Method of levels therapy for first-episode psychosis: rationale, design and baseline data for the feasibility randomised controlled Next Level study

Robert Griffiths, Warren Mansell, Timothy A Carey, Dawn Edge, Richard Emsley, Sara J Tai, Robert Griffiths, Warren Mansell, Timothy A Carey, Dawn Edge, Richard Emsley, Sara J Tai

Abstract

Background: Method of levels (MOL) is an innovative transdiagnostic cognitive therapy with potential advantages over existing psychological treatments for psychosis.

Aims: The Next Level study is a feasibility randomised controlled trial (RCT) of MOL for people experiencing first-episode psychosis. It aims to determine the suitability of MOL for further testing in a definitive trial (trial registration ISRCTN13359355).

Method: The study uses a parallel group non-masked feasibilityRCT design with two conditions: (a) treatment as usual (TAU) and (b) TAU plus MOL. Participants (n = 36) were recruited from early intervention in psychosis services. Outcome measures are completed at baseline, 10 and 14 months. The primary outcomes are recruitment and retention.

Results: Participants' demographic and clinical characteristics are presented along with baseline data.

Conclusions: Next Level has recruited to target, providing evidence that it is feasible to recruit to a RCT of MOL for first-episode psychosis.

Declaration of interest: None.

Keywords: Method of Levels; feasibility; first-episode psychosis; randomised controlled trial.

Figures

Fig. 1
Fig. 1
CONSORT diagram. TAU, treatment as usual; MOL, method of levels. a. n for follow-up and analysis not yet available.

