BRITISH JOURNAL OF PSYCHIATRY (2006), 188, 37^45 Specialised care for early psychosis: symptoms, social functioning and patient satisfaction Randomise

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1 BRITISH JOURNAL OF PSYCHIATRY (2006), 188, 37^45 Specialised care for early psychosis: symptoms, social fuctioig ad patiet satisfactio Radomised cotrolled trial PHILIPPA A. GARETY, TOM K. J. CRAIG, GRAHAM DUNN, MIRIAM FORNELLS-AMBROJO, SUSANNAH COLBERT, NIKOLA RAHAMAN, JASON REED ad PADDY POWER Backgroud The provisio of early itervetio services for people with psychosis is UKgovermet policy, although evidece for beefit of such services is sparse. Aims To evaluate the effects of a service providig specialised care for early psychosis (the Lambeth Early Osetteam) o cliical ad social outcomes, ad o service user satisfactio. Method Oe hudred ad forty-four people with psychosis, presetig to metal health services for the first or secod time (if previously failed to egage i treatmet), were radomly allocated to care by the early osetteam or to stadard care.iformatio was obtaied o symptoms, treatmet adherece, social ad vocatioal fuctioig, satisfactio ad quality of life.relapse ad rehospitalisatio data have bee reported separately. Results Outcomes for the participats treated by the early osetteam were sigificatly better at18 moths for aspects of social ad vocatioal fuctioig, satisfactio, quality of life ad medicatio adherece. Symptom improvemet did ot sigificatly differ betwee the groups. Coclusios The provisio of specialised care for early psychosis ca achieve better outcomes.the study therefore provides support for curret policy. Declaratio of iterest Noe. Fudig detailed i Ackowledgemets. The provisio of specialist metal health services for people early i the course of their psychotic disorder is a matter of cosiderable debate worldwide (McGorry et al,, 1996; Pelosi & Birchwood, 2003). Despite the cotroversy, the adoptio of early itervetio services is ow policy i the UK (Departmet of Health, 2001). There are few radomised cotrolled trials of early itervetio, ad prelimiary fid- igs have bee reported oly for the OPUS study i Demark (Nordetoft et al,, 2002) ad for a small study i south Lodo (Kuipers et al,, 2004). Although people with first episodes of psychosis respod well to iitial treatmet, they frequetly relapse ad a substatial proportio of people develop persistig symptoms (Maso et al, 1995; Wiersma et al,, 1998; Robiso et al,, 1999). Social ad fuctioal deteriora- tio is also a marked feature of the early course of the disorder (Wyatt et al,, 1997; Birchwood et al,, 1998). I aimig to improve these outcomes, some offer a pack- age of care ad itervetios especially adapted for people with early psychosis (Cullberg et al,, 2002; Nordetoft et al, 2002; Malla et al,, 2003; Kuipers et al, 2004); other iitiatives ivolve the pro- visio of idividual treatmets, such as cogitive behavioural therapy ad sup- portive cousellig (Lewis et al,, 2002; Tar- rier et al,, 2004), or family itervetios (Zhag et al,, 1994; Lisze et al,, 1996). It is therefore importat to examie a rage of outcomes. I this study we set out to ivestigate whether a ew commuity team (the Lambeth Early Oset team), providig a specialist service for people with a o- affective psychosis who preset to services for the first time (or secod time, if they previously failed to egage i treatmet), would achieve better outcomes tha exist- ig services. I a earlier study (Craig et al,, 2004) we foud evidece to suggest that the Lambeth Early Oset service achieved superior outcomes i rehospitalisatio over 18 moths ad that participats mai- taied higher rates of cotact with services. Participats were also less likely to relapse; however, whe adjusted for baselie imbal- aces i geder, past episode ad ethicity, this improvemet i relapse rate failed to remai statistically sigificat. The study reported here aimed to test the hypotheses that the itervetio would be associated at 18 moths with: (a) lower symptoms ad improved isight; (b) better adherece to prescribed medi- catio; (c) greater satisfactio with services ad quality of life; (d) better social fuctioig, icludig occupatio, housig ad relatioships; (e) fewer adverse evets, icludig home- lessess, violece ad self-harm; (f) lower overall costs of care (to be reported separately). METHOD Study desig ad cotext The study was a radomised cotrolled trial (Iteratioal Stadard Radomised Cotrolled Trial Number ). Eligible patiets were radomly allocated to care from the early oset team or from a commuity metal health sector team. The settig, Lambeth, is a socially deprived ad ethically diverse ier-city borough of Lodo. Metal health services for the borough are provided by the South Lodo ad Maudsley Natioal Health Service (NHS) Trust. The experimetal service The Lambeth Early Oset team is a multi- discipliary team comprisig oe team leader, oe part-time cosultat (2 ses- sios), oe traiee psychiatrist, a half-time cliical psychologist, oe occupatioal therapist, four commuity psychiatric urses ad two healthcare assistats. It was established i Jauary 2000 o prici- ples of assertive outreach (Departmet of Health, 2001), providig a sigle poit of access for all the metal health ad social welfare eeds of its patiets, with a exteded-hours service 5 days per week (0.800 h to h) ad ope from h to h at weekeds ad public holidays. The itervetios provided by the team were specially adapted for a group with early psychosis ad followed protocols ad mauals from the Early Psychosis 37

