Abstract
Internationally and locally there is interest in improving services to young people in the early phase of psychotic illness. In Australia, over the past decade, many mental health services have reoriented, aiming to provide better treatments for young people with psychotic disorders. The Early Psychosis Prevention and Intervention Network for Young People (EPPINY) of the Northern Sydney Area Health Service, is one such service. The aim of the EPPINY project was that through staff education and service restructuring, there would be improvement in treatments and concomitant improvements in clinical outcomes.
There are two cornerstones to the early psychosis intervention philosophy: intervene early and intervene well. The question of when to intervene relates to research firstly on the putative prodrome [1–6] and secondly on the longer term impact of the duration of untreated psychosis [6–22]. Providing earlier treatment for psychosis is an important long-term goal of our Area Health Service, but our initial priority was to provide high quality treatment [4], [5], [12],[23–26].
The key components of this ‘high quality’ treatment include low-dose antipsychotic medication [27–35], working with families [36–43] and individual therapy, including psychoeducation, supportive therapy and cognitive therapy [41],[43–48]. To date, research demonstrating the efficacy of these interventions for early psychosis is limited and lags behind clinical practice [49].
Outcome studies of early intervention programs
Two important studies have compared specialized early psychosis intervention programs with treatment as usual.
The Early Psychosis Prevention and Intervention Centre (EPPIC) in Melbourne, compared young people from the first-episode early psychosis treatment program in 1993, to an historical control receiving standard care from 1989 to 1992 [12]. Key elements of the early psychosis treatment program included a mobile assessment team, reduced inpatient treatment, continuity of care, a day program for recovering patients, specialist family work, cognitively orientated psychotherapy for early psychosis and low dose medication strategies. Levels of psychopathology, as reflected in the total Brief Psychiatric Rating Scale (BPRS) scores, were comparable in the first 12 months for the two samples. Data show that despite low-dose medication, the EPPIC sample achieved equally good remissions and equally low subsequent levels of positive symptoms as the historical control. Levels of negative symptoms however, were significantly higher in the EPPIC sample at the initial stabilization or recovery point, but significantly lower during subsequent follow-up compared with the control group. There was no difference in depressive symptomatology between the two groups. In addition, economic evaluation found the EPPIC program to be more cost-effective than the pre-EPPIC program over a 12-month follow-up period [50–52].
The Swedish ‘Parachute Project’ [32] compared an experimental group with both an historical and a prospective control group. The experimental group were patients treated in 17 centres in Sweden for a first psychotic episode in 1996 and 1997. There were no fixed treatment schedules but individualized treatments were directed by principles such as treatment without delay, family meetings, individualized psychotherapy, specialized stable treatment team, low dose medication and the availability of crisis home care.
The historical control group comprised first-episode psychosis patients treated with standard care in 1991 and 1992. The prospective control group received treatment as usual in the Uppsala University Hospital between 1995 and 1997, which consisted of inpatient treatment initially with low dose medication but no specific psychological or family treatment.
The 1-year follow-up data indicate that the experimental group differed significantly from other groups, having a higher level of satisfaction with care and a reduction in inpatient care. Global Assessment of Functioning values for the experimental group were similar to the prospective control but significantly better than the historical comparison group. Psychiatric symptoms measured by the BPRS at 12 months were similar in the prospective and experimental groups. Unfortunately, BPRS measures were not available for the historical control. In exploring the findings of this project, McGorry comments that the control group of the University clinic was not actually ‘standard care’ but in fact above average ‘standard’ [53].
The clinical approaches outlined in these two projects provided the direction for the education program and restructuring of our service in northern Sydney. The aim of this paper is to describe the effects of these changes on clinical outcomes in a naturalistic study.
Additional aims of the research project include the evaluation of service provision, published in this edition [54] and staff attitudes toward early intervention for first-episode psychosis [55]. Service provision was measured by a medical record audit of all firstepisode patients over two separate 6-month periods. The first, in 1997, occurred prior to staff education and service restructuring while the second audit, in 1999, occurred during ongoing staff training and after specialized early psychosis services had been established. The audit found there was a significant improvement in 10 out of the 23 clinical indicators that were measured. This included increases in the provision of psychoeducation, relapse prevention strategies, continuity of care, involvement of families and prescribing practices consistent with a low-dose medication approach [54].
