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Psychological, social and welfare interventions for
psychological health and well-being of torture survivors
(Protocol)
Patel N, Kellezi B, Williams ACDC
ThisisareprintofaCochraneprotocol,preparedandmaintainedbyTheCochraneCollaborationandpublishedinTheCochrane
Library2011,Issue10
http://www.thecochranelibrary.com
Psychological,socialandwelfareinterventionsforpsychologicalhealthandwell-beingoftorturesurvivors(Protocol)
Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
CONTRIBUTIONSOFAUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
DECLARATIONSOFINTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
SOURCESOFSUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Psychological,socialandwelfareinterventionsforpsychologicalhealthandwell-beingoftorturesurvivors(Protocol) i
Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
[InterventionProtocol]
Psychological, social and welfare interventions for
psychological health and well-being of torture survivors
NimishaPatel1,2,BlerinaKellezi1,3,AmandaCdeCWilliams4
1AuditandEvaluation,FreedomfromTorture,London,UK.2SchoolofPsychology,UniversityofEastLondon,London,UK.3Centre
forCriminology,UniveristyofOxford,Oxford,UK.4ResearchDepartmentofClinical,Educational&HealthPsychology,University
CollegeLondon,London,UK
Contactaddress:AmandaCdeCWilliams,ResearchDepartmentofClinical,Educational&HealthPsychology,UniversityCollege
London,GowerStreet,London,WC1E6BT,[email protected]@ucl.ac.uk.
Editorialgroup:CochraneDepression,AnxietyandNeurosisGroup.
Publicationstatusanddate:New,publishedinIssue10,2011.
Citation: PatelN,KelleziB,WilliamsACDC.Psychological,socialandwelfareinterventionsforpsychologicalhealthandwell-beingof
torturesurvivors.CochraneDatabaseofSystematicReviews2011,Issue10.Art.No.:CD009317.DOI:10.1002/14651858.CD009317.
Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
ABSTRACT
Thisistheprotocolforareviewandthereisnoabstract.Theobjectivesareasfollows:
Primaryobjective
1.Toassessbeneficialandadverseeffectsofpsychological,socialandwelfareinterventionsversusnotreatmentforthereductionof
psychologicaldistressintorturesurvivors.
Secondaryobjectives
2.Todescribethequalityandgeneralisabilityofthestudiesevaluatingtheeffectsofthesetreatmentapproachesontorturesurvivors,
andspecifically:
• toprovideanobjectiveassessmentofriskofbiasinthesestudies;
• todescribethespecificpopulationsevaluatedinstudiesoftorturesurvivors(includingdemographics,tortureexperiencesand
psychologicalstatus);
• todescribethevarietyofinterventionsthathavebeenevaluatedinthesepopulations;and
• todescribetheoutcomesevaluatedintheseinterventionstudies.
BACKGROUND 400,000torturesurvivorsliveintheEuropeanUnionalone,with
similarestimatesintheUSA(Jaranson,1995).
Reports of torture and other ill-treatment come from over 150
countries (AI 2010). The International Rehabilitation Con- Unlikemanyotherclientgroups,thehealthconcernsoftorture
sortium for Torture Survivors (IRCT 2010) estimates around survivors are addressed in theliterature and in clinical practice,
Psychological,socialandwelfareinterventionsforpsychologicalhealthandwell-beingoftorturesurvivors(Protocol) 1
Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
notspecificallyorsolelyintermsofcommonhealthproblems,but 2. Socialinterventionsaimtoincreasesocialinvolvementor
bytheirexperienceoftortureandotherill-treatmentasdefinedby participationtoimprovesurvivors’healthandwell-being,and
theUnitedNationsConventionagainstTortureandOtherCruel, maybedeliveredatindividualorgrouplevels.Thefocusofthe
Inhuman or Degrading Treatment or Punishment (CAT) (UN interventionmayvary,fromeducationalinitiativestoredress.
