Comparison between extension of specialised early intervention for first episode psychosis and regular care: a randomised controlled trial
| ISRCTN | ISRCTN11889976 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11889976 |
| Protocol serial number | MCT-94189 |
| Sponsor | Douglas Hospital Research Centre (Canada) |
| Funder | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-94189) |
- Submission date
- 20/03/2009
- Registration date
- 10/06/2009
- Last edited
- 06/07/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ashok Malla
Scientific
Scientific
Douglas Hospital Research Centre
6875 LaSalle BLVD
Montreal
H4H 1R3
Canada
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open-label randomised controlled design |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | PEPP RCT |
| Study objectives | 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(s) | Douglas Institute Research Ethics Board (REB) approved in June 2007; last modification approved in November 2008. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. Clinical outcome, measured upon entry and every three months until completion |
| Completion date | 01/04/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 240 |
| Total final enrolment | 217 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/04/2009 |
| Date of final enrolment | 01/04/2014 |
Locations
Countries of recruitment
- Canada
Study participating centre
Douglas Hospital Research Centre
Montreal
H4H 1R3
Canada
H4H 1R3
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2019 | 06/07/2020 | Yes | No |
| Protocol article | protocol | 14/02/2015 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
06/07/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