Method
The Early Psychosis Prevention and Intervention Network for Young People began in 1997. Interested staff from the adult and adolescent services in Northern Sydney met monthly with the aim of improving services provided to young people with psychotic disorders. Staff education was the initial aim of EPPINY but as the group gathered momentum service restructure was also addressed.
Staff education
Workshops addressed early intervention strategies for medication, psychological, family and social interventions. Other topics included adolescent development, drug and alcohol comorbidity and cognitive therapy. Workshops were supported at a managerial level and were open to all adult, adolescent, inpatient and community staff members. Initially, the EPPINY committee chose the content of the workshops, but later this was determined by staff surveys.
Changes in service delivery
Northern Sydney Mental Health Service encompasses a population of 750 000, and is comprised of four sub-areas. The first sub-area early psychosis intervention team began in February 1998. By early 2000 three of the four adult community services had re-orientated to create a specific early psychosis intervention team. The fourth sub-area elected to have a part-time early psychosis co-ordinator working within a general adult mental health team. This sub-area also managed a house for early psychosis patients with staff visiting daily.
There was no additional mental health funding for these changes. There was, however, considerable clinician and managerial support and gradually shifting staff and facilities toward the management of early psychosis patients.
The early intervention teams provided assertive community treatment case management in a youth-friendly environment. Regular evening family education meetings were available in all sub-areas. Other key features of the treatment were a strong focus on engagement of the patient and family, low-dose antipsychotic medication, supportive and cognitive therapy, individual and family psychoeducation, availability of family therapy, recovery-focused rehabilitation with resumption of work and studies prioritized and availability of day programs with social and psychoeducational component. These specialized teams function within an integrated mental health service which provides 24-hour, seven days per week crisis intervention, assertive community care and acute inpatient care if required.
Participants
All individuals aged between 15 and 26 entering the Northern Sydney Mental Health Services between January 1998 and December 1999 for first treatment of a first psychotic episode were eligible to participate in the study.
Procedure
The study was approved by the three area ethics committees of Northern Sydney Mental Health Service. However, considerable potential data was lost through delays at this level, resulting in the staff education process beginning 6 months prior to the collection of outcome measures.
The education component of the project commenced in 1997, while service restructuring and data collection commenced in 1998. Therefore, no true historical control was possible; rather, patients receiving treatment in the early phase of the project were compared with patients of the middle and latter phase of the project.
Case managers invited their patients to participate in the research project. The case manager co-ordinated the completion of the scales at intake, 3 months and 12 months. There was no extra time or funding allocated to clinicians to perform this additional task, but it encouraged a culture of routine outcome assessment in the service. Approximately 100 clinicians from across the area were trained in the reliable use of the assessment instruments. Completed questionnaires were returned to the research team along with the patient's written consent.
Measures
The assessment package contained questionnaires rated variously by the clinician, the carer (usually family member) and the young person themselves. Psychiatric symptoms, suicidality, substance use, general health and social functioning, life skills, quality of life, service satisfaction and the experience of caregivers were measured [Table 1.
Early Psychosis Prevention and Intervention Network for Young People (EPPINY) project outcome measures
This paper reports upon clinical outcomes as rated by the case manager using the Brief Psychiatric Rating Scale-Extended (BPRS-E), the Scale for the Assessment of Negative Symptoms (SANS), and the Health of the Nation Outcome Scale (HoNOS). There were insufficient numbers returned of the other questionnaires to analyze statistically.
Statistical methods
Clinical improvements over the first 12 months of treatment were analyzed using all the available data (intake, n = 75; 3 months, n = 56; 12 months, n = 36). A 3 · 4 (assessment points by scale scores) repeated measures ANOVA was employed to identify differences in outcome scores across the assessment periods. Two a priori contrasts were carried out to investigate patterns of improvement. The first contrast compared the intake assessment with the 3-month assessment. The second contrast examined whether continued improvements were present from 3 to 12 months of treatment. A Bonferroni correction was employed and a p-value of 0.025 was considered significant.
Impact of service improvements on 12-month clinical outcomes were addressed using the 36 patients for whom 12-month data was available. These patients were divided into three groups according to when they entered the service. The ‘early’ group entered the service during the first 8 months of data collection between January and August, 1998 (n = 14), the ‘mid’ group entered the service in the middle 8 months, between September, 1998 and April, 1999 (n = 13) while the ‘late’ group entered between May and December, 1999 (n = 9), being the final 8 months of entry into the project. A 3 · 4 (entry groups by measures) ANOVA was conducted to investigate differences in 12-month clinical outcomes for the three groups. Two a priori contrasts compared the ‘early’ and ‘late’ groups and the ‘mid’ group and the ‘late’ group. A Bonferroni correction resulted in an alpha level of 0.025 being considered significant.
