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journal of clinical pharmacy and therapeutics 2011 doi 10 1111 j 1365 2710 2011 01299 x originalarticle efcacy of the trial based thought record a new cognitive therapy strategy designed ...

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                Journal of Clinical Pharmacy and Therapeutics (2011)                                                   doi:10.1111/j.1365-2710.2011.01299.x
                ORIGINALARTICLE
                Efficacy of the trial-based thought record, a new cognitive
                therapy strategy designed to change core beliefs, in social
                phobia
                I. R. de Oliveira* MD, PhD,V.B.Powell*PsyD,A.Wenzel PhD,M.Caldas*PsyD,
                C.Seixas*PsyD,C.Almeida*PsyD,T.Bonfim*PsyD,M.C.Grangeon*PsyD,M.Castro*
                                      ˜
                PhD,A.Galvao* MD, R. de Oliveira Moraes* MD and D. Sudak MD
                *Department of Neuroscience and Mental Health, University Hospital Professor Edgard Santos, Federal
                University of Bahia, Salvador, Bahia, Brazil, Department of Psychiatry, University of Pennsylvania,
                Philadelphia, PA, and Department of Psychiatry, Drexel University, Philadelphia, PA, USA
                SUMMARY                                                                   Distress Scale (SADS), Beck Anxiety Inventory,
                                                                                          and Clinical Global Impression – Improvement.
                What is known and Background: Social anxiety                              In addition, a one-way ANCOVA, taking baseline
                disorder(SAD)oftenfollowsachroniccourseand                                values as covariates, showed that TBTR was sig-
                is associated with substantial impairment in                              nificantly more efficacious than CCT in reducing
                functioning. Although results from clinical trials                        the scores of FNE (P =0Æ01 at mid-treatment and
                clearly establish evidence for efficacy of cognitive                       P =0Æ004 at post-treatment), and SADS (P =0Æ03
                behavioural therapy in treating this disorder, up                         at post-treatment).
                to 50% of patients with SAD show little or no                             Whatis new and Conclusion: This study provides
                improvement. Thus, new approaches that have                               preliminary evidence that TBTR is at least as
                promised in improving the efficacy of treatment                            efficacious as CCT in reducing symptomsofSAD,
                for SAD are needed. One such approach is the                              pointing to the need for additional studies of
                trial-based thought record (TBTR), which targets                          TBTR in SAD and other psychiatric disorders.
                the restructuring of patients’ core beliefs.
                Objective: To determine whether patients receiv-                          Keywords: cognitive therapy, psychological treat-
                ing TBTR would report fewer symptoms of social                            ment, randomized trial, social anxiety disorder,
                anxiety and general psychiatric distress following                        trial-based thought record
                treatment, relative to conventional cognitive
                therapy (CCT).
                Methods: A two-arm randomized trial comparing                             WHATISKNOWNANDOBJECTIVE
                TBTR (n = 17) with a set of CCT techniques
                (n = 19), which included the standard seven-                              Social anxiety disorder (SAD), the most common
                column dysfunctional thought record and the                               anxiety disorder, often follows a chronic course and
                positive data log in SAD patients according to                            is associated with substantial impairment in func-
                DSM-IV.                                                                   tioning. Over the past two decades, much effort has
                Results: Scores        on many outcome measures                           been devoted to developing cognitive behavioural
                decreased significantly across the course of treat-                        approaches to treat this condition. Although results
                ment in both groups (P <0Æ001), including the                             from clinical trials clearly establish evidence for
                Liebowitz Social Anxiety Scale, Fear of Negative                          cognitive behavioural therapy’s (CBT) efficacy (1,
                Evaluation Scale (FNE), Social Avoidance and                              for a comprehensive meta-analysis), in many
                                                                                          instances, 40–50% of patients with SAD show little
                Received 17 April 2011, Accepted 09 August 2011                           or no improvement (2). Recently, scholars have
                                                                                ´
                Correspondence: Professor I. R. de Oliveira, Programa de Pos-             refined cognitive behavioural treatments to target,
                         ˜                       ´                        ´
                Graduac¸ao em Medicina e Saude, Hospital Universitario Pro-
                fessor Edgard Santos, Salvador, Bahia CEP 40110-060, Brazil.              more specifically, cognitive processes believed to
                Tel.⁄fax: +55 71 32417154; e-mail: irismar.oliveira@uol.com.br            maintain and exacerbate symptomatology (3, 4).
                2011 Blackwell Publishing Ltd                                                                                                              1
               2   I. R. de Oliveira et al.
               Results from these investigations suggest that these      attorney’s plea [evidence not supporting the core
               targeted protocols result in greater reductions in        belief (14)], prosecutor’s response to the defendant’s plea
               self-reported social anxiety than earlier cognitive       [point-counter-point by discounting the evidence
               behavioural protocols. Despite these gains, scholars      (15)], defense attorney’s response to the prosecutor’s plea
               havecalledforcontinuedinvestigationintotargeted           [sentence reversal (16)], juror’s verdict [debriefing
               cognitive behavioural strategies to maximize the          and upward arrow technique (13, 17)] and prepara-
               efficacy of treatment and eliminating strategies that      tion for the appeal [positive data log (PDL) (6, 18)].
               prove to be unnecessary (5).                                It is possible that TBTR is a cognitive behavio-
                  Oneapproach that has the promise to be fruitful        ural approach that could improve the efficacy of
               in the cognitive behavioural treatment of SAD is the      CBT for SAD, as it focuses on the deepest level of
               modification of core beliefs. Core beliefs are global,     cognition (i.e. core beliefs) that is theorized to drive
               rigid and fundamental beliefs that people have            the expression of socially anxious symptoms. Our
               about themselves, the world and⁄or the future (6).        objective was to compare TBTR (8, 9) with con-
               Core beliefs influence the types of cognitions that        ventional cognitive therapy (CCT) in patients who
               people experience in specific situations. For exam-        met DSM-IV criteria for generalized SAD (19).
               ple, a person with the core belief, ‘I am incompe-        Specific strategies implemented by therapists in
               tent’, will likely predict that he will be unable to      CCT included the seven-column dysfunctional
               function adequately during a job interview. A per-        thought record (DTR) (14) and the PDL (6, 18).
               son with the core belief, ‘I am unlikable’, will likely   These two strategies were used in the CCT condi-
               predictthatotherswillnotbeinterestedinwhatshe             tion because they mirrored the tools used in TBTR.
               has to say at a social gathering. As a result, both of    Specifically, TBTR is, in itself, a thought record that
               these people would likely experience a great deal of      is modified to reflect the courtroom nomenclature.
               social anxiety. Although patients receiving CBT           Moreover, the therapeutic work that takes place
               usually   report   significant  improvement after          during the ‘preparation for the appeal’ is similar to
               developing strategies to modify unhelpful situa-          the activity that is performed using the PDL, in that
               tional cognitions, cognitive theory and clinical          both tools require patients to record evidence that
               experience suggest that the greatest amount of            supports a new, more adaptive core belief. In other
               change is usually observed when unhelpful core            words, many of the therapeutic activities that take
               beliefs are identified and modified (7).                    place in session are similar between the two con-
                  Recently,anovelcognitivebehaviouralapproach            ditions, but TBTR packages these tools in a con-
               to address unhelpful core beliefs has been devel-         ceptual   framework that is designed to be
               oped, called the trial-based thought record (TBTR)        particularly compelling, engaging and generaliz-
               (8, 9), which is part of a broader approach, trial-       able.
               based cognitive therapy (TBCT) (10, 11). This               The purpose of this study was to assess the dif-
               approach uses a judicial process as a metaphor, in        ferential efficacy of TBTR and CCT in the treatment
               which the therapist engages the patient in a simu-        of social phobia. It was hypothesized that patients
               lation of a trial. By means of TBTR, patients re-acti-    receiving TBTR would report decreased symptoms
               vate unhelpful core beliefs and associated negative       of social anxiety and psychiatric distress following
               emotions and reduce their effect with disconfirma-         treatment to at least the same degree as patients
               tory evidence. The repeated use of TBTR has the           receiving CCT. Such a finding would suggest that
               potential to result in deactivation of unhelpful core     TBTR is another targeted cognitive behavioural
               beliefs, modifying their structure and content. The       approach that has promise in improving the effi-
               ultimate outcome of the TBTR approach is the neu-         cacy of treatment for SAD.
               tralization of unhelpfulcorebeliefsasmorecredible
               evidence in support of helpful core beliefs is incor-
               porated. TBTR includes several strategies already         MATERIALANDMETHODS
               used in cognitive therapy (CT), labelled with court-      Design
               room nomenclature, including the inquiry [down-
               ward arrow technique (12, 13)], prosecutor’s plea         This is a two-arm clinical trial comparing TBTR
               [evidence supporting the core belief (14)], defense       with a set of CCT techniques, which included the
                                                              2011 Blackwell Publishing Ltd, Journal of Clinical Pharmacy and Therapeutics
                                                                                                     Efficacy of the trial-based thought record   3
               standard seven-column DTR, as proposed by                               Participants’ characteristics are presented in
               Greenberger and Padesky (14), and the PDL, as                        Table 1.
