Pragmatic randomised controlled trials in psychiatry

A rating scale for depression

Hamilton, M. (1960) · Journal of Neurology, Neurosurgery & Psychiatry · doi:10.1136/jnnp.23.1.56 · Cited by 32,817

Analysis of longitudinal data

Everitt, B. (1998) · British Journal of Psychiatry · doi:10.1192/bjp.172.1.7 · Cited by 4,331

Improving the Quality of Reporting of Randomized Controlled Trials: The CONSORT Statement

Begg, C. (1996) · JAMA · doi:10.1001/jama.1996.03540080059030 · Cited by 3,127

The number needed to treat: a clinically useful measure of treatment effect

Cook, R. J., & Sackett, D. L. (1995) · BMJ · doi:10.1136/bmj.310.6977.452 · Cited by 1,885

Why we need observational studies to evaluate the effectiveness of health care

Black, N. (1996) · BMJ · doi:10.1136/bmj.312.7040.1215 · Cited by 1,598

Explanatory and Pragmatic Attitudes in Therapeutical Trials

Schwartz, D., & Lellouch, J. (2009) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2009.01.012 · Cited by 1,253

Explanatory and pragmatic attitudes in therapeutical trials

Schwartz, D., & Lellouch, J. (1967) · Journal of Chronic Diseases · doi:10.1016/0021-9681(67)90041-0 · Cited by 1,185

Confidence intervals for the number needed to treat.

Altman, D. G. (1998) · BMJ · doi:10.1136/bmj.317.7168.1309 · Cited by 938

The Efficacy and Safety of Donepezil in Patients with Alzheimer's Disease: Results of a US Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial

Rogers, S. L., & Friedhoff, L. T. (1996) · Dementia and Geriatric Cognitive Disorders · doi:10.1159/000106895 · Cited by 743

Costing psychiatric interventions.

Beecham, J. K., & Knapp, M. R. J. (1992) · Kent Academic Repository (University of Kent) · Cited by 710

A feasibility study for a pragmatic randomised controlled trial comparing cast immobilisation versus no immobilisation for patients following first-time patellar dislocation

Armstrong, B. M., Hall, M. C., Crawfurd, E., & Smith, T. O. (2011) · The Knee · doi:10.1016/j.knee.2011.08.004 · Cited by 17

Are trials of psychological and psychosocial interventions for schizophrenia and psychosis included in the NICE guidelines pragmatic? A systematic review

Gastaldon, C., Mosler, F., Toner, S. K., Tedeschi, F., Bird, V., Barbui, C., & Priebe, S. (2019) · PLoS ONE · doi:10.1371/journal.pone.0222891 · Cited by 16

Face-to-Face and Telephone Counseling for Problem Gambling

Tse, S. S.-K., Campbell, L., Rossen, F. V., Wang, C., Jull, A., Yan, E., & Jackson, A. C. (2012) · Research on Social Work Practice · doi:10.1177/1049731512466150 · Cited by 15

Trial of risperidone in India – concerns

Srinivasan, S., Pai, S., Bhan, A., Jesani, A., & Thomas, G. (2006) · The British Journal of Psychiatry · doi:10.1192/bjp.188.5.489 · Cited by 14

Total Sleep Deprivation Followed by Bright Light Therapy as Rapid Relief for Depression: A Pragmatic Randomized Controlled Trial

Ioannou, M., Szabó, Z., Widmark-Jensen, M., Vyrinis, G., Karlsson, C., & Steingrimsson, S. (2021) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2021.705090 · Cited by 13

Schemazentrierte emotiv-behaviorale Therapie (SET): Eine randomisierte Evaluationsstudie an Patienten mit Persönlichkeitsstörungen aus den Clustern B und C

Zorn, P., Roder, V., Müller, D., Tschacher, W., & Thommen, M. (2007) · Verhaltenstherapie · doi:10.1159/000110129 · Cited by 13

Conducting research in everyday psychiatric settings: identifying the challenges to meaningful evaluation

Oestrich, I. H., Austin, S. F., & Tarrier, N. (2007) · Journal of Psychiatric and Mental Health Nursing · doi:10.1111/j.1365-2850.2007.01043.x · Cited by 13

Treating Gulf War Veterans' Illnesses—Are More Focused Studies Needed?

