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      Thinking Well: A randomised controlled feasibility study of a new CBT therapy targeting reasoning biases in people with distressing persecutory delusional beliefs

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          Abstract

          Background and objectives

          Delusional beliefs with persecutory content are common in psychosis, but difficult to treat. Interventions targeting hypothesised causal and maintaining factors have been proposed as a way of improving therapy. The current study is a feasibility randomised controlled trial of the ‘Thinking Well (TW)’ intervention: This novel approach combines the recently developed Maudsley Review Training Programme (MRTP), with additional, focussed cognitive-behavioural therapy sessions.

          Methods

          31 participants with distressing persecutory delusions and schizophrenia spectrum disorders were randomised to TW or to treatment as usual in a 2:1 ratio. Participants completed outcome assessments at 0 (baseline), 1 (post-MRTP), 6 (post-TW) and 8 (follow-up) weeks. Key outcomes included belief flexibility, paranoia, and delusional conviction and distress. Participants allocated to TW completed the MRTP package and four CBT sessions with a clinical psychologist.

          Results

          Recruitment proved feasible. Participants reported the intervention was relevant and had resulted in positive changes in thinking and mood, which they could use in everyday life. Treatment effects were moderate-large for key outcomes including belief flexibility, paranoia conviction and distress. The additional TW sessions appeared to confer benefits over MRTP alone.

          Limitations

          Assessments were not carried out blind to treatment condition. Recruitment was opportunistic, from an identified pool of research participants. Finally, a few participants had already completed the MRTP as part of a previous study.

          Conclusions

          The TW intervention appears to be feasible and acceptable to participants, and the effects of treatment are promising. A fully powered randomised controlled trial of the intervention is warranted.

          Highlights

          • The Thinking Well intervention was feasible to deliver and feedback was positive.

          • Analyses suggest large effects post intervention, with confidence intervals favouring the intervention.

          • Effects on state paranoia were not sustained; future work should focus on maintenance.

          • A larger study powered to detect changes in key outcomes is warranted.

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          Most cited references33

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          Design and analysis of pilot studies: recommendations for good practice.

          Pilot studies play an important role in health research, but they can be misused, mistreated and misrepresented. In this paper we focus on pilot studies that are used specifically to plan a randomized controlled trial (RCT). Citing examples from the literature, we provide a methodological framework in which to work, and discuss reasons why a pilot study might be undertaken. A well-conducted pilot study, giving a clear list of aims and objectives within a formal framework will encourage methodological rigour, ensure that the work is scientifically valid and publishable, and will lead to higher quality RCTs. It will also safeguard against pilot studies being conducted simply because of small numbers of available patients.
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            Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis.

