Primary prevention of psychosis through interventions in the prodromal phase

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN20328848
• Date of registration: 31/10/2014
• Prospective Registration: No
• Primary sponsor: Stavanger University Hospital (Norway)
• Public title: Primary prevention of psychosis through interventions in the prodromal phase
• Scientific title: Primary Prevention Of Psychosis through interventions in the symptomatic prodromal phase. A pragmatic Norwegian Ultra High Risk study.
• Date of first enrolment: 01/03/2012
• Target sample size: 240
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN20328848
• Study type: Interventional
• Study design: Parallel control design comparing incidence of first episode psychosis between 2 catchment areas with Prodromal Detection and Treatment (PDT) (with two catchment areas without PDT program. (Treatment)
• Phase: Not Applicable

Countries of recruitment

Norway

Contacts

• Name: Jan Olav Johannessen

Key inclusion & exclusion criteria

Inclusion criteria: Incidence study inclusion criteria:
1. The patient is listed in the national register and residing in the catchment areas of Stavanger, Fonna, Bergen, and Østfold
2. Between 13 and 65 years
3. Meet diagnostic criteria in DSM-IV for first episode schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, affective psychoses (Bipolar I disorder, Bipolar II disorder with psychotic symptoms, Major depressive disorder with psychotic symptoms) or psychotic disorders NOS
4. The patient is (or has recently been) active psychotic with symptoms of delusions, hallucinations, disturbed thinking, unsuitable/bizarre behaviour which cannot clearly be explained by organic reasons. The symptoms must have lasted the whole day for several days or several times a week for several weeks, not limited to some brief moments corresponding to a score of at least 4 on one or more of the following positive and negative symptom scale (PANSS) symptoms: P1 (delusions), P3 hallucinations), P5 (grandiose thinking), P6 (suspiciousness) and G9 (unusual thought content); 5. This is the first episode of the condition that is being adequately treated. i.e. the patient has not received antipsychotic treatment corresponding to 75% of a defined daily dosage for more than eight weeks (shorter if the symptoms remit)
6. There are no known neurological or endocrine disorders that may have caused the presenting psychotic symptoms
7. The patient is not mentally retarded with an IQ below 70
8. Able to understand and speak Norwegian
9. Able to understand and sign informed consent/assent for minors' document.
Prodromal inclusion and exclusion criteria
1. The patient is listed in the national register and residing in the catchment areas of: Stavanger and Fonna
2. Between 13 and 65 years
3. Meet diagnostic criteria for prodromal syndrome SIPS criteria
4. Does not meet current or life-time criteria for any psychotic disorder
5. The symptoms are not better accounted for by an axis I, axis II or substance use disorder with the exception of schizotypal personality disorder (the presence of any of these disorders in itself is not an automatic reason for exclusion)
6. Does not use any antipsychotic medication currently and have not used antipsychotic medication (regardless of dosage) for more than four weeks lifetime
7. No known neurological or endocrine disorders that may have caused the presenting psychotic symptoms
8.The patient is not mentally retarded with an IQ below 70
9. The patient must be able to understand and speak Norwegian
10. The patient must be able to understand and sign an informed consent or assent for minors' document
Exclusion criteria: All referals not fullfilling inclusion criteria described above

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

First episode psychosis, schizophrenia/prodromal, ultra-high risk state/primary prevention
Mental and Behavioural Disorders

Intervention(s)

The study consenting prodromal patients will participate in an individual 2 year follow-along containing the following elements:
1. One-to-one monitoring of clinical status, symptom levels (prodromal and psychotic), risk profiles (suicidality, dangerousness), instrumental and social functioning
2. One-to-one case management to help deal with clinical, familial, social and vocational crises, needs and deficits
3. Omega-III fatty acids, in the form of 2g fish oils containing approx. 1.5 g Etyl-Eicosapentaeonic Acid/DHA with 80 mgs Vitamin E per day for 12 weeks
4. Individual cognitive behavioral therapy (CBT) to deal with social/cognitive distortions and deficits and to maintain real world investment (based on the EDIE II study. They will be offered 26 sessions of CBT within a six months period. The CBT sessions will be based on established cognitive models, be collaborative, problem orientated, formulation driven, normalizing, educational and time-limited with Socratic questioning/ guided discovery
5. Individuals that experience functional loss will in addition receive single-family psycho-education to inform patients and families about current problems, how to understand and cope with them, especially within the family.
6. Anti-anxiety agents and anti-depressants will be available if the patient is so symptomatic that they otherwise would be prescribed these agents by their GPs
7. Antipsychotic medication will be available if the patient either enters the study with any SIPS positive symptom score at the level of 5, or if any positive prodromal symptom score(s) moves from a level of 3 or 4 to a 5. Use will be open labeled based on the patients' current symptom profile. The type and dose of medication will be reviewed by an independent clinical practice safety monitoring board.

Primary Outcome(s)

The primary outcome will be the rate of conversion to psychosis. This is ascertained by the Structured Interview for DSM-IV (SCID) (Kiddie SADS for adolescents (13-17 years)) assisted by the Positive and Negative Syndrome Scale (PANSS).

Secondary Outcome(s)

1. If the combination of information campaigns and detection teams modelled will help in identifying individuals at high risk of developing psychosis early
2. If a graded, multi-modal treatment program will reduce rates of conversion compared to the rates seen in follow-along assessments.
3. Study number of days to convertion for those who develop first episode psychosis
4. Study number of/and days in treatment for individuals who progress to a state below prodromal/UHR state criteriea
Assessed monthly for the first six months and then every three months for the next eighteen months.

Secondary ID(s)

N/A

Source(s) of Monetary Support

The Norwegian Extra Foundation for Health and Rehabilitation through EXTRA funds (Norway), Health West trust grant (grant 911508 and grant 911881) (Norway)