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Department of Psychology, Institute of Psychiatry, King's College, London and South London and Maudsley NHS Trust, London
Health Services Research Department, Institute of Psychiatry, King's College, London
School of Epidemiology and Health Science, University of Manchester, Manchester
Department of Psychology, Institute of Psychiatry, King's College, London
Department of Psychiatry and Behavioural Sciences, Royal Free and University College London Medical School
South London and Maudsley NHS Trust, London, UK
Correspondence: Professor Philippa Garety, PO Box 77, Department of Psychology, Institute of Psychiatry, De Crespigny Park, London SE5 8AF, UK. Tel: +44 (0)20 7848 5046; e-mail: p.garety{at}iop.kcl.ac.uk
Declaration of interest None. Funding detailed in Acknowledgements.
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ABSTRACT |
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Aims To evaluate the effects of a service providing specialised care for early psychosis (the Lambeth Early Onsetteam) on clinical and social outcomes, and on service user satisfaction.
Method One hundred and forty-four people with psychosis, presenting to mental health services for the first or second time (if previously failed to engage in treatment), were randomly allocated to care by the early onsetteam or to standard care. Information was obtained on symptoms, treatment adherence, social and vocational functioning, satisfaction and quality of life. Relapse and rehospitalisation data have been reported separately.
Results Outcomes for the participants treated by the early onsetteam were significantly better at18 months for aspects of social and vocational functioning, satisfaction, quality of life and medication adherence. Symptom improvementdid not significantly differ between the groups.
Conclusions The provision of specialised care for early psychosis can achieve better outcomes. The study therefore provides support for current policy.
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INTRODUCTION |
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In this study we set out to investigate whether a new community team (the Lambeth Early Onset team), providing a specialist service for people with a non-affective psychosis who present to services for the first time (or second time, if they previously failed to engage in treatment), would achieve better outcomes than existing services. In an earlier study (Craig et al, 2004) we found evidence to suggest that the Lambeth Early Onset service achieved superior outcomes in rehospitalisation over 18 months and that participants maintained higher rates of contact with services. Participants were also less likely to relapse; however, when adjusted for baseline imbalances in gender, past episode and ethnicity, this improvement in relapse rate failed to remain statistically significant. The study reported here aimed to test the hypotheses that the intervention would be associated at 18 months with:
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METHOD |
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The experimental service
The Lambeth Early Onset team is a multidisciplinary team comprising one
team leader, one part-time consultant (2 sessions), one trainee psychiatrist,
a half-time clinical psychologist, one occupational therapist, four community
psychiatric nurses and two healthcare assistants. It was established in
January 2000 on principles of assertive outreach
(Department of Health, 2001), providing a single point of access for all the mental health and social
welfare needs of its patients, with an extended-hours service 5 days per week
(0.800 h to 20.00 h) and open from 09.00 h to 17.00 h at weekends and public
holidays. The interventions provided by the team were specially adapted for a
group with early psychosis and followed protocols and manuals from the Early
Psychosis Prevention and Intervention Centre
(1997) early intervention
service (Edwards & McGorry,
2002) and, for cognitive-behavioural therapy, pilot work conducted
locally (Jolley et al,
2003). A mix of medication management, cognitive-behavioural
therapy, vocational input and family interventions was provided according to
individual need. The emphasis of the whole programme was on helping the
patient retain or recover functional capacity to return to study or work, to
resume leisure pursuits and retain or re-establish supportive social networks.
A family and carers support group was established, as was a social activity
programme open to all patients in the service. Staff were selected who had an
interest in working with younger people and who were sensitive to the needs
and concerns of the local minority ethnic population.
