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Cognitive-behavioural therapy compared with standardised medical care for adults with dissociative non-epileptic seizures: the CODES RCT.

التفاصيل البيبلوغرافية
العنوان: Cognitive-behavioural therapy compared with standardised medical care for adults with dissociative non-epileptic seizures: the CODES RCT.
المؤلفون: Goldstein LH; Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK., Robinson EJ; Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.; School of Population Health and Environmental Sciences, King's College London, London, UK., Pilecka I; Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK., Perdue I; Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK., Mosweu I; King's Health Economics, King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK., Read J; Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK., Jordan H; Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK., Wilkinson M; Canterbury Christ Church University, Salamons Institute for Applied Psychology, Tunbridge Wells, UK.; South London and Maudsley NHS Foundation Trust, London, UK., Rawlings G; School of Clinical Psychology, University of Sheffield, Sheffield, UK., Feehan SJ; Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK., Callaghan H; Department of Clinical Neuroscience, Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK., Day E; Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK., Purnell J; Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK., Baldellou Lopez M; Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK., Brockington A; Department of Neurology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK., Burness C; The Walton Centre NHS Trust, Liverpool, UK., Poole NA; Department of Neuropsychiatry, St George's Hospital, South West London and St George's NHS Mental Health NHS Trust, London, UK., Eastwood C; Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK., Moore M; Centre for Social Justice and Global Responsibility, School of Law and Social Sciences, London South Bank University, London, UK., Mellers JD; South London and Maudsley NHS Foundation Trust, London, UK., Stone J; Department of Clinical Neuroscience, Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK., Carson A; Department of Clinical Neuroscience, Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK., Medford N; South London and Maudsley NHS Foundation Trust, London, UK., Reuber M; Academic Neurology Unit, Royal Hallamshire Hospital, University of Sheffield, Sheffield, UK., McCrone P; King's Health Economics, King's College London, Institute of Psychiatry, Psychology and Neuroscience, London, UK., Murray J; Department of Health Services & Population Research, Institute of Psychiatry,Psychology and Neuroscience, King's College London, London, UK., Richardson MP; Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK., Landau S; Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK., Chalder T; Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
المصدر: Health technology assessment (Winchester, England) [Health Technol Assess] 2021 Jun; Vol. 25 (43), pp. 1-144.
نوع المنشور: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: NIHR Journals Library Country of Publication: England NLM ID: 9706284 Publication Model: Print Cited Medium: Internet ISSN: 2046-4924 (Electronic) Linking ISSN: 13665278 NLM ISO Abbreviation: Health Technol Assess Subsets: MEDLINE
أسماء مطبوعة: Publication: <2013-> : Southampton, UK : NIHR Journals Library
Original Publication: Winchester, UK : National Co-Ordinating Centre for HTA, c1997-
مواضيع طبية MeSH: Cognitive Behavioral Therapy* , Quality of Life*, Adult ; Cost-Benefit Analysis ; Humans ; Quality-Adjusted Life Years ; Seizures/therapy ; Treatment Outcome
مستخلص: Background: Dissociative (non-epileptic) seizures are potentially treatable by psychotherapeutic interventions; however, the evidence for this is limited.
Objectives: To evaluate the clinical effectiveness and cost-effectiveness of dissociative seizure-specific cognitive-behavioural therapy for adults with dissociative seizures.
Design: This was a pragmatic, multicentre, parallel-arm, mixed-methods randomised controlled trial.
Setting: This took place in 27 UK-based neurology/epilepsy services, 17 liaison psychiatry/neuropsychiatry services and 18 cognitive-behavioural therapy services.
Participants: Adults with dissociative seizures in the previous 8 weeks and no epileptic seizures in the previous year and meeting other eligibility criteria were recruited to a screening phase from neurology/epilepsy services between October 2014 and February 2017. After psychiatric assessment around 3 months later, eligible and interested participants were randomised between January 2015 and May 2017.
