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l
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..lorti)rAl.{.}1,' l)ri nlt'tl irr /'.^\'.'1.
(iolrvrighl iL)2{)(.tilby LipJrin<:ciltlVillialts & Wilkins

Treatment of Acute Psychosis Without Neuroleptics: T$o-Year

Outcomes From the Soteria Project

JOHN R. BOLA,Prr.D.,ranclI,ORENR. MOSHER.M.D.!

Tire Soteria project (1971-19811)<:ornparedresiclent.ial treaturenl.irr the r:omnrunity

and rninitrtal use of antipsychotir: nredication with "usurll" hospital treatment tor
patients witir early episode schizophrenia spectrurn psychosis. Newly diagnosecl
DSM-II schizopltre'niasubjects were assignedc:onsec:utir.'ely ( 1971to 1976,l/ : 7tl)
or randontly 1197{ito 1979,t\ : 100) to the }rospital or Soteria ancl followed tor 2
years. Atlutission diagnoseswere subsequentlyconverled to DSM-N schizophrenia
and scltizopirrettifomi disorder. Mult,ivadate analyses er,.ah-ratetd hypotheses of erlual
or better outcotnes in Soteria on eight individual outcorne measures and a conpos-
ite outcoute scale in three ways: for endlloint subjects (.V : 160), for contplet,ing
sulrjects (l{ : 129), and for completing subjects correctecl for diff'erential attrition
(tV : 12!)).Endlroint sub.jectsexhibiteclsnrall to rnediunr effect size trends lavoring
experintetrtal treal,tnent. Completing subjects hacl significerntly better c:onrposit.e
outcomes of a nredittnteftec:tsize at Soteria (+.47 SD,,1r: .03). Corlpleting sulrjects
with schiznphreniaexhibited a large effect size benefit n'ith Soteria treatment ( +.81
SD, 1; : .02), particularly in clornaiusof psychopatholog.y,wor-k, and social l\rnc-
tioning. Soteria treattrtentresulted in tretter'2-yearoutcclmesfi:r patients with newlv
diagnosed schizophrenia spec:trum psyr:hoses,partictrlarly for completing subjet:ts
antl for those wittr schizopltrenia.In adclition,rinly 58%of Soteria su[jer:ts rer:r,rived
ar-rtipsychoticmedicatious during the follow-up periocl, and only 19/owere contin-
uouslv maintained on antipsychotic medications.
-,1 I',ert: IVIenlDi,.sl9L:2lg*229.2003

If is notatrle that, lJOyears after its initial design
and implementation ancl 17 years since completiorl
of'data collection, the Soteria project is still produc-
ing irifonnat,ion I'eler.'ant to today's management of
psychosis. Soteria's original aim was to assess
whether a specially designeclintensive psychosocial
treatment, a relationship-locused therapeutic milieu
incorlrorating minimal use of antipsychotic medica-
tions tor 6 weeks, coulcl produce equivalent or better
outr:omes in treating newly diagnoseclpatients with
schizophrenia conrpared vvith general hospital psy-
chiatric warrl treatment rsllh antipsychotic nredica-
tions. Sol,eriaalso inteucled to reduce the proportion
'
l)ep:rr'lnrent ol'Soci:tl Work, [,rriversity of Southern C]alifor-
nia, NlllF-!12, Los ,A,ngeles.California 900E9-0411.Sencl reprinL
letlrrests to I)r. IJola.
' Sotet'ia
Associates, San I)iegt.r,Calit'omia.
Tlris researcrh rvas supporlt'd by grants fronr the Nati<lnal
Institrrl.e of Merital Ilealth.
I)rc:senteclin paft at the World Psychiatric Assoc:iation's Intet-
rrat,ir;tralCr-rtigressin Nlaclritl, Spinn, October"2, 2001.
Ttre arrl.hr-rrst,irank Leonarcl S. Miller. [']r.f)., Lr(l Berkeley, antl
,fim trlintz, Ph.l)., Ir(]I,A, lor their help r+'ith statistical consulta-
tions, anrl John NI. L)avis, M.D., Llniversit.v oI lllinois, lor critiqLre
ol'an ea.rlier ,,'eLsion<lf lLris nr:rnusc'r'ipt.
of patients rnaintained on antiltsychotic mer{icatiorrs
(thereby recltrcing exposure to dnrg-incluced toxici-
ties) and to re(luc:e the rate at which early-episo(le
clients became chronic users of mental health ser-
vices. This study is unique in errnploying a relatively
lalge sample (1/ : 179) of clients newlir diagnclsecl
with DSM-II ^schizophrenia (cliagnoses were strbse-
quently converted to DSM-IV schizophrenia and
schizophrenifbnn disorder) in a rluasiexlrerimental
research design conrpadng multiple otrtconres at 2
years.
F'or many years, antipsychotic medications have
l,reenthe treatment of r:hoice for patie'nt,swith early
episode psychotic: disorriers (APA, 1997; Cole et al.,
1966;Lehmzurand Stein\A'achs,1998).Ilowever, pl'e-
scription of conventional antipsychotics c:arriessub-
stantial risk of ch'ug toxicities (Poptrl ancl Trezza,
1998) and structural brain change.s(e.9., N'fatisenet
&1., 1998), While atyprical antipsychotics exlribit a
morr) benign shr-rrt-termsidereffect prohlc (Worlelct
al., 2000), there has r-rot yet treen adequzrte t,irrle'
obseling their etl'ects to nrle out t-.r-nergeltceoI-
adtlitional long-t,erm toxicities. F'or example, tlre ru:-
cently reporterl asso<:iation oI' atypical iurtipsyc:hot-