Comparison services
For the borough of Lambeth, community services at the time were provided
through five mental health teams, each providing a range of assessment,
treatment and continuing care to a geographically defined sector. Sector teams
typically comprised psychiatrists, psychiatric nurses, occupational therapists
and part-time clinical psychologists. Each of these sector community teams was
associated with inpatient facilities on one of three hospital sites. Prior to
the establishment of the early onset team, all people presenting with
suspected first episodes of psychosis were seen either by the sector community
team or the associated in-patient service following referral from the person's
general practitioner, through accident and emergency departments of local
hospitals, or following contact with another statutory agency (e.g. police or
courts). If admitted, the patient was followed up by a sector team on
discharge.
The control condition was standard care as delivered by the sector community teams. These teams received no special training or support in the management of early psychosis, although they were not discouraged from following best practice guidelines. Given that the UK government's decision to implement early psychosis services and the publication of implementation guidelines on the management of early psychosis emerged during the life of the study, it is to be expected that all sector teams were attempting best practice within the limitations of generic services.
Participants, recruitment and randomisation
All patients aged 16-40 years with an address in Lambeth and presenting,
from January 2000 for an 18-month recruitment period, for the first time with
a non-affective psychosis (an ICD-10 diagnosis of F20-29: schizoaffective and
delusional disorders; World Health
Organization, 1992) were eligible for inclusion. Patients with
organic psychosis or with a primary alcohol or drug addiction were excluded.
In addition, patients who met these demographic and diagnostic criteria who
had presented once previously but had immediately disengaged and were not
known to any of the existing mental health services were also deemed eligible.
Inability to speak English was not an exclusion criterion, but asylum-seekers
who were liable to enforced dispersal were excluded. In order to identify
suitable patients, all admissions to hospital and all new referrals to
out-patient sector teams were screened over an 18-month period to identify
potential cases using a sensitive psychosis screening assessment
(Jablensky et al,
1992). Eligibility for the study was then confirmed by a member of
the research team (N.R.), who confirmed symptoms using the Item Group
Checklist of the Schedules for Clinical Assessment in Neuropsychiatry (SCAN;
Wing et al, 1990),
the likely date of onset of disorder and prior history of contact with
psychiatric services, and finally assigned a provisional diagnosis using the
Operational Clinical Research Criteria (OPCRIT;
McGuffin et al, 1991)
computer program.
Patients who were selected as eligible for the study were then randomly allocated to receive care from the early onset team or from sector community team services using a sequence of sealed, opaque envelopes containing the outcome of randomisation. The latter used randomised permuted blocks of varying block size between two and six. The process of randomisation and allocation was carried out independently of the research or clinical team by the trial statistician (G.D.), based in Manchester. The study was approved by the local research ethics committee and a decision was made to allow randomisation prior to seeking consent and as soon as possible after making initial contact with services. All patients were subsequently informed of the randomisation and written consent was then sought to collect outcome data from case notes and by interview. The rationale and procedure for this are fully described by Craig et al (2004). In practice, only one patient objected to the randomisation and was therefore treated by the local sector team, although this individual's data were analysed as allocated to the early onset team.
Measures
Standardised assessments by trained independent research staff were
administered at baseline within 1 week of randomisation and at 18 months'
follow-up.
Baseline assessments
Socio-demographic data were recorded, including age, gender, marital
status, accommodation, education and employment. The participants' clinical
state, overall functioning and levels of depression were assessed using the
following measures.
Clinical state. The Positive and Negative Syndrome Scale (PANSS; Kay et al, 1987) is a 30-item, seven-point rating instrument with sub-scale scores for positive symptoms, negative symptoms, general psychopathology and a total score (total scale range 30-210).
Overall functioning. The Global Assessment of Function (GAF; Endicott et al, 1976) is a widely used scale measuring overall functioning during the previous month, on a hypothesised continuum (scored 0-100) between severe psychiatric morbidity and health. It has been shown to have good interrater reliability for use with people with psychosis (Startup et al, 2002).
Depression. The Calgary Depression Rating Scale, a nine-item scale (score range 0-27) designed for rater assessment of symptoms of depression in people with schizophrenia, has been shown to have adequate reliability and validity (Addington et al, 1993).