Results
Characteristics of the sample
In total, 215 first-episode psychosis patients were registered with the project. Of these, 94 consented to participate in the study and provided data. Patients who participated in the project did not differ from the non-participants in age, gender or diagnosis (p < 0.23). Intake assessments were completed for 75 people, 3-month assessments for 56 people and 12-month assessments for 36 people. A complete data set of intake, 3-month and 12-month measures was available for 22 people and these patients are referred to as the matched sample.
The most common reason given for non-completion of intake assessments was that the patient was considered too unwell to give informed consent. Discharge from the service and insufficient contact for the completion of measures were the primary reasons given for the non-completion of 3- and 12-month assessments. As case managers completed the assessment tools, non-completion may reflect case manager differences such as attitudes towards routine outcome assessment and early intervention, as well as patient characteristics such as willingness to participate. At all three time periods staff shortages also hindered data collection. Of the 94 people participating in the study, 68% were male. The average age at intake was 20.4 years (SD = 2.7, range = 15–25).
Comparison between matched sample and other patients
The symptomatology of the matched sample did not differ significantly from the larger sample at intake and 3 months (intake: p < 0.21; 3 months: p < 0.20). At the 12-month assessment, the matched sample had a significantly lower BPRS total score (F = 10.12; df = 1,31; p = 0.03); BPRS positive psychotic index (F = 12.76; df = 1,32; p = 0.001) and HoNOS total score (F = 5.88; df = 1,32; p = 0.02). However, their level of negative symptomatology as measured by the SANS summary score did not differ from those in the larger group (F = 0.84; df = 1, 31; p = 0.37) [Table 2.
Descriptive statistics for measures of psychiatric symptomatology by assessment point
Clinical improvements over first 12 months
Analysis of variance revealed significant improvements on the four measures of symptomatology (BPRS total score, BPRS Positive Psychotic Index, SANS summary score and HoNOS total score) over the first 12 months of treatment for the matched sample. BPRS total score (F = 16.5; df = 2, 24; p < 0.0005), BPRS Positive Psychotic Index (F = 32.8; df = 2, 24; p < 0.0005), SANS summary score (F = 9.6; df = 2, 24; p < 0.0005), HoNOS total score (F = 19.0; df = 2, 24; p < 0.005).
A priori contrasts [Table 3 revealed that for these four measures there was a significant improvement in symptomatology from intake to the 3-month assessment. There was no significant further change in scores from the three to the 12-month assessment for any measure. Thus, for this sample, gains were made in the first 3 months of treatment and these were maintained but no further significant improvements in symptomatology occurred.
Change in psychiatric symptomatology over the first 12 months of treatment
The improvement from intake to three months was confirmed with data from a larger sample of 44 patients who had completed the intake and 3-month but not 12-month assessments. The pattern of results for this larger sample was the same as those found for the matched sample with significant improvements on all four measures (all p < 0.05).
Impact of service improvements on 12-month clinical outcomes
The 36 patients with complete 12-month data were included in this analysis of variance. There were no significant differences among the early (n = 14), mid (n = 13) and late (n = 9) entry groups for BPRS total score (F = 0.88; df = 2, 39; p = 0.43), BPRS Positive Psychotic Index (F = 0.72; df = 2, 40; p = 0.49) and HoNOS total score (F = 0.15; df = 2, 39; p = 0.86). The main effect for the SANS summary score resulted in a trend (F = 2.86; df = 2, 41; p = 0.07), indicating some differences in the level of negative symptoms at the 12-month assessment among the three entry groups. As the BPRS and HoNOS did not show any overall differences according to entry group, contrasts were only conducted on the SANS summary score. The first contrast was significant (p = 0.019), indicating fewer negative symptoms at 12 months for the patients entering the service late in the project compared with those entering the service early in the project. The second contrast was not significant, indicating that there were no differences in negative symptomatology across the shorter period from the mid to the late groups.
Discussion
Young people receiving treatment for their first psychotic episode experienced significant improvements in symptoms during the first 3 months of treatment. These gains were maintained at 12 months on all measures.