219
220 I } O [ , AA N I ) N I 0 S } I t i R
ics w-ith tliabetes nrellitus (Sernyak et al., 2002) is
(:ause for sonre concenl.
In developing the Soteria approach to treatment,
the clesire to nrinirnizerrnedication-induced toxicities
converged with three additional factors: the recog-
nition of significant rates of recovery withotrt drug
treatment in early episode llsvchosis, the obsenra-
tion that many patients dcl not benefit from metlica-
tions (through cimg treatnrent resistanc'e and non-
compliance), aud a valuing of interpersonal care and
treatment of mentally ill patient,s.
Rates of recovery without meclications are signit-
i<:ant, partic:ularly frrr those with early episode psy-
chosis. l'or example, placeb<l recovery in the acute
phase of the early NIMTI rnultisite trial wa.s appl'ox-
imately 37% (Clole et al., 1964),arcl the placebo-treated
group had ferwer rehospitalizations at I year postdi,s-
charge (Schooler et al., 1967). Estimates of placebcr
respons€] rates fbr patients with acute schizophrenia
range flom 1fflo to 4fflo (Davis et aJ., 1989; Thornley et
al., 2001), with a median of 2l:o/o(Di-xon et al., 1995).
Long-tenrr frrllow-up stucties coucluctecl prior to the
widesl-l'eacl use of ilntipsychotic drugs report, func-
tiorul reco\()ry ratcs greater than 500/o(Rleuler, 1978;
Oionrpi, 1980;Huber et al., 1980).
Not all psychotic patients benefit from dmg treat-
'l'reatment
ment. resistance to cclnventional antipsy-
ch<>tic agents is estimated to be ZU/o to 40o/o
(Ilellewell, 1999). Nonc:om1:lianc:e w'ith conventional
arrtipsychotics is estimated to be 4Io/oLo55o/o (F'entort
et al., 1997). lurproved compliance with at,ypical an-
tipsychotics is often assumed but has not yet been
established (Wahlbeck et aI., 2001).
"'I'raitement moral," a hulnAnistic trend in the c:u'e
anti treat,ment of persons witli mental illness, c'anbe
tlacred t<l Pinel's removing chains fi'onr the nren in
Paris' Bi<,:etre'Ilospital in 1797. Following in the
hruuanistic tleatment tradit,iott, Soteria incorpot'ated
aspect,s of moral treatmetrt (Rockhovell, 196:l),
Sullivan's (1962) interpersonal theory and specially
designed milieu at SheJrarcl-Praff,Hospital in the
1920s, and the "der,,eloprnental crisis" notion that
growth nray be possible from psychosis (Laing, 1967;
Ilenninger, 1959; Perry, 1974).
'I'his
is the first report, li'om the entire Soteria
sarnple using multivariate methods to test hypothe-
ses of cclmlrarable outcomes over a Z-year period.
We use l,wo-tailed tests to evaluate hypotheses for
ea<rhoutcorne in three ways: for endpoint, sub.iects
(N : 160), for cc'rmpletingsub.jects (/t' : 129'),and
I'or c'ompleting sub.lects ac{iust,edfor different,ial at-
trition (,\ : 129; Heckrnan, 1979). Subsequently, we
cronclur:teci tests lor schizopht'etriaand schizophreni-
lorm subjects separately.
Methods
St,tlrly De,sigrt,
TI-reSoteria pr<lject emp loye d a rlua^siex1rerime r-rtal
treatrnent comparison using consecntivc space-
available treatmernt assignment in tire fir'st ccihofl
(1971 to 1976, /V : 79) and an experimental <lesign
with ranclom assignment in the st:conci cohort (1976
to 1979,.A/: 100).
Subjer:ls
Sub,ject,swere recruitecl from two county l-rostrrital
trrsyr:hiatricenergency rooms in the San F rancisco
Bay Area. Nl persons meeting the follou'ing crit,eria
lyere zrskedto participate: initial rliagnosis of sr:hizo-
phrt:nia by threre indeperndent clinir:ians (per DSM-
D; at least four of seven cardinal synrlrtoms of
schizophrenia (thinking or speech clisturbances)
catat,clnic motor l-rehavior, paranoici icleation, hallu-
cinations, delusional thinking other than paranoid,
bluntecl or inappropriate emotion, clisturtrance of'
social behavior and interpersonal relations); .juttged
in need of hospitalization; no lnore than one previ-
ous hospitalization for 4 weeks or krss with a diag-
nosis of schizolrhrenia; agecl 15 to i32years; ancl nc>t
manied. These criteria were intencied to produce a
relativel.y poor prognosis g.roup, at heightene.d risk
for a chronic corlrse, through the exclusion of older
and manied patient,s (Strauss itnd Llarpenterr, 197.9).
After description of the study to the sub.jects, writ-
ten informecl consent wa^s obtained fronr lratients
ancl their families, if available.
Emelgency r'oom stzrff psychiatrists made initial
diagnoses. An irtdepenilent research team trained t<-r
maintain interrzrter reliability (Kappa) of .80 or bet-
ter on all measrtres made subsetluent assessments.
Merasureswere takernat ently, 72 hours (clesigrredto
screen out drug-ittdu<:ed psychoses), 6 u'eeks, I
year, ancl 2 years postadmission. Most lbllow'-up
measures were face valicl (e.9., v!'ork, Iir,'ingarrange-
rttents, r'ehospitalization, etc. ).
The ethnicity of subjects (I/ : 171) was 80% Eu-
ropeiur American, 9o/oAlrican American, and ll't/a
other ethnic gr(rups. Sixty-four percent (A' : 179)
were male and.16% wel'e temale. The rnean age \4ras
21.7 years (range, 15 to 32 years; SD : 3.4; rV: 179),
with the average client coming frorn Hollingheacl's
(1957) lower.mitlclle class (higher score is lower
social class: cla-ssIII is ZfJto 4i3;rnean SIIS score :
42.3; S D : 16.1;range, 11 to 77; A : 159).
Treahrnnts
Soteria providecl pleclominantly extramerli<:al
treatment, employing a cleveloJrmental crisis ap-
 I'IAROI l1'(l( ) i\'IES
SO'l'liRIA:'I'WO-Y
proach to recovely fr'onl psychosis. Treatment in-
volved a slnall, homelike, intensive, iute4rersonally
fcrcusecl theratrleutic milieu with a nonprofessiclnal
sta.ff that exlrected ret:ovely and relatecl with clients
"in ways that do rtot result in tlte invalidation of the
experient'e of madness" (Mosher and Menn, 1978a,