Assessment at 18 months
Clinical measures were repeated as described above. In addition, the
following factors were assessed.
Insight and treatment adherence. The Scale for the Assessment of Insight (David et al, 1992) is a well-established measure of insight, assessed by nine items, six items scored 0-2 and three items scored 0-4, scale range 0-24 (high scores representing good insight). In the Expanded version (SAI-E; Kemp et al, 1998), adherence to medication is assessed by researcher interview using the compliance sub-scale of the SAI-E, resulting in a summary score on a scale of 1-7, where 1 represents complete refusal and 7 represents active participation, readily accepts and shows some responsibility for medication regimen. Adherence was also independently assessed over the entire 18 months from case-note records of prescribing and clinician-assessed adherence: time to first point of non-adherence to prescribed medication was defined as months from baseline to the first month in which it was recorded that the patient had discontinued the medication for any reason.
Satisfaction. The Verona Service Satisfaction Scale (Ruggeri & Dall'Agnola, 1993) professionals skills and behaviour' subscale (eight applicable items, scored 1-5, total scale range 8-40) is a self-report Likert scale addressing patients' satisfaction with community-based psychiatric services, with good sensitivity, test-retest reliability and content validity (Ruggeri et al, 1994). A separate summary item, belief that the treatment is right for you, is scored 1-10. The professionals' skills and behaviour sub-scale has been found to make a major contribution to reported satisfaction with services (Ruggeri et al, 1994).
Quality of life. The Manchester Short Assessment of Quality of Life (MANSA; Priebe et al, 1999) comprises 12 subjective items on a seven-point rating scale (from couldn't be worse to couldn't be better, scored 1-7, range 12-84), assessing satisfaction with life in general and in a range of domains, such as vocational, financial, friendships, leisure, personal safety, physical health and mental health. Four objective items, answered yes or no, assess the existence of a close friend, contacts with friends per week, accusation of a crime and victimisation of physical violence. It has good concurrent validity and internal consistency.
Clinical record data. The patients' clinical state, social functioning, contact with clinical services and uptake of treatment were monitored through their clinical case-note files across the entire 18-month period of the study. Detailed extracts concerning mental state, treatment adherence, service contact and interventions and social functioning were compiled, from which all information that might provide clues as to whether the patient was being seen by the early onset team or receiving standard care had been removed. These records were used to rate recovery and relapse in our earlier study by independent raters, masked to condition, with good interrater reliability (Craig et al, 2004), and were used in the same way in this study for rating social recovery cross-sectionally at the 18-month follow-up point, on a three-point scale (no, partial and full) of recovery to baseline levels, in the following areas:
The interrater reliability for ratings of social recovery was good or excellent (according to conventional evaluation of kappa values; Robson, 1993) (n=23; housing, k=0.69, P <0.001; vocational k=0.70, P <0.001; relationships, k=0.83, P <0.001).
Adverse incidents. Adverse incidents from NHS trust incident records and case-note data included death, prison, self-harm, violence to others and homelessness.
Assessor masking
The research assistants, although independent of service provision, were
not unaware of treatment group allocation; this was impracticable, given that
this was a study of the effects of allocation to a whole service. However, the
case-note data were rated masked to condition. In order to test the success of
the efforts to ensure masking, the two assessors guessed whether each
participant had been receiving care from the early onset team or the sector
community services. The two raters correctly guessed the allocation of 60% of
participants, which is marginally better than chance (95% CI 52-63%, k=0.20).
The adverse incident data were recorded and extracted for the whole sample by
trust staff masked to treatment condition.
Data analysis
The sample size for the study was calculated on the basis of the estimated
reduction in relapse rates (the primary outcome). A total of 120 patients were
required to show a reduction of relapses in the experimental condition at 18
months from 60% to 40% of the sample, with a power of 80% at
=0.05. The
analysis was done using STATA release 8
(StataCorp, 2003).