References

    1. National Institute for Health and Care Excellence. Psychosis and Schizophrenia in Adults: Treatment and Management NICE, 2014.
    1. National Institute for Health and Care Excellence. Surveillance Report 2016–Psychosis and Schizophrenia in Children and Young People: Recognition and Management NICE Guideline CG155 (2013) NICE, 2016.
    1. Jauhar S, McKenna PJ, Radua J, Fung E, Salvador R, Laws KR. Cognitive-behavioural therapy for the symptoms of schizophrenia: systematic review and meta-analysis with examination of potential bias. Br J Psychiatry 2014; 204: 20–9.
    1. Turner DT, van der Gaag M, Karyotaki E, Cuijpers P. Psychological interventions for psychosis: a meta-analysis of comparative outcome studies. Am J Psychiatry 2014; 171: 523–38.
    1. Wykes T, Steel C, Everitt B, Tarrier N. Cognitive behavior therapy for schizophrenia: effect sizes, clinical models, and methodological rigor. Schizophr Bull 2008; 34: 523–37.
    1. Berry K, Haddock G. The implementation of the NICE guidelines for schizophrenia: barriers to the implementation of psychological interventions and recommendations for the future. Psychol Psychother 2008; 81: 419–36.
    1. Ince P, Haddock G, Tai S. A systematic review of the implementation of recommended psychological interventions for schizophrenia: rates, barriers, and improvement strategies. Psychol Psychother Theory Res Pract 2016; 89: 324–50.
    1. Prytys M, Garety PA, Jolley S, Onwumere J, Craig T. Implementing the NICE guideline for schizophrenia recommendations for psychological therapies: a qualitative analysis of the attitudes of CMHT staff. Clin Psychol Psychother 2011; 18: 48–59.
    1. Royal College of Psychiatrists, Healthcare Quality Improvement Partnership, NHS England. Report of the Early Intervention in Psychosis Audit HQIP and the Royal College of Psychiatrists, 2016.
    1. Kilbride M, Byrne R, Price J, Wood L, Barratt S, Welford M, et al. Exploring service users’ perceptions of cognitive behavioural therapy for psychosis: a user led study. Behav Cogn Psychother 2013; 41: 89–102.
    1. Wood L, Burke E, Morrison A. Individual cognitive behavioural therapy for psychosis (CBTp): a systematic review of qualitative literature. Behav Cogn Psychother 2015; 43: 285–97.
    1. Achim AM, Maziade M, Raymond R, Olivier D, Mérette C, Roy M-A. How prevalent are anxiety disorders in schizophrenia? A meta-analysis and critical review on a significant association. Schizophr Bull 2011; 37: 811–21.
    1. Addington D, Addington J, Patten S. Depression in people with first-episode schizophrenia. Br J Psychiatry 1998; 172 (suppl 33): 90–2.
    1. Barrowclough C, Haddock G, Wykes T, Beardmore R, Conrod P, Craig T, et al. Integrated motivational interviewing and cognitive behavioural therapy for people with psychosis and comorbid substance misuse: randomised controlled trial. BMJ 2010; 341: 1–12.
    1. Braga RJ, Reynolds GP, Siris SG. Anxiety comorbidity in schizophrenia. Psychiatry Res 2013; 210: 1–7.
    1. Buckley PF, Miller BJ, Lehrer DS, Castle DJ. Psychiatric comorbidities and schizophrenia. Schizophr Bull 2009; 35: 383–402.
    1. Morrison AP. A manualised treatment protocol to guide delivery of evidence-based cognitive therapy for people with distressing psychosis: learning from clinical trials. Psychosis 2017; 9: 271–81.
    1. Harvey AH, Watkins E, Mansell W, Shafran R. Cognitive Behavioural Processes Across Psychological Disorders: A Transdiagnostic Perspective to Research and Treatment. Oxford University Press, 2004.
    1. Mansell W, Harvey A, Watkins ER, Shafran R. Cognitive behavioral processes across psychological disorders: a review of the utility and validity of the transdiagnostic approach. Int J Cogn Ther 2008; 1: 181–91.
    1. Carey TA, Tai SJ, Stiles WB. Effective and efficient: using patient-led appointment scheduling in routine mental health practice in remote Australia. Prof Psychol Res Pract 2013; 44: 405–14.
    1. Tai SJ. Using perceptual control theory and the method of levels to work with people who experience psychosis. Cogn Behav Ther 2009; 2: 227.
    1. Tai SJ. An introduction to using the method of levels (MOL) therapy to work with people experiencing psychosis. Am J Psychother 2016; 70: 125–48.
    1. Waller H, Emsley R, Freeman D, Bebbington P, Dunn G, Fowler D, et al. Thinking well: a randomised controlled feasibility study of a new CBT. J Behav Ther Exp Psychiatry 2015; 48: 82–9.
    1. Freeman D, Dunn G, Startup H, Pugh K, Cordwell J, Mander H, et al. Effects of cognitive behaviour therapy for worry on persecutory delusions in patients with psychosis (WIT): a parallel, single-blind, randomised controlled trial with a mediation analysis. Lancet Psychiatry 2015; 2: 305–13.
    1. Carey TA. The Method of Levels: How to do Psychotherapy Without Getting in the Way. Living Control Systems Publishing, 2006.
    1. Carey TA, Mansell W, Tai SJ. Principles-Based Counselling and Psychotherapy: A Method of Levels Approach. Routledge, 2015.
    1. Mansell W, Carey TA, Tai S. A Transdiagnostic Approach to CBT Using Method of Levels Therapy: Distinctive Features. Routledge, 2013.
    1. Craig P, Dieppe P, Macintyre S, Mitchie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ 2008; 337: 979–83.
    1. Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat 2005; 4: 287–91.
    1. Ashworth M, Shepherd M, Christey J, Matthews V, Wright K, Parmentier H, et al. A client-generated psychometric instrument: the development of ‘PSYCHLOPS’. Couns Psychother Res 2004; 4: 27–31.
    1. Czachowski S, Seed P, Schofield P, Ashworth M. Measuring psychological change during cognitive behaviour therapy in primary care: a Polish study using “PSYCHLOPS” (Psychological Outcome Profiles). PLoS ONE 2011; 6: e27378.
    1. Evans C, Connell J, Barkham M, Margison F, McGrath G, Mellor-Clark J, et al. Towards a standardised brief outcome measure: psychometric properties and utility of the CORE-OM. Br J Psychiatry 2002; 180: 51–60.
    1. Higginson S, Mansell W. What is the mechanism of psychological change? A qualitative analysis of six individuals who experienced personal change and recovery. Psychol Psychother Theory, Res Pract 2008; 81: 309–28.
    1. Bird T. An Investigation of Transdiagnostic Processes and Interventions in Clinical and Non-Clinical Settings (unpublished doctoral thesis). University of Manchester, 2013.
    1. Neil ST, Kilbride M, Pitt L, Nothard S, Welford M, Sellwood W, et al. The questionnaire about the process of recovery (QPR): a measurement tool developed in collaboration with service users. Psychosis 2009; 1: 145–55.
    1. Miller SD, Duncan BL, Brown J, Sparks JA, Claud DA. The Outcome Rating Scale: a preliminary study of the reliability, validity, and feasibility of a brief visual analog measure. J Br Ther 2003; 2: 91–100.
    1. Duncan BL, Miller SD, Sparks JA, Claud DA, Reynolds LR, Brown J, et al. The session rating scale: preliminary psychometric properties of a ‘working’ alliance measure. J Br Ther 2003; 3: 3–12.
    1. Alsawy S, Mansell W, Carey TA, McEvoy P, Tai SJ. Science and practice of transdiagnostic CBT: a perceptual control theory (PCT) approach. Int J Cogn Ther 2014; 7: 334–59.
    1. Marken RS, Mansell W. Perceptual control as a unifying concept in psychology. Rev Gen Psychol 2013; 17: 190–5.
    1. Carey TA. Patient-Perspective Care: A New Paradigm for Health Systems and Services. Routledge, 2018.
    1. Carey TA, Tai SJ. MOL session evaluation In Transdiagnostic Approach to CBT Using Method of Levels Therapy: Distinctive Features (eds Mansell W, Carey TA, Tai SJ): 139–41. Routledge, 2012.
    1. Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ 2016; 355: i5239.
    1. Szymczynska P, Walsh S, Greenberg L, Priebe S. Attrition in trials evaluating complex interventions for schizophrenia: systematic review and meta-analysis. J Psychiatr Res 2017; 90: 67–77.
    1. Teare M, Dimairo M, Shephard N, Hayman A, Whitehead A, Walters SJ. Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study. Trials 2014; 15: 264.
    1. Marshall M, Lewis S, Lockwood A, Drake R, Jones P, Croudace T. Association between duration of untreated psychosis and outcome in cohorts of first-episode patients a systematic review. Arch Gen Psychiatry 2005; 62: 975–83.
    1. McGorry PD, Killackey E, Yung A. Early intervention in psychosis: concepts, evidence and future directions. World Psychiatry 2008; 7: 148–56.
    1. Mainous AG III, Smith DW, Geesey ME, Tilley BC. Factors influencing physician-referrals of patients to clinical trials. J Natl Med Assoc 2008; 100: 1298–303.
    1. Greenwood KE, Sweeney A, Williams S, Garety P, Kuipers E, Scott J, et al. 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: 126–35.
    1. Birchwood M, Trower P. The future of cognitive behavioural therapy for psychosis: not a quasi-neuroleptic for psychosis. Br J Psychiatry 2006; 188: 107–8.
    1. Chadwick P. Person-Based Cognitive Therapy for Distressing Psychosis. John Wiley & Sons, 2006.

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