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Trial registered on ANZCTR


Registration number
ACTRN12606000101583
Ethics application status
Approved
Date submitted
14/03/2006
Date registered
15/03/2006
Date last updated
20/08/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
The DEPTH Project: Detection, Evaluation, and Psychological Therapy for Health
Scientific title
Randomised controlled trial of cognitive behaviour therapy to prevent psychosis among people with at-risk mental states
Universal Trial Number (UTN)
Trial acronym
DEPTH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ultra-high risk for the development of a psychotic disorder 1065 0
Condition category
Condition code
Mental Health 1145 1145 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study intervention is Cognitive Behaviour Therapy. This treatment will follow that employed by Morrison and colleagues in the EDIE trial, as described in the manual for that trial. Interventions are tailored to address the problems identified by the patients and are based on shared formulations. Therapists encourage collaborative empiricism, use guided discovery and recommend homework. However, this form of CBT differs somewhat from other forms in that it is designed specifically for preventing transition to psychosis among young high-risk individuals. Problems of substance use and dependence will be addressed with the techniques of motivational interviewing and CBT developed by Baker and Bucci for substance problems among people with psychoses.

Duration of treatments: 26 therapy (weekly) sessions
Intervention code [1] 939 0
Treatment: Other
Comparator / control treatment
The control intervention is Non-Directive Reflective Listening: this is a form of person-centred counselling in which, within a therapeutic setting, the therapist offers empathic reflections while adopting a stance of genuineness or congruence and unconditional positive regard. Patients will be invited to discuss any topics they wish, not necessarily issues related to at-risk mental states, and the direction of content throughout the treatment will be for the patients to determine.
Duration of treatments: 26 therapy (weekly) sessions
Control group
Active

Outcomes
Primary outcome [1] 1541 0
The primary outcome will be length of survival without the development of levels of positive psychotic symptoms of such severity that they mark a threshold at which anti-psychotic medication would normally be commenced. This severity threshold is defined as ratings in the psychotic range on the Comprehensive Assessment of At-Risk Mental States (CAARMS) positive items with frequencies of 3 to 6 times a week, plus the symptoms have persisted for more than one week. The development of mania, dangerous behaviour, or suicidality, defined as ratings of 5 or more on the corresponding scales of the CAARMS, will also be regarded as a transition and will also constitute a cue for the commencement of appropriate medication (Transition to psychosis).
Timepoint [1] 1541 0
Formally assessed once a month for the first 6 months and once every 2 months for the next 6 months
Secondary outcome [1] 2778 0
Group differences in rates of change of symptoms assessed by the CAARMS.
Timepoint [1] 2778 0
Formally assessed once a month for the first month and once every two months for the next 6 months.
Secondary outcome [2] 2779 0
Group differences in rates of change of substance use assessed by the OTI.
Timepoint [2] 2779 0
Formally assessed once a month for the first month and once every two months for the next 6 months.
Secondary outcome [3] 2780 0
Group differences in rates of change of social functioning assessed by the Quality of Life Scale.
Timepoint [3] 2780 0
Formally assessed once a month for the first month and once every two months for the next 6 months.