fi 716). Experimental treaturent was provicled at two
far:ilitiers: at Soteria ancl a replication facility,
Eman<ln. Artipsychotic medications were ordinarily
not used cluring the first 6 weeks of treatntent. How-
erver,there were explicit criteria for their short-term
use rltrring this period; 760/o(62 of 82) received no
antipsychotic rneclic'ation.sduring the initial 45-clay
period. AJter 6 weeks, medication presctiption deci-
sions lvere made at a treatment conference that
includecl the client, stalT, and the c:onsulting psychi-
atrist^ A manual describing Soteria treatment in
greatr-'r' det,aii has been published in [iermart
(Mosher et al., 1994).
Control facilities \4'ere well-staffed general hospi
tal psychiatrii: units gealed towat'd "rapid evaluation
ancl placement in other parts of the county's treat-
rnerrt nc,twork" (Mosher ancl Menn, 1978a,p 717). In
(94%,85 of 90) were
thr.se'unit"s,virtually all sr-rb.jects
treatcd with continuous courses of antipsychotic
me-dication (average 700 mg chlotpromazine equir.'-
alents per cla;y),and nearly all were prescribed post-
rlischargt. nredications. On discharge, subjects were
referred to an extensive array of outpatient services.
X'Ieasurr:s
F)ight outcome rneasures were used: readmission
to 24-hour care (yes or no), number of readtnissions,
rlays in reaclmission(s), a glotral psycltopathology
scale ('N'losheret al., 1971; 1 to 7, higher is nrore
syrnptomati<:), a global imtrtrovemet'rt scale (Mosher
et al., 1!i71; codecl I to 7, 1 : much improventent,
4 : lro cliange, 7 : utucl-r worse), living indepen-
dently or with peers (yes or no), an ordit"ralmeasure
of working (none, part-tinre, full-tinte), and the so-
c:ial functiouitrg stttrscale of the tsrief F ollow-up Rat-
ing (tlFR; Sokis, 1970). [.'or cornpleting .subjects
(i/ : 129), obsen'ations to the 2-yeat'follow-up eval-
tuatiou were nsed. Endlroint analyses (I/ : 160) used
observations to tire last postdischarge obsetvation.
flonrlrosit,e orttc'ome sca^leswere created ftrr end-
point aucl r:onrplcting subjects frotn the eight out-
c:onle measures by conveft,ing each to standardized
(:) scores oriented with lrositive values for better
outcornes and summing. Missittg values were set to
the sub.ject's rnean score on available standardized
rneasrrres 1-ctr5o/oof mis.sing endpoint and 8% of
rnissing completet' infonnation. Cronbach's alpha
was .77 and .74 for the entlpoint scale and the conl-
221
pleter s<:ale, respectively. Composite sc'akls \4rere
then restandarclized, allowing subsequent analyses
tci be interl,n'eted in stattdard cleviation (effect size)
units (Neter et ai., 199ti).
DSM-II schizophrenia patients with symptonrs for
at least ti montlm were rediagnosecl with schizophre-
nia (,129/0, 71 of 1ii9) because the addition of this
criterion was the primaty change frorn the DSM-II to
t)SM-lII and has been <:arriecllbrward into the DSM-
IV. Sub.iectsnot meeting t,his criterion were rediag-
nosetl with schizophreniform disorcler (58o/o,{i8 of
169). A variabie approximating clays of antipsychotic
ruseduring the follow-up period (betweert thr. end of
experimental control clf meclication at ,{5 days and
the c-rbservationat, 2 years) wa^screated as the pro-
portion clf use (0 : llo use, .33 : occasional rtse,
.b7 : f requent use, I : continuous use ) tirnes the
lengtli (in days) of the observation perriod atrd
strnrmecl(mean [SD] : 327.5 pTrtl; range, 0 to ti85).
S l ati sti c:alA rml ysi s
In main effect anal;zses,thc influence of expeli-
mentzrl treatnrent, on corntrrosi[e outcorne and ot-t
each outcome rnca^surewas estinrateclin three ways:
lbr endpoint sub,jects (1/ : 160), fclr c:ontpleting
subjects (1V : 129), and for completing sutrjects
statistically adjusted for difft-.rential attrition (Sote-
ria nonat,trition is 83% [68 of 82] u.s.hospital nonat-
trition of 6ll%' [61 of 97]; chi-square : 8.86, rlJ' : 1,
p : .00). This presents a range of platnible trt'at-
'I'hese
ment etfect estim:rtes for each outcome. anal-
yses employed control variables ftrr the protrlortiotr
of su[jects diagnosed with schizophreuia (47'Yo [32 of
681 in Soteria us. 2lIYo[7 of 58J of hospital compl-
etrrrs;chi-sclual'e: 4.75, dJ': l,'p : .04) ancl for the
length of time in the posttlischarge follow.up periocl
because Soteria's clesign allowecl longer initial treat-
nrent, stays (mean : 548 postdist:harge days for'
Soteria completers us. 677 tor hospil,al completers;
t : 5.89, df : L28,,p : .00).
Due to ditf'erential attrition across treatmeut
groups, Heckman'.s (1979) procedure for correctittg
attrition bierswas usecl in one set of trealrnent effect
estimates for comtrlleters (Tables I througli 13,r:ol-
umn 4). This procedure involr,'es three steps: esti-
mating a probit moclel on rtonattritiott frour bix;eiine
variables, calculating a function of the probaliility
that a sulrject was ttot, lost to follow-up (tite iuverse
mills ratio), ancl usir-rgthis tunction as a covariate in
multivariate estimates of treatntent t-.ffects. l'he in-
verse nrills ratio fi'otn tlte probit rnodel on notrattri-
tion was assessedfbr collinearity with other t:ontrol
variables (Stolzenberg ancl Relles, 1997; scltizophre-
nia, clays in the follow-u1r periocl); none n'as found
222 BOLAANI) N{()SHER
'fAtsLF]
I
iIt t'uirrul E,l,fect
s rtf'Ilt.7tn'i,m IJS) uul
Complc.tt,lsOom'eclul.frtrAtlrili,on ('N ,,, I29)
( )tttc:orrteVirriable F)rtdllt.rittt"'' (lotttplt:1.nrs" ' ( ' o r n p l c t t ' r ' sA r [ j r r s t ' t l ' ' '
. ?i 1 ,
Oonrpositr olltc{ )lue'r .17 .;ll't'r
Social frrnctioning" .!0 .18 .08
(llulltrl psv('l lopal ltolog.v/ .05 .21*'r .20r"r'
lmlrrovetnt'nt in pslichopalhology1' .09 .17+ 1'7rl