               demonstratedbyTompkinset al.(18).Concealment
               of random allocation was provided by an inde-                        Treatment protocol
               pendent person not participating in the treatment
               protocol. Treatment was provided by five well-                        Treatment comprised 12 one-hour individual ses-
               trained     cognitive     therapists     (see    description         sions of either TBTR (experimental group) or CCT
               below), who followed a therapist manual for both                     (contrast    group) during 10 weeks and every
               TBTR and CCT. Because the purpose of this study                      2 weeks during the last 4 weeks (4-month dura-
               was to assess the role of belief change on SAD                       tion). Sessions 1–5 in both treatment conditions
               symptoms, exposure was not actively encouraged.                      consisted of psychoeducation concerning the cog-
                                                                                    nitive model and cognitive errors and completion
               Participants                                                         of the conceptualization diagram (6). From session
               Participants were recruited by means of adver-
               tisements in local newspapers and interviews by                      Table 1. Patients demographic characteristics
               the first author in local radios and televisions about
               social anxiety. People who met DSM-IV (19) criteria                  Variablea                      TBTR (n = 17) CCT (n = 19)
               for generalized SAD were included in the study.
               All patients were assessed at an anxiety disorders                   Gender
               clinic in a university teaching hospital. The Ethics                   Women, n (%)                   12 (70Æ6)        15 (78Æ9)
               Committee at the University Hospital Professor                       Age
               Edgard Santos of Federal University of Bahia                           Mean (SD)                    33Æ9(9Æ9)         34Æ9 (13Æ4)
                                                                                      Range                        19Æ0–56Æ019Æ0–68Æ0
               approved the study.                                                  Education, n (%)
                  Participants who signed the informed consent                        1st degree (8 years)            2 (11Æ8)          0 (0Æ0)
               form were assessed using the Mini International                        2nd degree (3 years)            9 (52Æ9)        12 (63Æ2)
               Neuropsychiatric Interview (MINI), a short struc-                      College⁄university              6 (35Æ3)          7 (36Æ8)
               tured diagnostic interview developed by psychia-                     Marital status, n (%)
               trists and clinicians in the United States and Europe                  Married⁄living together         5 (29Æ4)          7 (36Æ8)
               to determine DSM-IV and ICD-10 psychiatric                             Divorced⁄widowed                2 (11Æ8)          2 (10Æ5)
               disorders with an administration time of approxi-                      Single                         10 (58Æ8)        10 (52Æ6)
               mately 15 min (20). The Brazilian version of the                     Ethnic status, n (%)
               MINIshowedsatisfactorypsychometricproperties,                          White                           6 (35Æ3)          8 (42Æ1)
               with     j >0Æ50,     sensitivity > 0Æ70     and specific-              Black                           3 (17Æ6)          1 (5Æ3)
               ity > 0Æ70) (21). This interview was conducted by                      Mixed                           8 (47Æ1)        10 (52Æ6)
               three interviewers (MC, AG and ROM) who had                          Monthly family
                                                                                     incomeb
               extensive experience in using it in previous studies                   Mean (SD)                    2286 (3714)      2036 (1711)
               by our group (22). To be included in the study,                      Employment⁄
               participants met the following criteria: fulfil DSM-                   occupation
               IV criteria for SAD, generalized type; be of age                       Employed                        8 (47Æ1)          7 (36Æ8)
               18–70; be able to read and write; and be able to                       Student                         3 (17Æ6)          7 (36Æ8)
               understand and sign the informed consent. Exclu-                       Homemaker                       3 (17Æ6)          1 (2Æ8)
               sion criteria included major comorbid Axis I psy-                      Sick-leave⁄Retired⁄             3(5Æ9)            4 (2Æ8)
               chiatric     disorders       (e.g.    major      depression,           Unemployed
               schizophrenia and bipolar disorder), alcohol or                      Concurrent medication,            1(5Æ9)            2 (10Æ5)
               substance use⁄abuse in the past 6 months; suicide                     n (%)
               risk; inability to read and write; and presently                     aNo significant differences were found in any of the above
               being in psychotherapy. Use of psychotropic                          variables.
               medications was accepted if used in stable doses in                  b
                                                                                     US$equivalence to local currency (Brazilian ‘real’) in 4 October
               the past month.                                                      2010: US$ 1Æ00 = R$ 1Æ67.
