None listed
Conditions
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.
Interventions
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 prevent
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
Sponsors
Prof. Mike Startup, University of Newcastle
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
12 Years to 30 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed