The effects of reducing worry in patients with persecutory delusions: study protocol for a randomized controlled trial

Trials

David Kingdon¹  Helen Startup¹  Graham Dunn²  Daniel Freeman³ 

[1] Academic Department of Psychiatry, Faculty of Medicine, University of Southampton, College Keep, 4-12 Terminus Terrace, Southampton, SO14 3DT, UK;Centre for Biostatistics, Institute of Population Health, Manchester University, Jean McFarlane Building, Oxford Road, Manchester, M13 9PL, UK;Department of Psychiatry, Oxford University, Warneford Hospital, Oxford OX3 7JX, UK

关键词: Schizophrenia;    CBT;    Worry;    Persecutory;    Delusions;   

Others  :  1095138
DOI  :  10.1186/1745-6215-13-223

 received in 2012-07-31, accepted in 2012-11-02,  发布年份 2012

【 摘 要 】

Background

Our approach to advancing the treatment of psychosis is to focus on key single symptoms and develop interventions that target the mechanisms that maintain them. In our theoretical research we have found worry to be an important factor in the development and maintenance of persecutory delusions. Worry brings implausible ideas to mind, keeps them there, and makes the experience distressing. Therefore the aim of the trial is to test the clinical efficacy of a cognitive-behavioral intervention for worry for patients with persecutory delusions and determine how the worry treatment might reduce delusions.

Methods/Design

An explanatory randomized controlled trial - called the Worry Intervention Trial (WIT) - with 150 patients with persecutory delusions will be carried out. Patients will be randomized to the worry intervention in addition to standard care or to standard care. Randomization will be carried out independently, assessments carried out single-blind, and therapy competence and adherence monitored. The study population will be individuals with persecutory delusions and worry in the context of a schizophrenia spectrum diagnosis. They will not have responded adequately to previous treatment. The intervention is a six-session cognitive-behavioral treatment provided over eight weeks. The control condition will be treatment as usual, which is typically antipsychotic medication and regular appointments. The principal hypotheses are that a worry intervention will reduce levels of worry and that it will also reduce the persecutory delusions. Assessments will be carried out at 0 weeks (baseline), 8 weeks (post treatment) and 24 weeks (follow-up). The statistical analysis strategy will follow the intention-to-treat principle and involve the use of linear mixed models to evaluate and estimate the relevant between- and within-subjects effects (allowing for the possibility of missing data). Both traditional regression and newer instrumental variables analyses will examine mediation. The trial is funded by the UK Medical Research Council (MRC)/NHS National Institute of Health Research (NIHR) Efficacy and Mechanism Evaluation (EME) Programme.

Discussion

This will be the first large randomized controlled trial specifically focused upon persecutory delusions. The project will produce a brief, easily administered intervention that can be readily used in mental health services.