2 GARETY ET AL Prevetio ad Itervetio Cetre (1997) early itervetio service (Edwards & McGorry, 2002) ad, for cogitive behavioural therapy, pilot work coducted locally (Jolley et al,, 2003). A mix of medi- catio maagemet, cogitive behavioural therapy, vocatioal iput ad family itervetios was provided accordig to idividual eed. The emphasis of the whole programme was o helpig the patiet retai or recover fuctioal capacity to retur to study or work, to resume leisure pursuits ad retai or re-establish suppor- tive social etworks. A family ad carers support group was established, as was a social activity programme ope to all patiets i the service. Staff were selected who had a iterest i workig with youger people ad who were sesitive to the eeds ad cocers of the local mior- ity ethic populatio. Compariso services For the borough of Lambeth, commuity services at the time were provided through five metal health teams, each providig a rage of assessmet, treatmet ad co- tiuig care to a geographically defied sector. Sector teams typically comprised psychiatrists, psychiatric urses, occu- patioal therapists ad part-time cliical psychologists. Each of these sector commuity teams was associated with i- patiet facilities o oe of three hospital sites. Prior to the establishmet of the early oset team, all people presetig with sus- pected first episodes of psychosis were see either by the sector commuity team or the associated i-patiet service followig referral from the perso s geeral practitioer, through accidet ad emergecy de- partmets of local hospitals, or followig cotact with aother statutory agecy (e.g. police or courts). If admitted, the pa- tiet was followed up by a sector team o discharge. The cotrol coditio was stadard care as delivered by the sector commuity teams. These teams received o special traiig or support i the maagemet of early psychosis, although they were ot discouraged from followig best practice guidelies. Give that the UK govermet s decisio to implemet early psychosis services ad the publicatio of implemetatio guidelies o the maage- met of early psychosis emerged durig the life of the study, it is to be expected that all sector teams were attemptig best practice withi the limitatios of geeric services. Participats, recruitmet ad radomisatio All patiets aged years with a address i Lambeth ad presetig, from Jauary 2000 for a 18-moth recruitmet period, for the first time with a o- affective psychosis (a ICD 10 diagosis of F20 29: schizoaffective ad delusioal disorders; World Health Orgaizatio, 1992) were eligible for iclusio. Patiets with orgaic psychosis or with a primary alcohol or drug addictio were excluded. I additio, patiets who met these demo- graphic ad diagostic criteria who had preseted oce previously but had immedi- ately disegaged ad were ot kow to ay of the existig metal health services were also deemed eligible. Iability to speak Eglish was ot a exclusio criter- io, but asylum-seekers who were liable to eforced dispersal were excluded. I order to idetify suitable patiets, all admissios to hospital ad all ew referrals to out- patiet sector teams were screeed over a 18-moth period to idetify potetial cases usig a sesitive psychosis screeig assess- met (Jablesky et al,, 1992). Eligibility for the study was the cofirmed by a member of the research team (N.R.), who cofirmed symptoms usig the Item Group Checklist of the Schedules for Cliical Assessmet i Neuropsychiatry (SCAN; Wig et al, 1990), the likely date of oset of disorder ad prior history of cotact with psychiatric services, ad fially assiged a provi- sioal diagosis usig the Operatioal Cliical Research Criteria (OPCRIT; McGuffi et al,, 1991) computer program. Patiets who were selected as eligible for the study were the radomly allocated to receive care from the early oset team or from sector commuity team services usig a sequece of sealed, opaque evelopes cotaiig the outcome of radomisatio. The latter used radomised permuted blocks of varyig block size betwee two ad six. The process of radomisatio ad allocatio was carried out idepedetly of the research or cliical team by the trial statisticia (G.D.), based i Machester. The study was approved by the local research ethics committee ad a decisio was made to allow radomisatio prior to