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ResearchArticle
TheCOVID-19pandemichasrequiredfamilyphysicianstorapidlyaddressincreasingmentalhealthproblemswithlimitedresources.Vulnerablehome-basedseniorswithchronicphysicalconditionsandcommonlyundermanagedsymptomsofanxietyanddepressionwererecruitedinthispilotstudytocomparetwobriefself-careinterventionstrategiesforthemanagementofsymptomsofdepressionand/oranxiety.
WeconductedapilotRCTtocomparetwotele-healthstrategiestoaddressmentalhealthsymptomseitherwith1)validatedCBTself-caretoolsplusuptothreetelephonecallsfromatrainedlaycoachvs.2)theCBTself-guidedtoolsalone.Theinterventionswereabbreviatedfromthosepreviouslytrialedbyourteam,toenabletheircompletionin2months.Objectivesweretoassessthefeasibilityofdeliveringtheinterventionsduringapandemic(recruitmentandretention);andassessthecomparativeacceptabilityoftheinterventionsacrossthetwogroups(satisfactionandtooluse);andestimatepreliminarycomparativeeffectivenessoftheinterventionsonseverityofdepressionandanxietysymptoms.Becausewewereinterestedinwhethertheinterventionswereacceptabletoawiderangeofolderadults,nomentalhealthscreeningforeligibilitywasperformed.
90eligiblepatientswererandomized.93%ofstudycompletersconsultedtheself-caretoolsand84%ofthoseinthecoachedarmreceivedatleastsomecoachingsupport.Satisfactionscoreswerehighamongparticipantsinbothgroups.Nodifferenceindepressionandanxietyoutcomesbetweenthecoachedandnon-coachedparticipantswasobserved,butcoachingwasfoundtohaveasignificanteffectonparticipants’useandperceivedhelpfulnessofthetools.
Bothinterventionswerefeasibleandacceptabletopatients.Trainedlaycoachingincreasedpatients’engagementwiththetools.Self-caretoolsofferalowcostandacceptableremoteactivitythatcanbetargetedtothosewithimmediateneeds.Whileeffectivenessresultswereinconclusive,thismaybeduetothelackofeligibilityscreeningformentalhealthsymptoms,abbreviatedtoolkit,andfewercoachingsessionsthanthoseusedinourpreviouseffectiveinterventions.
Editor:MulindaNyirenda,KamuzuUniversityofHealthSciences,MALAWI
Received:February2,2023;Accepted:January10,2024;Published:February15,2024
Competinginterests:Theauthorshavedeclaredthatnocompetinginterestsexist.
Listofabbreviations:CBT,CognitiveBehaviourTherapy;RCT,RandomizedControlledTria;RAs,:Researchassistants;BOMC,BlessedOrientation-Memory-Concentrationquestionnaire;PHQ-9,PatientHealthQuestionnaire9item;GAD-7,GeneralizedAnxietyDisorderquestionnaire7item;CSQ-3,3itemClientSatisfactionQuestionnaire;CLSA,CanadianLongitudinalStudyonAging
Thepandemicsuggestedaneedtorapidlyanddifferentlyaddressmentalhealthproblemswhenresourceswerelimited.OurteamevaluateddeliveryofanabbreviatedversionofouraforementionedeffectiveCBTself-caretoolkitoveratimeframeonethirdaslongasthatpreviouslysuccessful.ThisinterventionaimedforoperationalizationduringtheCOVID-19pandemiconacohortofhome-basedolderadults(65+years)withchronicphysicalillness.Becausewewishedtodeterminewhetherthetoolkitwithorwithoutcoachingwouldbeacceptabletoabroaderaudienceandanticipatedthatmentalhealthsymptomswouldbecommonamongolderadultsduringthepandemic,weoptednottoscreenforthepresenceofmentalhealthsymptomsaswehadinpreviousstudies.
DuringanacutestageofanearlywaveoftheCOVID-19pandemic,wesetouttoconductPanDIRECT,apilotRCT,tocomparetwobriefself-careinterventionstrategiesformanagementofsymptomsofdepressionandanxiety.Thefirstinvolvedself-directeduseofCBTself-caretoolssuppliedbythestudy,whilethesecondemployedthesametools,butsupportedbyatelephone-based,trainedlaycoach.Objectivesweretoassess1)feasibilityofdeliveringtheinterventionsduringapandemicbasedon:a)successfulrecruitmentofeligibleparticipantsintothestudy,b)participantcompletionoftheinterventions,andc)fidelityofdeliveryofthecoaching;2)comparativeacceptabilityoftheinterventionsinthetwogroupsbasedondegreeofuseoftheself-caretoolsandsatisfactionwiththeassignedintervention;3)preliminarycomparativeeffectivenessofcoachedvsnon-coachedinterventionsonseverityofdepressionandanxietysymptomsateightweeks;and4)participatingpatients’familyphysicians’viewsonthevalueandacceptabilityofstudy-generatedinformationsenttothemabouttheirpatients.
