Martha Sajatovic|Marilyn A. Davies|Stephen J. Ganocy|Mark S. Bauer|Kristin A. Cassidy|Robert W. Hays|Roknedin Safavi|Frederic C. Blow|Joseph R. Calabrese
A Comparison of the Life Goals Program and Treatment as Usual for Individuals With Bipolar Disorder
Case Western Reserve University|University School
back table contents previous article next article articlefull accessa comparison life goals program treatment usual individuals bipolar disordermartha sajatovic mdmarilyn davies msn phdstephen j ganocy phdmark bauer mdkristin cassidy marobert w hays rnroknedin safavi mdfrederic c blow phdjoseph r calabrese mdmartha sajatovic mdsearch papers authormarilyn davies msn phdsearch papers authorstephen j ganocy phdsearch papers authormark bauer mdsearch papers authorkristin cassidy masearch papers authorrobert w hays rnsearch papers authorroknedin safavi mdsearch papers authorfrederic c blow phdsearch papers authorjoseph r calabrese mdsearch papers authorpublished online1 sep 2009httpsdoiorg101176ps20096091182aboutsectionspdfepub toolsadd favoritesdownload citationstrack citations shareshare onfacebooktwitterlinked inemail although many patients bipolar disorder helped rapid expansion pharmacopoeia treatment bipolar disorder 1 treatment effectiveness remains suboptimal rates treatment nonadherence variable generally substantial order 12 64 2 3 4 5 although mood stabilizers cornerstone treatment bipolar disorder previous studies demonstrated psychotherapies including psychoeducational interventions specific bipolar disorder may enhance pharmacotherapy improve clinical outcome 6 7 8 9 suggested various psychoeducational interventions briefer steppedcare packages 10 11 comprehensive group packages 6 also aid treatment adherence however effects psychosocial approaches including psychoeducation treatment adherence consistent need identify core components psychosocial interventions affect treatment adherence resource limitations found many clinical settings 12 life goals program lgp manualdriven structured group psychotherapy program individuals bipolar disorder 13 lgp focused systematic education individualized application problem solving context mental disorder promote illness selfmanagement 13 demonstrated patients bipolar disorder participating lgp may significantly improve knowledge bipolar disorder 13 lgp developers suggested medication adherence could improved lgp 13 interestingly clinical characteristics usually associated poor outcome substance abuse reported correlate diminished lgp participation success moreover collaborative chronic care management models adapted bipolar disorder include lgp shown significant improvements clinical outcome 14 15 16 17 function 15 quality life 15 longterm multisite randomized controlled trials previously published trials used lgp within context combined care approach 14 15 16 17 published data lgp may specifically affect treatment adherence populations persons bipolar disorder randomized controlled multicomponent intervention study included lgp among multiple components conducted managed care setting specifically evaluate medication adherence 16 randomized controlled collaborative care model ccm study department veterans affairs included lgp one multiple components evaluated medication adherence secondary outcome find difference ccm group control group 17 ccm study several components possible separate effects lgp activities nurse care management 14 15 best knowledge previous studies using controlled methodology tested lgp standalone intervention randomized controlled study examined 164 outpatients bipolar disorder community mental health center randomly assigned standardized psychoeducation lgp treatment usual see whether differences groups treatment adherence attitudes behaviors anticipated patients received lgp would demonstrate improvement treatment adherence attitudes well improvement bipolar symptoms functional statusmethodsthis project randomized controlled study determined effects treatment adherence attitudes behaviors standardized psychoeducational intervention lgp added treatment usual among outpatients bipolar disorder treated community mental health center patients qualified study entry randomly assigned treatment usual treatment usual plus lgp assessed baseline three six 12month followupsstudy population eligible study participants type type ii bipolar disorder confirmed miniinternational neuropsychiatric inventory 18 order obtain realworld generalizable sample patients bipolar disorder established minimal exclusion criteria inability provide informed consent inability rated psychiatric rating scales similar prior randomized controlled trials collaborative care management models 14 17 study approved local institutional review board study participants recruited clinician referrals selfreferred response posted advertisements study conducted july 11 2002 june 6 2007 lgp lgp based behavioral principles social learning selfregulation theories underlie collaborative practice model 13 lgp supported explicit manuals uses preset script topic focus topic sequence delivered research staff trained use program developers study principal investigators ms mad lgp organized two phasesphase ii cover illness education management problem solving phase lgp core psychoeducational intervention study delivered six weekly interactive group sessions content format psychoeducational groups described detail elsewhere 13 19 group size generally six eight