1984),Article1. 3. Welfareinterventionsaimtobenefitsurvivors’healthand
well-beingthroughimprovingsocialconditionssuchashousing
Tortureisadeliberateassaultuponthebody,thepsyche,theiden-
oraccesstohealthservices,andareusuallydeliveredatthelevel
tity and the integrity of theperson, aiming to dehumanise, de-
ofthecommunity.
grade,destroyordebilitateandrendertheindividualhelpless.Its
impact on psychological health can be short term and/or long-
lastingandmayaffecttheindividual’sinterpersonalrelationships.
Howtheinterventionmightwork
Theimpactof torturecanextendbeyondtheindividual tohis/
herfamily,community andsocietybyperpetuatinguncertainty, Psychologicalinterventions,withorwithoutculturaladaptation,
mistrust, suspicion and terror. Individual problems in physical, may target a specificproblemsuch asflashbacks to thetrauma,
psychologicalandsocialhealthcanresultfrombothphysicaland orabroadspectrumofmooddisorders;interventionscaneffect
psychological methods of torture, usually used in combination. change via a number of mechanisms, including exposure and/
The physical,psychological andother dimensions of well-being oremotionalprocessingwith/orwithoutcognitiverestructuring,
interactandmanifestincomplexanddiverseways,impactingon cognitiveprocessing,meaningmaking,and/orinterpretation.Psy-
the capacity of individuals to function in daily life within their chologicalinterventionsmayadditionallydrawonpolitical(asin
familiesandcommunities.Additionally,torturesurvivorsincoun- documentation)oreducationalprinciples.
triesofexilecanexperiencemanyadditionaldifficulties,impact- Socialinterventionscaneffectchangethroughreframingorrein-
ingontheirwell-being(e.g.legalproceedings,racism,inadequate terpreting the relationships of the survivor with their family or
housingorhomelessness). community.Theymayimprovesocialfunctioning,socialintegra-
tionandparticipation,andrestoretrust.Socialinterventionsmay
Physicalhealthproblemsrelatedtotorturehavebeenwidelydoc-
alsodrawonpolitical(asinpublicrecognitionofwrong)anded-
umented(Jacobs2001;Moreno2002;Norredam2005;forare-
ucationalprinciples.
view seeJaranson 2011; Montgomery 2011; Quiroga2005), as
Welfare interventions aim to improve the material conditions
havepsychologicalhealthproblems(e.g.Basoglu2001;Johnson
(suchashousing)andenvironmentalandservicecontext(suchas
2008;Patel2007).Torture-relatedphysicalhealthproblemsnot
healthcareandavailabilityofpurposefulactivity)whichareasso-
onlycausedisabilityorrestrictedfunctioningbutcanalsoproduce
ciatedwithmentalandphysicalhealthandwellbeing.
additionalpsychologicalproblems,resultinginsignificantimpact
onoverallsocialfunctioningandwell-beingoftorturesurvivors.
Whyitisimportanttodothisreview
Intheeraofevidence-basedhealthcare,thereisconsiderableem-
Descriptionoftheintervention
phasisonservicesprovidingtreatmentsdemonstratedtobeeffec-
Thereislimitedinformationaboutthetypesofinterventionspro- tive. However,evidence for interventions with torture survivors
videdtotorturesurvivors.Theavailableliterature(McIvor1995; comespredominantlyfromstudieswhichinvolveneithertorture
Quiroga2005)pointstoarangeofinterventions,somepsycholog- survivorpopulations,norpopulationsdiverseincultural,ethnic,
ical,somemedical,andmanyinvolvingavarietyofapproachesin- religiousandpoliticalbackgroundsandwhosefirstlanguageisnot
tendedtoaddressthedifficultiesexperiencedbytorturesurvivors, English.Arguably,bothhealthcareprovidedtotorturesurvivors,
includingwelfareissues,legalproceedingsrelatedtotheirasylum and the methodsand tools used to evaluate its relevance,effec-
claims,housingandsocialintegration.Sincethereisnoevidenceof tivenessandimpact,arebasedonconceptsofhealthandwell-be-
apsychologicalsyndromespecifictotorture(Westermeyer1998), ing,andpsychologicalmodelsandoutcometools,whicharenot
the treatment literature inevitably focuses on the treatment of developedorvalidatedwithtorturesurvivors. Apreviousreview
PTSD,asonediagnosis,amongsttorturesurvivors. found veryfewstudies hadbeenconducted, allwith significant
1. Psychologicalinterventionsaimtochangecognitive, limitations,includinglackofcontrolgroups,variableuseofdiag-
emotionalorbehaviouraloutcomesand,inthispopulation,can nosticcriteria,lackofvalidationofthemeasuresused,andvery
bedeliveredtotheindividual,family,group,orcommunity.The smallsamplesizes(Quiroga2005).