Intention-to-treat analyses compared the two groups in terms of
cross-sectional outcomes at 18 months, with all available participant data in
the analysis. First, for all variables except the case-note data and adverse
incidents, estimates of intervention effects on the outcome scores were
obtained through the use of a regression (analysis of covariance, ANCOVA)
using the relevant baseline score as a covariate if assessed; subsequent
analyses also entered as covariates ethnicity, gender and whether first or
second episode to allow for baseline imbalances in these variables. Finally,
the sensitivity of the results to the missing follow-up data was examined by
repeating the above regression analyses, but with the additional use of
inverse probability weighting (Heyting
et al, 1992; Everitt
& Pickles, 1999) to adjust for rates of attrition that were
dependent on both treatment group and selected baseline covariates. The
weights were determined (for each randomised group separately) using a
logistic regression to predict missing PANSS values, using ethnic group,
gender, number of previous episodes, contact with family and having a stable
relationship as predictors (the weight being the reciprocal of the predicted
probability of having a non-missing outcome measure). The clinical record data
outcomes, with low levels of missing data, were analysed for group differences
at 18 months by w2 tests or t-tests. A Cox's proportional
hazards model was used to test the association between non-adherence to
prescribed medication and group membership, ethnicity, gender and whether
first episode.
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RESULTS |
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Clinical outcomes, satisfaction and social outcomes
The summary data for the clinical measures (PANSS, GAF and Calgary
Depression Scale) at baseline and at 18 months are given in
Table 1. Comparisons were made
between groups on the scores for these measures by means of separate ANCOVAs,
first with baseline score as a covariate, then entering ethnicity, gender and
whether first or second episode as covariates. The estimated intervention
effects are shown in Table 2.
There was a trend for an effect of the intervention on PANSS total scores,
largely attributable to a significant effect on PANSS negative symptoms in the
first analysis; however, this effect becomes non-significant when adjusting
for differences in other baseline variables. There is no effect on the Calgary
Depression Scale. There are consistently significant effects on the GAF
favouring the intervention group.
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Data for insight, satisfaction, quality of life and interview-rated treatment adherence at 18 months are given in Table 3. Comparisons were made between groups for intervention effects using ANCOVAs, with a second analysis entering ethnicity, gender and whether first or second episode as additional covariates (Table 4). There is no effect on insight; however, there is a just-significant effect on treatment adherence and consistently significant effects on service user satisfaction and self-rated quality of life, all favouring the intervention group. Inspection of individual items reveals that the significant differences on the Verona Service Satisfaction Scale were attributable to satisfaction with the manners of staff, the perceived competence of staff, staff willingness to listen, satisfaction with the type of service offered, and the separate summary item: belief that the treatment is right for me (P <0.01). On the MANSA, individual subjective items reported by the intervention group as of better quality (P <0.10) were life in general, accommodation, people that you live with, relationship with family, physical health and mental health. The objective items (existence of a close friend, contacts with friends per week, accusation of a crime and victimisation of physical violence) did not differ between the groups.
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The analyses were then repeated allowing for the same baseline covariates, but with additional adjustments provided using inverse probability weights to allow for non-random patterns of missing data (see Tables 2 and 4). For the most part, these showed few differences from the results after adjustment for the baseline differences in ethnicity, gender and episode (the second sets of analyses). However, the effect on the Verona Service Satisfaction Scale is no longer significant.
The number of months for which the groups maintained adherence to prescribed medication was entered into a survival analysis (Fig. 2). A Cox's regression analysis showed that the groups differed significantly: the hazard ratio for the risk of discontinuing medication for a person in the control group was 1.5 times that of a person in the intervention group (n=131, hazard ratio 1.5, 95% CI 1.05-2.2; P=0.029). Half of the intervention group had first discontinued medication for any reason by 9 months, whereas half of the control group had first stopped taking medication by 5 months (Fig. 2). There was a slightly higher proportion of those who discontinued medication against medical advice at least once over the entire 18 months, as documented in the case notes, in the control group (95%; 57/60) compared with the intervention group (79%; 37/47).