members completion six weekly psychoeducational sessions participants encouraged attend optional phase ii monthly group sessions addressed goal setting problem solving unstructured format described bauer mcbride 13 adherence issues specifically targeted phase lgp 13 session 3 therapist helps members recognize role medication nonadherence ineffective coping behaviors perpetuating high mania triggering manic episode session 5 therapist helps members consider adherence medication adaptive coping response signs symptoms depression triggers depressive episodes finally session 6 therapist addresses individualized adherence issues assisting patients personal care plan lgp intervention administered study coprincipal investigator mad doctoratelevel registered nurse psychiatric counselor masters level supervised study coprincipal investigator addition use lgp treatment manual 13 lgp training consisted oneday intensive onsite training ongoing telephone support developers lgp fidelity intervention assessed coprincipal investigator attended first six months psychiatric counselorled lgp sessions coprincipal investigator mad delivered feedback key lgp format content issues end session lgp administered addition treatment usual staff working study investigators made reminder telephone calls lgp participants weekly group sessions individuals reachable telephone sent reminder letters lgp delivered group format lgp sessions always occur days individuals regular treatmentasusual appointments staff community mental health center generally supportive welcoming respect lgp process offered use group room community mental health center staff working study investigators hold lgp sessions treatment usualtreatmentasusual services patients bipolar disorder community mental health center typically include medication management psychiatrist psychosocial therapy counseling mental health clinicians phd psychologists mental health nurses psychiatric social workers access social services case management individuals require intensive assistance data collected specific treatmentasusual services study participantsmeasuressociodemographic clinical information sociodemographic clinical information including age gender education occupation social class 20 ethnicity age onset illness psychiatric comorbidity collected participants confirmed medical record selfreported history sexual physical abuse also collected reported relationship treatment adherence among adults serious mental illness 21 treatment adherence adherence attitudes measured tenitem drug attitude inventory dai although direct measure adherence behavior dai demonstrated associated degree adherence psychotropic medication among individuals serious mental illness 22 known relatively unaffected psychiatric symptom severity 23 dai simple truefalse format questionnaire assesses domains patients attitudes including positive negative experience locus control attitudes toward medication possible scores range 0 10 higher scores indicating better attitudes toward medication responses scored euphoricdysphoric continuum 93 higher scores corresponding euphoric end spectrum treatment adherence behaviors evaluated selfreported treatment adherence behaviors srtab within past 30 days similar selfreported adherence methods reported trials persons bipolar disorder 24 psychotropic medications assessed adherence individuals asked provide estimate 0 25 50 75 100 closest average adherence prescribed psychotropics combined participants informed information confidential would shared treatment providers exception circumstances individual acute risk harm self others symptoms global psychopathology functional status substance abuse symptoms measured 24item hamilton depression rating scale hamd 25 26 young mania rating scale ymrs 27 functional impairments caused illness assessed global assessment scale gas 28 substance abuse comorbidity assessed continuous measure using portion standardized instrument addiction severity index asi 29 possible scores hamd range 0 74 higher scores indicating severe depression possible scores ymrs range 0 44 higher scores indicating severe mania possible scores gas range 0 100 higher scores indicating higher functional status possible scores asi range 0 4 higher scores indicating severe substance abusedata analysisdescriptive analysis data performed standard univariate techniques available spss software categorical data compared chi square analysis fishers exact test continuous data compared students test first study lgp standalone intervention sensitivity analyses conducted evaluate effect intervention respect completer analyses last observation carried forward outcome lgp participation intensity well respect patientspecific variables age gender ethnicity marital status education social class suicide history substance abuse history history abuse psychosis depression mania severity functional status past hospitalizations mixedmodel repeatedmeasures analysis used test differences dai scores three subgroups different levels lpg attendance sessions one three sessions four six sessions treatmentasusual group analysis adjusted covariates sas proc mixed software used assess model included subgroups three subgroups different levels lpg attendance treatmentasusual group time fixed effects baseline hamd ymrs gas scores covariates dai scores repeated measure study participants treated random components model compound symmetry variancecovariance matrix used