Eligibility
Key inclusion criteria
reside within the boundaries of the Hunter New England Health Area or the former Mid-Western region of the Greater Western Area Health Service, meet criteria for one or more of 3 ‘at-risk mental states’ (ARMS). These three groups are operationally defined as follows: Group A (state and trait risk factors): A combination of a first-degree relative with a history of any psychotic disorder, or the patient meets DSM-IV criteria for a diagnosis of schizotypal personality disorder, and any change in mental state or functioning which has resulted in a loss of at least 30% on the Global Assessment of Functioning scale for at least one month. Group B (attenuated psychotic symptoms): The person has developed one or more prodromal symptoms which represent a change in their functioning, different from their normal personality, and which occur with a frequency of at least several times a week and have been occurring for at least one week. The symptoms include ideas of reference, odd beliefs or magical thinking, perceptual disturbance, suspiciousness or paranoid thinking, and behaviour that is odd, eccentric or peculiar. The symptoms must deviate significantly from normal, as defined by ratings in the prodromal range on the Comprehensive Assessment of At Risk Mental States (CAARMS). Group C (transient psychotic symptoms): The person has a history during the previous year of brief limited intermittent psychotic symptoms (BLIPS) lasting less than one week before resolving spontaneously. The symptoms are defined by the presence of one or more ratings in the psychotic range on the CAARMS positive items: disorders of thought content, perceptual abnormalities, disorganised speech.
Minimum age
12 Years
Maximum age
30 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Meet criteria for a past or current DSM-IV psychotic disorder, have previously been prescribed anti-psychotic medication, have an organic mental disorder or intellectual disabilities, are at serious suicidal or homicidal risk (they will be eligible for inclusion once this risk has resolved), have an inadequate command of the English language.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/email
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified by gender, site, and receipt of antidepressant medication, using a system of central and external randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
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] 1251 0
Government body
Name [1] 1251 0
National Health & Medical Research Council Project Grant
Address [1] 1251 0
Level 5, 20 Allara Street
Canberra ACT 2601
Country [1] 1251 0
Australia
Primary sponsor type
Individual
Name
Prof. Mike Startup, University of Newcastle
Address
School of Psychology, University of Newcastle, NSW 2308
Country
Australia
Secondary sponsor category [1] 1107 0
Individual
Name [1] 1107 0
Prof. Vaughan Carr
Address [1] 1107 0
Centre for Brain and Mental Health Research, University of Newcastle, 2300
Country [1] 1107 0
Australia
Secondary sponsor category [2] 1108 0
Individual
Name [2] 1108 0
A/Prof Amanda Baker
Address [2] 1108 0
Centre for Brain and Mental Health Research, University of Newcastle, 2300
Country [2] 1108 0
Australia
Secondary sponsor category [3] 1109 0
Individual
Name [3] 1109 0
A/Prof Ulrich Schall
Address [3] 1109 0
Centre for Brain and Mental Health Research, University of Newcastle, 2300
Country [3] 1109 0
Australia
Secondary sponsor category [4] 1110 0
Individual
Name [4] 1110 0
Dr Helen Stain
Address [4] 1110 0
Centre for Rural and Remote Mental Health, Broomfield Hospital, Orange, NSW
Country [4] 1110 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2582 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 2582 0
Locked Bag No 1, New Lambton, NSW 2305
Ethics committee country [1] 2582 0
Australia
Date submitted for ethics approval [1] 2582 0
Approval date [1] 2582 0
23/02/2006
Ethics approval number [1] 2582 0
05/12/07/3.23
Ethics committee name [2] 2583 0
Human Research Ethics Committee of the University of Newcastle
Ethics committee address [2] 2583 0
Ethics committee country [2] 2583 0
Australia
Date submitted for ethics approval [2] 2583 0
01/12/2005
Approval date [2] 2583 0
15/02/2006
Ethics approval number [2] 2583 0
H-183-0206
Ethics committee name [3] 2584 0
Human Research Ethics Committee of the Greater Western Area Health Service
Ethics committee address [3] 2584 0
PO Box 143, The Lodge, Gorman's Hill Road, Bathurst, NSW 2795
Ethics committee country [3] 2584 0
Australia
Date submitted for ethics approval [3] 2584 0
20/03/2006
Approval date [3] 2584 0
17/07/2006
Ethics approval number [3] 2584 0
GW2006/04

Summary
Brief summary
The study will compare the effectiveness of cognitive behaviour therapy (CBT) and a non-directive psychotherapy matched for therapist input in delaying or preventing transition to psychosis among young people at high risk for psychosis. It is expected that patients assigned to CBT will: (1) show lower rates of transition to psychosis during the 12-month follow-up period; (2) survive longer without becoming psychotic even if they do make a transition during the 12-month follow-up period; (3) show better outcomes at 6 and 12 months in terms of psychotic and non-psychotic symptoms, quality of life and social functioning, whether or not they become psychotic.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36164 0
Address 36164 0
Country 36164 0
Phone 36164 0
Fax 36164 0
Email 36164 0
Contact person for public queries
Name 10128 0
Mr Sean Halpin
Address 10128 0
Psychological Assistance Service
Hunter Health Service
43 Brunker Road
Broadmeadow NSW 2292
Country 10128 0
Australia
Phone 10128 0
+61 2 49610431
Fax 10128 0
+61 2 49610435
Email 10128 0
Sean.Halpin@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 1056 0
Professor Mike Startup
Address 1056 0
School of Psychology
University of Newcastle
Callaghan NSW 2308
Country 1056 0
Australia
Phone 1056 0
+61 2 49215979
Fax 1056 0
+61 2 49216980
Email 1056 0
Mike.startup@newcastle.edu.au

No information has been provided regarding IPD availability
Summary results
No Results