interventionmaydrawonavarietyoftheoreticalandtherapeutic Mostoftheliteratureonpsychologicalandphysicalhealthdiffi-
schools,butcanbegroupedintobroadmodelsincluding cultiesexperiencedbytorturesurvivors(beforeorwithouttreat-
behavioural,cognitivebehavioural,integrative,humanisticand ment)isbasedonprofessionaloracademicaccounts,muchinthe
psychodynamicpsychologicalinterventions. formofclinical opinions andcase studies(forreviewsseeLund
Psychological,socialandwelfareinterventionsforpsychologicalhealthandwell-beingoftorturesurvivors(Protocol) 2
Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
2008;Quiroga2005).Thereisrelativelylittleliteratureonout- 1.Toassessbeneficialandadverseeffectsofpsychological,social
comesofhealthcareinterventionswithtorturesurvivors,andwhat andwelfareinterventionsversusnotreatmentforthereductionof
existsisdominatedbycasestudiesandclinicalnarratives,withfew psychologicaldistressintorturesurvivors.
cohortstudiesandfewertrials.Someofthesestudieshaveaimed
toraiseawareness(andfunding)forspecificinitiativesaswellas
informingthewiderfield,sopoliticalexpediencyhasoftenbeen Secondaryobjectives
moreimportantthanacademicintegrity.Intheliteratureexamin-
2.Todescribethequalityandgeneralisabilityofthestudieseval-
inghealthcareoutcomesfortorturesurvivors,thereiswidespread
uating the effectsof these treatment approacheson torture sur-
use of assessment or evaluation tools, which are frequently di-
vivors,andspecifically:
agnosis-based and developed in the West for Western, English-
• toprovideanobjectiveassessmentofriskofbiasinthese
speakingpopulationsandstandardisedonthesamepopulations.
studies;
Fewofthetoolstranslatedforthestudyoftorturesurvivorshave
• todescribethespecificpopulationsevaluatedinstudiesof
demonstratedvalidity(Bracken1995;Johnson2008;Patel2003;
torturesurvivors(includingdemographics,tortureexperiences
Thakker 1999), and many traditional assessment and outcome
andpsychologicalstatus);
measureshavebeencriticisedforfailingtodemonstratelinguistic
• todescribethevarietyofinterventionsthathavebeen
orsemanticequivalence,therebylackingconstructvalidityforcul-
evaluatedinthesepopulations;and
turallydiversepopulations(e.g.Elsass2009;Gurr2001;Hollifield
• todescribetheoutcomesevaluatedintheseintervention
2002;Mahtani2003;Newlands2004;Patel2000;VanOmmeren
studies.
2001)includingmanyrefugeesandasylumseekerswhoaresur-
vivorsoftorture.
Whilst there exists a vast body of research on the treatment of
PTSD in various populations, such studies are rarely based on
torturesurvivor samples(Bisson 2009;Nicholl2004).Theyare METHODS
thereforeunlikelytoaddresstherangeofdifficultiesbeyondPTSD
and depression (e.g. racism, destitution) experienced by torture
survivors(forexamplePatel2007).Therearenumerousmethod- Criteriaforconsideringstudiesforthisreview
ologicalproblemswithapplyingpsychiatricdiagnosticcriteriato
thisclientgroup(Quiroga2005)andquestionsremainaboutthe
validity of psychiatric diagnoses in general (Boyle 1999; Boyle
Typesofstudies
2002;Kutchins1997;Pilgrim1999).Inparticular,thevalidityof
Randomisedcontrolledtrials(RCTs),clusterRCTs,andquasiran-
adiagnosis ofPTSDintorturesurvivorshasbeenchallengedas
domisedcontrolledtrials(QRCTs)willbeincluded.QRCTswill
medicalisingthesociopoliticalproblemoftorture(Bracken1995;
beincludedbecause,duetothedifficultiesofconducting RCTs
Bracken1998;Patel2003;Summerfield2001).