Hotopf, M. H. (2003) · JAMA · doi:10.1001/jama.289.11.1436 · Cited by 13

An evaluation of time‐limited psychodynamic psychotherapy for couples: A pilot study

Balfour, A., & Lanman, M. (2011) · Psychology and Psychotherapy Theory Research and Practice · doi:10.1111/j.2044-8341.2011.02030.x · Cited by 12

Determinants of first- and second-generation antipsychotic drug use in clinically unstable patients with schizophrenia treated in four European countries

Barbui, C., Nosè, M., Mazzi, M. A., Bindman, J. P., Leese, M., Schene, A. H., Becker, T. M., Angermeyer, M. C., Koeter, M. W. J., Gray, R. J., et al. (2006) · International Clinical Psychopharmacology · doi:10.1097/01.yic.0000185022.48279.db · Cited by 12

Drug treatments for schizophrenia: pragmatism in trial design shows lack of progress in drug design

Cheng, F., & Jones, P. B. (2013) · Epidemiology and Psychiatric Sciences · doi:10.1017/s204579601200073x · Cited by 11

An Economic Evaluation of Coordinated Specialty Care (CSC) Services for First-Episode Psychosis in the U.S. Public Sector.

Murphy, S. M., Küçükgöncü, S., Bao, Y., Li, F., Tek, C., Breitborde, N. J. K., Gülöksüz, S., Phutane, V. H., Özkan, B., Pollard, J., et al. (2018) · PubMed · Cited by 11

Validation of the Longitudinal Interval Follow-Up Evaluation for the Long-Term Measurement of Mood Symptoms in Bipolar Disorder

Porter, R., Moot, W., Inder, M., Crowe, M., Douglas, K. M., Carter, J. D., & FRAMPTON, C. M. A. (2022) · Brain Sciences · doi:10.3390/brainsci12121717 · Cited by 10

Is Mental Health Services Research in Need of Randomised Controlled Trials?

Kallert, T. W. (2005) · Psychiatrische Praxis · doi:10.1055/s-2005-866911 · Cited by 10

Pathway Evidence of How Musical Perception Predicts Word-Level Reading Ability in Children with Reading Difficulties

Cogo‐Moreira, H., de Ávila, C. R. B., Ploubidis, G. B., & Mari, J. D. J. (2013) · PLoS ONE · doi:10.1371/journal.pone.0084375 · Cited by 10

Five Burning Questions

ZITO, J. M. (2002) · Journal of Developmental & Behavioral Pediatrics · doi:10.1097/00004703-200202001-00005 · Cited by 9

Development of a registry for monitoring psychotropic drug prescriptions: aims, methods and implications for ordinary practice and research

Barbui, C., Nosè, M., Rambaldelli, G., Bonetto, C., Levi, D., Patten, S. B., Tansella, M., & Psychotropic Drug Registry Study Group (2005) · International Journal of Methods in Psychiatric Research · doi:10.1002/mpr.1 · Cited by 9

Do findings from new trials for schizophrenia fit with existing evidence: not duped … just beguiled?

Adams, C. E., & Jayaram, M. (2007) · Epidemiologia e Psichiatria Sociale · doi:10.1017/s1121189x00002281 · Cited by 9

Epidemiology in community psychiatric research: common uses and methodological issues

Skapinakis, P., & Lewis, G. (2001) · Epidemiologia e Psichiatria Sociale · doi:10.1017/s1121189x00008502 · Cited by 8

Review: Comparing drug treatments in epilepsy

Chadwick, D. W., Shukralla, A. A., & Marson, A. G. (2009) · Therapeutic Advances in Neurological Disorders · doi:10.1177/1756285609102327 · Cited by 8

Clinical databases of patients receiving antidepressants

Barbui, C., Tognoni, G., & Garattini, S. K. (2002) · Journal of Affective Disorders · doi:10.1016/s0165-0327(00)00370-0 · Cited by 8

Can current electronic systems meet drug safety and effectiveness requirements?

