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Thought Field Therapy Compared to Cognitive Behavioral Therapy and Wait-List for Agoraphobia PDF

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Preview Thought Field Therapy Compared to Cognitive Behavioral Therapy and Wait-List for Agoraphobia

fpsyg-08-01027 June20,2017 Time:12:32 #1 ORIGINALRESEARCH published:20June2017 doi:10.3389/fpsyg.2017.01027 Thought Field Therapy Compared to Cognitive Behavioral Therapy and Wait-List for Agoraphobia: A Randomized, Controlled Study with a 12-Month Follow-up AudunC.Irgens1*,AsleHoffart2,3,TorE.Nysæter4,VegardØ.Haaland3,5, Finn-MagnusBorge2,AreH.Pripp6,EgilW.Martinsen7andTorilDammen8 1DPSAust-Agder,SørlandetHospital,Arendal,Norway,2ResearchInstitute,ModumBad,Vikersund,Norway,3Department ofPsychology,UniversityofOslo,Oslo,Norway,4DepartmentofPsychiatry,SørlandetHospital,Arendal,Norway, 5DepartmentofPsychiatry,SørlandetHospital,Kristiansand,Norway,6OsloCentreofBiostatisticsandEpidemiology, ResearchSupportServices,OsloUniversityHospital,Oslo,Norway,7UniversityofOslo,InstituteofClinicalMedicine,Oslo UniversityHospital,DivisionofMentalHealthandAddiction,Oslo,Norway,8DepartmentofBehavioralSciencesinMedicine, InstituteofBasicMedicalSciences,FacultyofMedicine,UniversityofOslo,Oslo,Norway Editedby: GianMauroManzoni, Background: Thought field therapy (TFT) is used for many psychiatric conditions, but UniversitàdegliStudieCampus,Italy its efficacy has not been sufficiently documented. Hence, there is a need for studies Reviewedby: RaymondCliffordHawkins, comparingTFTtowell-establishedtreatments.ThisstudycomparestheefficacyofTFT FieldingGraduateUniversity, andcognitivebehavioraltherapy(CBT)forpatientswithagoraphobia. UnitedStates SuzieXuWang, Methods: Seventy-two patients were randomized to CBT (N = 24), TFT (N = 24) or a LeedsBeckettUniversity, wait-listcondition(WLC)(N=24)afteradiagnosticprocedureincludingtheMINIPLUS UnitedKingdom that was performed before treatment or WLC. Following a 3 months waiting period, *Correspondence: AudunC.Irgens the WL patients were randomized to CBT (n = 12) or TFT (n = 12), and all patients [email protected] were reassessed after treatment or waiting period and at 12 months follow-up. At first we compared the three groups CBT, TFT, and WL. After the post WL randomization, Specialtysection: Thisarticlewassubmittedto we compared CBT (N = 12 + 24 = 36) to TFT (N = 12 + 24 = 36), applying the ClinicalandHealthPsychology, pre-treatment scores as baseline for all patients. The primary outcome measure was a asectionofthejournal symptom score from the Anxiety Disorders Interview Scale that was performed by an FrontiersinPsychology interviewerblindedtothetreatmentcondition.Forstatisticalcomparisons,weusedthe Received:23February2017 Accepted:02June2017 independentsample’st-test,theFisher’sexacttestandtheANOVAandANCOVAtests. Published:20June2017 Results: Both CBT and TFT showed better results than the WLC (p < 0.001) at post- Citation: Irgens AC,Hoffart A,Nysæter TE, treatment. Post-treatment and at the 12-month follow-up, there were not significant Haaland VØ,Borge F-M,Pripp AH, differencesbetweenCBTandTFT(p=0.33andp=0.90,respectively). Martinsen EW and Dammen T (2017)ThoughtFieldTherapy Conclusion:ThispaperreportsthefirststudycomparingTFTtoCBTforanydisorder. ComparedtoCognitiveBehavioral ThestudyindicatedthatTFTmaybeanefficienttreatmentforpatientswithagoraphobia. TherapyandWait-List forAgoraphobia:ARandomized, TrialRegistration:https://clinicaltrials.gov/,identifierNCT00932919. ControlledStudywitha12-Month Follow-up.Front.Psychol.8:1027. Keywords: thought field therapy, cognitive behavioral therapy, agoraphobia, psychotherapy, anxiety, energy doi:10.3389/fpsyg.2017.01027 psychology FrontiersinPsychology|www.frontiersin.org 1 June2017|Volume8|Article1027 fpsyg-08-01027 June20,2017 Time:12:32 #2 Irgensetal. TFTvs.CBTforAgoraphobia INTRODUCTION (Kringlenetal.,2001;Grantetal.,2006),andcompareittoCBT, whichisawell-establishedandempiricallysupportedtreatment Anxietydisordersarecommon(Kringlenetal.,2001),although ofchoiceforthiscondition(Butleretal.,2006;NortonandPrice, the number of therapists delivering documented effective 2007;NationalGuidelineClearingHouse,2011). treatmentshasbeenlimited(Collinsetal.,2011).Itistherefore Imaginalexposureisacommonmethodusedinthetreatment ofvaluetotestothertherapiesaimedatreducingthesymptoms of anxiety disorders and PTSD, either alone or in combination ofanxietydisorders,particularlytherapiesthatpractitionerscan withothertherapeutictechniquessuchasCBT(FoaandKozak, learnquicklyandeasily.Onesuchgroupoftherapiesaretheso- 1986;Arntzetal.,2007). calledenergypsychologytherapies,primarilyintheformsofTFT Both TFT and EFT apply imaginal exposure combined with (CallahanandTrubo,2001)orEFT(Craig,2007).Thesetherapies tapping on acupoints (Church and Feinstein, 2013). They have consist of imaginal exposure combined with acupressure, i.e., their offspring in the clinical contributions of the American tappingatacupoints,andaimtoreduceanxietyoverthecourse psychologist Roger Callahan (Callahan and Trubo, 2001), who of a few sessions (Callahan and Trubo, 2001), thus having the soughttoenhancetheeffectofCBTbytappingonspecificpoints potential to reach many patients. These methods may also be on the body, called acupoints, known from ancient Chinese more acceptable for patients who are reluctant to experience