inthispopulation,averysmallnumberofRCTsareexpectedto
Therearenosystematicreviewsonwhichtreatmentapproaches
beidentified.
areeffectivewithtorturesurvivorsexperiencingarangeofpsycho-
Therewillbenorestrictionsonpublicationtype,status,language
logical,social,welfareandinterpersonalproblems,hencetheneed
ordate.Iffulldetailscanbeobtainedfromtheauthors,conference
forthissystematicreview.Inviewofthewiderangeofevidence
abstractswillbeincluded,asrelevantmaterialisoftenpublishedby
thatmightberelevanttothetreatmentofthispopulation,thisre-
torturesurvivorcentresthemselves.Wherethereisanindication
viewwillbeasinclusiveaspossible.Unlesscomparablestudiesare
thattherearedatainconferencepublicationsandthecontactwith
identified,thereviewwillnotattempttodirectlycomparetheef-
authorsisunsuccessful,suchstudieswillbeindicatedinaseparate
fectsofdifferentinterventions,andinsteadwillprovideadetailed
sectionlabelled’studiesawaitingclassification’.
descriptionoftheavailableevidence,summarisingthefeaturesof
thesestudiesanddescribingtreatmentoutcomesforanyspecific
diagnosticgroupsidentified.
Typesofparticipants
Formal diagnoses in these populations are frequently not avail-
able. Therefore,thereview will notbe restrictedto participants
meetingspecific diagnoses, butwill instead include participants
OBJECTIVES who have survived any type of torture, as defined by the study
authors.Torturesurvivorsmaybefoundamongrefugees,asylum
seekers,warsurvivorsandsurvivorsoforganisedviolence,andin
diverse settings, such as prison, detention centre, refugee camp,
Primaryobjective
accommodationcentre,healthcarefacility,andcommunity.
Psychological,socialandwelfareinterventionsforpsychologicalhealthandwell-beingoftorturesurvivors(Protocol) 3
Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
Participantsofallageswillbeincludedand,asfaraspossible,stud- Rehabilitation services for torture survivors have arisen largely
iesonchildrenandyoungpeople(<18)andthosetargetingadults frompsychologicalinterventions.Medicalinterventions,includ-
willbeanalysedseparately.Exceptionsincludestudiesevaluating ingpharmacologicalinterventions,whereoffered,areusuallyof-
familyorothersystemicinterventions.Wherenecessary,authors feredincombination with other psychosocial interventions and
willbecontactedtorequestseparatedataforchildrenandadults. willthereforebeexcludedfromthereview.
Typesofinterventions Typesofoutcomemeasures
Interventionsprovidedinthisfieldtendtobepragmaticandrarely Oneoftheobjectivesofthisreviewistodescribetheoutcomes
followtreatmentmanuals/protocolsormeetthestrictcriteriaex- evaluated in these studies. We will summarise any measures of
pectedinothersettings. For thisreason our inclusion criteriais psychologicalhealthbenefitandwell-being.However,studiesof
broad.However,inAppendix1wesetoutafulllistofthepsy- populations whichincludetorturesurvivors addressaverywide
chotherapies,asdefinedbytheCochraneCollaborationDepres- range of outcomes, including many non-standardised measures
sion,AnxietyandNeurosisGroup,sothatreadersmayunderstand specificallydevelopedforthatstudy (Jaranson 2011).Rarelydo
howthesetherapiesrelatetooneanother. measuresundergotheconceptualscrutinywhichshouldprecede
Wewillincludeanypsychological,socialorwelfareintervention translationandtesting(Johnson2006)andmeasuresareoftennot
whichaimstoimprovehealthandwell-beingoftorturesurvivors. translatedintothefirstorfluentlanguageofresearchparticipants
1. Psychologicalinterventions.Thesewillinclude andtestedbeforeuse(onlyafewtraumainstrumentshavebeen
psychodynamicandpsychoanalytictherapies,behaviouraland translatedandundergonesomevaliditytestinginsomelanguages).