seekig coset ad as soo as possible after makig iitial cotact with services. All patiets were subsequetly iformed of the radomisatio ad writte coset was the sought to collect outcome data from case otes ad by iterview. The ratioale ad procedure for this are fully de- scribed by Craig et al (2004). I practice, oly oe patiet objected to the radomis- atio ad was therefore treated by the local sector team, although this idividual s data were aalysed as allocated to the early oset team. Measures Stadardised assessmets by traied ide- pedet research staff were admiistered at baselie withi 1 week of radomisatio ad at 18 moths follow-up. Baselie assessmets Socio-demographic data were recorded, icludig age, geder, marital status, accom- modatio, educatio ad employmet. The participats cliical state, overall fuctio- ig ad levels of depressio were assessed usig the followig measures. Cliical state.. The Positive ad Negative Sydrome Scale (PANSS; Kay et al,, 1987) is a 30-item, seve-poit ratig istru- met with sub-scale scores for positive symptoms, egative symptoms, geeral psy- chopathology ad a total score (total scale rage ). Overall fuctioig.. The Global Assessmet of Fuctio (GAF; Edicott et al,, 1976) is a widely used scale measurig overall fuc- tioig durig the previous moth, o a hypothesised cotiuum (scored 0 100) betwee severe psychiatric morbidity ad health. It has bee show to have good iterrater reliability for use with people with psychosis (Startup et al,, 2002). Depressio.. The Calgary Depressio Rat- ig Scale, a ie-item scale (score rage 0 27) desiged for rater assessmet of symptoms of depressio i people with schizophreia, has bee show to have adequate reliability ad validity (Addigto et al,, 1993). Assessmet at 18 moths Cliical measures were repeated as described above. I additio, the followig factors were assessed. Isight ad treatmet adherece.. The Scale for the Assessmet of Isight (David et al, 38

3 SPECIALISED CARE FOR EARLY PSYCHOSIS 1992) is a well-established measure of isight, assessed by ie items, six items scored 0 2 ad three items scored 0 4, scale rage 0 24 (high scores represetig good isight). I the Expaded versio (SAI E; Kemp et al,, 1998), adherece to medicatio is assessed by researcher iter- view usig the compliace sub-scale of the SAI E, resultig i a summary score o a scale of 1 7, where 1 represets complete refusal ad 7 represets active participa- tio, readily accepts ad shows some resposibility for medicatio regime. Adherece was also idepedetly assessed over the etire 18 moths from case-ote records of prescribig ad cliicia- assessed adherece: time to first poit of o-adherece to prescribed medicatio was defied as moths from baselie to the first moth i which it was recorded that the patiet had discotiued the medicatio for ay reaso. Satisfactio.. The Veroa Service Satisfac- tio Scale (Ruggeri & Dall Agola, 1993) professioals skills ad behaviour sub- scale (eight applicable items, scored 1 5, total scale rage 8 40) is a self-report Likert scale addressig patiets satisfactio with commuity-based psychiatric services, with good sesitivity, test retest reliability ad cotet validity (Ruggeri et al,, 1994). A separate summary item, belief that the treatmet is right for you, is scored The professioals skills ad behaviour sub-scale has bee foud to make a major cotributio to reported satisfactio with services (Ruggeri et al,, 1994). Quality of life.. The Machester Short Assessmet of Quality of Life (MANSA; Priebe et al,, 1999) comprises 12 subjective items o a seve-poit ratig scale (from could t be worse to could t be better, scored 1 7, rage 12 84), assessig satis- factio with life i geeral ad i a rage of domais, such as vocatioal, fiacial, friedships, leisure, persoal safety, physi- cal health ad metal health. Four objective items, aswered yes or o, assess the existece of a close fried, cotacts with frieds per week, accusatio of a crime ad victimisatio of physical violece. It has good cocurret validity ad iteral cosistecy. Cliical record data.. The patiets cliical state, social fuctioig, cotact with clii- cal services ad uptake of treatmet were moitored through their cliical case-ote files across the etire 18-moth period of the study. Detailed extracts cocerig metal state, treatmet adherece, service cotact ad itervetios ad social fuc- tioig were compiled, from which all iformatio that might provide clues as to whether the patiet was beig see by the early oset team or receivig stadard care had bee removed. These records were used to rate recovery ad relapse i our earlier study by idepedet raters, masked to coditio, with good iterrater reliability (Craig et al,, 2004), ad were used i the same way i this study for ratig social recovery cross-sectioally at the 18-moth follow-up poit, o a three-poit scale ( o, partial ad full ) of recovery to baselie levels, i the followig areas: (a) Housig: i-patiet care, homelessess or