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A new generation of pragmatic trials of psychosocial interventions is needed

  • M. Ruggeri (a1), A. Lasalvia (a1) and C. Bonetto (a1)
  • DOI: http://dx.doi.org/10.1017/S2045796013000127
  • Published online: 20 March 2013
Abstract

This Editorial addresses the crucial issue of which research methodology is most suited for capturing the complexity of psychosocial interventions conducted in ‘real world’ mental health settings. It first examines conventional randomized controlled trial (RCT) methodology and critically appraises its strengths and weaknesses. It then considers the specificity of mental health care treatments and defines the term ‘complex’ intervention and its implications for RCT design. The salient features of pragmatic RCTs aimed at generating evidence of psychosocial intervention effectiveness are then described. Subsequently, the conceptualization of pragmatic RCTs, and of their further developments – which we propose to call ‘new generation’ pragmatic trials – in the broader routine mental health service context, is explored. Helpful tools for planning pragmatic RCTs, such as the CONSORT extension for pragmatic trials, and the PRECIS tool are also examined. We then discuss some practical challenges that are involved in the design and implementation of pragmatic trials based on our own experience in conducting the GET UP PIANO Trial. Lastly, we speculate on the ways in which current ideas on the purpose, scope and ethics of mental health care research may determine further challenges for clinical research and evidence-based practice.

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Corresponding author
*Address for correspondence: Professor M. Ruggeri, Department of Public Health and Community Medicine, Section of Psychiatry, University of Verona, Policlinico G.B. Rossi, Piazzale L.A. Scuro 10, 37134 Verona, Italy. (Email: mirella.ruggeri@univr.it)
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This list contains references from the content that can be linked to their source. For a full set of references and notes please see the PDF or HTML where available.

T Becker , B Pushner (2013). Complex interventions in mental health services research: potential, limitations and challenges. In Improving Mental Health Care: the Global Challenge (eds. G. Thornicroft, M. Ruggeri and D. Goldberg), John Wiley: Chichester.

L Bird , A Arthur , K Cox (2011). Did the trial kill the intervention? Experiences from the development, implementation and evaluation of a complex intervention. BMC Medical Research Methodology 11, 24.

IM Blackburn , IA James , DL Milne , C Baker , S Standart , A Garland , FK Reichelt (2001). The Revised Cognitive therapy scale (CTS-R). Psychometric properties. Behavioural and Cognitive Psychotherapy 29, 431446.

I Boutron , D Moher , DG Altman , KF Schulz , P Ravaud (2008 a). Extending the CONSORT Statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Annals of Internal Medicine 148, 295309.

I Boutron , D Moher , DG Altman , KF Schulz , P Ravaud (2008 b). Methods and processes of the CONSORT group: example of an extension for trials assessing nonpharmacologic treatments. Annals of Internal Medicine 148, W6066.

M Campbell , R Fitzpatrick , A Haines , AL Kinmonth , P Sandercock , D Spiegelhalter , P Tyrer (2000). Framework for design and evaluation of complex interventions to improve health. British Medical Journal 321, 694696.

MK Campbell , G Piaggio , DR Elbourne , DG Altman , for the CONSORT Group (2012). CONSORT 2010 statement: extension to cluster randomised trials. British Medical Journal 345, e5661.

NC Campbell , E Murray , J Darbyshire , J Emery , A Farmer , F Griffiths , B Guthrie , H Lester , P Wilson , AL Kinmonth (2007). Designing and evaluating complex interventions to improve health care. British Medical Journal 334, 455459.

B Candy , M King , L Jones , S Oliver (2011). Using qualitative synthesis to explore heterogeneity of complex interventions. BMC Medical Research Methodology 11, 124132.

SV Catts , BI O'Toole , VJ Carr , T Lewin , A Neil , MG Harris , AD Frost , BR Crissman , K Eadie , RW Evans (2010). Appraising evidence for intervention effectiveness in early psychosis: conceptual framework and review of evaluation approaches. Australian and New Zealand Journal of Psychiatry 44, 195219.

DL Chambless , SD Hollon (1998). Defining empirically supported therapies. Journal of Consulting and Clinical Psychology 66, 718.

R Drake , G Haddock , N Tarrier , R Bentall , S Lewis (2007). The psychotic symptom rating scales (PSYRATS): their usefulness and properties in first episode psychosis. Schizophrenia Research 89, 119122.

G Dunn (2013). Pragmatic trials of complex psychosocial interventions: methodological challenges. Epidemiology and Psychiatic Sciences, this issue.

L Goldbeck , B Vitiello (2011). Reporting clinical trials of psychosocial interventions in child and adolescent psychiatry and mental health. Child and Adolescent Psychiatry and Mental Health 5, 4.