Interventions: Standardised medical care consisted of input from neurologists and psychiatrists who were given guidance regarding diagnosis delivery and management; they provided patients with information booklets. The intervention consisted of 12 dissociative seizure-specific cognitive-behavioural therapy 1-hour sessions (plus one booster session) that were delivered by trained therapists, in addition to standardised medical care.
Main Outcome Measures: The primary outcome was monthly seizure frequency at 12 months post randomisation. The secondary outcomes were aspects of seizure occurrence, quality of life, mood, anxiety, distress, symptoms, psychosocial functioning, clinical global change, satisfaction with treatment, quality-adjusted life-years, costs and cost-effectiveness.
Results: In total, 698 patients were screened and 368 were randomised (standardised medical care alone, n  = 182; and cognitive-behavioural therapy plus standardised medical care, n  = 186). Primary outcome data were obtained for 85% of participants. An intention-to-treat analysis with multivariate imputation by chained equations revealed no significant between-group difference in dissociative seizure frequency at 12 months [standardised medical care: median of seven dissociative seizures (interquartile range 1-35 dissociative seizures); cognitive-behavioural therapy and standardised medical care: median of four dissociative seizures (interquartile range 0-20 dissociative seizures); incidence rate ratio 0.78, 95% confidence interval 0.56 to 1.09; p  = 0.144]. Of the 16 secondary outcomes analysed, nine were significantly better in the arm receiving cognitive-behavioural therapy at a p -value < 0.05, including the following at a p -value ≤ 0.001: the longest dissociative seizure-free period in months 7-12 inclusive post randomisation (incidence rate ratio 1.64, 95% confidence interval 1.22 to 2.20; p  = 0.001); better psychosocial functioning (Work and Social Adjustment Scale, standardised treatment effect -0.39, 95% confidence interval -0.61 to -0.18; p  < 0.001); greater self-rated and clinician-rated clinical improvement (self-rated: standardised treatment effect 0.39, 95% confidence interval 0.16 to 0.62; p  = 0.001; clinician rated: standardised treatment effect 0.37, 95% confidence interval 0.17 to 0.57; p  < 0.001); and satisfaction with treatment (standardised treatment effect 0.50, 95% confidence interval 0.27 to 0.73; p  < 0.001). Rates of adverse events were similar across arms. Cognitive-behavioural therapy plus standardised medical care produced 0.0152 more quality-adjusted life-years (95% confidence interval -0.0106 to 0.0392 quality-adjusted life-years) than standardised medical care alone. The incremental cost-effectiveness ratio (cost per quality-adjusted life-year) for cognitive-behavioural therapy plus standardised medical care versus standardised medical care alone based on the EuroQol-5 Dimensions, five-level version, and imputed data was £120,658. In sensitivity analyses, incremental cost-effectiveness ratios ranged between £85,724 and £206,067. Qualitative and quantitative process evaluations highlighted useful study components, the importance of clinical experience in treating patients with dissociative seizures and potential benefits of our multidisciplinary care pathway.
Limitations: Unlike outcome assessors, participants and clinicians were not blinded to the interventions.
Conclusions: There was no significant additional benefit of dissociative seizure-specific cognitive-behavioural therapy in reducing dissociative seizure frequency, and cost-effectiveness over standardised medical care was low. However, this large, adequately powered, multicentre randomised controlled trial highlights benefits of adjunctive dissociative seizure-specific cognitive-behavioural therapy for several clinical outcomes, with no evidence of greater harm from dissociative seizure-specific cognitive-behavioural therapy.
Future Work: Examination of moderators and mediators of outcome.
Trial Registration: Current Controlled Trials ISRCTN05681227 and ClinicalTrials.gov NCT02325544.
Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 25, No. 43. See the NIHR Journals Library website for further project information.