priso were rated as o recovery, sheltered or supported accommodatio as partial recovery ad retur to previous idepedet accommodatio (icludig livig with family members) or acquirig ew idepedet accom- modatio as full recovery. (b) Vocatioal or educatioal status: full recovery was rated for retur to, or takig up, full-time idepedet employmet or full-time educatio; partial recovery was rated for part- time work or educatio, or for supported work or activity pro- grammes; o recovery was rated for o regular scheduled work or educa- tioal activity. The case-ote data were also aalysed to record total umber of moths egaged i regular scheduled work or educatioal activity over the etire 18-moth period. (c) Relatioships: full recovery was rated for retur to or establishmet of close persoal relatioships, with a parter or family; partial recovery was rated for evidece of some ogoig social cotact with frieds or family; o recovery was rated for o evidece of ay regular social relatioship or activity. The iterrater reliability for ratigs of social recovery was good or excellet (accordig to covetioal evaluatio of kappa values; Robso, 1993) (¼23;( housig, k¼0.69, P50.001; vocatioal k¼0.70, P50.001; relatioships, k¼0.83, P50.001). Adverse icidets.. Adverse icidets from NHS trust icidet records ad case-ote data icluded death, priso, self-harm, violece to others ad homelessess. Assessor maskig The research assistats, although idepe- det of service provisio, were ot uaware of treatmet group allocatio; this was impracticable, give that this was a study of the effects of allocatio to a whole ser- vice. However, the case-ote data were rated masked to coditio. I order to test the success of the efforts to esure maskig, the two assessors guessed whether each par- ticipat had bee receivig care from the early oset team or the sector commuity services. The two raters correctly guessed the allocatio of 60% of participats, which is margially better tha chace (95% CI 52 63%, k¼0.20). The adverse icidet data were recorded ad extracted for the whole sample by trust staff masked to treatmet coditio. Data aalysis The sample size for the study was cal- culated o the basis of the estimated reductio i relapse rates (the primary outcome). A total of 120 patiets were required to show a reductio of relapses i the experimetal coditio at 18 moths from 60% to 40% of the sample, with a power of 80% at a¼0.05. The aalysis was doe usig STATA release 8 (Stata- Corp, 2003). Itetio-to-treat aalyses compared the two groups i terms of cross-sectioal outcomes at 18 moths, with all available participat data i the aalysis. First, for all variables except the case-ote data ad adverse icidets, estimates of itervetio effects o the out- come scores were obtaied through the use of a regressio (aalysis of covariace, ANCOVA) usig the relevat baselie score as a covariate if assessed; subsequet aalyses also etered as covariates ethi- city, geder ad whether first or secod episode to allow for baselie imbalaces i these variables. Fially, the sesitivity of the results to the missig follow-up data was examied by repeatig the above re- gressio aalyses, but with the additioal use of iverse probability weightig (Heytig et al,, 1992; Everitt & Pickles, 1999) to adjust for rates of attritio that were depedet o both treatmet group ad selected baselie covariates. The weights were determied (for each radomised group separately) usig a logistic re- gressio to predict missig PANSS values, 39

4 GARETY ET AL usig ethic group, geder, umber of previous episodes, cotact with family ad havig a stable relatioship as predictors (the weight beig the reciprocal of the pre- dicted probability of havig a o-missig outcome measure). The cliical record data outcomes, with low levels of missig data, were aalysed for group differeces at 18 moths by w 2 tests or t-tests. A Cox s pro- portioal hazards model was used to test the associatio betwee o-adherece to prescribed medicatio ad group member- ship, ethicity, geder ad whether first episode. RESULTS Participat recruitmet ad follow-up Over the 18-moth study period 144 per- sos who met iclusio criteria preseted ad were radomly allocated to either the early oset team or the sector com- muity team (Fig. 1). Data o the primary Fig. 1 Flow of participats through study. outcomes of relapse ad rehospitalisatio were obtaied o 135 (94%) of these patiets over the 18-moth follow-up (Craig et al,, 2004) ad for 132 patiets (92%: itervetio group 94%, stadard care group 89%) we had case-ote records from which iformatio was draw o social outcomes (housig, vocatioal activity ad relatioships), medicatio adher- ece ad adverse evets at the 18-moth follow-up poit. A rather lower proportio of eligible patiets coseted to ad com- pleted the research iterview for the other outcomes at 18 moths: ¼99 (69%); i- tervetio group ¼55 (77%), stadard care group ¼44 (60%). The reasos for o-completio