Working"
Any .01 '05 .08
I.'trIl-tiur.e .02 .04 .07
L i v i n g a l o r r eo r w i l l t p e e l s ' .18'i::i .l9i' .t7
Reilrlrtissir>n/ -.10 --.Oit; -.1t;1.
k -.:10 -.11 -.gg{,*,
N ulutlrr o1'readmissions
Days in reaclrnissionl -.9;J -4.6 -2:j.(j
" l:stiuates control for schizophrenia./schizophrenifomr
disorderand nulnber of daysbetweeninitial disdlaxge&
i' Estjnr{tesconhd for the schizophrenitschizophreuifoml disor
dilTerential atlrition by treatnent group.
" Signiti(ancetests are trro-tailed:*p <-:.10,**p .i .06.
'/ Dilferenm in the cotnlosite outcomefor Sotedasub,iects(in standarddeviationlmits).
'' Differcncein the probabilityof membershipin the two best categodes(hal'inglittle or tro p8ychopathologs).
J Ilifference ill the probability of ntembe-Fhipin the two best categories (having excellent or very good impi)ve-rBent in psychopatholosr).
'r l)ilfen:lxre in the prubability of the eventoccurring(readmission).
" Differcnce in the expected value Glumber of readmissions).
' llifference ir the expe{rted\'alue (da}s in readmission).
/ Differen{ie in lhe pmbirbility of ttre ei?nt occuning (living al('le or u'ifl pecJ:t).
i I)itTerencein the prcbability of the e\crts occurring(any work, firiltime work).
' Differencein sociai ftrnetioning(on a ii point scale).

