REFOCUS Trial protocol for a cluster randomised controlled trial of a pro-recovery intervention within community based mental health teams 英文参考文献.docVIP
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REFOCUS Trial protocol for a cluster randomised controlled trial of a pro-recovery intervention within community based mental health teams 英文参考文献
Sladeetal.BMCPsychiatry2011,11:185
/1471-244X/11/185
STUDY PROTOCOL
OpenAccess
REFOCUSTrial:protocolforaclusterrandomised
controlledtrialofapro-recoveryintervention
withincommunitybasedmentalhealthteams
MikeSlade*,VictoriaBird,ClairLeBoutillier,JulieWilliams,PaulMcCroneandMaryLeamy
Abstract
Background:Thereisaconsensusabouttheimportanceof‘recovery’inmentalhealthservices,buttheevidence
baseislimited.
Methods/Design:Atwocentre,clusterrandomisedcontrolledtrial.Participantsarecommunity-basedmentalhealth
teams,andserviceusersaged18-65yearswithaprimaryclinicaldiagnosisofpsychosis.InrelationtotheREFOCUS
M/refocus,whichdescribesa12-month,pro-recoveryinterventionbasedonthe
REFOCUSModel,theobjectivesare:(1)ToestablishtheeffectivenessoftheinterventiondescribedintheREFOCUS
Manual;(2)TovalidatetheREFOCUSModel;(3)ToestablishandoptimisetrialparametersfortheREFOCUSManual;
and(4)Tounderstandtherelationshipbetweenclinicaloutcomesandrecoveryoutcomes.Thehypothesisforthe
mainstudyisthatserviceusersintheinterventionarmwillexperiencesignificantlygreaterincreasesinmeasuresof
personalrecovery(asmeasuredbytheQPR)comparedtoserviceusersreceivingcarefromcontrolteams.The
hypothesisforthesecondarystudyisthatblackserviceusersintheinterventionarmwillexperiencesignificantly
greaterincreasesinmeasuresofpersonalrecovery(asmeasuredbytheQPR)andclientsatisfaction(asmeasuredby
theCSQ)comparedtoBlackserviceusersreceivingcarefromcontrolteams.
Theinterventioncomprisestreatmentasusualplustwocomponents:recovery-promotingrelationshipsandworking
practices.Thecontrolconditionistreatmentasusual.TheprimaryoutcmeistheProcessofRecoveryQuestionnaire
(QPR).Secondaryoutcomesaresatisfaction,Goalsetting-PersonalPrimaryOutcome,hope,well-being,empowerment,
andqualityoflife.PrimaryoutcomesforthesecondarystudywillbeQPRandsatisfaction.Costdatawillbeestimated,
andclinicaloutcomeswillalsobereported(symptomatology,need,socialdisability,functioning).
29teams(15interventionand14control)willberandomised.Withineachteam,15servicesus
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