of data collectio are show i Figure 1. Sample characteristics As would be expected of a early psychosis populatio, the majority of the sample were male (65%) ad sigle (70%), ad the average age was 26 years. More tha half were from a miority ethic, predomi- atly of Africa or Caribbea paretage. Over half were uemployed (62%). The majority met ICD 10 diagostic criteria for schizophreia (69%). Experimetal ad cotrol groups were similar for all characteristics, icludig the duratio of utreated psychosis, except that the iter- vetio group had sigificatly fewer males (itervetio group 55% v.. cotrol group 74%), a higher proportio of first-ever epi- sode (86% v.. 72%) ad a higher propor- tio of White ethicity (38% v.. 25%). A more detailed descriptio of the sample is give by Craig et al (2004). Cliical outcomes, satisfactio ad social outcomes The summary data for the cliical measures (PANSS, GAF ad Calgary Depressio Scale) at baselie ad at 18 moths are give i Table 1. Comparisos were made betwee groups o the scores for these measures by meas of separate ANCOVAs, first with baselie score as a covariate, the eterig ethicity, geder ad whether first or secod episode as covariates. The esti- mated itervetio effects are show i Table 2. There was a tred for a effect of the itervetio o PANSS total scores, largely attributable to a sigificat effect o PANSS egative symptoms i the first aalysis; however, this effect becomes o-sigificat whe adjustig for differ- eces i other baselie variables. There is o effect o the Calgary Depressio Scale. There are cosistetly sigificat effects o the GAF favourig the itervetio group. Data for isight, satisfactio, quality of life ad iterview-rated treatmet adher- ece at 18 moths are give i Table 3. Comparisos were made betwee groups for itervetio effects usig ANCOVAs, with a secod aalysis eterig ethicity, geder ad whether first or secod episode as additioal covariates (Table 4). There is o effect o isight; however, there is a just-sigificat effect o treatmet adher- ece ad cosistetly sigificat effects o service user satisfactio ad self-rated qual- ity of life, all favourig the itervetio group. Ispectio of idividual items reveals that the sigificat differeces o the Veroa Service Satisfactio Scale were attributable to satisfactio with the ma- ers of staff, the perceived competece of staff, staff willigess to liste, satisfactio with the type of service offered, ad the separate summary item: belief that the 40

5 SPECIALISED CARE FOR EARLY PSYCHOSIS Table 1 Cliical symptom assessmets at baselie ad at18 moths Itervetio group Baselie treatmet is right for me (P50.01).( O the MANSA, idividual subjective items reported by the itervetio group as of better quality (P50.10)( were life i geer- al, accommodatio, people that you live with, relatioship with family, physical health ad metal health. The objective items (existece of a close fried, cotacts with frieds per week, accusatio of a crime ad victimisatio of physical vio- lece) did ot differ betwee the groups. The aalyses were the repeated allow- ig for the same baselie covariates, but with additioal adjustmets provided usig iverse probability weights to allow for o-radom patters of missig data (see Tables 2 ad 4). For the most part, these showed few differeces from the results after adjustmet for the baselie differeces i ethicity, geder ad episode (the secod sets of aalyses). However, the effect o the Veroa Service Satisfactio Scale is o loger sigificat. Score Mea (s.d.) 18 moths Baselie Score Mea (s.d.) Cotrol group Score Mea (s.d.) 18 moths The umber of moths for which the groups maitaied adherece to prescribed medicatio was etered ito a survival aa- lysis (Fig. 2). A Cox s regressio aalysis showed that the groups differed sigifi- catly: the hazard ratio for the risk of discotiuig medicatio for a perso i the cotrol group was 1.5 times that of a perso i the itervetio group (¼131, hazard ratio 1.5, 95% CI ; P¼0.029). Half of the itervetio group had first discotiued medicatio for ay reaso by 9 moths, whereas half of the cotrol group had first stopped takig medicatio by 5 moths (Fig. 2). There was a slightly higher proportio of those who discotiued medicatio agaist medi- cal advice at least oce over the etire 18 moths, as documeted i the case otes, i the cotrol group (95%; 57/60) compared with the itervetio group (79%; 37/47). The social outcomes (housig, voca- tioal activity ad relatioships) at 18 Score Mea (s.d.) PANSS Total 67.4 (17.2) 51.2 (15.2) 73.3 (19.7) 58.9 (14.2) Positive symptoms 17.2 (6.2) 11.8 (5.1) 18.9 (6.4) 14.0 (5.9) Negative symptoms 15.1 (7.0) 11.9 (5.1) 17.8 (12.7) 14.8 (5.4) Geeral 35.0 (7.7) 27.4 (7.6) 36.6 (8.1) 30.2 (7.0) GAF (15.3) (15.3) (14.8) (15.1) Calgary Depressio Scale (3.5) (3.3) (3.2) (3.5) GAF,Global Assessmet of Fuctio; PANSS, Positive ad Negative Sydrome Scale. moths are show i Table 5. Compari- sos of full recovery with combied partial ad o recovery are made betwee the groups usig w 2 tests. Although housig ad vocatioal/educatioal outcomes do ot sigificatly differ betwee groups, relatioships outcomes are sigificatly better i the itervetio group. Ay vocatioal ad educatioal activity i a give moth across the 18-moth period, as recorded i the case otes, was also aalysed. The itervetio group was egaged i a activity for sigificatly more moths (6.9 moths, s.d.