Holbrook, A. M., Grootendorst, P. V., Willison, D., Goldsmith, C. H., Sebaldt, R. J., & Keshavjee, K. (2005) · PubMed Central · Cited by 8

Implementation of guidelines on Family Involvement for persons with Psychotic disorders: a pragmatic cluster randomized trial. Effect on relatives’ outcomes and family interventions received

Norheim, I., Pedersen, R., Selle, M. L., Røssberg, J. I., Hestmark, L., Heiervang, K. S., Ruud, T., Åsholt, V. M., Hansson, K. M., Møller, P., et al. (2024) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2024.1381007 · Cited by 7

Uso del índice de cambio fiable en la evaluación de la efectividad de intervenciones clínicas: aplicación en un programa formativo en asma

Montero, M., Castillo, I. I., Matellanes, B., & Montero, J. M. (2015) · Atención Primaria · doi:10.1016/j.aprim.2014.12.007 · Cited by 7

Research Methodology Evaluating Complementary and Alternative Therapies

Tamayo, C., Boon, H. S., Ghishan, F. K., & Trinh, K. (2002) · Drug Information Journal · doi:10.1177/009286150203600308 · Cited by 6

Repetitive transcranial magnetic stimulation for the treatment of major depressive disorder: an evidence-based analysis.

(2004) · Europe PMC (PubMed Central) · Cited by 7

Patients’ preferences and counselling for depression in primary care

Lam, R. W. (2001) · The Lancet · doi:10.1016/s0140-6736(00)04076-9 · Cited by 6

Practical Clinical Trials in Psychopharmacology

Vitiello, B. (2015) · Journal of Clinical Psychopharmacology · doi:10.1097/jcp.0000000000000295 · Cited by 6

The role of acute day hospital treatment for mental health care: Research context and practical problems of carrying out the international multi-centre EDEN-study

EDEN-study group, Kallert, T. W., Priebe, S., Schützwohl, M., Briscoe, J., & Glöckner, M. (2004) · Springer eBooks · doi:10.1007/978-3-642-18826-8_18 · Cited by 6

Associations of Clozapine Use With Psychosocial Functioning and Quality of Life in Patients With Schizophrenia: A Community-Based Cross-Sectional Study

Kim, S., Kim, S., Choe, A. Y., & Kim, E. (2021) · Psychiatry Investigation · doi:10.30773/pi.2021.0190 · Cited by 5

When, Why, and How to Conduct Research in Child and Adolescent Psychiatry: Practical and Ethical Considerations

Chen, D. T., & Shepherd, L. L. (2009) · Psychiatric Clinics of North America · doi:10.1016/j.psc.2009.03.003 · Cited by 5

What is the “best intro”—explanatory versus pragmatic antipsychotic drug trials

Leucht, S., & Davis, J. M. (2020) · The Lancet Psychiatry · doi:10.1016/s2215-0366(20)30436-3 · Cited by 6

Schizophrenia trials: past, present and future

Adams, C. E. (2002) · Epidemiologia e Psichiatria Sociale · doi:10.1017/s1121189x00005649 · Cited by 5

Occupational therapy and psychosis: POINTER feasibility study for a pragmatic clinical trial

Inman, J., Bannigan, K., & Akhurst, J. (2021) · British Journal of Occupational Therapy · doi:10.1177/03080226211000257 · Cited by 4

Consequences of randomized clinical trial design decisions need to be clarified

Riddle, D. L. (2016) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2016.02.028 · Cited by 4

Antidepressant treatment in children and adolescents: Bridging the gap between efficacy and effectiveness