J Green (2006). The evolving randomised controlled trial in mental health: studying complexity and treatment process. Advances in Psychiatric Treatment 12, 268279.

J Green , G Dunn (2008). Using intervention trials in developmental psychiatry to illuminate basic science. British Journal of Psychiatry 192, 323325.

P Hawe , A Shiell , T Riley (2004). Complex interventions: how “out of control” can a randomised controlled trial be? British Medical Journal 328, 15611563.

M Hotopf , R Churchill , G Lewis (1999). Pragmatic randomised controlled trials in psychiatry. British Journal of Psychiatry 175, 217223.

MA Hussey , JP Hughes (2007). Design and analysis of stepped wedge cluster randomized trials. Contemporary Clinical Trials 28, 182191.

SR Kay , A Fiszbein , LA Opler (1987). The positive and negative syndrome scale for schizophrenia. Schizophrenia Bulletin 13, 261276.

DM Kent , A Alsheikh-Ali , RA Hayward (2008). Competing risk and heterogeneity of treatment effect in clinical trials. Trials 9, 3035.

HC Kraemer (2013). Discovering, comparing, and combining moderators of treatment on outcome after randomized clinical trials: a parametric approach. Statistics in Medicine Jan 10. doi: 10.1002/sim.5734. [Epub ahead of print].

HC Kraemer , E Stice , A Kazdin , D Offord , D Kupfer (2001). How do risk factors work together? Mediators, moderators, and independent, overlapping, and proxy risk factors. American Journal Psychiatry 158, 848856.

J Mahon , A Laupacis , A Donner , T Wood (1996). Randomised study of n of 1 trials versus standard practice. British Medical Journal 312, 10691074.

S Melfsen , M Kuehnemund , J Schwieger , A Warnke , C Stadler , F Poustka , U Stangier (2011). Cognitive behavioral therapy of socially phobic children focusing on cognition: a randomised wait-list control study. Child and Adolescent Psychiatry and Mental Health 5, 5.

DC Mohr , B Spring , KE Freedland , V Beckner , P Arean , SD Hollon , J Ockene , R Kaplan (2009). The selection and design of control conditions for randomized controlled trials of psychological interventions. Psychotherapy and Psychosomatics 78, 275284.

BK Nastasi , J Hitchcock (2009). Challenges of evaluating multilevel interventions. American Journal of Community Psychology 43, 360376.

PP Roy-Byrne , CD Sherbourne , MG Craske , MB Stein , W Katon , G Sullivan , A Means-Christensen , A Bystritsky (2003). Moving treatment research from clinical trials to the real world. Psychiatric Services 54, 327332.

M Ruggeri , C Bonetto , A Lasalvia , G De Girolamo , A Fioritti , P Rucci , P Santonastaso , G Neri , F Pileggi , D Ghigi , M Miceli , S Scarone , A Cocchi , S Torresani , C Faravelli , C Zimmermann , A Meneghelli , C Cremonese , P Scocco , E Leuci , F Mazzi , M Gennarelli , P Brambilla , S Bissoli , ME Bertani , S Tosato , K De Santi , S Poli , D Cristofalo , M Tansella (2012). A multi-element psychosocial intervention for early psychosis (GET UP PIANO TRIAL) conducted in a catchment area of 10 million inhabitants: study protocol for a pragmatic cluster randomized controlled trial. Trials 13, 73.

E Salmoirago-Blotcher , IS Ockene (2009). Methodological limitations of psychosocial interventions in patients with an implantable cardioverter-defibrillator (ICD): a systematic review. BMC Cardiovascular Disorders 9, 56.

D Schwartz , J Lellouch (1967). Explanatory and pragmatic attitudes in therapeutical trials. Journal of Chronic Disease 20, 637648.

M Slade , S Priebe (2001). Are randomised controlled trials the only gold that glitters? British Journal of Psychiatry 179, 286287.

G Thornicroft , T Wykes , F Holloway , S Johnson , G Szmukler (1998). From efficacy to effectiveness in community mental health services. PRiSM Psychosis Study 10. British Journal of Psychiatry 173, 423427.

KE Thorpe , M Zwarenstein , AD Oxman , S Treweek , CD Furberg , DG Altman , S Tunis , E Bergel , I Harvey , DJ Magid , K Chalkidou (2009). A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. Journal of Clinical Epidemiology 62, 464475.

D Torgerson , B Sibbald (1998). Understanding controlled trials: what is a patient preference trial?. British Medical Journal 316, 360.

M Zelen (2006). Randomized consent designs for clinical trials: an update. Statistics in Medicine 9, 645656.

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