¼6.6; ¼67) tha the cotrol group (4.2 moths, s.d.¼5.3; ¼65); t¼2.689, P¼ This advatage for the itervetio was also apparet whe comparig the groups i terms of those who had spet 6 moths or more egaged i a educatioal or vocatioal activity: itervetio group 49% (33/67), cotrol group 29% (19/65); w 2 ¼5.54, d.f.¼1, P¼ Adverse evets ad homelessess At 18 moths, oe participat receivig stadard care had died of ukow cause ad aother was i priso. Adverse icidet records from the cliical services (i-patiet ad commuity) over the 18-moth study period were examied. These revealed that 12 members of the early oset team group (17%) ad 14 of the cotrol group (19%) were recorded as ivolved i a violet act towards a member of staff; 14 of the iter- vetio group (20%) ad 15 of the cotrol group (20%) were violet towards aother patiet or a member of the public. Six of the itervetio group (8%) ad 5 of the cotrol group (7%) were recorded as hav- ig egaged i self-harm, such as takig a overdose. I terms of homelessess, Table 2 Cliical symptoms: estimated treatmet effects at18 moths Itervetio effect Adjusted for ethicity, geder ad episode With iverse probability weights Coefficiet (95% CI) P Coefficiet (95% CI) P Coefficiet (95% CI) P PANSS Total 5.74 (70.30 to 11.79) (71.14 ( to 11.65) (70.96( to 10.76) 0.10 Positive symptoms 1.32 (71.01( to 3.65) (71.07 to 3.91) (70.73( to 3.56) 0.19 Negative symptoms 2.30 (0.02 to 4.57) 0.048* 1.62( (70.78 to 4.02) (70.97 to 3.79) 0.24 Geeral 2.19 (70.75( to 5.13) (70.97 to 5.25) (70.87 to 4.82) 0.17 GAF (15.46 to 71.98) 0.01* (715.89( to 71.65) 0.02* ( ( to 71.16) 0.02* Calgary Depressio Scale 0.93 (70.47( to 2.33) (70.51 ( to 2.47) (70.62 to 2.36) 0.25 GAF,Global Assessmet of Fuctio; PANSS, Positive ad Negative Sydrome Scale. *P

6 GARETY ET AL Table 3 Measure Isight ad adherece at baselie ad18 moths, ad satisfactio ad quality of life at18 moths from case-ote records ad researcher equiries, at 18 moths, 1 participat from the itervetio group ad 2 from the cotrol group were homeless, ad the whereabouts of 5 (7%) ad 10 (14%) cotrol participats could ot be ascertaied. I terms of housig, 5 (7%) iter- vetio group members ad 2 (3%) of the cotrol group were i supported accommo- datio, 59 (83%) of the itervetio group ad 54 (74%) of the cotrol group were i idepedet accommodatio or residig with family, ad 1 of the itervetio group ad 3 of the cotrol group were i other (e.g. shared housig). DISCUSSION Baselie Itervetio group Beefits of early itervetio This study is oe of the first UK radomised cotrolled trials to report the effects of a early itervetio service, ad, ideed, is oe of very few worldwide. It provides support for the curret govermet policy of developig such services. It is ot oly i the UK that this is relevat; may other coutries, icludig Caada, Austra- lia, Demark ad Norway, are egaged i 18 moths Baselie Cotrol group 18 moths Mea (s.d.) Mea (s.d.) Mea (s.d.) Mea (s.d.) Isight (6.9) (7.2) (5.7) (7.7) Adherece (1.5) (1.4) (1.3) (1.8) Satisfactio (4.8) (5.9) Quality of life (12.6) (12.4) 1. Scored o the Scale for Assessmet of Isight ^ Expaded (SAI^E); higher scores represet better isight. 2. Scored o the SAI^E compliace sub-scale; higher scores represet better adherece. 3. Scored o theveroa Service Satisfactio Scale. 4. Scored o the Machester Short Assessmet of Quality of Life; higher scores represet better quality of life. similar programmes to establish early itervetio services. The results idicate that the provisio of a specialist service for people early i the course of psychosis has a rage of beefits: at 18 moths it has superior social outcomes, i regaiig or establishig social relatioships, i time spet i vocatioal activity ad i global fuctioig; it is more satisfactory to parti- cipats tha geeric sector services, ad leads to a higher reported quality of life. It also improves observer-rated ad case- ote records of adherece to medicatio. These are i additio to the previously reported beefits of icreased cotact with services ad reductio i hospitalisatio (Craig et al,, 2004). There were fewer recorded icidets of most categories of adverse evets i the Lambeth Early Oset team group (death, priso, homelessess ad violece but ot self-harm), although these are relatively rare evets for the whole sample ad do ot differ sigificatly. The recorded icidece of self-harm over 18 moths i 7.6% of the whole sample is somewhat lower tha that reported i the oly comparable study, by Nordetoft et al (2002), who