Trial registration

Current Controlled Trials ISRCTN23197625

【 授权许可】

   
2012 Freeman et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Peralta V, Cuesta MJ: Dimensional structure of psychotic symptoms: an item-level analysis of SAPS and SANS symptoms in psychotic disorders. Schizophr Res 1999, 38:13-26.
• [2]Freeman D, Garety PA: Comments on the content of persecutory delusions: Does the definition need clarification? Br J Clin Psychol 2000, 39:407-414.
• [3]Sartorius N, Jablensky A, Korten A, Ernberg G, Anker M, Cooper JE, Day R: Early manifestations and first-contact incidence of schizophrenia in different cultures. Psychol Med 1986, 16:909-928.
• [4]Applebaum PS, Robbins PC, Roth LH: Dimensional approach to delusions: comparison across types and diagnoses. Am J Psychiatry 1999, 156:1938-1943.
• [5]Freeman D, Garety P, Kuipers E, Fowler D, Bebbington PE, Dunn G: Acting on persecutory delusions: the importance of safety seeking. Behav Res Ther 2007, 45:89-99.
• [6]Castle DJ, Phelan M, Wessely S, Murray RM: Which patients with non-affective functional psychosis are not admitted at first psychiatric contact? Br J Psychiatry 1994, 165:101-106.
• [7]Freeman D, McManus S, Brugha T, Meltzer H, Jenkins R, Bebbington P: Concomitants of paranoia in the general population. Psychol Med 2011, 41:923-936.
• [8]Onwumere J, Smith B, Kuipers E: Family intervention in psychosis: working with persecutory delusions. In Persecutory Delusions. Edited by Freeman D, Bentall R, Garety P. Oxford: Oxford University Press; 2008:351-365.
• [9]Bebbington P, Pilling S, Whittington C: Pharmacological management of persecutory delusions. In Persecutory Delusions. Edited by Freeman D, Bentall R, Garety P. Oxford: Oxford University Press; 2008:305-328.
• [10]National Institute for Health and Clinical Excellence (NICE): Schizophrenia: the NICE guideline on core interventions in the treatment and management of schizophrenia in adults in primary and secondary care - updated edition. National Clinical Guideline Number 82. London: National Collaborating Centre for Mental Health; 2010.
• [11]Garety P, Fowler D, Freeman D, Bebbington P, Dunn G, Kuipers E: A randomised controlled trial of cognitive behavioural therapy and family intervention for the prevention of relapse and reduction of symptoms in psychosis. Br J Psychiatry 2008, 192:412-423.
• [12]Freeman D, Garety PA, Kuipers E, Fowler D, Bebbington PE: A cognitive model of persecutory delusions. Br J Clin Psychol 2002, 41:331-347.
• [13]Freeman D: Suspicious minds: the psychology of persecutory delusions. Clin Psychol Rev 2007, 27:425-457.
• [14]Freeman D, Garety PA: Worry, worry processes and dimensions of delusions. Behav Cogn Psychother 1999, 27:47-62.
• [15]Freeman D, Garety PA, Kuipers E: Persecutory delusions: developing the understanding of belief maintenance and emotional distress. Psychol Med 2001, 31:1293-1306.
• [16]Startup H, Freeman D, Garety PA: Persecutory delusions and catastrophic worry in psychosis: developing the understanding of delusion distress and persistence. Behav Res Ther 2007, 45:523-537.
• [17]Morrison AP, Wells A: Relationships between worry, psychotic experiences and emotional distress in patients with schizophrenia spectrum diagnoses and comparisons with anxious and non-patient groups. Behav Res Ther 2007, 45:1593-1600.
• [18]Bassett M, Sperlinger D, Freeman D: Fear of madness and persecutory delusions. Psychosis 2009, 1:39-50.
• [19]Freeman D, Pugh K, Antley A, Slater M, Bebbington P, Gittins M, Dunn G, Kuipers E, Fowler D, Garety PA: A virtual reality study of paranoid thinking in the general population. Br J Psychiatry 2008, 192:258-263.
• [20]Freeman D, Pugh K, Vorontsova N, Antley A, Slater M: Testing the continuum of delusional beliefs: an experimental study using virtual reality. J Abnorm Psychol 2010, 119:83-92.
• [21]Freeman D, Brugha T, Meltzer H, Jenkins R, Stahl D, Bebbington P: Persecutory ideation and insomnia. J Psychiatr Res 2010, 44:1021-1026.
• [22]Freeman D, Stahl D, McManus S, Meltzer H, Brugha T, Wiles N, Bebbington P: Insomnia, worry, anxiety and depression as predictors of the occurrence and the persistence of persecutory ideation. Soc Psychiatry Psychiatr Epidemiol 2012, 47:1195-1203.
• [23]Foster C, Startup H, Potts L, Freeman D: A randomised controlled trial of a worry intervention for individuals with persistent persecutory delusions. J Behav Ther Exp Psychiatry 2010, 41:45-51.
• [24]Kendler KS, Campbell J: Interventionist causal models in psychiatry. Psychol Med 2009, 39:881-887.
• [25]Meyer TJ, Miller ML, Metzger RL, Borkovec TD: Development and validation of the Penn State Worry Questionnaire. Behav Res Ther 1990, 28:487-495.
• [26]Haddock G, McCarron J, Tarrier N, Faragher FB: Scales to measure dimensions of hallucinations and delusions: the psychotic symptom rating scales (PSYRATS). Psychol Med 1999, 29:879-889.
• [27]Horvath AO, Greenberg LS: Development and validation of the Working Alliance Inventory. J Couns Psychol 1989, 36:223-233.
• [28]Council MR: Guidelines for Good Clinical Practice in Clinical Trials. London: MRC; 1998.
