Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000594628
Ethics application status
Approved
Date submitted
20/09/2005
Date registered
5/10/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot study of psychotherapeutic intervention for complex presentations of first-episode psychosis
Scientific title
A pilot study to evaluate the feasibility, safety and efficacy of psychotherapeutic intervention for comorbid BPD and first-episode psychosis
Universal Trial Number (UTN)
Trial acronym
Mauve Zone
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Borderline Personality Disorder 722 0
Early psychosis 723 0
Condition category
Condition code
Mental Health 799 799 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a pilot study of 16 sessions of Cognitive Analytic Therapy (CAT) (run over 16 weeks) compared to treatment as usual (TAU) for young people aged 15 to 24 years with co-occurring first episode psychosis and full or sub-threshold BPD. Patients who consent to be involved in the current study will be randomized to TAU or TAU + CAT. Measures will be undertaken at three time-points: baseline, end of treatment phase (for both conditions), and 6 month follow up. Measures include: demographics, and standardized measures of diagnosis, psychopathology, psychosocial functioning, substance abuse, treatment adherence and service utilization.
Intervention code [1] 655 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1021 0
a) to refine an appropriate form of CAT for this group of patients and to produce a treatment manual directly at the end of the study
Timepoint [1] 1021 0
Outcomes (b) and (c) will be completed at the end of the treatment phase (for both conditions), and six months after the treatment phase.
Primary outcome [2] 1022 0
b) to check the validity of outcome measures
Timepoint [2] 1022 0
Outcomes (b) and (c) will be completed at the end of the treatment phase (for both conditions), and six months after the treatment phase.
Primary outcome [3] 1023 0
c) to explore effects in relation to psychopathology, psychosocial functioning, and quality of life over a 6-month follow-up period, with a view to conducting a larger randomized trial.
Timepoint [3] 1023 0
Outcomes (b) and (c) will be completed at the end of the treatment phase (for both conditions), and six months after the treatment phase.
Secondary outcome [1] 1916 0
To evaluate the safety of CAT for this group.
Timepoint [1] 1916 0
Safety will be measured at both the end of the treatment phase (for both conditions) and six months after the completion of the treatment phase.
Secondary outcome [2] 1917 0
To evaluate the feasibility of CAT for this group.
Timepoint [2] 1917 0
Feasibility will be measured at the end of the treatment phase.

Eligibility
Key inclusion criteria
(1) Eligibility for EPPIC program, 1 week or more of psychotic symptoms with less than 6 months of active previous treatment (i.e., antipsychotic medication); and (2) Diagnosis of four or more DSM-IV BPD traits (APA, 1994).
Minimum age
15 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Severe and enduring psychotic symptoms, defined as scores of 4 or more on 1 or more psychotic items of the Brief Psychiatric Rating Scale (BPRS) which have persisted for more than 1 month (Overall & Gorham, 1962); (2)Unable to converse in, or read English without an interpreter; (3) Intellectual deficits, such that unable to meaningfully participate in the psychotherapy; and (4) Already given informed consent for another psychotherapy trial at ORYGEN Youth Health, or already received a course of CAT.

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)
Random Numbers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number computer program, password secured
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
An effectiveness study with treatment as usual as a control
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 887 0
Self funded/Unfunded
Name [1] 887 0
Country [1] 887 0
Primary sponsor type
Other
Name
Orygen Research Centre and Orygen Youth Health
Address
Country
Australia
Secondary sponsor category [1] 749 0
None
Name [1] 749 0
nil
Address [1] 749 0
Country [1] 749 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2173 0
ORYGEN Youth Health
Ethics committee address [1] 2173 0
Ethics committee country [1] 2173 0
Australia
Date submitted for ethics approval [1] 2173 0
Approval date [1] 2173 0
Ethics approval number [1] 2173 0

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

Contacts
Principal investigator
Name 35222 0
Address 35222 0
Country 35222 0
Phone 35222 0
Fax 35222 0
Email 35222 0
Contact person for public queries
Name 9844 0
Associate Professor John Gleeson
Address 9844 0
ORYGEN Youth Health
Locked Bag 10
Parkville VIC 3052
Country 9844 0
Australia
Phone 9844 0
+61 409386523
Fax 9844 0
Email 9844 0
jgleeson@unimelb.edu.au
Contact person for scientific queries
Name 772 0
Dr Andrew Chanen
Address 772 0
ORYGEN Youth Health
Locked Bag 10
Parkville VIC 3052
Country 772 0
Australia
Phone 772 0
+61 3 93422800
Fax 772 0
Email 772 0
achanen@unimelb.edu.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.