T.q.tsLE2

(N : 49), atul (:ornpltters(''rtn'rrted..fbr

Attritiott f N : 49)
( )utt:otne Vitriir"trle Endpoint"'' C-lornpleters"' (-lor1
trr1,,
rr'tr Adiustrrd""
Oonrposite ttrrtcouled .39 .38 .81'k'l'
Sor:ial [\ rrrctir-rniug' .64** .67j"k .irl)*
t i l o b ; r l p s y c l t u p a lI t o l u g y ' .34*'i .44|- ''14'r"i'
Inrproveurenl in psychopafholog-vg .34r't' .,1!lf i' ..19r,r,
Workingr'
arl' .18 ,)|
.,)f .4(Ji'*
I,\rll-tirne .11) -Lt) .211't+
Lir,'ing alone or lvitlt !r(,els? .19 .27 .28
Iteaclnrissir-rn' .05 .l! -.?I't'
r -.92
N Lrmtler of reacft-nissitltts .36 .il8
l)a.r's in rea(llnission/ al')
3.1.fl -:1.83
" Ilstinrates control for nunrber of dal,s betw'een rnitiitl discharge anrl Z-year fbllow.up.

' S i g t r i f l c a n < :tee s l s a r e t w * t a i l e t l : * p ' , : . 1 0 ,* * p . . - . 0 5 .

'/ DilTerence in the compclsite out('c)lne f'or Sotena
treatment (in standzrrd devi:rtion units,).
'
I)jftt'rence in ttre prohatrility of rnetnbership in ttre two best t'ategories (htrving littie or no trrsyclro1ratlrology).
/ Difference itt the probatiilitv of trtentbetshipitr tlre tw'o best r:at,egories(having excellent or very good inrprovetutnl).
1/I)ifference in the probability of the event occuning (readrnission).
''
Diflirlence in tlre e'r1rt,r:tecl vahrt' (rrrurrberof rearlnrissir.rns).
'
[)ifference in tlte expected value (ciaysin readmission).
/ []ift'erenc't-in the probability olthe event r-rcrr:urring (ii\,ing alone or n'ith peers).
I' I)ifferenc,. in the
lrrobability of the events occuring (iury work, full-time *'ork).
t
I)ift'erencein soc'ial fun<rtiorring(on a l3 pclint s(:ale).

(the largest correlation was with schizophrenia,
Pearsr-ln r' : -.06, NS). The two-stage fleckman
procedure resulLs irr a small clistortion of standard
error (lstinrates through uscl of an estimated rather
than an ol)senred inverse mills ratio. lnitial efforts to
coll'ect the st,andard en'ols resulted in onl5r slight
p-value chariges (in the third decinral place); t,here'-
fore, they were left uncorrected.
These analytic procedures werer r€)peated sepa-
rately lor endlloint (It' : 63) and conlpleting sub-
 SOI'FIRIA:]'W{)'YFIAROl rf( l( )I\'IFIS 223
TAtsLF]3
i\'lot'rfirLll
Oorrrpleting Suhjects (N ,.=,3{//, iltld (:otrtplelers Cctnr.tctcd.f'rtrAtlritict}u,f N ='. 8{/)
FlntlJ;oinLo' ('otttplt'tr'rs"' (,lornplcl crs Adjtrsl t:ti""

Oonrposit,ec)utcolre'r '1fl .r.)r) .'r+

Social liructionitrg' -.lt) -.15 -.22
(ikrbal psychollatholt>gy/ .03 .08 .07
Inrprovernenl in psyc'hopatholog// .06 .05 .06
lVorkingt'
Any -.0I -.0t) -.09
l\rll-tirne -.01 -.Oti *.u8
l , i v i r r ga k r n e o r u i l l t I ' e e r s t .t7 I't
.t2
lte;xlntission' -.19* -.l(i -.:01'
N rrnrtlt'r' of re:rclnrissiotts/' -.59+ *.gg*+ - L24*1
l)ays in roacltnission/ - 16.,{ -30.c) - . 7 1. { t
" llst-inrates contnrl for nurnber' of days between initial discharge and 2-year tbllovr.up.

' Signifir-'an<'e
tests are tw'o-tailed: *p '.< .10, **p < .05.
'1Diffr'rence in conrposite orrtcorne for Sotcria treatnrent (in stturdard deviation unitsl.
' I)ifferenc't' in sociai fllni'tioning
1on a i3 trloint scale).
/ I.)ilference in the probability of memberchip in the tw'o best categories (travrnglittle cn'no
;lsychopathology).
I'l)ifference in tht'probability of menrbership in the tlvo best categt.rnesthaving excellent or very goorl irnprroveur(iut).
" lJiftirrenct, in tlre Jrrotratrility of the events ocr:urring (any r,r'ork,ltll-tirne rvork).
t l)ifference in the probatrility of the event occurring (living alone or rr,.ithpeers).
i Differenct- in the probability of thc event occllning (readmissiorr),
A Difft'rc'nr.'ein the expet:l,e<ivahte (reatlnrissions).
' f)ifl'ererrcein the e-xper.:terJ value ldays in readrnission).