reported that 11.3% of their first-episode sample egaged i self-harm over a 1-year follow-up period. (We do ot, however, coclude that this reflects a particularly low rate i the curret study. The defiitios ad data collectio methods were ot idetical i the two studies ad we cosider that our data may be susceptible to uderreportig, especially i the cotrol group, more of whom were out of cotact with services.) For some variables vocatioal activity ad medicatio adher- ece the results offer clearer support for the effects of early oset team care whe usig data draw from the etire 18-moth period tha cross-sectioally at 18 moths. This may, i part, reflect the larger sample size icluded, especially for the cotrol group, whe usig case-ote data rather tha data obtaied from researcher iterviews. Symptoms Despite the beefits described above, it appears that the specialist early oset ser- vice does ot specifically improve persistig symptoms. As would be expected, give that the iitial assessmets were made i the acute episode of illess ad the follow- up was 18 moths later, symptoms did improve substatially over time i both groups. However, cotrary to our hypoth- esis, allocatio to the early oset team service had few sigificat effects o symp- toms, with o effect o positive psychotic symptoms or geeral psychopathology ad o improvemet o a scale of depressio. There is some evidece of beefits for egative symptoms; however, whe adjust- mets are made for chace baselie differeces ad to accout for missig data, the differece is o loger sigificat. Isight also was ot sigificatly improved. Give the evidece for the effectiveess of cogitive behavioural therapy i reducig persistig symptoms (Pillig et al,, 2002) ad the promisig fidigs from the Study Table 4 Isight, adherece, satisfactio ad quality of life: estimated treatmet effects at18 moths Measure 1 Itervetio effect Adjusted for ethicity, geder ad episode With iverse probability weights Coefficiet (95% CI) P Coefficiet (95% CI) P Coefficiet (95% CI) P Isight (76.20 to 0.31) (75.94( to 1.05) (76.91( to 0.86) Adherece (71.45 to 70.06) 0.033* (71.49( to 0.02) (71.93( to 70.07) 0.036* Satisfactio 3.19 (1.00 to 5.37) 0.005** 2.98 (0.62 to 5.33) 0.014* 1.57 (70.97( to 4.10) Quality of life ( ( to 70.74) 0.026* ( to 71.69) 0.011* ( to 71.61) 0.010* 1. See foototes totable 3. *P50.05, **P

7 SPECIALISED CARE FOR EARLY PSYCHOSIS explicit focus o work i these areas was importat. Give the importace of employmet i assistig i the log-term recovery from schizophreia (Warer, 1994) ad the beeficial role of protective social relatioships (e.g. Jablesky et al, 1992), this study adds to the literature by demostratig it is possible to itervee to improve these factors by offerig a early psychosis service. Fig. 2 Adherece to prescribed medicatio over18 moths (survival aalysis): solid lie, itervetio group; dashed lie, stadard care group. of Cogitive Reality Aligmet Therapy i Early Schizophreia (SoCRATES) trial of psychological treatmets i early psychosis (Tarrier et al,, 2004), it is ot clear why early oset team care, which icluded cogitive behavioural therapy, did ot re- sult i greater symptomatic improvemets. The early oset service delivered iterve- tios i a pragmatic mix, accordig to patiet preferece ad idetified eed. These itervetios were also provided i the cotrol teams, although at a lower rate (Craig et al,, 2004). It may be that a more systematic approach to the provisio of cogitive behavioural therapy should be attempted i early itervetio services, esurig that all who are willig to receive this therapy have a reasoable umber of sessios (at least te; Natioal Istitute for Cliical Excellece, 2002) ad especially targetig those with persistig symptoms (Jolley et al,, 2003). Rage of outcomes A stregth of this study is that it provides data o a rage of outcomes. Studies of Table 5 ad o recovery) cliical itervetios or services for people with psychosis are ofte criticised for providig oly cliical data o relapses, readmissio ad symptoms (Natioal Istitute for Cliical Excellece, 2002). We report, i additio, service user satis- factio data, quality of life ad a rage of social outcomes, ad adverse evets. The satisfactio ad quality of life data are ecouragig, i that they suggest that service users with early psychosis i geeral fid the provisio of a service with active outreach acceptable. It is also oteworthy that major adverse evets were certaily ot icreased, if ot sigificatly less fre- quet, i the itervetio group. Of course, this study does ot tell us how the improve- mets occurred; it was ot desiged or powered to test hypotheses cocerig mediators of treatmet outcomes. It is poss- ible that key factors resultig i reductios i relapse ad rehospitalisatio were the maiteace of cotact with service users ad cotiuace of medicatio. It is perhaps less plausible to attribute the social ad vocatioal beefits to these vari- ables aloe; we