medicine(Huietal.,2000).TFTwasfirstusedasatreatmentfor in vivo exposure to feared situations, as is required in CBTs anxietydisordersandtraumaticmemories,andhassubsequently (Hawtonetal.,1989). beenusedforanincreasingnumberofconditions(Andradeand In an overview from 2012 on research in the field of Feinstein,2003;Feinstein,2012). energy psychology therapies (Feinstein, 2012), 18 RCTs were The therapy commences with imaginal exposure, with the described, of which 15 demonstrated large ES on at least therapistaskingthepatienttofocusontheselectedincident,and one clinical outcome for TFT or EFT. One study showed tomakeitasvividaspossible.Thetherapistcanhelpthepatient a moderate ES (d = 0.67), while in two studies the ES through questions in relation to what the patient sees, smells, could not be calculated. More recently, Church published whoisthereandwhatisthemostfrighteningthoughtjustnow RCTsdemonstratingremarkablypromisingresultsfromasmall or at the time of the incident (Eia, 2012). The patient is asked number of sessions with EFT for trauma symptoms (Church to rate his/her feelings on a Subjective Units of Distress Scale etal.,2012;Church,2014;ChurchandBrooks,2014;Churchand (SUDS)(Wolpe,1990)from0to10,with0beingwithoutnegative Palmer-Hoffman,2014). emotionand10beingasbadasthepatientcanimagine(Callahan Of the 18 RCTs, only two addressed the use of TFT for andTrubo,2001). anxiety disorders (Schoninger and Hartung, 2010; Irgens et al., It is preferable that the patients do the tapping themselves, 2012). Schoninger and Hartung (2010) demonstrated a highly while the therapist instructs them on where and how to tap, significant reduction (ES = 1.52) in public speaking anxiety often by tapping on themselves on the same acupoints as the following TFT (N = 28) compared to a wait-list condition patients are instructed to use. The tapping is performed from (WLC)(N =20).Irgensetal.(2012)foundasignificantlylarger five to 10 times on each acupoint, firmly but not too hard. The symptom reduction in patients with various, often comorbid, patientclearlyfeelsthetapping,thoughitshouldnotcauseany anxiety disorders treated with TFT (N = 23) compared to the painorbruising.Accordingtotheactualtypeofanxietyorother WLC (N = 22) on 50% of the outcome measures. In these problem, the therapist chooses an algorithm, i.e., a sequence of studies, the improvements were sustained at 5 and 12 months, acupointsprescribedintheTFTmanual.Thepatientisaskedto respectively. bear in mind the emotion or traumatic memory evoked by the Tofurtherextendpreviousfindings,thepurposeofthepresent therapist’squestion,whilethepatienthim/herselftapsthechosen study was to perform a trial in which TFT was applied for a acupoints in the prescribed sequence. Sometimes, the therapist prevalentandinvalidatinganxietydisordersuchasagoraphobia doesthetappingatthebeginningofthetreatment,asitmaybe difficult for patients to concentrate on both their thoughts and emotions,whileatthesametimebeinginstructedastotheproper Abbreviations: ACQ, Agoraphobic Cognitions Questionnaire; ADIS, Anxiety acupointtotapon,particularlyduringastateofhigharousal. Disorders Interview Schedule; ANCOVA, analyses of covariance; ANOVA, The acupoints are situated on the hands and fingers, as well analyses of variance; BAI, Beck Anxiety Inventory; BDI, Beck Depression Inventory; BSQ, Body Sensations Questionnaire; BZ, benzodiazepines; CBT, as on the face and the chest. There are one or more tapping cognitivebehaviortherapy;CI,confidenceinterval;CTS,CognitiveTherapyScale; algorithms for various negative emotions, and in addition to DSM-IV,diagnosticandstatisticalmanualofmentaldisorders;EFT,emotional thealgorithmscomesaprocedurethatincludeseyemovements, freedomtechniques;EMDR,eyemovementdesensitizationandreprocessing;ES, countingandhummingwhiletappinganacupointontheedgeof effectsize;EXTRA,NorwegianExtraFoundationforHealthandRehabilitation; FU, follow-up; ICD-10, international statistical classification of diseases and thehand(CallahanandTrubo,2001). healthrelatedproblemsversion10;LOCF,lastobservationcarriedforward;MI, Several theories have been proposed as to how the energy MobilityInventory;MI-AAL,MobilityInventoryAlone;MINIPLUS,MiniPlus psychologytherapiesmayacquirebeneficialeffectsforpsychiatric InternationalNeuropsychiatricInterview;NREPP,NationalRegistryofEvidence- basedProgramsandPractices;PDA,panicdisorderwithagoraphobia;PTSD,post- conditions (Ruden, 2007; Feinstein, 2010). However, based on traumaticstressdisorder;RCT,randomizedcontrolledtrial;SAMHSA,Substance a lack of empirical evidence, we evaluated the theories as being AbuseandMentalHealthServicesAdministration;SCIDII,StructuredClinical speculative.Inadditiontowhatisobtainedbyimaginalexposure, InterviewforDSMPersonalityDisorders;SPSS,statisticalpackageforthesocial possible beneficial effects may have the same neurobiological sciences;SUDs,subjectiveunitsofdiscomfort;TFT,thoughtfieldtherapy;TIR, traumaticincidentreduction;WL,wait-list. correlates as in EMDR (Hartung and Galvin, 2003), a form FrontiersinPsychology|www.frontiersin.org 2 June2017|Volume8|Article1027 fpsyg-08-01027 June20,2017 Time:12:32 #3 Irgensetal. TFTvs.CBTforAgoraphobia of therapy that has been more studied than TFT and EFT. andverballyaboutthestudy,andwereaskedtoreferpatientsto In a comprehensive discussion on possible theoretical models theprincipalinvestigator(AI).Ofthe72patients,51(71%)were of EMDR, Bergmann (2010) described these