References: Qual Life Res. 2011 Dec;20(10):1727-36. (PMID: 21479777)
JAMA. 1994 Dec 14;272(22):1749-56. (PMID: 7966923)
Lancet Psychiatry. 2020 Jun;7(6):491-505. (PMID: 32445688)
Arch Intern Med. 2006 May 22;166(10):1092-7. (PMID: 16717171)
Neurol India. 2010 Jan-Feb;58(1):48-52. (PMID: 20228463)
Epilepsy Behav. 2012 Jan;23(1):7-9. (PMID: 22093246)
J Neurol Neurosurg Psychiatry. 2011 Sep;82(9):961-6. (PMID: 21325661)
Seizure. 2004 Mar;13(2):71-5. (PMID: 15129833)
Neurology. 2011 Aug 9;77(6):564-72. (PMID: 21795652)
Br J Psychiatry. 2002 May;180:461-4. (PMID: 11983645)
Med Care. 1996 Mar;34(3):220-33. (PMID: 8628042)
J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57. (PMID: 9881538)
Epilepsia. 2000 Oct;41(10):1330-4. (PMID: 11051130)
Clin Psychol (New York). 2008;15(3):243-253. (PMID: 21369344)
Trials. 2017 Jun 6;18(1):258. (PMID: 28587649)
Epilepsia. 2005 Nov;46(11):1788-95. (PMID: 16302859)
Psychol Med. 2017 May;47(7):1215-1229. (PMID: 28065191)
Seizure. 2008 Jul;17(5):431-6. (PMID: 18282726)
Epilepsy Behav. 2017 Oct;75:143-145. (PMID: 28865250)
Epilepsy Curr. 2015 Nov-Dec;15(6):353-7. (PMID: 26633963)
Front Neurol. 2017 Mar 29;8:106. (PMID: 28424653)
Behav Cogn Psychother. 2016 Sep;44(5):620-4. (PMID: 26898543)
J Neurol Neurosurg Psychiatry. 2004 May;75(5):743-8. (PMID: 15090571)
Epilepsia. 2019 Nov;60(11):2182-2193. (PMID: 31608436)
Seizure. 2004 Apr;13(3):146-55. (PMID: 15010051)
Seizure. 2003 Dec;12(8):568-72. (PMID: 14630495)
Epilepsy Behav. 2014 Apr;33:45-8. (PMID: 24632352)
Cogn Behav Ther. 2011;40(1):15-33. (PMID: 21337212)
Neurology. 2010 Jun 15;74(24):1986-94. (PMID: 20548043)
Health Econ. 2018 Jan;27(1):7-22. (PMID: 28833869)
Epilepsy Behav. 2018 Dec;89:70-78. (PMID: 30384103)
Stat Med. 1991 May;10(5):797-9. (PMID: 2068432)
Epilepsia. 1998 Apr;39(4):432-7. (PMID: 9578034)
Seizure. 2019 Oct;71:8-12. (PMID: 31158560)
Epilepsy Behav. 2016 Oct;63:50-56. (PMID: 27565438)
BMJ. 2008 Sep 29;337:a1655. (PMID: 18824488)
Psychosomatics. 1997 Nov-Dec;38(6):535-42. (PMID: 9427850)
Indian J Psychol Med. 2017 Jul-Aug;39(4):399-406. (PMID: 28852229)
Epilepsy Behav. 2006 May;8(3):451-61. (PMID: 16540377)
Epilepsia. 2007 Nov;48(11):2086-92. (PMID: 17645540)
Dtsch Arztebl Int. 2013 Apr;110(15):263-8. (PMID: 23667393)
Epilepsy Behav. 2004 Dec;5(6):818-25. (PMID: 15582828)
Seizure. 1998 Oct;7(5):385-90. (PMID: 9808114)
Epilepsy Behav. 2017 Aug;73:197-203. (PMID: 28648970)
Epilepsy Res. 1994 May;18(1):75-83. (PMID: 8088259)
Clin Neurol Neurosurg. 2012 Dec;114(10):1304-7. (PMID: 22537871)
Epilepsia. 2013 Nov;54(11):2005-18. (PMID: 24111933)
Epilepsia. 2018 Jun;59(6):1109-1123. (PMID: 29750340)
Behav Cogn Psychother. 2012 Mar;40(2):175-91. (PMID: 21929831)
Qual Life Res. 2009 Aug;18(6):727-35. (PMID: 19424821)