express correlational structure repeated dai measurements influence covariates dai scores determined significance magnitude sign appropriate estimated coefficient covariateresultsbaseline status initially 166 individuals met study entry criteria two enrolled subsequently identified study exclusion criteria therefore 164 individuals enrolled study eightyfour individuals randomly assigned lgp plus treatment usual 80 individuals randomly assigned treatment usual table 1 presents demographic clinical characteristics two groups two groups closely matched baseline significant differences groups demographic clinical variables table 1 baseline demographic clinical characteristics 164 outpatients bipolar disorder randomly assigned life goals program treatment usualtable 1 baseline demographic clinical characteristics 164 outpatients bipolar disorder randomly assigned life goals program treatment usualenlarge tablebaseline scores dai srtab also similar two groups sample good representation participants racial ethnic minority groups 40 preponderance female participants nearly 70 group overall demonstrated moderately severe depressive symptoms meansd hamd score186113 minimal moderate manic symptoms mean ymrs score7454 impaired functioning mean gas score574122 total sample 52 32 current mania hypomania 50 30 current psychotic symptoms comorbid substance abuse either current lifetime seen 87 n143 total sample 2 n3 sample least moderately severe levels current substance abuse evaluated asi study deliberately focus individuals known nonadherence baseline attitudes toward medication moderately good mean dai score7423 average study participants reported took 81 prescribed bipolar medication treatmentsstudy outcomesstudy participation overall 128 participants63 75 group assigned lgp plus treatment usual 65 81 treatmentasusual groupparticipated baseline assessment least one followup rating among participants group assigned lgp plus treatment usual slightly less half n41 49 participated four six sessions phase lgp sessions another 14 n12 participated one three sessions 37 n31 never participated group sessions completion core lgp phase psychoeducation fewer 10 n8 participants chose attend phase ii unstructured groups adherence attitudes outcome measure significant difference dai scores time group assigned lgp plus treatment usual treatmentasusual group similarly significant differences groups srtab symptom measures psychopathology functional status followup points selected outcomes two groups presented table 2 although significant temporal pattern improvements adherence attitudes behaviors symptoms functional status patients time statistically significant difference groups table 2 change baseline adherence attitudes adherence behaviors symptoms functional status among individuals bipolar disorder participating life goals program treatment usualtable 2 change baseline adherence attitudes adherence behaviors symptoms functional status among individuals bipolar disorder participating life goals program treatment usualenlarge tableexploratory analyses given high rates nonparticipation lgp conducted secondary analysis change dai score baseline comparing three subgroups different levels lpg attendance sessions one three sessions four six sessions treatmentasusual group indicated figure 1 individuals partial full participation appeared improved attitudes toward medication three sixmonth followups however oneyear followup difference scores three lgp subgroups effect sizes three months 07 persons attending lgp sessions 16 persons attending one three sessions 59 persons attending four six sessions six months effect sizes 35 35 49 respectively figure 1 figure 1 changes attitudes toward bipolar medications among individuals life goals program lgp stratified intensity participation treatment usual emerging body literature suggests psychosocial treatments effective among individuals ill past mood episodes 28 thus assessed whether individuals symptoms psychosis substance abuse lower functional status previous hospitalizations psychiatric substance abuse indications differences outcome lgp plus treatment usual versus treatment usual mixedmodel repeatedmeasures analysis tests fixed effects table 3 found trend p056 higher levels depressive severity baseline measured hamd predict negative attitudes toward bipolar medications time measured dai time treatment predicted positive attitudes toward bipolar medications time measured dai variables significant table 3 mixedmodel repeatedmeasures results tests fixed effects among individuals bipolar disorder participating life goals program lgp treatment usualtable 3 mixedmodel repeatedmeasures results tests fixed effects among individuals bipolar disorder participating life goals program lgp treatment usualenlarge tableas noted methods section additional analyses conducted evaluate effect intervention respect completer analyses last observation carried forward patientspecific variables compared persons lgp group go sessions participated sessions go sessions younger mean age 37284 years versus 445112 years p004 less education mean years education 12523 years versus 14027 years p010 demographic clinic factors significantly differentfinally conducted additional secondary analysis excluded individuals selfreported high rates treatment adherence 75 baseline evaluate whether lgp effects among individuals known nonadherent partially adherent baseline treatment effect subsample