theories as being referredfromthesesixoutpatientclinics(N =40,57%)orfrom speculative(Bergmann,2010). theirGP(N =11,15%).Newsofthestudywasspreadbyword- Thought field therapy may contain procedures partly being of-mouthandthroughinterviewsinprintmedia.Asaresult,21 similar to those based on emotional processing theory. When patients (29%) contacted the prime investigator directly (CBT thepatientisaskedtothinkabouttheproblem,thought,images, n=12,TFTn=9). feelings,andmemoriesassociatedwiththeproblemareelicited. Before diagnostic procedures were performed, patients were Thus, this procedure can be conceived as a form of imaginal given verbal information about the study and gave their verbal exposure to the problem (Foa et al., 2007). Imaginal exposure consenttobescreened.Patientswereenrolledbythefirstauthor isbasedonemotionalprocessingtheory(FoaandKozak,1986). (AI), given a written description of the study and their written Accordingtothistheory,emotionalprocessingisfacilitatedwhen informedconsentwasalsoobtainedafterbeingassessedasbeing thepatientisemotionallyconnectedwiththeproblem,butatthe eligible for study inclusion. Treatment started in January 2007, sametimefeelsincontrolandisnotoverwhelmedwithanxiety. andaFUwascompletedinSeptember2010. The effect of acupressure may be understood as promoting Study Entry Criteria this process. By the gentle tapping, the patient is anchored in the here-and-now, being reminded that he/she is now sitting Tobeeligible,patientshadtobe18yearsofageorolderandmeet in the room and that his/her experiences are only thoughts the DSM-IV criteria for the diagnosis of either “panic disorder and not reality. Moreover, when the therapist performs or with agoraphobia” or “agoraphobia without a history of panic instructsthetappingitreinforcestheexperienceofthetherapist’s disorder”astheirprincipaldisorderinneedoftreatment,aswell presence, which may support the feeling of being helped and asahighlevelofavoidance,measuredasascoreof2.5orhigher thus staying in control. The experience that the therapist uses ontheMI-AAL(Chamblessetal.,1985). or instructs a specific and concrete procedure (tapping across Exclusion criteria were a moderate to high risk of suicide, prescribed acupoints on the body) with certainty promotes the ongoing substance abuse or dependence, and a history of belief that the procedure is safe and effective. Together, these psychosis. three factors may stimulate the feeling of being in control and Patients were allowed to use any type of prescribed this helps the patient overcome his/her tendency to suppress medication,althoughnewmedicationforanxietywasnotallowed feelingswhilethinkingabouthis/herproblemandratherengage tobeinitiated. emotionallywiththeproblem.Thus,weproposethatTFTmay Design workbypotentiatingtheeffectofimageryexposure.Inaddition, acupressure may have some so far unknown physiological or Seventy-two patients were randomly assigned to treatment neurologicaleffects. with CBT (N = 24), TFT (N = 24), or a 3-month WL Because TFT and EFT are applied by numerous therapists, (N = 24), applying block randomization stratified by gender. both with and without a professional health-care education Therandomizationwasmadebyastatisticianusingtherandom (Schwarz, personal communication, December 23, 2013), we numbergeneratorinSPSS,whiletherandomizationkeywaskept wantedtostudytheefficacyofTFTinarandomizedclinicaltrial. secret from the study personnel by a secretary, and was only Inaddition,wethinkitisespeciallyimportantwithRCTsinthe revealed to the principal investigator (AI) after the diagnostic fieldofenergypsychology,comparingTFTtoawell-established procedures and blinded assessment were completed. After the psychotherapyasCBT,becausethereareonlyfewsuchstudiesyet waiting period, the WL patients (n = 24) were again randomly inthisfield. assignedbyanidenticalrandomizationprocedureaspreviously describedtoeitherCBT(N=12)orTFT(N=12). MATERIALS AND METHODS Assessments and Diagnostics The ADIS interviews and self-report assessments (DiNardo The study was designed as a longitudinal RCT comparing TFT et al., 1994) were conducted at pre-treatment, post-treatment, (N=24),CBT(N=24)anda3monthsWLC(N=24),Figure1. and at 12-month FU. Before inclusion, patients were assessed We chose to include a wait list condition since TFT had not by the structured clinical interviews MINI PLUS (Sheehan been tested for agoraphobia in previous studies. Three months et al., 1998) for DSM-IV Axis I and SCID II (American durationoftheWLCwaschosenbecausetheCBTtreatmentof PsychiatricAssociation,1994)forAxisIIdisorders,bothofwhich 12sessionswassupposedtolastforabout3months. were performed by the principal investigator (AI). Decisions on enrollment in the study were made by the principal Recruitment investigator. Using video, 10 of the MINI PLUS and 10 of the Thepatientswereprimarilyrecruitedfromthecatchmentareaof SCID II interviews were reassessed by an experienced research theSørlandetHospitalinthesouthernpartofNorwaybetween psychiatrist (TD). There was a total agreement regarding the January 2007 and December 2008, after approval from the diagnoses of agoraphobia and panic disorder, and a consensus regional committee for medical and health research ethics. The was reached for the presence of the other diagnoses after leadersofthesixoutpatientclinicswereinformedbothinwriting discussion. The MINI PLUS and SCID II interviews were FrontiersinPsychology|www.frontiersin.org 3 June2017|Volume8|Article1027 fpsyg-08-01027 June20,2017 Time:12:32 #4 Irgensetal. TFTvs.CBTforAgoraphobia FIGURE1|Flowdiagram. repeated at the 12-month FU, and the interviewer (AI) knew BDI(Becketal.,1961),theBAI(Becketal.,1988),theACQ,and the treatment condition of the patient at the time of the last theBSQ(Chamblessetal.,1984). assessment. The ADIS interviews (DiNardo et al., 1994) were performed byoneoftwopsychologistsorapsychiatricregistrar,allofwhom Measures wereblindedtothepatient’streatmentcondition.Beforethestart The primary outcome measures were cumulative scores on ofthestudy,theyscoredthreeADISinterviewsfromvideos,and avoidanceandanxietyfromtheADIS(DiNardoetal.,1994)for comparedanddiscussedtheirperformancewiththefirstauthor agoraphobia,asusedbyCraskeetal.