ZITO, J. M., & Safer, D. J. (2001) · Current Psychiatry Reports · doi:10.1007/s11920-001-0008-z · Cited by 4

Study design and protocol development process

Stroup, T. S., McEvoy, J. P., & Lieberman, J. A. (2010) · Cambridge University Press eBooks · doi:10.1017/cbo9780511712265.002 · Cited by 3

The GiSAS study: Rationale and design of a pragmatic randomized controlled trial on aripiprazole, olanzapine and haloperidol in the long-term treatment of schizophrenia

Parabiaghi, A., D’Avanzo, B., Tettamanti, M., & Barbato, A. (2011) · Contemporary Clinical Trials · doi:10.1016/j.cct.2011.04.008 · Cited by 3

Invited commentary on: Treatment interventions and findings from research: bridging the chasm in child psychiatry

Harrington, R. (2000) · The British Journal of Psychiatry · doi:10.1192/bjp.176.5.420 · Cited by 3

Neurobehavioural characteristics and relapse in addiction

Bowden‐Jones, H., McPhillips, M. A., & Joyce, E. M. (2006) · The British Journal of Psychiatry · doi:10.1192/bjp.188.5.494 · Cited by 3

Midazolam sedates agitated patients more rapidly than haloperidol-promethazine

Waraich, P. S. (2004) · Evidence-Based Mental Health · doi:10.1136/ebmh.7.2.42 · Cited by 2

Limitations to Evidence‐Based Practice

Maier, T. (2012) · doi:10.1002/9781118156391.ebcp002004 · Cited by 2

Epiduroscopy and Epidural Steroid Injections

Merrill, D. G., Rathmell, J. P., & Rosenquist, R. W. (2008) · Anesthesiology · doi:10.1097/aln.0b013e3181649dd1 · Cited by 2

Evaluating the Evidence Base of Consultation-Liaison Psychiatry

Sensky, T. (2007) · Springer eBooks · doi:10.1007/978-0-387-69255-5_4 · Cited by 2

Pilot of Dialectical Behavior Therapy (DBT) skills training for people with psychosis spectrum conditions and high risk of suicide

Phalen, P. L., Lucksted, A. A., Fox, K., Yusuf, A., Hochheiser, J., Jones, N., Фетисова, А. С., Hackman, A. L., & Bennett, M. E. (2025) · Psychosis · doi:10.1080/17522439.2025.2570374 · Cited by 1

Effectiveness of implementing family involvement on patient outcomes in individuals with psychotic disorders: a pragmatic cluster randomised controlled trial

Norheim, I., Pedersen, R., Selle, M. L., Røssberg, J. I., Hestmark, L., Heiervang, K. S., Ruud, T., Åsholt, V. M., Hansson, K. M., Møller, P., et al. (2025) · BMC Psychiatry · doi:10.1186/s12888-025-07501-z · Cited by 2

Pragmatic Trials; the Mutual Shaping of Research and Primary Health Care Practice

Bal, R. A., Bont, A. A. D., Foets, M., & Jansen, Y. J. F. M. (2006) · Cited by 1

Clinical Epidemiology

Kirkbride, J. B., & Jeffery, A. (2024) · Cambridge University Press eBooks · doi:10.1017/9781911623861.002 · Cited by 1

Neurochemical regulation of auditory information processing studied with EEG/MEG: application to schizophrenia

Korostenskaja, M. (2008) · Työväentutkimus Vuosikirja

De rol van ‘informed consent’ in placebo-gecontroleerde, dubbelblinde, gerandomiseerde onderzoeken naar de effectiviteit van psychofarmaca

van den Burg, W. (2001) · Directieve therapie · doi:10.1007/bf03060270

Explanatory versus Pragmatic Trials? The Methods Make the Difference

Myles, P. S., Leslie, K., Chan, M. T. V., Forbes, A. B., Paech, M. J., Peyton, P. J., SILBERT, B. S., & Pascoe, E. M. (2008) · Anesthesiology · doi:10.1097/aln.0b013e3181654728