cognitivepsychotherapies(includingCBT,exposuretherapy), Furthermore,itisnotuncommontouseinterpreterstoassistin
interpersonalpsychotherapy,narrativetherapy,cognitiveanalytic datacollection(seeVarainpressformoredetail),compromising
therapy,anxiety/stressmanagementapproaches,systemic reliability(forexample,byintroducingvariationintheuseofterms
psychotherapies,counselling,supportiveandexperiential andresponseoptions).
psychotherapies,arttherapy,dramatherapy,dancetherapy,eye Wheredataareprovidedforspecificoutcomemeasuresthatcanbe
movementdesensitisationreprocessing(EMDR),hypnotherapy. summarised,bothcontinuousorcategoricaldatawillbeincluded.
Theseinterventionsmaybeundertakenwithindividualsorwith
familiesorgroups.
2. Socialinterventions.Theseconsistofinvolvementin Primaryoutcomes
communityactivities,reparationandjudicialactivities, 1. Reductiononascaleofpsychologicaldistress,e.g.General
educationalinitiatives(suchaslearningthehostcountry HealthQuestionnaire(GHQ);ShortFormHealthSurvey(SF-
language),andothers. 12)MentalHealthsubscale.
3. Welfareinterventions.Theseareexemplifiedbyprovision 2. Anyadverseeventsuchassuicideorself-harm.
ofinformationaboutlegalandwelfarerightsandentitlements,
findingnurseryandschoolplacesforchildren,productiveand
creativeactivitiesincludingworkinitiatives,andothers. Secondaryoutcomes
1. Change(positiveornegative)inpsychologicalstatusor
targetbehaviour.Thisislikelytobevariouslymeasuredas
Interventionsetting
changeinpsychologicalandemotionalsymptoms(suchas
Interventionscanbedeliveredinanysetting,includinghealthcare depression,PTSD,anxiety),whichwillbepooled;aschangein
clinicsandotherhealthcarefacilities,refugeecamps,communities, diagnosticcategory(suchasdepressionorPTSD);oras
survivors’homesanddetentionfacilities. individualorgrouplevelchangeinatargetbehaviour.
2. Change(positiveornegative)inqualityoflifeorwell-
being,forwhichtherearemultiplescaleseitherassessinglife
Comparators qualityorglobalsatisfactionwithlife;extentofdisability.
Thecontrolcomparisonwillbewaitinglist,notreatment,standard 3. Increasedparticipationandfunctioning,asmeasuredby
care/accesstostandardcare,attentioncontrol. engagementineducation,training,work,orcommunityactivity.
We will include trials where the intervention is added to non- 4. Changeinqualityand/orquantityoffamilyorsocial
psychosocialstandardcaregiventobothgroups. relationships.
Equivalencetrialswillbeincluded,butonlyifthecomparatorarm 5. Ratingsofpsychologicalfunctionmadebyothers,
canreasonablybetreatedasa’treatmentasusual’.Forthisreason, includingclinicians;andforchildren:parents,orteachers
non-equivalencetrials(comparisonoftwoactivetreatmentwith (ratingsbyparentsorteachersofchildren’sstatusarewidelyused
thehypothesisthattheireffectsdonotdiffer)willbeexcluded. inpsychologicalinterventions.)
Psychological,socialandwelfareinterventionsforpsychologicalhealthandwell-beingoftorturesurvivors(Protocol) 4
Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
6. Ratingsoftheinterventionitself,suchassatisfactionwith Greyliterature
intervention,ortherapeuticalliance. Inordertoidentifyrelevantgreyliterature,theRCTlibraryand
OPENSIGLEwereincludedinthelistofdatabasestobesearched.
Inaddition,arangeofpublicationtypeslikereports,conference
papers,posters,monographsandanthologieswillbeincludedin
Searchmethodsforidentificationofstudies thesearch.
Searcheswillbeconductedonelectronicdatabases,websitesand
thehandsearchingofreviewsandreferencelists.
Referencemanagersoftware
Thereferenceswillbemanagedusingthebibliographicsoftware
EndNote.