(2003).Secondaryoutcomes (AI). All ADIS interviews were videotaped and reevaluated by were measured using the following instruments: inference and thefirstauthor(AI),withfeedbackgiventotheinterviewerwhen distress from the ADIS, MI-AAL (Chambless et al., 1985), the necessary. FrontiersinPsychology|www.frontiersin.org 4 June2017|Volume8|Article1027 fpsyg-08-01027 June20,2017 Time:12:32 #5 Irgensetal. TFTvs.CBTforAgoraphobia To assess the competence of the CBT therapists, the during the therapy. If the patient thought of the problem from supervisors scored 15 of the 20 supervised sessions using different “directions,” more complex problems could be solved the CTS (Young and Beck, 1980, unpublished; Westra et al., bytreatingtraumaticmemoriesandotherdisturbingemotional 2011). The CTS comprises 16 items rated on a seven-point reactions,aspectbyaspect,inadditiontothespecificagoraphobic Likert scale from 0 (non-adherence to aspects of therapy) to 6 symptoms. With use of only the TFT algorithms for solving (adherence and very high skill). Item 15 is scored from 0 to complex problems there is a need for more than one session, 4. Items 1–6 characterized general therapeutic skills, and items and in Norway the guideline has been five sessions as taught 7–11 scored conceptualization, strategy and technique. Item 14 intheTFTeducationseminarsbyUldal(2007;Holmaas,2017). gave an overall rating, item 15 assessed whether you would Mostpatientshavecomplexproblemsandneedmorethanone select this therapist to participate if you were conducting an session to “unlock” several aspects of the patient’s difficulties. outcome study of cognitive therapy for agoraphobia, assuming Using the algorithms we expected that the patient used the the session was typical, with item 16 denoting how difficult the method by themselves. To secure that they learned properly patient was to work with. For TFT no such competence scale how to do the tapping it was desirable with more than one exists. session. Atthe12-monthFU,thepatientswereaskedforpossibleside effectsoftreatments.Thiswasposedasanopenquestion,aswe TFTTherapistandTraining werenotawareofwhattypeofsideeffectstoexpect.TheADIS AnexperiencedTFTtherapist,withnoformalhealtheducation interviewerswereaskedtoregisteratthe12monthsFUwhether or therapeutic experience other than that of being a TFT the patients let them know which therapeutic option they had therapist,conductedtheTFT.Inparticular,shehadnoexperience received,andtoguessthetreatmentconditionofeachpatient. with CBT. The TFT therapist was certified in Norway to the Algorithm level in 2003 and to the TFT Diagnostic Level by Interventions Callahan Techniques Ltd. in 2005. Based on Callahan’s manual ThoughtFieldTherapy for anxiety disorders and panic attacks, she constructed a TFT In this study, 36 patients were given a TFT treatment package manual in Norwegian specific for agoraphobia (Eia, 2012). of five 50- to 55-min sessions of individual therapy, which was The manual describes in detail how the TFT therapist guides standardprocedureinNorway(Irgensetal.,2012).Thetreatment the patient to target the memories and other thoughts that wasbasedontheTFTguidelinescreatedbyCallahanandTrubo trigger maximum anxiety, and prescribes the specific sequence (2001), and as with most psychotherapy, the treatment started of acupoints to be tapped by either the patient or therapist. withtakingthehistoryandcreatinganoverviewofthepatient’s This manual was discussed with both the study’s principal social situation and risk factors. The TFT therapist asked for supervisor (AH) and the principal investigator (AI), and has the first anxiety attack, traumatic incidents, the worst attack been used as a course manual for TFT therapist training in of anxiety and often also the most recent situation in which Norway.ItisnotpublishedbroadlybutavailableinNorwegian anxietyaffectedthepatient.Duringtherapy,patientswereasked upon request. The principal investigator supervised the TFT to: (a) recall the symptom that they wanted to get rid of, (b) therapist during the study to assure adherence to the manual, report the present SUD score (Wolpe, 1990), and (c) focus on as well as to ensure that she did evaluations of the risk of differentaspectsofthesymptomwhiletappingonasequenceof suicide and other issues on patient safety. Early- or middle- acupressure points that the TFT therapist prescribed (Callahan phase sessions with nine individual patients were videotaped and Trubo, 2001). Imaginal exposure was used to bring forth and evaluated by another experienced TFT therapist familiar someofthefeelingsorbodilysensationsofananxietyexperience. with the agoraphobia