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Comparison between extension of specialised early intervention for first episode psychosis and regular care: a randomised controlled trial

A randomised controlled evaluation of 'extended specialised early intervention service' versus 'regular care' for management of early psychosis over the five year critical period

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11889976
Enrollment
240
Registered
2009-06-10
Start date
2009-04-01
Completion date
Unknown
Last updated
2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First episode psychosis Mental and Behavioural Disorders Unspecified nonorganic psychosis

Interventions

Experimental intervention: extended specialised early intervention service (SEI) - Patients randomised to the experimental condition will receive an extension of the SEI service beyond

Sponsors

Douglas Hospital Research Centre (Canada)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The aim of our study is to demonstrate effectiveness of a model of care applicable to the largest number of persons with first episode psychosis (FEP) as they appear in clinical settings and not to show efficacy of a single treatment intervention for patients with pure unencumbered diagnoses. Therefore, the inclusion criteria are designed to recruit patients truly representative of FEP patients likely to be seen in any treatment facility: 1. Aged 18 - 35 years, either sex 2. Able to provide informed consent 3. Meeting Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for a psychotic disorder (schizophrenia spectrum psychoses and affective psychosis) confirmed by the Structured Clinical Interview for DSM-IV Axis I disorders Patient Edition 4. Have completed 24 months of treatment and follow-up in one of the two SEI services. Patients with co-morbid diagnosis of substance abuse and dependence will be included.

Exclusion criteria

Exclusion criteria: 1. Lack of ability to provide informed consent as assessed by requesting patient to provide brief summary of treatment protocol following presentation of the consent form 2. Lack of ability to speak either English or French fluently as assessed by the patient indicating English or French as the preferred language for communication 3. Intelligence quotient (I.Q.) below 70 as assessed using the Wechsler Adult Intelligence Scale (WAIS) short form

Design outcomes

Primary

MeasureTime frame
Defined by remission status, measured as the proportion of patients in complete remission (to make it comparable to the OPUS follow-up study in order to increase generalisability) achieved by patients for the entire period of three years of the additional intervention (following randomisation). Using sustained remission as the primary outcome measure is justified because of high association of length of remission and functional outcome (work and social functioning). Remission status will be measured upon entry and every three months (at evaluation) until completion at 3 years.

Secondary

MeasureTime frame
1. Clinical outcome, measured upon entry and every three months until completion 2. Functional outcome, measured every six months until completion 3. Quality of life, measured every six months until completion

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 5, 2026