Electronicsearches
Bibliographicdatabasesandtrialregisters:
• PsycINFO(Onlinedatabaseofpsychologicalliterature) Datacollectionandanalysis
• MEDLINE(Onlinedatabaseofhealthandmedical
journalsandothernewssources)
• EMBASE(Onlinedatabaseofhealthandmedicaljournals) Selectionofstudies
• WebofScience(Onlinemultidisciplinarydatabasecovering Studyselectionhastwostages.
allsciences) 1. Aninitialscreeningoftitlesandabstractsusingthe
• CINAHL(Onlinedatabaseofnursingandalliedhealth inclusioncriteria,withtheaimofidentifyingstudieswhichmay
literature) beeligibleandforwhichthefullpapershouldbeobtained.
• TheCochraneCentralRegisterofControlledTrials Whereabstractsarenotavailableelectronicallythefullpaperwill
(CENTRAL) besought.
• Lilacs(Onlinedatabaseonhealthsciences,publishedin 2. Thefullpaperswillbereadandselectedagainstthe
LatinAmericaandtheCaribbean) inclusioncriteriabytwooftheauthors[BK,AW]independently.
• OPENSIGLE(Onlinedatabaseofreportsandothergrey Thefinallistwillbeachievedaftercomparison,and
literatureproducedinEuropeuntil2005). disagreementswillberesolvedbydiscussion;wherethere
• WHO:InternationalClinicalTrialsRegistryPlatform continuestobedoubtordifference,thethirdreviewer[NP]will
(ICTRP) beconsultedtoachieveconsensus.
• PILOTS(Onlinedatabase,PublishedInternational If full details can be obtained from the authors, conference ab-
LiteratureOnTraumaticStress) stractswillbeincluded,asrelevantmaterialisoftenpublishedby
torturesurvivorcentresthemselves.Wherethereisanindication
thattherearedatainconferencepublicationsandthecontactwith
authorsisunsuccessful,suchstudieswillbeindicatedinaseparate
Searchingotherresources
sectionlabelled’studiesawaitingclassification’.
• OnlineLibraryoftheRehabilitationandResearchCentre
forTortureVictims(RCT)
• Referencelistsofreviewsemergingfromthesearches Dataextractionandmanagement
• Referencelistofthefinalsetofincludedstudies Adataextractionformisintheprocessofbeingdesignedusingas
• TableofContentsfromthetop10mostfrequentlycited amodeldataextractionprotocolsfromsimilarreviews.
sourcesemergingfromthesearch(expectedtobejournalissues). • Studydesign
• Settingofintervention
• Typeofinterventions
• Interventionprotocol
Searchterms
• Samplesizeatbaselineandoutcomeassessments
Thesearchtermswillbedeliberatelybroad,asmanystudiesare • Baselinecharacteristicsofthesample(age,gender,
conducted innon-Western, non-academic settings, with diverse nationality,ethnicity,typeoftortureexperienced,legalstatusif
reporting structures. The following strategy will be employed refugeesandasylumseekers,livingsituation,separationfrom
on the main bibliographic databases: (Population + RCT filter) closefamilymembers)
OR(Population+Intervention).ThesearchtermsforPsycINFO • Baselinemeasures
(asindicatedinAppendix2)willbeadaptedforeachrespective • Typeofpractitioner/therapists
database. • Language/sofassessment;translation,interpretation
Psychological,socialandwelfareinterventionsforpsychologicalhealthandwell-beingoftorturesurvivors(Protocol) 5
Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
• Propertiesofbaselinemeasures(language,translation, same,worse)willbere-categorizedintotwogroups.Wewillnot
validity) calculateNNTs.
• Outcomemeasuresatendofintervention(s)andatany Continuous data will be analysed using standardised mean dif-
follow-upassessment ferences(SMDsoreffectsizes)usingpooledstandarddeviations
• Completionrates and weighting for sample size, and calculating the 95% confi-
• Adherence,participationintreatment denceinterval.Self-orother-ratingscalesriskproducingseverely
• Riskofbiasofincludedstudies skeweddata,thatis,wheretheyproduceavaluebetween-1and
+1whenthedifferencebetweenthescalemaximumorminimum
Datawillbeextractedbytwoofthereviewers[BK,AW]indepen-
and themeanisdivided by thestandard deviation. Wheredata
dently,anddisagreementswillberesolvedbydiscussion. Where
are severely skewed, they will be normalised where possible by
therecontinuestobedoubtordifference,thethirdreviewer[NP]
transforms,orifthisdoesnotproduceasatisfactorydistribution,
willbeconsultedtoachieveconsensus.
willbedichotomised.SMDswillthenbeinterpretedindividually
withreferencetothequalityandreliabilityofthemeasurewhere
available.