manual. The therapist who evaluated the Mostofthetimeandfocusinthetreatmentwereonfeelingsor TFT sessions was instructed to secure adherence to the TFT bodilysensations.TheSUDlevelwasusedduringthesessionson algorithms and to pay special attention to use of non-TFT manyfeelingsorbodilysensations.Typicallyonebodilyfeeling approachesinthetapedTFTsessions.Unfortunately,thereisno was pressure in the chest area. With focus on this feeling the standardizedadherencemeasureavailableforTFTtreatmentthat SUD could start at 7, when tapping it was reduced to 5. Then hecoulduse. the therapist continued with the same algorithm and hopefully got a new reduction to 3 or lower. Often when the pressure in CognitiveBehavioralTherapy the chest was relieved a new feeling was noticed by the client, The CBT was conducted in accordance with a manual created “it feels like a lump in the gut.” If no SUD reduction was by David M. Clark and Paul M. Salkovskis, a revised version achieved after following the procedure a question to identify a of the manual described in Hawton et al. (1989). It consisted neworextendedfocusregardingtheproblem/feelingorsituation of 12 sessions of 50–55 min each. The first stage in therapy in focus was applied. Common questions were: “What is the introducedandsocializedthepatienttotheCBTmodelthrough worst thing about that feeling? What is the worst that can collaboration between patient and therapist on creating an happen in that situation?” Then the suitable algorithm was individualized cognitive model, based on the patient’s specific applied to treat the problem/feeling that was reported by the problems.TheCBTmodelassumesthatpatientsinterpretbodily patient. symptoms that normally occur during intense anxiety in a Often the therapist had to instruct the patients to use catastrophic way as signs of a bodily or mental disaster. An different algorithms to treat more complex problems arising avoidance of triggers that elicit anxiety and safety behavior FrontiersinPsychology|www.frontiersin.org 5 June2017|Volume8|Article1027 fpsyg-08-01027 June20,2017 Time:12:32 #6 Irgensetal. TFTvs.CBTforAgoraphobia when confronted with triggers both serve to maintain the symptom scores, ANCOVA analyses were applied with pre- catastrophic cognitions. Following the model from Clark and treatmentvaluesfortheprimaryeffectmeasuresasacovariate. Salkovskis, the CBT therapists aimed at forming a scientific Becausetherewerefewmissingdata,onlyapproximately5%, teamwiththeirpatientscalled“collaborativeempiricism”(Beck, weanalyzeddatausingtheprincipleof“intentiontotreat,”with 1979), for using this therapeutic style to create experiments to theLOCFforthemissingdata. test the meaning of the patients’ bodily symptoms. The most common was hyperventilation experiments and experiments Ethics Approval and Consent to to achieve a fast rise in pulse rates, where the patients’ Participate interpretationoftheirsymptomswassubsequentlychallengedto This study was carried out in accordance with the demonstrate that the fearful symptoms did not have dangerous recommendations of the Regional committee for medical causes, and that the symptoms would decline even if no and health research with written informed consent from actiontoreducethemwastaken.Patientandtherapistplanned all subjects. All subjects gave written informed consent in behavioral experiments to be performed between sessions, and accordance with the Declaration of Helsinki. The protocol was in a few cases, some of the sessions were used to accompany approved by the regional committee for medical and health the patient during exposure to out-of-office situations (e.g., research ethics (reference number S-06019). The study was elevators). In cognitive restructuring, such experiments aim registeredintheclinicaltrials.govin2006,butbyamistakeitwas to make the patients question the evidence supporting their notregisteredasreceiveduntilJuly3rd,2009. catastrophic interpretation of the symptoms, and to help them strengthen alternative and more benign beliefs. In addition, the therapy aimed at encouraging the patients to explore RESULTS that their need of avoidance and other safety strategies no longer existed, in order to let go of these anxiety maintaining Recruitment and participation are presented in the flowchart behaviors. (Figure 1). Of the 208 patients assessed for eligibility, 72 were found eligible, consented to study participation and were CBTTherapistsandTraining randomized to CBT, TFT, or WL. There were no differences The two CBT therapists were experienced psychiatrists with between the treatment groups in terms of receiving allocated formaltrainingandcertificationinCBT.Duringtheyearbefore treatmentorparticipatingatFU(Figure1). the start of the study, they were both trained in using the CBT No significant statistical differences were found between the manualforagoraphobiaandpanicdisordersbytwoexperienced groupsregardingpatientcharacteristicsatbaseline(Tables1,2). cognitivetherapistsandresearchers,whohaveaPh.D.inCBTfor Seventy-oneofthepatientshadpanicdisorderwithagoraphobia, agoraphobia(AH)andsocialphobia(FMB).Duringthisperiod while one patient had agoraphobia without panic disorder. For oftraining,thetherapistsweresupervisedbiweeklywithfeedback the 136 patients that were excluded from the study we only by phone on the video recordings of therapy sessions. During have data for gender and age at assessment, which were not the study, they