Researchassistants(RAs)attemptedtelephonecontactwiththe235individualstointroducethestudy,establishinterest,conductabriefscreeninginterviewtoassesseligibilityandobtainverbalconsentfollowingdescriptionofstudygoalsandinvolvement.Consentwasdocumentedbytheresearchassistantandcallswereaudio-recordedtopreservetheconsentprocess.Acopyoftheconsentformwaspostalmailedorsentelectronicallytorespondents.
Onstudyentry,participantswererandomizedtotheself-directedarm(toolsonly)ortheguidedarm(toolswithcoaching)byacomputer-generatedrandomizationscheduleusingrandomblocksizes,withanallocationratioof1:1(usingSASversion9.4).Thesequencewasconcealedandaparticipant’sassignmentappearedonlyoncethecoordinatorenteredtheuniqueparticipantID,dateofenrolmentandinformationonsymptomseverity.Participantswerestratifiedbasedonwhethertheirdepressionand/oranxietysymptomswerenonetomild(asmeasuredbythe9-itemPatientHealthQuestionnaire(PHQ-9)and/or7-itemGeneralizedAnxietyDisorderquestionnaire(GAD-7),scores<10)ormoderatetosevere(PHQ-9and/orGAD-7scores≥10).Adiscussionofthepsychometricsofthesetoolsfollows.
Thebaselineinterviewalsoincludedquestionsonhospitalizations,emergencydepartmentvisits,counsellingintheprevioussixmonths,COVIDdiagnosesinparticipantsorfamilymembers,presenceofafamilycaregiver,andreceptionofhomecareservices.Toreduceinterviewburden,datacollectedinthepreviousstudy(age,sex,countryoforigin,andeducationlevel)wereextracted.
Participantswereinvitedtoprovidetheirfamilyphysicians’contactinformationsothatthelattercouldbemailedareportoftheirpatients’studyinvolvementoncethepatientshadcompletedthestudy.Thereportsincludedbriefinformationonthestudy,participants’PHQ-9andGAD-7scoresatbaselineandfollow-up,instructionsonhowtointerpretthescores,andabriefpostalsurvey(forreturnbypre-paidstamped/addressedenvelope,fax,oremail).Thissurveyenquiredabout(1)usefulnessofthereport;(2)theirgeneralfamiliaritywithPHQ-9andGAD-7screeningtools;and(3)theirinteractionswithparticipantsduringthestudyperiod.Remindersweresenttonon-respondersfourweeksafterthefirstmailing.
Atfollow-up,over80%ofparticipantswhohadreceivedatleastonecoachcallreportedthatthenumberofcallsfeltappropriatetothemandhadhelpedthemunderstandandusethetools.Only32%indicatedthattheywouldhavepreferredtousethetoolswithoutcoachingsupport.
69%(43/62)ofstudycompletersagreedtohavereportssenttotheirfamilyphysiciansattheendofthestudy.46.5%(20/43)returnedcompletedsurveysincludedwiththereport.Therespondentsappearedtobeinvolvedinmentalhealthcaregiventhat80%and75%respectivelyusedthePHQ-9andtheGAD-7.55%(11/20)foundthepatientinformationsenttothemuseful,whiletheremainderheldaneutralopinion.Nonetheless70%(14/20)ofphysicianskepttheinformationforfilinginthepatients’medicalrecords,20%(4/20)usedittotrytoinitiateorconfirmpatientfollow-up,and90%(18/20)indicatedinterestinfuturereceptionofsimilarpatientinformation,ifitwasavailable.
Thisstudyoffersamethodologicalimprovementthatmayservefuturestudiesofsimilarinterventions:ratherthanaskingabouttooluseversusnon-use,weaskedparticipantstoreporttheirstageofuse(threepointscale,‘didn’tuse’,‘juststarted’,and‘wellunderway’),levelofuse(threelevels:readingcontentsofthematerials;havingsomeengagementwithmaterialstoidentifyrelevantself-careapproaches;andindicatingthatsomeapproacheswereatleastsomewhatapplied),andperceivedhelpfulness(fourpointscale,from“notatallhelpful”to“veryhelpful”).Wewereabletovalidatesomeofthesevariablesagainstcoachobservations.Thesevariablesappearedtobetterdiscriminatebetweenthestudygroupsinfavorofthecoachedgroup.
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