jects (l/ : 49) with insi<lious-c)nset schizoplu'enia,
?lnd lor endpoint (rV : 97) ancl completing subjects
(i/ : 80') r,r'ithschizophl'enifornr disorder. Subgroup
analyses rme(l the saure control variables, omitting
onlv the inrli<:ator variable for schizophrellia.
In each analysis, estinrat,eswere made with the
multivariate statistical proceclure appropriate for
the level of measurement of the dependent variable:
or(linaly least squares (OLS) r'egression for interval
lneasures (compositc outcome scale, social firnc-
tioning), a maximum likelihood probit for binary
categori(:al variables (readrnission, Iir,ing indelren-
dently), an ordered probit for orderecl categorical
variables (McKelvey tlnd Zavoina, 1975; global psy-
chopathology, improvemeut in psychopathology,
working), and a classical tobit for lower tmncated
inten'al nreasures (Tobin's probit, Tobin, 1958;num-
ber of readmissions, days in readmission).
Treatment effects from probit nloclels report th€l
rlifference in the probability of the clbsen'ed out-
come (readmission, living independently) for exper-
imental subjects. Experimental treatment estimates
from orclered probability rnodels reporf, the clift'er-
en(:€lin the combined probability of membership irr
the two best categories of the dependent variable.
Effect estimates on work functioning are presented
as the change in the probability of working full-time
and as the clralge in the probability of working at all
(working full-tinre plus working part-time) lbr exper'-
irnental subjects. F'or trturcated interal measures
(nunrber of rearhnissions, tlays in readmission), esti-
mates represent the change in the e4recterl value of
the clependerntvariable associated with experirnelrtal
treatnrent (see Breen, 1996,p 27, Eq. 2.18 for the slrec-
ification). fuialyses were conductetl using the statisti-
cal software packages SPSS and LIX,IDBP (LlMitecl
DEPendent variables: (]reene. 1998),
Results
Mairt Effer't,s
Main effect results for enclpoint subjects (.n/: 160;
Table 1, coiumn 2) inclicate that experimentally
treated sutrjects hacl a n<lnsignificant two tenths of a
standard der,'iationbertt,eroutcom€)s (+.17 SD, I :
1.07,d,f : 149, NS, all statistical tests are two taile.cl).
Experimentally treated endpoint strbjects had signif'-
icantly better outconres on one of the eight out-
comes: an 18% higher probabiii{y of living alone or
w i th peers (+ .18, z : 1.94,dtf : 147,trr : . 05) .
Results for completers, unaqiusted lor attlition
(l/ : 129; Table 1, column ll'), indicate that experi-
rlrentally treated strb.iectshad one thircl of a stanclard
deviation better composite outcomes (statistical
trr-'nd,+.35 SD, / : 1.73,df : 124,p : .09), incluclirrg
significantiy bett,er outc:omes on one of eight nrea-
sures: a 21% higher probability of har,ing no or very
low psychopatlrology scale scores (+.21, z : -2.5:1,
dJ':103,p:.01).
224
Main eftect results for completers adjusted for
attrition (N : l2t); l'able l, colnmn 4) indicate that
ex1-rerimentally treateci sub.jects had nearly one half
standarrl deviation better composite <lutcomes
( ^+ . 47S D, t - - 2 .2 0 , d l ' : 1 2 3 ,p : .0 3 ) and si gni fi -
cantl.y better outconres on two of eight rneasrires: a
20%,higher probability of meurbership in the lowest
two psychopathology c'ategories(*.20, z : -2.22,
rlJ' : 1gr,,p : .0il) and uearly one l.evverreadmissiorr
('-0.98, z : - 2.37, 4f : 123,P : .02).
Sr:hi e rryht'tt t,itt Stt Qie:cts
Ilndpoint schizophrenia subjects (// = 63; Table 2,
colurnn 2) had four tenths of a standard deviation
tretter r:onrposite outcontes in Soteria (not statisti-
c ally s ignif ic a n t; + .3 9 S I), rl : 1 .4 2 ,d J ' :6 0 ,p : .16).
This inclucle'ssignificantly bett,er outcomes on tltree
of eigirt mea^snres a 31o/o higher probability of har'ing
no or neailv no psychopa.thology(+.34, ; : -2.74,
4l' : l'>8,p : .01), a34o/ohiglier probability of mem-
hrt-.rshipirt the two best psychopathology improve-
nrerrt categclries(+.34, z : -2.16, df : 58, p : .03)
ancl six tenths of a point (on a 3-point scale) better
scrcrialfunctioning (+.64, f : 2.i34,df -- 45,p : .02).
{lnadiusled for attrition, schizophrenia compl-
eters ('I'able 2, colurnn l)) treated at Sotena had a
nonsigniticant four tenths of a st,anclarddeviatiorr
bet t er < r ut c o me(+ .3 8 SD , f : 1 .1 9 ,4 t' : 46,N S ) ancl
statistically significant benefits on three of eight
otrtcorrres'. a 44% higher probability of being in the
lcrwest two lrsychopathology categodes (+.44, z :
-2.13,
df : i36,p : .03), a49o/ohighel probability of
being in the best two psy<:hopathologyimprovement
c at egor ies( + .4 9 , z : -2 .7 5 , rIJ ' : 1 1 6p, : .01), ancl
frvo thirds of a point better social outcomes (f .67,
t : Z.lsi),tl,f' : i37,tt : .(')2).
Adjusted f<-rl differential attrition, conrpleting
schizophrenia subjects (l/ : 49; Tabie 2, column 4)
had eigltt tenths of a standard deviation better col"n-
pr-rsiteout,cornes when treated at Soteria (+.81 SD,
t : 2.42, 4f : 4ls,7t - .02) ancl sigruficantly better
outc'ornes on fcrur of eigltt measures: a M(% higher
likelihood of havirtg uo or nearly no psychopathol-
o g y ( + . 4 1 , 2 : - 2 . 1 1 , , { l ' : [ ) 5 , p : . 0 4 ) ,a 1 9 { X t h i g h e r
likelihood of having excellent, or very good psycho-
pathology improvement (+.48, z : -2.67, df : 34,
p : .01), and a 40o/ohigher probability of working
( + . , 40,z : 2.3 0 , tl f' : 4 0 ,p : .0 2 ).
,!it:lt i z o1th.r'ert tfo nn Suhj ects
Sc:hizophrenifcln endpoint sub,jects (1/ : 97; Ta-
lrle 3, coiurnn 2) had a nonsignifi<:anttwo tenths of a
B 0 L A A N I ) N{OSHI.]R
standarcl deviation better outcome at Soteria ( +. 19
SD, t : .92, df : 94, NS).
Llnac{iustedfor attrition, c:ompleting schizolrhreni-
tbmr subjects (rV : 80; Table 3, column il) had a
nonsignificant one tlrild standarcl cleviat,ion trett,er
corn;rosite outc<lme at Sot,eria (+.33 SD, t : 1.28,
df : 77, p : .20) that includes one statisticaily
significant findiug, approxinrately one fewer read-
nrission to 24-hour care (-0.98 readntits, z : - 1.98,
d,l":74,p:.05).
Ac{ustecl for attrition, comp}eting schizophreni-
'l'able l-1,
form subject.s (l/ : B0; column 4) hact a
nonsignificant one third stanclarcl der,'iation better
composite outct>me at Soteria (+.114 SD, I : 1,22,
d-f': 76, NS), incltrding signilicantly better outcomes
on one of eight, nleasures, an average clf one anci one
quarf er fewer reaclmissions ( - L.'24 reaclmits, e :
-2.36, d,l : 7b, : .02).
7t
Post ltoc Artulqsr:s
Post hoc analysis comparing enclpoint subjecLs
later lost to follow-up (9 Soteria and 22 hospital
subjects) founcl no conrposite out,come ditferences
(-0.18 L).s.: -0.23, f : .89, rl J' :29, N S ), indicat ing
that loss of a lriglt-functioning subgl'oup of hospital
subjects is nr>t a plausible explanatior-r ftir observed
Soteria treatment benefits.
Investigating whether Soteria acled to recluce
medication for all subjects or only for those not
rrtedicaterd during the follow-up period, nonmecli-
cated comple[ers (29 of 68 Soteria arrcl 2 of 61 hos-
pital subjects) \4.ere excluclecl in a comparison of
meilication use. This cornparison founcl no betll'een-
group clifferences (Soteria nrean : 421days rrs. hos-
pital mean : 4!37 days; I : -0.42, df : 96. NS),
indicating that experirnental tre'atment does not re-
duce the duration of rneclicatiorl use for those re-
ceir,'ingmedicatiorts l-rutonly re.ducesthe proportion
of patienls medicated.
Comparison of the proport,ions of Sot,eria-treated
schizophrenia vel'sus scltizophreniforru sub.ject,snot
receiving antipsychotic niedications during the fol-
low-up period found no signific:ant differenccr: 44%of
sclrizophrenilonn (16 of lJ6) versus 47o/oof schizo-