Health Serv Res. 1999 Dec;34(5 Pt 2):1189-208. (PMID: 10591279)
Epilepsy Res. 2002 Feb;48(3):187-97. (PMID: 11904237)
Epilepsia. 1995 Nov;36(11):1131-7. (PMID: 7588458)
Neurology. 1996 Jun;46(6):1499-507. (PMID: 8649537)
Br J Gen Pract. 2019 Apr;69(681):e262-e269. (PMID: 30692089)
Psychosomatics. 2007 May-Jun;48(3):230-8. (PMID: 17478592)
BMJ. 2002 May 18;324(7347):1183. (PMID: 12016181)
Epilepsy Behav. 2011 Aug;21(4):402-6. (PMID: 21752718)
Lancet. 2011 Mar 5;377(9768):823-36. (PMID: 21334061)
Stat Methods Med Res. 2007 Jun;16(3):219-42. (PMID: 17621469)
Seizure. 2010 Jan;19(1):40-6. (PMID: 19963406)
J Neurol Neurosurg Psychiatry. 2006 May;77(5):616-21. (PMID: 16614021)
J Neurol Neurosurg Psychiatry. 2012 Jul;83(7):761-2. (PMID: 22665451)
Trials. 2015 May 03;16:204. (PMID: 25935741)
Qual Life Res. 2006 Jun;15(5):899-914. (PMID: 16721649)
Epilepsy Behav. 2020 Apr;105:106943. (PMID: 32078929)
Epilepsy Behav. 2020 Oct;111:107230. (PMID: 32640411)
J Nerv Ment Dis. 2001 Jan;189(1):38-43. (PMID: 11206663)
Value Health. 2012 Jul-Aug;15(5):708-15. (PMID: 22867780)
J Clin Epidemiol. 2005 Dec;58(12):1217-9. (PMID: 16291464)
J Psychosom Res. 2010 Mar;68(3):285-92. (PMID: 20159215)
Epilepsia. 2016 Feb;57(2):171-81. (PMID: 26701628)
Epilepsia. 2009 Mar;50(3):579-82. (PMID: 19317887)
Clin Psychol Rev. 2016 Jul;47:55-70. (PMID: 27340856)
Epilepsy Behav. 2014 Apr;33:77-86. (PMID: 24632427)
Seizure. 2019 Mar;66:22-25. (PMID: 30772644)
Seizure. 2016 Oct;41:100-11. (PMID: 27522576)
Epilepsy Behav. 2015 Nov;52(Pt A):169-73. (PMID: 26432009)
Health Econ. 2005 May;14(5):487-96. (PMID: 15497198)
Epilepsy Behav. 2014 Feb;31:295-303. (PMID: 24239434)
Cochrane Database Syst Rev. 2014 Nov 07;(11):CD010628. (PMID: 25379990)
Epilepsy Behav. 2015 May;46:60-5. (PMID: 25882323)
Psychosom Med. 2007 Dec;69(9):889-900. (PMID: 18040100)
Epilepsy Behav. 2007 Nov;11(3):409-12. (PMID: 17905668)
Epilepsy Behav. 2004 Aug;5(4):587-92. (PMID: 15256198)
Clin Psychol Rev. 2016 Apr;45:157-82. (PMID: 27084446)
J Neurol Neurosurg Psychiatry. 2015 Mar;86(3):295-301. (PMID: 24935983)
Epilepsy Behav. 2017 Aug;73:273-279. (PMID: 28624511)
Neurology. 1999 Sep 22;53(5):933-8. (PMID: 10496249)
Seizure. 2017 Feb;45:142-150. (PMID: 28063373)
BMJ Open. 2019 May 9;9(5):e026493. (PMID: 31072856)
Epilepsy Behav. 2016 Apr;57(Pt A):23-28. (PMID: 26921594)
Postgrad Med J. 2005 Aug;81(958):498-504. (PMID: 16085740)
Neurology. 2010 Jan 5;74(1):64-9. (PMID: 20038774)
Ann Neurol. 2003 Mar;53(3):305-11. (PMID: 12601698)
Epilepsy Behav. 2019 Jun;95:100-111. (PMID: 31030077)
J Neurol Neurosurg Psychiatry. 2011 Sep;82(9):967-9. (PMID: 21421771)
Epilepsy Behav. 2011 Apr;20(4):668-73. (PMID: 21440511)
Neurology. 2002 Feb 12;58(3):493-5. (PMID: 11839862)
