome [3] 0 0
To identify factors predicting uptake and effectiveness
Timepoint [3] 0 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
Minimum age
16 Years
Maximum age
65 Years
Sex
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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2000
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)
VIC
Recruitment hospital [1] 0 0
Whittlesea Community Mental Health Service - Epping
Recruitment hospital [2] 0 0
Darebin Community Mental Health Service - Preston
Recruitment postcode(s) [1] 0 0
3076 - Epping
Recruitment postcode(s) [2] 0 0
3072 - Preston

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
William Buckland Foundation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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
https://clinicaltrials.gov/ct2/show/NCT00239122
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John Farhall, BA(Hons), MA
Address 0 0
LaTrobe University, NorthWestern Mental Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00239122