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2 tests. Although housing and
vocational/educational outcomes do not significantly differ between groups,
relationships outcomes are significantly better in the intervention group.
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Any vocational and educational activity in a given month across the
18-month period, as recorded in the case notes, was also analysed. The
intervention group was engaged in an activity for significantly more months
(6.9 months, s.d.=6.6; n=67) than the control group (4.2 months,
s.d.=5.3; n=65); t=2.689, P=0.008. This advantage
for the intervention was also apparent when comparing the groups in terms of
those who had spent 6 months or more engaged in an educational or vocational
activity: intervention group 49% (33/67), control group 29% (19/65);
2=5.54, d.f.=1, P=0.019.
Adverse events and homelessness
At 18 months, one participant receiving standard care had died of unknown
cause and another was in prison. Adverse incident records from the clinical
services (in-patient and community) over the 18-month study period were
examined. These revealed that 12 members of the early onset team group (17%)
and 14 of the control group (19%) were recorded as involved in a violent act
towards a member of staff; 14 of the intervention group (20%) and 15 of the
control group (20%) were violent towards another patient or a member of the
public. Six of the intervention group (8%) and 5 of the control group (7%)
were recorded as having engaged in self-harm, such as taking an overdose. In
terms of homelessness, from case-note records and researcher enquiries, at 18
months, 1 participant from the intervention group and 2 from the control group
were homeless, and the whereabouts of 5 (7%) and 10 (14%) control participants
could not be ascertained. In terms of housing, 5 (7%) intervention group
members and 2 (3%) of the control group were in supported accommodation, 59
(83%) of the intervention group and 54 (74%) of the control group were in
independent accommodation or residing with family, and 1 of the intervention
group and 3 of the control group were in other (e.g. shared
housing).
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DISCUSSION |
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Symptoms
Despite the benefits described above, it appears that the specialist early
onset service does not specifically improve persisting symptoms. As would be
expected, given that the initial assessments were made in the acute episode of
illness and the follow-up was 18 months later, symptoms did improve
substantially over time in both groups. However, contrary to our hypothesis,
allocation to the early onset team service had few significant effects on
symptoms, with no effect on positive psychotic symptoms or general
psychopathology and no improvement on a scale of depression. There is some
evidence of benefits for negative symptoms; however, when adjustments are made
for chance baseline differences and to account for missing data, the
difference is no longer significant. Insight also was not significantly
improved. Given the evidence for the effectiveness of cognitive-behavioural
therapy in reducing persisting symptoms
(Pilling et al, 2002)
and the promising findings from the Study of Cognitive Reality Alignment
Therapy in Early Schizophrenia (SoCRATES) trial of psychological treatments in
early psychosis (Tarrier et al,
2004), it is not clear why early onset team care, which included
cognitive-behavioural therapy, did not result in greater symptomatic
improvements. The early onset service delivered interventions in a pragmatic
mix, according to patient preference and identified need. These interventions
were also provided in the control teams, although at a lower rate
(Craig et al, 2004).
It may be that a more systematic approach to the provision of
cognitive-behavioural therapy should be attempted in early intervention
services, ensuring that all who are willing to receive this therapy have a
reasonable number of sessions (at least ten;
National Institute for Clinical
Excellence, 2002) and especially targeting those with persisting
symptoms (Jolley et al,
2003).
Range of outcomes
A strength of this study is that it provides data on a range of outcomes.