Cochrane Database Syst Rev. 2014 Feb 11;(2):CD006370. (PMID: 24519702)
Psychosomatics. 1998 May-Jun;39(3):263-72. (PMID: 9664773)
Seizure. 2003 Jul;12(5):287-94. (PMID: 12810341)
Epilepsia. 2013 Mar;54 Suppl 1:53-67. (PMID: 23458467)
BMC Neurol. 2015 Jun 27;15:98. (PMID: 26111700)
Epilepsy Behav. 2002 Oct;3(5):455-459. (PMID: 12609268)
Seizure. 2018 Feb;55:93-99. (PMID: 29414141)
Psychosomatics. 2004 Nov-Dec;45(6):492-9. (PMID: 15546826)
Med Care. 2004 Sep;42(9):851-9. (PMID: 15319610)
J Neurol Neurosurg Psychiatry. 1997 Feb;62(2):200. (PMID: 9048729)
Epilepsy Behav. 2016 Oct;63:17-19. (PMID: 27541836)
Epilepsia. 2011 Nov;52(11):2133-8. (PMID: 21955156)
Psychosom Med. 2005 Nov-Dec;67(6):906-15. (PMID: 16314595)
Epilepsia Open. 2017 Jun 23;2(3):307-316. (PMID: 29588959)
Neurology. 2010 Sep 28;75(13):1166-73. (PMID: 20739647)
Epilepsia. 2010 Jan;51(1):70-8. (PMID: 19453708)
JAMA Psychiatry. 2014 Sep;71(9):997-1005. (PMID: 24989152)
Clin Psychol Rev. 2006 Dec;26(8):1020-40. (PMID: 16472897)
Psychosomatics. 2013 Jan-Feb;54(1):28-34. (PMID: 23194931)
BMJ. 2000 Sep 16;321(7262):694-6. (PMID: 10987780)
Lancet Psychiatry. 2018 Apr;5(4):307-320. (PMID: 29526521)
J Neurol. 1990 Feb;237(1):35-8. (PMID: 2319265)
J Affect Disord. 2019 Feb 15;245:98-112. (PMID: 30368076)
Seizure. 1992 Mar;1(1):7-10. (PMID: 1344323)
Seizure. 2000 Jul;9(5):314-22. (PMID: 10933985)
J Neuropsychiatry Clin Neurosci. 1999 Fall;11(4):458-63. (PMID: 10570758)
Cochrane Database Syst Rev. 2014 Nov 01;(11):CD011142. (PMID: 25362239)
Cogn Behav Neurol. 2004 Mar;17(1):41-9. (PMID: 15209224)
J Psychosom Res. 2020 Jul;134:110124. (PMID: 32348898)
Behav Cogn Psychother. 2018 Jan;46(1):84-100. (PMID: 28756794)
Epilepsia. 2014 Jan;55(1):156-66. (PMID: 24446955)
Psychotherapy (Chic). 2009 Mar;46(1):125-38. (PMID: 22122575)
J Gen Intern Med. 2001 Sep;16(9):606-13. (PMID: 11556941)
Epilepsy Behav. 2011 Feb;20(2):308-11. (PMID: 21195031)
Seizure. 2000 Jun;9(4):280-1. (PMID: 10880289)
Epilepsy Res. 1999 Apr;34(2-3):241-9. (PMID: 10210039)
Epilepsia. 2011 Feb;52(2):292-300. (PMID: 21299547)
Psychosom Med. 2007 Dec;69(9):881-8. (PMID: 18040099)
Seizure. 2018 Aug;60:44-56. (PMID: 29906707)
Epilepsia. 2018 Jan;59(1):203-214. (PMID: 29152734)
CNS Spectr. 2016 Jun;21(3):239-46. (PMID: 26996600)
Acta Neurol Scand. 1990 Nov;82(5):335-40. (PMID: 2281751)
Neurology. 2006 Jun 13;66(11):1644-7. (PMID: 16769934)
معلومات مُعتمدة: United Kingdom DH_ Department of Health
فهرسة مساهمة: Keywords: COGNITIVE–BEHAVIOURAL THERAPY; CONVERSION DISORDER; COST–BENEFITS ANALYSIS; DISSOCIATIVE DISORDERS; EPILEPSY; MEDICALLY UNEXPLAINED SYMPTOMS; NEUROLOGY; NEUROPSYCHIATRY; NON-EPILEPTIC SEIZURES; QUALITATIVE RESEARCH; QUALITY OF LIFE; QUALITY-ADJUSTED LIFE-YEARS; RANDOMISED CONTROLLED TRIAL; SEIZURES; THERAPEUTIC ALLIANCE