each received feedback on 10 video recorded significantlydifferentfromthe72studypatients. sessions. Over the period of treatment and FU, the proportion of patients who changed their psychotropic medication (n = 27) Data Analysis did not significantly differ between patients receiving CBT The power calculations were originally performed for a non- (n=15)orTFT(n=12).Furthermore,therewerenosignificant inferioritystudyconceptassuming70%effectivenessforCBTand between-group differences among patients who reduced (TFT 85% for TFT, with 80% strength and 10% CI and an accepted n = 8, CBT n = 10) or increased their dosage (TFT 10% delta, yielding 34 patients in each therapy group. As both n = 4, CBT n = 5). Patients who used benzodiazepines the criteria for estimating effectiveness for TFT, and the non- (Bz.) regularly or occasionally showed a trend toward lesser inferiority margin for scores on the ADIS avoidance scale are reduction on the primary outcome of avoidance than the highly uncertain, we present our findings as a conventional other patients in the study both pre-post (Bz. = 1.19, no superioritytrialwithtwo-sidedstatisticaltests. Bz. = 1.79, p = 0.09) and pre-12 months FU (Bz. = 1.13, no StatisticswereperformedfirstonthethreeconditionsCBT12 Bz. = 1.64, p = 0.19), and no difference between CBT or TFT sessions(n=24)andTFTfivesessions(n=24)aftertreatment (p=0.80). and WL (n = 24) after a 3 months waiting period (Table 3), Theproportionofpatientswhoreceivedadditionaltreatment and on the two conditions CBT (n = 36) and TFT (n = 36) at during the trial (n = 14) did not significantly differ between 12-monthFU,applyingthepre-treatmentscoresasbaselinefor the CBT- (n = 8) and the TFT (n = 6) condition. Additional allpatients(Table4). treatments were supportive therapy (CBT = 2, TFT = 3), Independent sample’s t-test and Fisher’s exact test were three-five extra sessions with their study therapist due to acute used for a statistical comparison between the two groups for situationsnotrelatedtotheiragoraphobia(CBT=1,TFT=2), continuousandcategoricaldata,respectively. othertherapistcontact(CBT=4,TFT=1)andacuteinpatient Repeated measures ANOVA was used to assess treatment care(CBT=1). across the three FU times, and ESs (Cohen’s d) were calculated Eleven patients (CBT = 8, 22%, TFT = 3, 8%, Fisher’s using G∗Power 320. To adjust for differences in pre-treatment exact test, p = 0.19) dropped out of the scheduled treatment FrontiersinPsychology|www.frontiersin.org 6 June2017|Volume8|Article1027 fpsyg-08-01027 June20,2017 Time:12:32 #7 Irgensetal. TFTvs.CBTforAgoraphobia TABLE1|Demographicdataforthethreeoriginalgroups. Characteristic Group TFT(n=24) WL(n=24) CBT(n=24) M(SD) M(SD) M(SD) Ageatstudystart,years 39.3(11.8) 40.9(12.7) 33.8(12.0) Durationofsymptoms,years 11.1(8.5) 15.1(13.4) 11.7(9.5) NumberofAxisIdiagnoses,mean 2.0(1.2) 2.3(1.6) 2.7(1.3) n(%) n(%) n(%) Female 18(75) 18(75) 18(75) Affectivedisorder,current∗ 4(17) 7(29) 10(42) Affectivedisorder,lifetime∗ 14(58) 15(33) 18(75) Oneormoreanxietydisorders,inadditiontoagoraphobiawith/withoutpanicdisorder 9(38) 11(46) 11(46) Abuseofalcoholordrugs,lifetime 1(4) 3(13) 3(13) Numberofpatientsdiagnosedwithoneormorepersonalitydisorders 4(17) 6(25) 4(17) Numberofpatientsregularlyusingbenzodiazepines 2(8) 5(21) 1(4) Numberofpatientsoccasionallyusingbenzodiazepines 3(13) 6(25) 5(21) Numberofpatientsusingantidepressants 14(58) 15(63) 12(50) ∗Includesmajordepressiveepisode,recurrentdepression,bipolardisordertype2anddysthymia. TABLE2|Demographicdataforthetwotherapygroups. Characteristic Group TFT(n=36) CBT(n=36) M(SD) M(SD) Ageatstudystart,years 39.1(12.2) 36.9(12.7) Durationofsymptoms,years 11.8(8.8) 13.5(12.2) NumberofAxisIdiagnoses,mean 2.1(1.4) 2.5(1.4) n(%) n(%) Female 27(75) 27(75) Affectivedisorder,current∗ 8(22) 13(36) Affectivedisorder,lifetime∗ 21(58) 26(72) Oneormoreanxietydisorders,inadditiontoagoraphobiawith/withoutpanicdisorder 15(42) 16(44) Abuseofalcoholordrugs,lifetime 4(11) 3(8) Numberofpatientsdiagnosedwithoneormorepersonalitydisorders 9(25) 5(14) Numberofpatientsregularlyusingbenzodiazepines 4(11) 4(11) Numberofpatientsoccasionallyusingbenzodiazepines 6(17) 8(22) Numberofpatientsusingantidepressants 21(58) 20(56) ∗Includesmajordepressiveepisode,recurrentdepression,bipolardisordertype2anddysthymia. at various stages. In the CBT group, the dropouts completed Threeofthe11dropoutswerelosttoFU(CBT=2,TFT=1), 2–10 of the 12 scheduled sessions; the three TFT dropout while eight attended the FU evaluations (CBT = 6, TFT = 2). patients completed 3–4 of the 5 sessions. Among the Among these eight, three did not fill in self-report measures dropouts, three (CBT = 2, TFT = 1) ended their therapy post-treatment, but did attend the interview for assessing the because they experienced significant symptom reduction and primaryeffectvariable. experienced no need for further sessions, whereas one TFT Reliability Testing patient dropped out due to moving to another part of the country,butexperiencedconsiderablesymptomreductionafter Due to practical reasons, 47 of the 227 ADIS interviews were three sessions. The reduction in the primary effect variable performed by the first author. When rescored from video by of avoidance symptoms did not differ between dropouts two of the primary interviewers (ES, VØH) who were blinded from CBT (0.98, CI 1.64) or TFT (0.42, CI 0.49), F 0.09, to the first author’s score, the intra-class correlation (ICC) p0.77. was 0.94 (CI 0.90 – 0.97). These results compare well with FrontiersinPsychology|www.frontiersin.org 7 June2017|Volume8|Article1027 fpsyg-08-01027 June20,2017 Time:12:32 #8 Irgensetal. TFTvs.CBTforAgoraphobia TABLE3|Mean,standarddeviations,andeffectsizes(Cohen’sd)forpatientsrandomizedtotreatmentwith(1)CBT12sessions(n=24)or(2)TFTfivesessions (n=24),or(3)a3monthswait-list(n=24),measuredatbaselineandaftertreatmentorwaitingperiod.F-valueswerecomputedforCBTandTFTinrelationtowait-list, asaCondition×Timeeffectacrosstheassessments. (1)Immediatelybefore (2)Immediatelyafter treatmentorwaitingperiod treatmentorwaitingperiod M SD M SD d F(1,48) P ADISanxiety CBT 2.91 1.16 1.24 1.32 1.60 41.4 TFT 3.57 1.44 1.95 1.67 1.11 25.2 0.89 Wait-list 3.13 1.02 3.28 1.30 −0.17 ADISavoidance CBT 2.70 1.23 1.01 1.31 1.61 49.7 TFT 3.26 1.59 1.64 1.76 1.06 28.2 0.85 Wait-list 2.85 0.95 3.18 1.34 −0.39 ADISinference CBT 6.17 1.58 2.38 2.28 1.75 27.0 TFT 5.67 1.93 3.21 2.52 1.02 7.38 0.06 Wait-list 6.33 1.01 5.54 1.56 0.47 ADISdistress CBT 6.08 1.61 2.50 2.38 1.63 36.9 TFT 6.08 1.74 3.54 2.40 1.02 14.8 0.14 Wait-list 6.17 1.40 5.92 1.61 0.18 MIalone CBT 3.35 0.55 2.16 0.85 1.78 39.1 TFT 3.56 0.66 2.62 1.00 0.89 11.7 0.35 Wait-list 3.42 0.58 3.30 0.64 0.29 BDI CBT 16.3 9.68 11.1 9.35 0.90 8.26 TFT 13.8 8.28 8.71 7.23 0.55 4.81 0.94 Wait-list 14.1 11.8 14.3 12.5 −0.03 BAI CBT 25.8 13.6 13.9 13.6 0.94 15.7 TFT 21.4 10.8 14.0 10.8 0.58 5.40 0.22 Wait-list 25.5 14.0 25.0 14.4 0.08 ACQfrequency CBT 2.14 0.57 1.72 0.55 0.99 14.0 TFT 2.07 0.45 1.68 0.46 0.70 9.42 0.88 Wait-list 2.32 0.54 2.38 0.74 −0.15 ACQbelief CBT 25.3 15.1 11.5 10.8 1.18 13.6 TFT 24.0 11.7 13.0 12.0 0.75 7.68 0.50 Wait-list 31.7 14.2 32.6 21.1 −0.07 BSQ CBT 2.71 0.75 2.09 0.70 0.78 4.04 TFT 2.60 0.63 1.98 0.71 0.77 3.97 1.00 Wait-list 2.90 0.86 2.72 1.02 0.26 P-valueswerecomputedforthedifferencesbetweenCBTandTFT. CBT,cognitivebehavioraltherapy;TFT,thoughtfieldtherapy;ADISanxiety,meansymptomscoreonanxiety;ADISavoidance,meansymptomscoreonavoidance;ADIS inference,inferenceondailylifefromagoraphobicsymptoms;ADISdistress,distressindailylifefromagoraphobicsymptoms;MIalone,MobilityInventory,subscale alone;BDI,BeckDepressionInventory;BAI,BeckAnxietyInventory;ACQ,AgoraphobicCognitionsQuestionnaire,scalesonfrequencyofthoughtsandbeliefinthoughts; BSQ,BodySensationsQuestionnaire. those found by Brown et al. (2001), who reported a Pearson’s describingthetherapistasgood.Foritem15,themeanscorewas r of 0.86 for the rating of agoraphobic avoidance from the 3.0(range1.0–4.0),whichmeansalikely“yes”tothequestionon ADIS. choosingthistherapistforanewstudy.Foritem16,themeanwas 1.4(range0.0–4.0),withascoreof0sayingthatthepatientwas Treatment Integrity notdifficult,whilea3denotesamediumdifficultpatient. SevenCBTsessionsfromthestartingphaseandeightfromthe Thereisnosystematictreatmentfidelityinstrumentdeveloped mid-phasewereassessedusingtheCTS.Forbothitems1–6and for TFT. The external experienced TFT therapist, who viewed items 7–11, the therapists were scored as being good, with a nine sessions by video, confirmed that the content of the meanof4.0(range3.2–4.8)and4.0(range2.6–5.0),respectively. TFT treatment was in accordance with standard content and Foritem14themeanwas3.9(range2.5–5.0),withascoreof4 proceduresinallsessions. FrontiersinPsychology|www.frontiersin.org 8 June2017|Volume8|Article1027 fpsyg-08-01027 June20,2017 Time:12:32 #9 Irgensetal. TFTvs.CBTforAgoraphobia TABLE4|MeansandstandarddeviationsforpatientstreatedwithCBT(n=36)orTFT(n=36),measured:(1)immediatelybeforetreatment;(2)aftertreatment;(3) 12monthsaftertreatment. (1)Immediatelybefore (2)Immediatelyafter (3)Twelvemonthsafter treatment treatment treatment M SD M SD d M SD d F(1,72) P ADISanxiety CBT 3.02 1.23 1.36 1.41 1.32 1.66 1.67 0.93 TFT 3.48 1.38 1.99 1.76 1.03 1.93 1.60 1.06 0.68 0.51 ADISavoidance CBT 2.84 1.26 1.15 1.41 1.33 1.45 1.71 0.92 TFT 3.25 1.51 1.74 1.80 1.06 1.67 1.60 1.10 0.76 0.47 ADISinference CBT 5.92 1.59 2.58 2.30 1.40 2.53 2.93 1.25 TFT 5.69 1.80 3.44 2.59 0.99 3.14 2.60 1.04 2.00 0.14 ADISdistress CBT 5.89 1.64 2.50 2.36 1.48 3.00 2.81 1.12 TFT 6.17 1.65 3.72 2.59 1.00 3.42 2.57 1.09 1.58 0.21 MIalone CBT 3.31 0.56 2.23 0.81 1.49 2.24 0.89 1.33 TFT 3.49 0.67 2.58 1.05 0.89 2.51 1.12 0.87 0.36 0.70 BDI CBT 14.6 9.37 10.1 9.16 0.78 10.8 8.41 0.55 TFT 15.0 11.1 9.81 10.2 0.59 10.7 11.1 0.53 0.07 0.93 BAI CBT 25.0 12.4 13.2 13.0 1.02 13.6 12.2 0.88 TFT 23.1 13.7 15.4 14.2 0.54 14.2 14.5 0.62 0.95 0.39 ACQfreq. CBT 2.11 0.55 1.75 0.60 0.73 1.59 0.51 0.85 TFT 2.28 0.65 1.80 0.71 0.73 1.81 0.61 0.70 0.91 0.41 ACQbelief CBT 25.9 14.3 14.1 13.2 0.78 9.75 9.23 0.95 TFT 28.1 13.8 17.3 18.7 0.64 18.4 17.2 0.59 1.82 0.17 BSQ CBT 2.66 0.73 2.06 0.70 0.78 1.91 0.64 0.95 TFT 2.70 0.89 2.09 0.97 0.67 2.20 0.86 0.50 1.32 0.27 Effectsizes(Cohen’sd)wereestimatedinrelationtobefore-treatmentvalues.FvalueswerecomputedasaConditionXTimeeffectacrosstheassessments. CBT,cognitivebehavioraltherapy;TFT,thoughtfieldtherapy;ADISanxiety,meansymptomscoreonanxiety;ADISavoidance,meansymptomscoreonavoidance;ADIS inference,inferenceondailylifefromagoraphobicsymptoms;ADISdistress,distressindailylifefromagoraphobicsymptoms;MIalone,MobilityInventory,subscale alone;BDI,BeckDepressioninventory;BAI,BeckAnxietyInventory;ACQ,AgoraphobicCognitionsQuestionnaire,scalesonfrequencyofthoughtsandbeliefinthoughts; BSQ,BodySensationsQuestionnaire. Primary Outcomes