Studies of clinical interventions or services for people with psychosis are
often criticised for providing only clinical data on relapses, readmission and
symptoms (National Institute for Clinical
Excellence, 2002). We report, in addition, service user
satisfaction data, quality of life and a range of social outcomes, and adverse
events. The satisfaction and quality of life data are encouraging, in that
they suggest that service users with early psychosis in general find the
provision of a service with active outreach acceptable. It is also noteworthy
that major adverse events were certainly not increased, if not significantly
less frequent, in the intervention group. Of course, this study does not tell
us how the improvements occurred; it was not designed or powered to test
hypotheses concerning mediators of treatment outcomes. It is possible that key
factors resulting in reductions in relapse and rehospitalisation were the
maintenance of contact with service users and continuance of medication. It is
perhaps less plausible to attribute the social and vocational benefits to
these variables alone; we suggest that the team's explicit focus on work in
these areas was important. Given the importance of employment in assisting in
the long-term recovery from schizophrenia
(Warner, 1994) and the
beneficial role of protective social relationships (e.g.
Jablensky et al,
1992), this study adds to the literature by demonstrating it is
possible to intervene to improve these factors by offering an early psychosis
service.
Limitations of the study
The study had a number of methodological limitations. The sample size was
designed to be adequate for the primary outcome of relapse, but proved
somewhat underpowered for the adjustments required by chance baseline
differences in variables likely to affect outcome. Another methodological
concern was follow-up rates. We had previously discovered that there was a
high rate of disengagement and loss to clinical follow-up from existing
services in this early psychosis group within the Lambeth inner-city area
(Garety & Rigg, 2001).
Thus, although one strength of the study was its inclusion of all first
episodes from a defined geographical area, enhancing the generalisability of
our findings, this strategy paradoxically also led to a substantial limitation
as it necessarily increased the inclusion of substantial numbers of patients
who would traditionally fail to engage with treatment or agree to participate
in detailed follow-up interviews. We anticipated that this might prove a
problem as it has also been reported in other studies (e.g.
Kemp et al, 1998) and
might also result in differential attrition between groups, given that the
Lambeth Early Onset service was aiming explicitly to improve rates of contact.
This proved to be the case despite vigorous attempts at follow-up. To deal
with this, in order to reduce sole reliance on face-to-face contacts, case
notes and other routinely collected clinical records (e.g. adverse incidents)
were used, where possible, to provide data for some of our secondary outcomes.
Where reliance on face-to-face research interviews was necessary, for example
for clinical symptom assessments and service user satisfaction, we employed
statistical techniques to test for the sensitivity of the results to the
non-randomness of missing data. Not being in a stable relationship and not
having contact with family members at baseline predicted missing data at 18
months. In general the results were not changed by the sensitivity tests;
however, there was an effect on the satisfaction results, which suggests that
the satisfaction data should be treated with some caution. A third limitation
is that the research assessors were not masked to condition. Trials with
inadequate allocation concealment have been shown to report larger treatment
effects than those in which concealment has been achieved
(Schulz et al, 1995).
Given that this was a trial of allocation to a complete service, rather than a
study of a discrete and time-limited intervention, masking was not possible,
since it was not possible (or safe) to contact participants totally
independently of the clinical service. The outcomes reported in this study
are, however, not restricted to assessor ratings. Finally, this is a study of
a new team from its inception. None of the original team had prior experience
in early intervention. As has been noted, this team was learning on the job
and developing skills as the study progressed
(Singh, 2005). This may have
limited the capacity of the clinicians in this new team to deliver the most
effective mix of interventions.
The Lambeth Early Onset trial adds to the evidence base by demonstrating that a newly formed specialist early intervention team achieved improved outcomes at 18 months in a number of different outcome domains, when compared with the provision of services by generic teams. It would clearly be of interest to examine the effects of this service over a longer follow-up period and also to compare the effects of a specialist team with the provision of phase-specific interventions delivered by a different service model, such as specialist workers within generic teams. However, this study does provide support for the current UK policy on early intervention.
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Clinical Implications and Limitations |
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LIMITATIONS
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ACKNOWLEDGMENTS |
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Received for publication December 3, 2004. Revision received March 7, 2005. Accepted for publication March 11, 2005.
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