pl'rrenia subjects (1i) of 32) were not drug treatecl
(chi-square : .10.d,f : l, NS), indicating Soteria was
equally effective in reclucing ant,ipsychotic medica-
tion use in both groups.
Discussion
tuIuirt Fittd'lngs
Despite some treatntent crossoverr during the fol-
low-up periorl, strikingly trerreficial effects of Soteria
 SOl'ltRIA:'l'W()-YIIAROII'f(l( )illFls 22it
treatment are still evitlent at tl're 2-year follow-u1r components of treatment, and similarities between
periocl. This is particularly notable because an ear- Soteria ancl factors hypothesized as responsible fkrr
lier leport, of 2-year out,comes from the fir'st c'ohort favorable developing country outcomes in World
of this study descritretl more moclest benefits Healtli Organization stuclies (Jablensky et al., 1992:
(Nlo.slrerand Menn, 197fla).These results externdantl Leff et al., 1992).
refine previous reports by including both cohorts
ancl conclucting rnultivariate enclpotnt and two com- i,r,fuIel hodol,og.g
An.o.['yl,
pleting sutr.ject trnalyses. Recall that previously re-
The nrore favorable results in the present analyses
lrortetl (Mosher ancl Menn, 1978b; Mosher et al., seem partly due to the larger sarnple and mrlre con-
1995) separate cohort analyses of 6-week data
temporary st,atistical methods. We have notecl sev-
shorved signilicant and comparable synrptomatic
eral inlportant variables relaterl to outc<lmes ancl
irnpror"'ement for both groups clespite marked cliffer-
different acl'oss treat,rnent groups (scliizophrerria,
ences irr neruroleptic treatment.
length of ttre postdischarge follow-rip period, and
Three sets of treatment elfect estimates show a
attdtion). The contrast between these ancl pre'"'i-
patten'r of small to medium effect size trenelits for
ously reported results highlights the import,ance of
Soteria that, are larger for completing than fclr end-
including rn statistical analyses relevant control l,'ari-
point subjects. This may be partly due to completers
ables that are a) scientitically related to sttrcly design
having the full 2-year period in whir:h to recover'.The
(length of foilclw-r"rpperi<xl; Wyatt, 1991), b) theoret-
possibility thal, a gr'oup of higlter funr:tioning control
icaily related to outcome (schizophrenia; Lrohen and
sr"rbjer:tsmay harre been lost to lollow-up between
Cohen, 1983), or c) rnay affect tlie generalizability of
enclpoint and cclmtrrletion turns out not to be an
resulLs (differential attrition rates; Heclcnan, 1979).
exlrlanation frrr Soteria benefits because endpoint
To illustrate this point, control variables fi'om the
subjerctslost to follt-rw-up had comparable outcomes
re.gression on composite outcome were adcled one
in trclth treatnrent, gt'cltt1rs.flowevet', due to higher
at a time using t:ornpleting subjects (rV : 129; Table
attriti<ln among the hospital-treated subjects, espe-
1, compare with row 1). When only experimental
cially alnong hospital-treated schizoprhrenia sub-
treatment was included in the regression, the effect
.jr:r:ts,elfect estimates for con-rpleting subjects unad- size estiniate (regression coefficient, in stzurdard de-
.justecl for attrition are likely to contain a bias. viation units) for experimental treatrnent was .12
'fhe'refore,
the third set of treat,rnent effect estirnates
and not statistically significant (t : .66, dJ' : 127,
uses a statistical procedure developed by Nobel Lau-
p : .51). This is analogous to the cornmonl.Vused,
rt:ate,JamesHeckmau (2000 in Economics) to rrtore
and lterhaps overly simplist.ic, two-group l-test used
ac<'urately estimate the eff'ec'tsof Soteria treatment
ir-rearlier reports" When the r.ariable fbr lengt,h of the
oll ir nelv sanrple of similar clients. A{usting for
follow-up per"iod was added, the effect size estirrratc
clifferential attrition, colntrlleting subjects treated at,
fbr experimental treatment ber:ame ..')2 (f : 1.63,
Soteda had nearly oue half of'a standarcl deviation
better composite' outcome scores than the usuai 4 t ' : 1 2 6 ,p : .11),Adding the variablefor schizo-
ptrrenia (and its missing value inclicator'), the elfect
treatment group (T'able 1, column 4), a "medium"
size estimate for experimental treatment became .ili>
effect size (Cohen, 1987) that is statistically and
(Table 1, r'ow 1, c:olumn j-];/ : 1.73, 4f': I24, p :
1x'acticerlly significant. Soteria-treated sub.jects also .08). Finally, adding the indicator lor the probability
had lou'er psychopathology scores and fewer rearl-
of nonattritiou, the eff'ect size estimate for experi-
missions than ltospital-t,reated subjects.
merrtal treatment became, a.sreportecl here, .47 (Ta-
When consiclering schizophrenia subjects sel)a-
ble l, row 1, colttmn 4; t : 2.20, df : I23,7t : .0ll).
rately, results inclicate even more favorable out-
Thus, it appears that previous reports fronr Soteria
collles in the Soteria-treat,erl grc)up. Adiusted for
have untlerestimated the benefits of experimental
diff'erential attrition, these subjects have signifi-
treatment through omission of important control
cantly better corrrposite outcomes of a large effect
vilriables. In sum, we view these mult.ivariate ana-
size (Cohen, 1987; "large" effect size : .80) despite
lytic methocls as more approJrriate than previously
not lrt:ing lllol'e frequently meciicaterl in Soteria than
usecl bivariate' merthods and as producing relatively
schizophreniform subj ects.
unbiixed estimates of the effec:tir,'enessof Sclteria
treatment.
IVhe l,4r' c:ourL[s.lor' 7hese lri ntlirLgs,)
TreuttrtenL Co nuponeruts
These favorable finrlings flom Soteria call for
sorne explanation. Therefore, we exarnined possible, A nuurber of therrapeutic ingredients in Soteria
exlilanations in t,hree areas: analytic rnethorlolclgy, treatrnent have been suggesteclby Mosher (2001) a^s
22(i [}OLA ANI) IIIOSHt.]R
likely sources <lf benefit, including a) the milieu, b)
attitudes of staff and residents, c) quality of relation-
sliips, ancl d) supportive social processes.
XLilLeu, Differen<:es between experimental and
hospital urilieus were assessed with the Moos Ward
Atmosphere (WAS) and (lommunity Oriented Pro-
grarn llnvironment Scales (COPES; Moos, 1974). Sig-
nificant, differcnces were found on 8 of 10 subscalcs,
notably favoring the exlrerimental milieu <in involve-
rnent, support., ancl splontar-reity(Wendt et al., 1983).
Al.liturles Soteria staff wix significantly more
intuitive, intro','ertecl,flexible, and tolerant than hos-
Jrital staff (Hirshleld et al., 1977). Soteria's atmo-
spherrewas imbued with the expectation that recov-
ery florn psvchosis was to be expectecl (Mosher,
200r).
Th,erapeuticRelutionsh,'i,'rts.Perhaps the most im-
poftant therapeutic ingredient in Soteria emerged
from the quality of relationships that formecl, in p&rt,
because of tlie additional t,rrratment tinre allowed.
Within staff-resident relationships, an integrative
context was cr€)ateclto promote understanding and
the discovery of meaning r,r'ithin the subjective ex-
perience of psychosis. Resitlentswere encouagecl to
aclcnowleclge precipitating events ancl emotions ancl tcl
discuss an<l eventually place thern into perspective
within the continrritv of their life zurd social network.
Soc:'iuli{elutrn'ks. Tlte role of social net,works in
pror.'irling direct suJrtrrort and buffering stress for
patient,switlt psychotir: disordels has been well doc
runented ('Iluchanan, 1991-r). Social strppott has been
positively con'elatecl with fuvorable outcomes
(Erickson et al., 1998). Psychotic patients tencl alscr
to har.e diminishing social support networks (Coheu
anrl Sokolovsk-v, 1978). To address this deficit, tlre
Soteria project providecl a surrogate fanrilv for cli-