Assessmentofriskofbiasinincludedstudies
Ifauthorsarewillingtoproviderawdata,clinicalcutpoints(for
Risk of bias will be assessed for each included study using the
PTSDcaseness,forexample)canbeapplied.Inthemuchmore
CochraneCollaboration’riskofbias’tool(Higgins2008)andis-
likelyeventthatrawdataareunavailable,wewillapplythemeth-
suesraisedaroundstudiesofpsychologicaltreatmentinsystematic
odsdescribedbyPreston2000;inversevarianceweightsusingthe
reviews(Yates2005).Thefollowingdomainswillbeconsidered:
standard error.It remains likely that some severelyskewed data
1. Sequencegeneration:wastheallocationsequence
willhavetobeexcludedfromanalyses.
adequatelygeneratedbyamethodunrelatedtorecruitment
Bothdichotomousandcontinuousdataanalyseswillbedisplayed
decision?
usingforestplots.
2. Allocationconcealment:wasallocationadequately
concealed?
3. Sincepsychologicaltreatmentscannotblindpersonnel,and
Unitofanalysisissues
canrarelyblindparticipants,assessmentofbiaswillbemade
using(a)equivalenceoftreatmentexpectationsofparticipants
acrossarmsofthestudy;(b)presentationofthirdpartyoutcome
Multiarmedtrials
assessmentswherethethirdpartyisblindtotreatmentallocation?
If there are two or more treatment or comparison groups, we
4. Incompleteoutcomedataforeachmainoutcomeorclassof
willanalysethemseparatelybysplittingthecontrolgroupequally
outcomes:wereincompleteoutcomedataadequatelyaddressed?
betweenthetreatmentgroups(Higgins2008a).
5. Selectiveoutcomereporting:dotheresultspresentedmatch
theassessmentsdescribed?
6. Othersourcesofbias:wasthestudyapparentlyfreeofother
Clusterrandomisedcontrolledtrials
problemsthatcouldputitatahighriskofbias?Additionalitems
includedherearetherapistqualifications,treatmentfidelity,and Inthecaseofclusterrandomisation,wewilladjustfortheeffects
researcherallegiance/conflictofinterest. ofclusteringusinganICC.
The risk of bias will be assessed independently by two review
authors (BK and AW), who will then reach consensus on their
Dealingwithmissingdata
decisions,withanyremainingdisagreementsreferredtothethird
author(NP).Ifnecessary,furtherinformationwillbesoughtfrom Authorswillbecontactedtorequestmissingdata,suchasstandard
studyauthors. deviations. Loss and exclusion of data will be examined to try
Assessmentofriskofbiaswillusethreecategories:lowrisk,unclear to understand the reasons and implications, and if appropriate,
(information not providedor effectnot clear),and highrisk. A amethodsuchaslastobservation carriedforwardmaybe used.
riskofbiastablewillbeconstructedforeachstudy.Additionally, Where standard deviations are missing and unobtainable from
forestplotswillbeorderedbyriskofbiastoexamineforsystematic authors,wewillcalculatewherepossiblefromF,t,orpvalues,or
effectsonoutcome. fromstandarderror.Ifthisisnotpossible,thetrialwillbetreated
ashavingnouseabledata.
Wewillidentifyintentiontotreatanalysisasanimportantmarker
Measuresoftreatmenteffect
ofefforttoreducebias(seeAssessmentofriskofbiasinincluded
Dichotomous outcomes (improved/not improved) will be anal- studies).
ysedusingoddsratioswith95%confidenceintervals.Categori- Availablecasesanalyseswillbeincludedbutinterpretedwithcau-
caloutcomeswithmorethantwocategories(suchasimproved, tion.