Local Abstract: [plain-language-summary] Dissociative seizures resemble epileptic seizures or faints, but can be distinguished from them by trained doctors. Dissociation is the medical word for a ‘trance-like’ or ‘switching off’ state. People with dissociative seizures commonly have other psychological or physical problems. Quality of life may be low. The condition accounts for about one in every six patients seen in hospitals because of seizures. We wanted to find out if people with dissociative seizures receiving standardised treatment would also benefit from a talking therapy, called cognitive–behavioural therapy, made specific to this disorder. We did a randomised controlled trial to find out if people with dissociative seizures given standardised treatment and cognitive–behavioural therapy (talking therapy) would do better than those given standardised treatment alone. Standardised treatment of dissociative seizures began with careful diagnosis from a neurologist and then further assessment and treatment from a psychiatrist. In total, 368 people with dissociative seizures participated, with half receiving standardised treatment alone and half having talking therapy plus standardised treatment. We measured seizures and psychological and physical health in both trial groups. We also investigated whether or not cognitive–behavioural therapy was good value for money. After 12 months, patients in both trial groups seemed to have fewer monthly seizures, but there was no advantage in the talking therapy group. Patients in the talking therapy group had more consecutive days without seizures, reporting less impact from them in everyday situations. Patients in the talking therapy group, and their doctors, considered improvements to be better, and patients in this group reported greater satisfaction with treatment. However, the talking therapy was expensive and not as cost-effective as hoped. Interviews with patients and study clinicians showed that they valued aspects of both treatments and of the care provided by the multidisciplinary teams. Overall, cognitive–behavioural therapy designed for dissociative seizures plus standardised treatment was not better at reducing the total numbers of seizures reported, but did produce several positive benefits for participants compared with standardised treatment alone.
سلسلة جزيئية: ISRCTN ISRCTN05681227
ClinicalTrials.gov NCT02325544
تواريخ الأحداث: Date Created: 20210701 Date Completed: 20211025 Latest Revision: 20211025
رمز التحديث: 20221213
مُعرف محوري في PubMed: PMC8273679
DOI: 10.3310/hta25430
PMID: 34196269
قاعدة البيانات: MEDLINE
الوصف
تدمد:2046-4924
DOI:10.3310/hta25430