The impact of participation in research on practitioners: a qualitative study among practitioners who delivered interventions in the Helping Children Achieve study

Marlow, R., Hunt, W. T., Reville, M.-C., Lynes, A., Lowe, J., & Ford, T. J. (2013) · Journal of Children s Services · doi:10.1108/jcs-09-2012-0007

Can Quality of Life be Improved in Schizophrenia? Results From A Pragmatic, Randomized, Controlled Trial Comparing Olanzapine with First Generation Antipsychotics

de Lima, M. S., Breier, A. F., & Mari, J. D. J. (2007) · Progress in Neurotherapeutics and Neuropsychopharmacology · doi:10.1017/s1748232106000176

Good results in psychiatric health care and factors affecting them in Finland and in Greece

Tiri, H. (2005)

Conclusions

Bower, P., & Gilbody, S. M. (2010) · Cambridge University Press eBooks · doi:10.1017/cbo9780511861147.014

extension of the CONSORT statement Improving the reporting of pragmatic trials: an

Tunis, S., Haynes, B. R., Oxman, A. D., Moher, D., Treweek, S. P., & Gagnier, J. J. (2009)

Study Design, Statistical Inference and Literature Search in Surgical Research

Skapinakis, P., & Athanasiou, T. (2010) · Springer eBooks · doi:10.1007/978-3-540-71915-1_4 · Cited by 1

Shorter time interval treatments for early medical abortions : a mixed methods research approach

Madari, S. (2017) · University of Birmingham Institutional Research Archive (University of Birmingham)

¿Qué pruebas hay sobre la eficacia de los tratamientos en los trastornos somatomorfos?

Sumathipala, A. (2010) · Elsevier eBooks · doi:10.1016/b978-84-458-2037-7.00009-9

Measuring real world effectiveness of mandibular 2-implant overdentures - a pragmatic international multicenter study

Rashid, F. (2008) · eScholarship@McGill (McGill) · doi:10.82308/46471

Application of research evidence in clinical practice

Cipriani, A., Leucht, S., & Geddes, J. R. (2020) · doi:10.1093/med/9780198713005.003.0009

Matrix of Evidence Tool: Assessing the quality of real-world study designs (Preprint)Preprint

Hess, L. M., GOETZ, I. A., Muehlenkord, A., & Siebert, U. (2022) · doi:10.2196/preprints.42876

Participant opinions of randomised controlled trials within intellectual disability services

Robotham, D. (2010) · UCL Discovery (University College London)

Problemy z placebo i ślepą próbą magnetycznej stosowanych w psychiatrii

Zyss, T., Dudek, D., Zięba, A., Hese, R. T., Krawczyk, A., Gorczyca, P. W., & Sobiś, J. (2011) · PRZEGLĄD ELEKTROTECHNICZNY

A new generation of pragmatic trials of psychosocial interventions is needed

Ruggeri, M., Lasalvia, A., & Bonetto, C. (2013) · Epidemiology and Psychiatric Sciences · doi:10.1017/s2045796013000127 · Cited by 28

Randomized Controlled Trials in Psychiatry. Part II: Their Relationship to Clinical Practice

Mulder, R., Frampton, C. M., Joyce, P. R., & Porter, R. (2003) · Australian & New Zealand Journal of Psychiatry · doi:10.1046/j.1440-1614.2003.01176.x · Cited by 36

Randomised controlled trials of programmes

Kluiter, H., & Wiersma, D. (1996) · Cambridge University Press eBooks · doi:10.1017/cbo9780511752650.018 · Cited by 1

Uses and Limits of Randomised Controlled Trials in Mental Health Service Research

Taylor, R. E., & Thornicroft, G. (1996) · Springer eBooks · doi:10.1007/978-3-642-80202-7_11 · Cited by 9

Randomized controlled trials: still somewhat immature: commentary

Keitner, G. I. (2004) · African Journal of Psychiatry · doi:10.4314/ajpsy.v7i2.30162