Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-94189
Study information
Scientific title
A randomised controlled evaluation of 'extended specialised early intervention service' versus 'regular care' for management of early psychosis over the five year critical period
Acronym
PEPP RCT
Study hypothesis
Primary hypothesis:
Individuals in the experimental group will show higher rates of symptomatic remission and experience longer periods of remission than the control group throughout the extension period of three years.
Secondary hypotheses:
1. The difference in remission rates will be mediated by the level of medication adherence in the two groups
2. As the experimental group is expected to have higher levels of working alliance with their treatment providers than the control group, we hypothesise that the difference in the level of medication adherence between the two groups and retention in treatment will be predicted by working alliance
3. The experimental group will have better clinical outcomes (lower relapse rates and levels of symptoms), functional outcomes (social/occupational functioning), and quality of life than the control group
Finally, we will assess the cost-effectiveness of extended specialised early intervention (SEI) versus the control intervention. A hypothesis for this is not easily justified as the determination of whether the greater benefits are worth the extra cost, if incurred, is a matter of judgement. Cost-effectiveness analysis serves to clarify just what additional resources are required to achieve a given degree of additional benefit.
Ethics approval
Douglas Institute Research Ethics Board (REB) approved in June 2007; last modification approved in November 2008.
Study design
Open-label randomised controlled design
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
First episode psychosis
Intervention
Experimental intervention: extended specialised early intervention service (SEI) -
Patients randomised to the experimental condition will receive an extension of the SEI service beyond the current two years. It is important to recognise that it is the effectiveness of the total package of an extended SEI service, with its multiple components and not any single component of that model that is being tested. Individual treatment components included in the SEI extension are described below briefly with each component having its efficacy already well established in numerous controlled studies. The entire 'package' meets standards of optimum SEI service as outlined in the International Early Psychosis Association guidelines and has been proven to be effective after two years of delivery in several randomised controlled trials (RCTs) (e.g., the OPUS trial). In the proposed study, the SEI service will be extended for an additional three years for the experimental condition to cover the entire 'critical period'. Specifically, patients in the extended SEI service will receive the following:
1. Modified assertive case management
2. Continued emphasis on appropriate treatment goals
3. Continued family support and intervention
4. Cognitive Behaviour Therapy (CBT)
5. Treatment of problems associated with substance abuse
Control intervention: SEI for two years followed by regular care -
Patients randomised to the control condition will receive treatment as usual in general medical or regular psychiatric services that are normally available to all patients in the absence of an SEI service. Under usual circumstances, patients are provided treatment in a variety of settings and there is often great variability in the level and quality of care received by patients. Regular care can include any of the following:
1. Hospital out-patient services where most of the care is provided by psychiatrists with or without nursing or other professional involvement
2. Care by psychiatrists in community office practice
3. Care by family physicians with variable support from psychiatric services. Such care is usually provided in settings that treat other psychiatric patients with a variety of diagnoses and different levels of chronicity.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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 outcome measures
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
Overall trial start date
01/04/2009
Overall trial end date
01/04/2014
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
240
Participant 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
Recruitment start date
01/04/2009
Recruitment end date
01/04/2014
Locations
Countries of recruitment
Canada
Trial participating centre
Douglas Hospital Research Centre
Montreal
H4H 1R3
Canada
Sponsor information
Organisation
Douglas Hospital Research Centre (Canada)
Sponsor details
Perry Pavilion
Fourth Floor
Rm. E-4206
6875 LaSalle Blvd.
Borough of Verdun
Montreal
Quebec
H4H 1R3
Canada
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-94189)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25784411