               2011 Blackwell Publishing Ltd, Journal of Clinical Pharmacy and Therapeutics
              4   I. R. de Oliveira et al.
              6 forward, both treatments focused on restructur-      at intake, mid-treatment, post-treatment and at 12-
              ing core beliefs by means of, respectively, the        month follow-up assessments. The LSAS was the
              TBTR and CCT. TBTR differed from the contrast          primary efficacy measure, and the remaining
              group in that, besides simulating a judicial trial,    assessments were regarded as secondary efficacy
              patients were actively encouraged to discount the      measures.
              positives after they gathered the evidence not
              supporting the unhelpful core belief and then, by      Statistical analyses
              means of the sentence-reversal approach (17),
              were engaged in a second round searching for the       All patients who provided at least one post-initial
              evidence that supported the helpful core beliefs.      intervention assessment (sixth session onwards for
              This second round was not part of the conven-          LSAS and seventh session onwards for FNE and
              tional approach. TBTR also differed from the           SADS) were included in the analyses with last
              conventional approach in that the new core beliefs     observed data carried forward (LOCF). Data
              were uncovered by means of the ‘upward arrow           collected at   intake  (baseline), mid-treatment
              technique’ (13, 17).                                   (7 weeks), post-treatment (4 months) and follow-
                                                                     up (12 months) were used for statistical analyses.
              Therapists                                               Weusedt-tests and chi-squared tests to identify
                                                                     differences between the groups in demographic
              Therapists were psychologists who had attended         and clinical variables. A mixed ANOVAANOVA was used to
              a two-year cognitive therapy specialization course     evaluate the effectiveness of the interventions
              organized by two of us (IRO and VBP). They             during treatment and 12-month follow-up period,
              were invited to participate because they were          the number of evaluations being computed as
              among those who had the best performance               within-subject factor (time) and treatment modal-
              during their training. This course included 384 h      ity as a between-subject factor (group). The
              of theoretical information, 60 h of clinical work      following assumptions were tested: independence
              with patients and 86 h of supervision. Also,           of observations, normality and sphericity. When
              knowledge and competence was assessed in a             sphericity was violated, the degrees of freedom
              total of 23 monthly written exams. In addition to      (d.f.) were adjusted using the Greenhouse-Greisser
              being certified by this specialization course, all      corrected values, a conservative approach to deal
              therapists had at least 1 year of experience in        with multiple comparisons (27). To assess any
              private practice as certified cognitive therapists at   differences between groups at baseline, we used
              the time of this clinical trial start-up. All the      one-way analyses of variance (ANOVASANOVAS). Then, we
              therapists had their training in the same group in     used one-way analyses of covariance (ANCOVAANCOVAs)
              the course; thus, therapists in both arms (i.e.        with baseline scores as covariates. Level of sig-
              TBCT and CCT) had equivalent experience and            nificance was set at 0Æ05. All analyses were con-
              expertise.                                             ducted with SPSSSPSS 13.0 software. Within-subjects
                                                                     Cohen’s d effect sizes (ES) were also calculated
              Assessment                                             (28).
              All measures completed by participants were self-      RESULTS
              report in nature, except the Clinical Global
              Impression – Improvement (CGI-I) (23), which is        Of the 77 patients who provided informed consent
              an observer-rated measure. The Liebowitz Social        and completed initial assessment (Fig. 1), 30 did
              Anxiety Scale (LSAS) (24) and Beck Anxiety             not meet inclusion criteria. Therefore, 47 patients
              Inventory (BAI) (25) were assessed weekly during       were randomized to the treatment groups – 25
              treatment and again at 12-month follow-up. The         were allocated to TBTR and 22 were allocated to
              CGI-I was also assessed weekly and at post-treat-      CCT. However, four participants (three in the
              ment, but not at follow-up. The Fear of Negative       TBTR group and one in the CCT group) withdrew
              Evaluation Scale (FNE) (26) and the Social Avoid-      from the study before treatment. Of the 43 partici-
              ance and Distress Scale (SADS) (26) were assessed      pants who started treatment, 13 (30%) terminated
                                                          2011 Blackwell Publishing Ltd, Journal of Clinical Pharmacy and Therapeutics
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...Journal of clinical pharmacy and therapeutics doi j x originalarticle efcacy the trial based thought record a new cognitive therapy strategy designed to change core beliefs in social phobia i r de oliveira md phd v b powell psyd wenzel m caldas c seixas almeida t bonfim grangeon castro galvao moraes d sudak department neuroscience mental health university hospital professor edgard santos federal bahia salvador brazil psychiatry pennsylvania philadelphia pa drexel usa summary distress scale sads beck anxiety inventory global impression improvement what is known background addition one way ancova taking baseline disorder sad oftenfollowsachroniccourseand values as covariates showed that tbtr was sig associated with substantial impairment nicantly more efcacious than cct reducing functioning although results from trials scores fne p at mid treatment clearly establish evidence for post behavioural treating this up patients show little or no whatis conclusion study provides thus approaches ...

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