• [29]Boutron I, Moher D, Altman D, Schulz K, Ravaud P: Extending the CONSORT statement to randomized trials of nonpharmacologic treatment. Ann Intern Med 2008, 148:295-309.
• [30]Startup HM, Erickson TM: The Penn State Worry Questionnaire (PSWQ). In Worry and its Psychological Disorders. Edited by Davey GCL, Wells A. Chichester: Wiley; 2006:101-120.
• [31]Butler G, Gelder M, Hibbert G, Cullington A, Klimes I: Anxiety management: Developing effective strategies. Behav Res Ther 1987, 25:517-522.
• [32]Dugas MJ, Ladouceur R: Analysis and treatment of generalised anxiety disorder: A preliminary test of a conceptual model. Behav Res Ther 1998, 36:215-226.
• [33]Wells A: Cognitive Therapy of Anxiety Disorders: A Practice Manual and Conceptual Guide. Chichester: Wiley; 1997.
• [34]Leahy RL: The Worry Cure. Stop Worrying and Start Living. London: Piatkus; 2006.
• [35]Young JE, Beck AT: Cognitive Therapy Scale: Rating Manual. Philadelphia: Center for Cognitive Therapy; 1980.
• [36]Burns DD, Nolen-Hoeksema S: Therapeutic empathy and recovery from depression in cognitive-behavioural therapy: a structural equation model. J Consult Clin Psychol 1992, 59:305-311.
• [37]Beecham J, Knapp M: Costing psychiatric interventions. In Measuring Mental Health Needs. Edited by Thornicroft G, Brewin CR, Wing JK. London: Gaskell; 1992:163-184.
• [38]Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker S, Stewart-Brown S: The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes 2007, 5:63. BioMed Central Full Text
• [39]Green C, Freeman D, Kuipers E, Bebbington P, Fowler D, Dunn G, Garety PA: Measuring ideas of persecution and reference: the Green et al. Paranoid Thought Scales (G-PTS). Psychol Med 2008, 38:101-111.
• [40]Ehring T, Zetsche U, Weidacker K, Wahl K, Schönfeld S, Ehlers A: The Perseverative Thinking Questionnaire. J Behav Ther Exp Psychiatry 2011, 42:225-232.
• [41]Greenwood K, Sweeney A, Williams S, Gaerty P, Kuipers E, Scott J, Peters E: CHoice of Outcome In Cbt for psychosEs (CHOICE): The development of a new service user-led outcome measure of CBT for psychosis. Schizophr Bull 2010, 36:126-135.
• [42]Kay SR: Positive and Negative Syndromes in Schizophrenia. New York: Brunner; 1991.
• [43]Beck AT, Epstein N, Brown G, Steer R: An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol 1988, 56:893-897.
• [44]Vasey M, Borkovec TD: A catastrophising assessment of worrisome thoughts. Cogn Ther Res 1992, 16:505-520.
• [45]Startup HM, Davey GCL: Inflated responsibility and the use of stop rules for catastrophic worrying. Behav Res Ther 2003, 41:495-503.
• [46]Cartwright-Hatton S, Wells A: Beliefs about worry and intrusions: the meta-cognitions questionnaire and its correlates. J Anxiety Disord 1997, 11:279-296.
• [47]Davey GCL: The catastrophising interview procedure. In Worry and Its Psychological Disorders. Edited by Davey GCL, Wells A. Sussex: Wiley; 2006:157-178.
• [48]Freeston M, Rhéaume J, Letarte H, Dugas M, Ladouceur R: Why do people worry? Personal Individ Differ 1994, 17:791-802.
• [49]Wechsler D: Wechsler Abbreviated Scale of Intelligence (WASI). San Antonio TX: The Psychological Corporation; 1999.
• [50]Marsden J, Gossop G, Stewart D, Best D, Farrell M, Lehmann P, Edwards C, Strang J: The Maudsley Addition Profile (MAP). Addiction 1998, 93:1857-1867.
• [51]Weinman J, Petrie KJ, Moss-Morris R, Horne R: The Illness Perception Questionnaire: a new method for assessing the cognitive representation of illness. Psychol Heal 1996, 11:431-445.
• [52]Garety PA, Freeman D, Jolley S, Dunn G, Bebbington PE, Fowler D, Kuipers E, Dudley R: Reasoning, emotions and delusional conviction in psychosis. J Abnorm Psychol 2005, 114:373-384.
• [53]Wechsler D: Wechsler Adult Intelligence Scale-III/Wechsler Memory Scale. Third Edition Technical Manual. San Antonio: The Psychological Corporation; 1997.
• [54]Little RJA, Rubin DB: Statistical Analysis with Missing Data. 2nd edition. Chichester: New York: Wiley; 2002.
• [55]Dunn G, Maracy M, Tomenson B: Estimating treatment effects from randomized clinical trials with non-compliance and loss to follow-up: the role of instrumental variable methods. Stat Methods Med Res 2005, 14:369-395.
• [56]Baron R, Kenny DA: The moderator-mediator variable distinction in social psychological research. J Personal Soc Psychol 1986, 5:1173-1182.
• [57]Maracy M, Dunn G: Estimating dose–response effects in psychological treatment trials: the role of instrumental variables. Stat Methods Med Res 2011, 20:191-215.
• [58]Emsley R, Dunn G, White IR: Modelling mediation and moderation of treatment effects in randomised controlled trials of complex interventions. Stat Methods Med Res 2010, 19:237-270.
• [59]Freeman D: Improving cognitive treatments for delusions. Schizophr Res 2011, 132:135-139.
• [60]Myers E, Startup H, Freeman D: Cognitive behavioural treatment of insomnia in individuals with persistent persecutory delusions. J Behav Ther Exp Psychiatry 2011, 42:330-336.
• [61]Waller W, Freeman D, Jolley S, Dunn G, Garety P: Targeting reasoning biases in delusions. J Behav Ther Exp Psychiatry 2011, 42:414-421.