            The question of which antipsychotic drug should be preferred for the treatment of schizophrenia is controversial, and conventional pairwise meta-analyses cannot provide a hierarchy based on the randomised evidence. We aimed to integrate the available evidence to create hierarchies of the comparative efficacy, risk of all-cause discontinuation, and major side-effects of antipsychotic drugs. We did a Bayesian-framework, multiple-treatments meta-analysis (which uses both direct and indirect comparisons) of randomised controlled trials to compare 15 antipsychotic drugs and placebo in the acute treatment of schizophrenia. We searched the Cochrane Schizophrenia Group's specialised register, Medline, Embase, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov for reports published up to Sept 1, 2012. Search results were supplemented by reports from the US Food and Drug Administration website and by data requested from pharmaceutical companies. Blinded, randomised controlled trials of patients with schizophrenia or related disorders were eligible. We excluded trials done in patients with predominant negative symptoms, concomitant medical illness, or treatment resistance, and those done in stable patients. Data for seven outcomes were independently extracted by two reviewers. The primary outcome was efficacy, as measured by mean overall change in symptoms. We also examined all-cause discontinuation, weight gain, extrapyramidal side-effects, prolactin increase, QTc prolongation, and sedation. We identified 212 suitable trials, with data for 43 049 participants. All drugs were significantly more effective than placebo. The standardised mean differences with 95% credible intervals were: clozapine 0·88, 0·73-1·03; amisulpride 0·66, 0·53-0·78; olanzapine 0·59, 0·53-0·65; risperidone 0·56, 0·50-0·63; paliperidone 0·50, 0·39-0·60; zotepine 0·49, 0·31-0·66; haloperidol 0·45, 0·39-0·51; quetiapine 0·44, 0·35-0·52; aripiprazole 0·43, 0·34-0·52; sertindole 0·39, 0·26-0·52; ziprasidone 0·39, 0·30-0·49; chlorpromazine 0·38, 0·23-0·54; asenapine 0·38, 0·25-0·51; lurasidone 0·33, 0·21-0·45; and iloperidone 0·33, 0·22-0·43. Odds ratios compared with placebo for all-cause discontinuation ranged from 0·43 for the best drug (amisulpride) to 0·80 for the worst drug (haloperidol); for extrapyramidal side-effects 0·30 (clozapine) to 4·76 (haloperidol); and for sedation 1·42 (amisulpride) to 8·82 (clozapine). Standardised mean differences compared with placebo for weight gain varied from -0·09 for the best drug (haloperidol) to -0·74 for the worst drug (olanzapine), for prolactin increase 0·22 (aripiprazole) to -1·30 (paliperidone), and for QTc prolongation 0·10 (lurasidone) to -0·90 (sertindole). Efficacy outcomes did not change substantially after removal of placebo or haloperidol groups, or when dose, percentage of withdrawals, extent of blinding, pharmaceutical industry sponsorship, study duration, chronicity, and year of publication were accounted for in meta-regressions and sensitivity analyses. Antipsychotics differed substantially in side-effects, and small but robust differences were seen in efficacy. Our findings challenge the straightforward classification of antipsychotics into first-generation and second-generation groupings. Rather, hierarchies in the different domains should help clinicians to adapt the choice of antipsychotic drug to the needs of individual patients. These findings should be considered by mental health policy makers and in the revision of clinical practice guidelines. None. Copyright © 2013 Elsevier Ltd. All rights reserved.
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              SCAN. Schedules for Clinical Assessment in Neuropsychiatry.

              After more than 12 years of development, the ninth edition of the Present State Examination (PSE-9) was published, together with associated instruments and computer algorithm, in 1974. The system has now been expanded, in the framework of the World Health Organization/Alcohol, Drug Abuse, and Mental Health Administration Joint Project on Standardization of Diagnosis and Classification, and is being tested with the aim of developing a comprehensive procedure for clinical examination that is also capable of generating many of the categories of the International Classification of Diseases, 10th edition, and the Diagnostic and Statistical Manual of Mental Disorders, revised third edition. The new system is known as SCAN (Schedules for Clinical Assessment in Neuropsychiatry). It includes the 10th edition of the PSE as one of its core schedules, preliminary tests of which have suggested that reliability is similar to that of PSE-9. SCAN is being field tested in 20 centers in 11 countries. A final version is expected to be available in January 1990.
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                Author and article information

                Contributors
                Journal
                J Behav Ther Exp Psychiatry
                J Behav Ther Exp Psychiatry
                Journal of Behavior Therapy and Experimental Psychiatry
                Elsevier
                0005-7916
                1873-7943
                1 September 2015
                September 2015
                : 48
                : 82-89
                Affiliations
                [a ]King's College London, The Institute of Psychiatry, Psychology & Neuroscience, UK
                [b ]Centre for Biostatistics, Institute of Population Health, The University of Manchester, Manchester Academic Health Science Centre, UK
                [c ]Department of Psychiatry, Oxford University, Oxford, UK
                [d ]Mental Health Sciences Unit, Faculty of Brain Sciences, University College London, UK
                [e ]Department of Psychology, University of Sussex, Brighton, UK
                Author notes
                []Corresponding author. King's College London, The Institute of Psychiatry, Psychology & Neuroscience, PO77 Henry Wellcome Building, De Crespigny Park, London SE5 8AF, UK. Tel.: +44 (0)20 7848 0815; fax: +44 (0)20 7848 5006. helen.waller@ 123456kcl.ac.uk
                Article
                S0005-7916(15)00025-7
                10.1016/j.jbtep.2015.02.007
                4429971
                25770671
                74270810-dcc4-4042-9323-49e1366ffe98
                © 2015 The Authors

                This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

                History
                : 16 October 2014
                : 11 February 2015
                : 15 February 2015
                Categories
                Article

                Clinical Psychology & Psychiatry
                psychosis,reasoning,cbt,belief flexibility
                Clinical Psychology & Psychiatry
                psychosis, reasoning, cbt, belief flexibility

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