suggest that the team s Social recovery: housig, vocatioal activity ad relatioships at18 moths (full recovery v.. partial Itervetio group: full recovery %(/N) Cotrol group: full recovery %(/N) Housig 70 (46/66) 58 (36/62) Vocatioal/educatioal 33 (21/64) 21 (13/61) Relatioships 55 (34/62) 25 (14/57) w 2 d.f. P Limitatios of the study The study had a umber of methodological limitatios. The sample size was desiged to be adequate for the primary outcome of relapse, but proved somewhat uder- powered for the adjustmets required by chace baselie differeces i variables likely to affect outcome. Aother method- ological cocer was follow-up rates. We had previously discovered that there was a high rate of disegagemet ad loss to cli- ical follow-up from existig services i this early psychosis group withi the Lambeth ier-city area (Garety & Rigg, 2001). Thus, although oe stregth of the study was its iclusio of all first episodes from a defied geographical area, ehacig the geeralisability of our fidigs, this strategy paradoxically also led to a substatial limitatio as it ecessarily icreased the iclu- sio of substatial umbers of patiets who would traditioally fail to egage with treatmet or agree to participate i detailed follow-up iterviews. We aticipated that this might prove a problem as it has also bee reported i other studies (e.g. Kemp et al,, 1998) ad might also result i differ- etial attritio betwee groups, give that the Lambeth Early Oset service was aim- ig explicitly to improve rates of cotact. This proved to be the case despite vigorous attempts at follow-up. To deal with this, i order to reduce sole reliace o face-to-face cotacts, case otes ad other routiely collected cliical records (e.g. adverse icidets) were used, where possible, to provide data for some of our secodary outcomes. Where reliace o face-to-face research iterviews was ecessary, for example for cliical symptom assessmets ad service user satisfactio, we employed statistical techiques to test for the sesitiv- ity of the results to the o-radomess of missig data. Not beig i a stable relatio- ship ad ot havig cotact with family members at baselie predicted missig data at 18 moths. I geeral the results were ot chaged by the sesitivity tests; how- ever, there was a effect o the satisfactio 43

8 GARETY ET AL results, which suggests that the satisfactio data should be treated with some cautio. A third limitatio is that the research assessors were ot masked to coditio. Trials with iadequate allocatio coceal- met have bee show to report larger treatmet effects tha those i which cocealmet has bee achieved (Schulz et al,, 1995). Give that this was a trial of allocatio to a complete service, rather tha a study of a discrete ad time-limited itervetio, maskig was ot possible, sice it was ot possible (or safe) to cotact participats totally idepedetly of the cliical service. The outcomes reported i this study are, however, ot restricted to assessor ratigs. Fially, this is a study of a ew team from its iceptio. Noe of the origial team had prior experiece i early itervetio. As has bee oted, this team was learig o the job ad developig skills as the study progressed (Sigh, 2005). This may have limited the capacity of the cliicias i this ew team to deliver the most effective mix of itervetios. The Lambeth Early Oset trial adds to the evidece base by demostratig that a ewly formed specialist early itervetio team achieved improved outcomes at 18 moths i a umber of differet outcome domais, whe compared with the pro- visio of services by geeric teams. It would clearly be of iterest to examie the effects of this service over a loger follow-up period ad also to compare the effects of a specialist team with the provisio of phase-specific itervetios delivered by a differet service model, such as specialist workers withi geeric teams. However, this study does provide support for the curret UK policy o early itervetio. ACKNOWLEDGEMENTS The study was fuded by a grat from the Directo- rate of Health ad Social Care for Lodo R&D Orgaisatio ad Maagemet Programme. The research team is etirely idepedet of the fuders. T.C. ad P.P. have received support from Eli Lilly, AstraZeeca, Jasse-Cilag ad Novartis for attedig ad speakig at cofereces. REFERENCES Addigto, D., Addigto, J. & Maticka-Tydale, E. (1993) Assessig depressio i schizophreia: the Calgary Depressio Scale. British Joural of Psychiatry, 163 (suppl. 22), 39^44. CLINICAL IMPLICATIONS & Social ad cliical outcomes i early psychosis ca be improved by the provisio of a assertive outreach team offerig a package of evidece-based treatmets ad care. & Service users report a better quality of life ad greater satisfactio with a early itervetio service tha with geeric sector teams. & A systematic approach to moitorig ad prevetig the early developmet of persistig psychotic symptoms should be take. 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