theADISavoidancescale.ThemeandifferencebetweentheCBT Figure 2 shows the comparison of changes between CBT, TFT, and TFT groups on the 12-month FU was also non-significant: andtheWLfrombeforetoaftertheendoftherapyorthewaiting 0.041(95%CI−0.63–0.72),andp=0.90fortheADISavoidance period for the avoidance scale from the ADIS, a priori chosen scale. astheprimaryeffectvariable.Thereweresignificantdifferences between the WL group and the two treatment groups, with Secondary Outcomes p<0.001forthecomparisonsbetweenWLpatientsandpatients Table 3 shows the comparisons of changes between CBT, TFT, whoreceivedeitherCBTorTFT. andtheWLCfrompretoposttherapyorwaitingperiodforall Figure3showsthecomparisonofbeneficialchangesbetween parameters,includingESs,withF-valuesforCBTandTFTboth CBTandTFTfrombeforetreatmenttothe12-monthFUforthe computedinrelationtotheWLpatients.Thereweresignificant avoidancescalefromtheADIS. differencesbetweentheWLgroupandthetwotreatmentgroups Figure 4 illustrates the mean changes of the primary effect on all parameters, showing that CBT and TFT did better than variableacrossthethreetimepointsinthestudy. WL(p<0.05),exceptforBSQforwhichthep-valuewas0.050 The effects of the two assigned treatment modalities were forCBTand0.052forTFT.WhencomparingtheCBT(n=24) assessedwithanANCOVAmodel,adjustingfortheinitiallevelof and TFT (n = 24) groups at baseline, no parameters showed avoidancebeforetreatment.Forourprimaryoutcome,themean significantF-values. differencebetweentheCBTandTFTgroupsaftertreatmentwas The results of all outcome measures at 12 months FU are non-significant:−0.31(95%CI−0.93–0.32),andp=0.33for presentedinTable4.NoparametersshowedsignificantF-values, FrontiersinPsychology|www.frontiersin.org 9 June2017|Volume8|Article1027 fpsyg-08-01027 June20,2017 Time:12:32 #10 Irgensetal. TFTvs.CBTforAgoraphobia FIGURE2|MeansandconfidenceintervalsforchangesontheADIS symptomscoreforavoidance,frombeforetoafterwait-list(n=24)or treatmentwithCBT(n=24)orTFT(n=24). FIGURE4|Curvesshowingmeanchangeswitha95%CIintheprimary effectvariableofavoidancefromtheADIS,frombeforetoaftertreatmentwith CBT(n=36)orTFT(n=36),andfrombeforeto12monthsaftertreatment. remember such memories after the end of treatment, therefore receivingadditionaltreatmentimmediatelyaftertheFUperiod. Sixty-three(91%)ofthe69patientswhocompletedthestudy wereaskediftheyhadnegativeexperiencesduringtheresearch project, but none of the CBT patients reported this. One TFT patientwasdisappointedatonlyreceivingfivesessions,despitean approximate50%symptomreductionfrompretoposttreatment. In 66 of the 69 patients who met to FU (CBT = 33/34 and FIGURE3|MeansandconfidenceintervalsforchangesontheADIS TFT=33/35)theADISinterviewerswereinstructedtoassessat symptomscoreforavoidance,frombeforeto12monthsaftertreatmentwith theendoftheinterviewifanyinformationfromthepatienton CBT(n=36)orTFT(n=36). thetypeoftherapyreceivedwaspresent(yes/no),andwereasked toguesswhichtherapythepatientreceivediftheyhadsomeidea. For seven of the patients (CBT = 3, TFT = 4) the interviewers althoughallparameterstendedtowardmoreimprovementinthe gotinformationabouttypeoftherapy,andthusmakingaguess CBT group, with the exception of the symptoms of depression was not relevant. For 44 patients (CBT = 23, TFT = 21) the measured by the BDI. All ESs were in the range of medium interviewersstatedthattheyhadnoinformation,butstilldidnot (0.50–0.80) or high (above 0.80) (Cohen, 1988). On four of the makeanyguessoftypeoftherapythepatientshadreceived.For 10 parameters measured, the results from the CBT treatment 15patients(CBT=7,TFT=8)theinterviewersstatedthatthey conditionwereinahigherESgroupthantheTFT. hadnoinformationandmadeaguess.Theywerecorrectin11 At the 12-month FU, 18 (50%) of the CBT patients and 10 patients(CBTn=5,71%,TFTn=6,75%). (28%)oftheTFTpatientsnolongermetthediagnosticcriteria foragoraphobia(P=0.09). Nine(25%)TFTpatientshadoneormoreAxisIIdiagnoses DISCUSSION atthestartofthestudy,whileatthe12-monthFUsixnolonger hadanAxisIIdiagnosis.AmongtheCBTpatients,fivepatients This randomized, controlled trial showed that TFT did better (14%)hadanAxisIIdiagnosisatthestartofthestudy,whereas than the WL. TFT did not demonstrate results different from twoofthesehadnoAxisIIdiagnosisatthe12-monthFU. CBT,particularlynotonthetwoprimaryeffectvariables,which Six (18%) CBT patients and one TFT patient reported side werescoredbyratersblindedfortreatmentconditions.Intheir effects. Among the CBT patients, three reported increased studyfromBarlowetal.(2000)foundthatCBTwassuperiortoa intensity of symptoms, and the other three that the treatment placeboinpanicdisorders.AlthoughtheWLCisnotequivalent wasmoreunpleasantortiresomethanexpected.OneTFTpatient to the placebo, our study is in agreement with their results re-experienced traumatic memories that were not successfully (Figure2), also taking into consideration the above-mentioned treated during the five TFT sessions, and she continued to results for CBT, in addition to a study by Loerch et al. (1999), FrontiersinPsychology|www.frontiersin.org 10 June2017|Volume8|Article1027

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Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, Oslo, . based Programs and Practices; PDA, panic disorder with agoraphobia; PTSD, post- . prescribed acupoints on the body) with certainty promotes the .. Recruitment and participation are presented in the flowchart.
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