A comparison of 12-month outcomes between people treated in the early phase of the project and those treated in the late phase showed significant differences in their level of negative symptomatology. Young people entering the service later in the project had lower levels of negative symptoms at 12 months compared with those entering the project in the early phase, while those entering during the mid phase of the project did not differ from those entering later in the project. This suggests that improved outcomes were a gradual process over time.
The findings suggest that services provided in the second half of 1999 were more effective in the treatment of negative symptoms than services provided early in 1998. Changes in psychosocial treatments provided to patients, found by file audit, include an increase in individual psychosocial interventions (psychoeducation, group programs, case manager visits to inpatient units) and family interventions (psychoeducation, multiple family groups). Concurrent with this, there was a significant change in prescribing practices, with an increase in the use of atypical antipsychotic medication as first-line treatment and an increase in the use of benzodiazepines as adjunctive therapy [54].
Interestingly, the literature on the impact of atypical antipsychotic medications on negative symptoms is not yet conclusive. Some studies have found improvement in negative symptoms when compared to the typical antipsychotic agents [56–58]. However, one study found that the improvement was in secondary negative symptoms only (that is, those secondary to medication) [59] and another study found no beneficial effect of atypicals over typical antipsychotic medications on negative symptoms [60]. This is complicated further by the dose of medication in the comparisons. A meta-analysis [61] found that there was no clear evidence that atypical antipsychotic medications were more effective in the treatment of negative symptoms when the dose of typical antipsychotic medication was less than 12 mg/day of haloperidol (or equivalent).
In addition to the change in prescribing practices, one could speculate that the increased availability of psychosocial and family interventions [54] may have had some impact on negative symptoms. This was also combined with a positive change in staff attitudes toward early psychosis intervention treatments [55]. Medication adherence, patient engagement and hopeful attitude may also have had an impact but were not measured here.
Methodologically, it must be emphasized that this was a naturalistic study. There was no true historical control, partly due to the delays of the multiple ethics committees and the onerous consent process required. This resulted in data collection commencing 6 months after the education program commenced. Most importantly, the small return of all questionnaires, whether completed by clinician, family or patient, provides limited data. This can be explained by the complex consent process, in part due to the lack of funding for a researcher to conduct the questionnaires, and the concomitant reliance on the clinicians to complete this process. This resulted in a small, probably biased sample in terms of both patient and case manager characteristics. The patients who had questionnaires completed at all three time-periods may have been due to their own ill health, thus staying in treatment for the year, or it may have been a function of the case manager's determination to co-operate with the study program, and possibly other aspects of recommended care for this group of patients. However, this potential for bias would have occurred equally across all three time-periods. In addition, clinicians found that patients were often too unwell to provide informed consent for participation in the research project within the first month of treatment. The now mandatory collection of some of these measures in Australia would overcome this difficulty in future studies. The advantage of clinicians collecting the data, however, was that more than 100 clinicians were trained in the reliable use of the BPRS, HoNOS and SANS and an ethos of routine outcome assessment has been introduced into our early psychosis teams.
If a true historical control had been possible with data collected prior to the education program and service restructure, change in patient outcome may indeed have been greater. The file audit paper examines services provided prior to the education and restructuring intervention and supports this suggestion.
The small number of patient and family questionnaires returned precluded us from commenting on social functioning, patient and carer satisfaction and drug and alcohol use. Rate of premature drop-out from treatment, medication compliance, duration of untreated psychosis, premorbid adjustment, and cognitive function are also important issues that warrant assessment in future studies [18], [20], [62].
This was a ‘real-world’ study with methodological limitations and thus only speculative conclusions are possible. The enthusiasm of clinicians to improve service delivery to young people with psychotic disorders and their families has been a highlight of this project. Changes in service provision, in particular prescribing practices and psychosocial interventions, and changes in the attitudes of staff members toward treating patients with early psychosis were achieved. This combination of attitudinal and practice change is the most likely explanation for the demonstrated improvement in negative symptoms at 12 months.
Footnotes
Acknowledgements
We thank the patients and clinicians of the Northern Sydney Area Mental Health Service, and Dr Kowalenko and Dr O'Connor. Research funding was from the Commonwealth Department of Health and Aged Care and Northern Sydney Area Health Service. Dr Nash received a New South Wales Institute of Psychiatry Area of Need Fellowship in 1997.