treatmentbytime interaction however must noted relatively small number participants met criterion enough complete data conduct analysisdiscussionthis first randomized controlled trial lgp plus treatment usual versus treatment usual study conducted 164 adults bipolar disorder receiving care community mental health center found patients improved oneyear study duration although study results show statistically significant difference treatment groups 12month followup must emphasized fewer half patients randomly assigned lgp actually participated fully intervention relatively low rates study participation similarly low rates lgp attendance underscore difficulties conducting controlled trials individuals bipolar disorder community mental health center settings despite limitations secondary analyses give indication lgp plus treatment usual effect expected direction positive attitudes toward medication treatment however effect appeared disappear time absence structured ongoing intervention although individuals selfreported taking approximately 80 prescribed bipolar medication treatments baseline dai scores suggested individuals mixed attitudes toward medications additionally individuals depressive symptoms severe baseline trended lower dai scores indicating poorer attitudes toward medication end study suboptimal participation lgp sessions study contrasts sharply approximately 80 participants attended 75 lgp sessions two prior effectiveness trials collaborative care models included lgp intervention 14 15 16 may patients differed systematically way patients study study bauer colleagues 14 15 involved veterans study simon colleagues 16 involved members managed care health organization hmo department veterans affairs care setting culture may facilitate higher participation retention rates clinical trials whereas managed care populations often healthier less impaired might expected publicsector care population group individuals bipolar disorder quite ill baseline relatively low functioning approximately 75 sample history suicide attempts average one five previous hospitalizations mental disorders substance abuse possible attitudes toward medication perhaps psychosocial therapies sample might shaped experience rather severe ongoing symptoms well history extensive family personal trauma suggested individuals severe symptoms longer duration illness may respond less well psychosocial treatments bipolar disorder compared individuals illness recent onset euthymic 6 30 alternatively may factors related receiving care bipolar disorder community mental health center impede treatment found department veterans affairs 14 15 staff model hmos 16 notable difference trials 14 15 16 study presented lgp standalone treatment study whereas trials part integrated care management package nonetheless appeared progressive increase effect size lgp dose indicating either sufficient participation lgp even without integrated care model achieve desired effect participants participate adequately intervention ones greatest benefit challenges participation study often centered group time scheduling transportation problems getting clinic competing life demands work child care number individuals car relied public transportation always readily available times group sessions scheduled despite fact group leaders tried optimize timing group sessions participants additional impediment implementation psychoeducation cases group process although lgp groups supportive motivating individuals bipolar disorder 30 instances variations within group presence individuals psychotic symptoms disruptive heterogeneity within lgp groups differences cultural educational background health literacy could contribute isolation group members de andrs colleagues 31 conducted uncontrolled prospective study lgp taught group format noting individuals participating lgp improvements depressive symptoms selfreported stabilization mood study presented study de andrs colleagues 31 better participant retention phase 80 comparatively lower participation phase ii 38 however without comparison group difficult assess whether symptom improvement simply related improvement might occurred course usual clinical care unique effect lgp simple feasibility issues scheduling make lgp group format difficult thus attenuating realworld application benefit may accrue mutual learning support destigmatization benefits group format 13 accordingly lgp reformatted manualized individual treatment option facilitate dissemination cannot participate groups 32 alternative methods work around scheduling transportation problems include use telephonebased lgp used groups investigators 33 34 findings recommendations based study results interpreted acknowledging study sample included mainly patients depressive symptoms drawn entirely community mental health center although depression predominant mood state among individuals bipolar disorder community mental health center represents typical realworld setting many bipolar patients receive care findings may generalizable populations bipolar disorder symptoms mania receiving treatment mental health care settings also sample predominantly female possible nature group psychotherapy intervention acceptable women men uncontrolled study lgp among individuals bipolar disorder conducted switzerland similarly enrolled preponderance female patients 31 additional limitations include fact reliance selfreport may underestimate treatment adhere