A pilot randomised controlled trial comparing antipsychotic medication, to cognitive behavioural therapy to a combination of both in people with psychosis: rationale, study design and baseline data of the COMPARE trial

Abstract Aims: Ongoing NICE guidance recommends research on the clinical and cost effectiveness of psychological treatment alone, compared to antipsychotic medication and compared to psychological treatment and antipsychotic medication combined. The COMPARE study (Cognitive behaviour therapy or Medication for Psychosis- A Randomised Evaluation) was a pilot trial designed to inform a definitive trial to answer this question. Method: COMPARE was a single-site pilot randomised controlled trial to compare a standardised Cognitive Behaviour Therapy (CBT) intervention to treatment with antipsychotic medication (APs) and a combined treatment (CBT plus APs) in adults with psychosis. Participants were assessed using the Positive and Negative Syndrome Scale (PANSS) and followed up at 6, 12, 24 and 52 weeks. The primary outcomes were recruitment and retention of participants. We surveyed a wider population of staff and service users to further inform feasibility of a definitive trial. Results: We report the characteristics of the recruited sample at baseline (n = 75) and results from surveys. Conclusions: The study recruited to target demonstrating it is feasible to identify and recruit participants to a study of this kind. The survey results also suggest that such trials are feasible.Trial registration ISRCTN06022197.

[1]  A. Morrison.  A manualised treatment protocol to guide delivery of evidence-based cognitive therapy for people with distressing psychosis: learning from clinical trials , 2017 .

[2]  G. Haddock,et al.  A systematic review of service-user reasons for adherence and nonadherence to neuroleptic medication in psychosis. , 2017, Clinical psychology review.

[3]  T. Lincoln,et al.  The impact of negative treatment experiences on persistent refusal of antipsychotics. , 2016, Comprehensive psychiatry.

[4]  R. Bentall,et al.  Longitudinal predictors of subjective recovery in psychosis , 2016, British Journal of Psychiatry.

[5]  Antonio Vita,et al.  The Effect of Antipsychotic Treatment on Cortical Gray Matter Changes in Schizophrenia: Does the Class Matter? A Meta-analysis and Meta-regression of Longitudinal Magnetic Resonance Imaging Studies , 2015, Biological Psychiatry.

[6]  G. Dunn,et al.  Psychometric properties of the Questionnaire about the Process of Recovery (QPR) , 2014, Schizophrenia Research.

[7]  G. Dunn,et al.  Cognitive therapy for people with schizophrenia spectrum disorders not taking antipsychotic drugs: a single-blind randomised controlled trial , 2014, The Lancet.

[8]  O. Howes.  Cognitive therapy: at last an alternative to antipsychotics? , 2014, The Lancet.

[9]  D. Wiersma,et al.  Recovery in remitted first-episode psychosis at 7 years of follow-up of an early dose reduction/discontinuation or maintenance treatment strategy: long-term follow-up of a 2-year randomized clinical trial. , 2013, JAMA psychiatry.

[10]  R. Bentall,et al.  Psychosocial and neuropsychiatric predictors of subjective recovery from psychosis , 2013, Psychiatry Research.

[11]  P. Hutton,et al.  Antipsychotics: is it time to introduce patient choice? , 2012, British Journal of Psychiatry.

[12]  John M. Davis,et al.  Antipsychotic drugs versus placebo for relapse prevention in schizophrenia: a systematic review and meta-analysis , 2012, The Lancet.

[13]  T. Wykes,et al.  Selecting outcome measures in mental health: the views of service users , 2011, Journal of mental health.

[14]  H. Soydan,et al.  Antipsychotic medication for early episode schizophrenia. , 2011, The Cochrane database of systematic reviews.

[15]  M. Berk,et al.  Who needs antipsychotic medication in the earliest stages of psychosis? A reconsideration of benefits, risks, neurobiology and ethics in the era of early intervention , 2010, Schizophrenia Research.

[16]  Antti Tanskanen,et al.  11-year follow-up of mortality in patients with schizophrenia: a population-based cohort study (FIN11 study) , 2009, The Lancet.

[17]  S. Leucht,et al.  How effective are second-generation antipsychotic drugs? A meta-analysis of placebo-controlled trials , 2009, Molecular Psychiatry.

[18]  G. Dunn,et al.  Emotion and psychosis: Links between depression, self-esteem, negative schematic beliefs and delusions and hallucinations , 2006, Schizophrenia Research.

[19]  P. Garety,et al.  Connecting neurosis and psychosis: the direct influence of emotion on delusions and hallucinations. , 2003, Behaviour research and therapy.

[20]  Anna Rodgers.  The National Institute for Clinical Excellence (NICE) , 2002, Annals of the rheumatic diseases.

[21]  Christian R. Dolder,et al.  Prevalence of and risk factors for medication nonadherence in patients with schizophrenia: a comprehensive review of recent literature. , 2002, The Journal of clinical psychiatry.

[22]  A. Morrison.  THE INTERPRETATION OF INTRUSIONS IN PSYCHOSIS: AN INTEGRATIVE COGNITIVE APPROACH TO HALLUCINATIONS AND DELUSIONS , 2001, Behavioural and Cognitive Psychotherapy.

[23]  P. Morosini,et al.  Development, reliability and acceptability of a new version of the DSM‐IV Social and Occupational Functioning Assessment Scale (SOFAS) to assess routine social funtioning , 2000, Acta psychiatrica Scandinavica.

[24]  D. Torgerson,et al.  Understanding controlled trials: What is a patient preference trial? , 1998, BMJ.

[25]  R. H. Browne.  On the use of a pilot sample for sample size determination. , 1995, Statistics in medicine.

[26]  K J Rothman,et al.  The continuing unethical use of placebo controls. , 1994, The New England journal of medicine.

[27]  C. Brewin,et al.  Patient preferences and randomised clinical trials. , 1989, BMJ.

[28]  Y. Goldberg,et al.  Initial severity of schizophrenia and efficacy of antipsychotics: participant-level meta-analysis of 6 placebo-controlled studies. , 2015, JAMA psychiatry.

[29]  J. Ballenger.  11-year follow-up of mortality in patients with schizophrenia: a population-based cohort study (FIN11 study) , 2011 .

[30]  S. Saxena,et al.  The World Health Organization Quality of Life Assessment (WHOQOL): development and general psychometric properties. , 1998, Social science & medicine.

[31]  S. Kay,et al.  The positive and negative syndrome scale (PANSS) for schizophrenia. , 1987, Schizophrenia bulletin.

[32]  G. Huston.  The Hospital Anxiety and Depression Scale. , 1987, The Journal of rheumatology.