Psychological,socialandwelfareinterventionsforpsychologicalhealthandwell-beingoftorturesurvivors(Protocol) 6
Copyright©2011TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
Assessmentofheterogeneity Subgroupanalysisandinvestigationofheterogeneity
High levelsofheterogeneityare likelywheretherearesufficient
1. Childandadultstudieswillbeanalysedseparately.Thisis
trialsformeta-analysis.Wherethisissuggestedbytheforestplot
becausemethodsandoutcomesdifferverysubstantially,asdoes
(aspooroverlapofconfidenceintervalsandpresenceofoutliers)
usuallythetypeoftortureexperienced.
andthereisanI2statisticofover40%,itwillbeinterpretedusing
2. Iftherearesufficienttrials,wewillseparatestudies
Higgins2003,withreferencetoin/consistencyinthedirectionof
conductedonpopulationswhosemembersstillresideintheir
effects,andwithparticularreferencetovariationbetweenstudies
ownhomesvsthosewhoremainintheircountryoforiginbut
intreatmentaimsandmethodswhichmightsuggestthattheset
areinternallydisplacedvsthosewhoarerefugees.Thedifficulties
shouldbesplit.
anddangersofflightandofsettlingintoarefugeecampora
countrywhereasylumhasbeensoughtcompoundandaddto
theexistingproblemsandstressesonthetorturesurvivor.While
Assessmentofreportingbiases
thesearehardtoseparateonanindividuallevel,itmakessense
Thefollowingstepswillbeundertakentoaddressreportingbiases
wherepossibletorecognisethematatriallevel.
which might otherwise operate, particularly inrelation to stud-
iesinunder-resourcedsettingsandreportedinthegreyliterature.
Searchesinarangeofdatabasesincludingthoseinlanguagesother
thanEnglishandthoselistingnonpeerreviewedjournals;system- Sensitivityanalysis
atic searchof thereference listsof reviews in thefieldand final
includedstudies;manualsearchofthecontentpagesofthetopten Wherepossible,sensitivity analyseswillbeusedtoassesstheef-
sourcesofpublicationsyieldedfromthesearch;searchofdatabases fectof the differentmethodological decisions made throughout
thereviewprocess.Thesedecisionswillbetestedbysuccessively
forregisteredtrialswhichcouldyieldpublishedandunpublished
removing:
studies;andtheinclusioninthereviewofanyeligibleunpublished
aswellaspublishedstudies. 1. quasi-RCTstoleaveonlyRCTs;
Foreligiblestudies,asearchwillbemadespecificallyforpublished 2. cluster-randomisedtrialstoleaveindividuallyrandomised
protocols. trials;
3. trialsusingnon-ITTmethodstoleaveonlythoseanalysed
usingITT(tobeconsideredITTanalysistheanalysismust
Datasynthesis includeallparticipantswhoenteredtreatment,whetherornot
RevMan5softwarewillbeusedtoconductmeta-analysiswhere theyprovideddataattheendoftreatment).Nuesch2009has
feasible and appropriate. A random-effects model will be used foundthattrialswithintentiontotreatanalysesproducesmaller
giventhevarioussourcesofdiversitydescribedabove.Wheremeta- treatmenteffectsinmeta-analyses,andthisdifferenceisgreater
analysisisnotpossible,anarrativesummaryofevidencerelating inmeta-analysesinthepresenceofheterogeneity;and
totheprimaryandsecondaryobjectiveswillbeprovided. 4. unpublishedtrials.Sometreatmentstudiesinthisliterature
Wewillsummariseseparatelythosestudiesinvolvingdirectpsy- arepublishedinnonpeer-reviewedsources,suchaschaptersand
chological interventions with individuals, couples, families or internalreportsofNGOs.Toaddressconcernsaboutdifferences
groups.Wherestudiesincludebothadultandchildparticipants, inqualitybetweenthetwotypesofsources,sensitivityanalyses
theywillbeanalysedtothepredominantagegroup,orincluded willbeundertaken,restrictedtothosestudiesinpeer-reviewed
inbothanalysesasappropriate. journals.
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