Improving physical health and reducing substance use in psychosis – randomised control trial (IMPACT RCT): study protocol for a cluster randomised controlled trial

BMC Psychiatry

Study Protocol

Anita Patel¹  Daniel Stahl²  Diana Orr³  Philippa Lowe³  Bee Harries³  Maurice Arbuthnot³  Poonam Gardner-Sood⁴  David Hopkins⁵  Anthony David⁶  Khalida Ismail⁷  Shubulade Smith⁸  John Lally⁹  Fiona Gaughran^1,10  Robin M Murray^1,11  Kathryn E Greenwood^1,12  Zerrin Atakan^1,13 

[1] Centre for the Economics of Mental and Physical Health (CEMPH), Institute of Psychiatry at King's College London, London, UK;Department of Biostatistics, Institute of Psychiatry, King’s College London, London, UK;Department of Mental Health Sciences, Royal Free and University College Medical School, London, UK;Department of Psychosis Studies, Institute of Psychiatry, King’s College London, London, UK;Division of Ambulatory Care & Local Networks, King’s College Hospital NHS Foundation Trust, London, UK;King’s College London School of Medicine, London, UK;Institute of Psychiatry, King’s College London, London, UK;Institute of Psychiatry, King’s College London, London, UK;King’s College Hospital NHS Foundation Trust, London, UK;Institute of Psychiatry, King’s College London, London, UK;South London and Maudsley NHS Foundation Trust, London, UK;National Psychosis Service, South London and Maudsley NHS Foundation Trust, Denmark Hill, London, UK;Department of Psychosis Studies, Institute of Psychiatry, King’s College London, London, UK;National Psychosis Service, South London and Maudsley NHS Foundation Trust, Denmark Hill, London, UK;Institute of Psychiatry and the Biomedical Research Centre, BRC Nucleus, Maudsley Hospital, South London and Maudsley NHS Foundation Trust, Denmark Hill, London, UK;National Psychosis Service, South London and Maudsley NHS Foundation Trust, Denmark Hill, London, UK;Institute of Psychiatry, King’s College London, London, UK;School of Psychology, University of Sussex, Brighton, UK;Early Intervention in Psychosis Service, Sussex Partnership NHS Foundation Trust, Worthing, West Sussex, UK;Section of Neuroimaging, Department of Psychosis Studies, Institute of Psychiatry, King’s College London, London, UK;

关键词: Severe mental illness;    Schizophrenia;    Psychosis;    Metabolic syndrome;    Health promotion;    Randomised controlled trial;   

DOI  :  10.1186/1471-244X-13-263

 received in 2013-09-17, accepted in 2013-09-19,  发布年份 2013

来源: Springer

【 摘 要 】

BackgroundCardiovascular morbidity and mortality is increased in individuals with severe mental illnesses.We set out to establish a multicentre, two arm, parallel cluster randomized controlled trial (RCT) of a health promotion intervention (HPI), IMPACT Therapy. The patient-tailored IMPACT Therapy aims to target one or more health behaviours from a pre-defined list that includes cannabis use; alcohol use; other substance use; cigarette smoking; exercise; diet and diabetic control, prioritising those identified as problematic by the patient, taking a motivational interviewing and CBT approach.MethodsImpact therapy will be delivered by care coordinators in the community to the treatment group and will be compared to treatment as usual (TAU). The main hypothesis is that the addition of IMPACT Therapy (HPI) to TAU will be more effective than TAU alone in improving patients’ quality of life as measured by the Short Form-36, including mental health and physical health subscales on completion of the intervention at 12 months post randomisation. A subsidiary hypothesis will be that addition of IMPACT Therapy (HPI) will be more cost-effective than TAU alone in improving health in people with SMI 12 months from baseline. The IMPACT therapy patient groups’ improvement in quality of life, as well as its cost effectiveness, is hypothesised to be maintained at 15 months. Outcomes will be analyzed on an intention-to-treat (ITT) basis.DiscussionThe results of the trial will provide information about the effectiveness of the IMPACT therapy programme in supporting community mental health teams to address physical comorbidity in severe mental illness.Trial registrationISRCTN58667926.

【 授权许可】

CC BY   
© Gaughran et al.; licensee BioMed Central Ltd. 2013