ents in residence, and a client-centered postclis-
charge social netn'ork grew up de no\ro. The result
was [)eer support for conuntutity reintegration (e.9.,
peers helped to organize housing, education, work,
antl a social life) and alr ongoil-rg source of social
sul,rport.
Su,trtport'tr:t:Sor,rlal ltr^occsses. Social plocesses
were influencetl by a number of aspects of the pro-
gram (Mosher, 2001): the creation clf a family-like
atrnosphere, an egalitarian approach to relationships
ancl househokl func'ti<lning, and an enl'ironment that
rcspected a:rcl toleratecl indir,iclual differences and
aut<lnomy.
(.tulhral Fa,c{ors
Ilvicient contlasts between Soteria and hospital
treaturent cultures brings t,o rnincl the superior out,-
comes in developing countries for patients with
first-episode schizophrenia in World Ilealth Organi-
zation (WHO) stuclies (.lablensky et al., 1992; Lelf et
al., 1992; Whitaker',2002'). There are' nlany plausible
sirnilarities between Soteria and the support,ive and
collectir,'ist social processes trequently hypothesized
as responsible for bett,er developing country out.-
conles. The second WHO study aiso reportecl a 43Vo
lower ploportion of pat,ients maintaint:d on ant,ipsv-
chotic meclicrationsin cleveloping countries (16%'ls.
developed countries, 59%; .Iablensky et al., 1992).
StrLrl,yLi m i,tat'[on,s
Tliis study has a number of limitations that re-
strict the validity and generalizability of these find-
ings. One limitation arises from the inclusion of
some second-episode clients (lYo%,63 of 179 hacl
treen prer,'iously hospitalized) and requiring both
poor prclgnosis characteristics of young age anci utl-
rurarried.Thus, this sanrple can be considered to be
of somewl"ratpoorer prognosis than one representa-
tive of only filst-episode sc:hizophrenia spectrunr
clisorders.
Another limitation arises fi'om tht. lack of explicit
comparability between t,he rediagnosis of schizo-
phrerria used here (DSM-II schizophrenia atrcl an
insidious onset of sympt,orns fclr 6 month.s or nrore )
ancl a DSNI-IV diagnosis of schizophrenia. DSM-IV
also requirers diurinished functioning. lloweve'r, cli-
agnostic c:ritetia in the Soteria study were quite
rigorous, requiring agreement from tlu'ee inclt-.penclent
clirdcians, and since a]l werc cleemed in need of hos-
pitalization, imJraired functioning carl be assulne(l.
Attrition ot28tr/ogives rise to concerrr fol the sanl-
llle's representativeness. This is accolnpanied b.v
concern lor a possible bias in the treatment effect
estinrat,e due to greater attrition in the hospit,al
group (37W than in the experimental gronp (17%).
As cletailecl abr.rve,statistical methocls to control fbr
attrition bias ilr estimating treatment effects lvere
used (Heckman, 1979), but these methods certainly
do not leplace rnissing subjects.
It, is possible. that the use of inclepenclent raters
not blincl to treatment could have introduced a mea-
surerlrent bias. Wrile financial lirnitations precludecl
the use of blind reliewers, raters were inclepr:ndenl
of ther pro.ject, rotat,ed acl'oss condit,iorrs, and wel'e
trained to maintain high interrater reliability on the
few meastrres that, required rater judgment.
Ar aciclitionallirnitation derives from the quasiex-
perimental nature of the str.rcly.While second cohort
 FIAROt rT(lOlllF)S
SOI'FIRIA:'I'WO-Y
subjects were randomly it-ssignedto treatment, first
cohort subjects were assigned using a colmecutive
space ;rl'ailable decision rule. This raises the ques-
tion of group comparability. Althougl'r we clid not
firnd st,atistical evidence of het,ween-group differ-
ences at baseline, there were cleeuly some differ-
L.nccs.I)ifl'erences tencled to favnr the hospital group,
parlicularly with an initially lowel proportion of insid-
ious-onset schizclphlenia sutljecls that became signifi-
cantly clifferent lry fcrllow-up evaluation (addressc.d r,'ia
statistical control). Ilowever, sinrilar results have been
n<lted in conrparing fincting.s tiom experimental and
rluasiexperimental designs (Shadish and ltagsdale,
1!l9fl), especially when controlling for betrn'een-grouJ)
tliff'erenr:es.
( )l i.tt ical I nLltli r:rtt,io ns
On the whole. these data argue that a relationally
focused t,herapeutic milieu with minimai use of an-
K tiJrsyc:hotic clrugs, rather thzur drug treatment in the
hospital, should be a pref'erred treatment for per-
sons nern4v cliagnosed ll'ith schizophrenia spectrum
clisorrler. We think that the balance of risks and
irenefits a*ssociateclwith the commorl pract,ice of
nredicating nearly all early elrisocles of psychosis
should be reexamined. Itt additiotr, the search, be-
gun earlier. for treatment response subtypes in
schizophrenia spect.rum disorclers (Carpenter ancl
lleinrichs, l98l), particularly for pat,ienlsnot bene-
fiting fxrnr antips.ychotic medications, should be re-
sttmetl."'n
In marty mintls, and in cliuical practice guidelines
for schizopl^u'enia(APA, 1997; Irrauces et al., 1996;
l,eluran iurd Steinwachs, 1998), ther question of
rn,hetherto administer antipsychotics for all patients
with early episocles is answerecl affirmatively, and
discussion of alterriate irrteruentions is thereby
clclsecl. We regarrclthis c:losure of inquirv iLSprerna-
ture. Current Scandinar.ian projects involrdng in-
honre family crisis inten'euti<-rn,avoiding use of hos-
pitals ancl neuroleptics, ancl lrror,iding continuity of
teams and approach over an extended period have
sliown highly promising result,s for the treatment of
patients with newly diagnosecl psychosis (Lehtinen
'Ihe
ct al., 2000; Cullberg et al., 240D. St:andinar,'ian
results, Cliompi's Soteria replication (Ciomlri et al.,
1992, 1993), and thcr finclings reported hele indicate
t,hat,,contrary to lropular r,tews, mininral use rif an-
''
Bola Jll, Nlosher LIt (in press) I)redicting chug-free treatnrent
l'{lsp()rrseiu ar:ute psyc'lrosis fron-r lhe Soteria prcr.je<1.Srltizophl
jhrll.
l llr-rla
JIl, Nlosher LIt (in press) L)lzrshingider,rlogiesol sr:ieu-
1ific rliscorrrse'/ Sl'/i i,zrtnltr Bull.
227
tipsychotic medications combined with specially de-
signed llsyi:hosocial ir-rterventi<lnlor patients new-lv
icientified lr.ith schizophrenia sJrectrum disorders is
not harmfrrl but appears to be aclvantageous.
In a well-known reattalysis of mr-rstlyfirsf,-episode
schizophrenia spectrum stuclies comparirrg antipsy-
chotic medications vel'sus psvchosocial or urilieu
treatment, Wyatt (1991) concludetl: "e:rly intelen-
tion with neuoleptics in first-break schizophrenic pa-
tienls increa*sesthe likelihoocl of an improl'ecl lclng-
terrn course" (p 325). ThLs conchsicln has cont,ributed
to ertthusiasm for efforts to plevent psychosis tluouglr
"early inten'ention" in the proclrorne, often with low-
dose at,lpical antipsychotic medications. [{owel'er,
most of the studies reviewerl by Wyatt (1991) n'ere of
a preexpedmenta.l (mirrorimage) design that did not,
control nrany threats to internal r.alidity (Oa4tenter,
1997). In t-act, a preponderance of the few available
quasiexperirnental or t,xlrerinrentally clesigned t.ar{y
t
episode studies in u'hich olre group was initially not t
rnetlic:ated (Czrllenter et aL, 7977; Ciompi et nl., L992,
199i ; Lehtinen et al., 2000; Mc.rsherzur<lMenn, 1978a;
Rappaport et al., 1978; Schooler, 1967) show better
long-temr outcomes for the unrnedicateci subjects. [n
concert u'ith the fuller presentatiotr of Sotena results
heLe,these shrcliessuggest that specially designed psy-
chosocial iuter"u'tntion contbhred with minimal r-nedi-
caticln use may be an effective treatrnent strategy for
pafients with ein'ly episoile schiz<lpfuenizr spectrrurr
psychosis.
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