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

BMC Psychiatry

Shubulade Smith⁵  Kathryn E Greenwood⁴  Robin M Murray⁵  Maurice Arbuthnot⁸  Diana Orr⁸  Philippa Lowe⁸  Bee Harries⁸  David Hopkins⁶  Anthony David⁵  Anita Patel⁷  Poonam Gardner-Sood⁹  John Lally⁹  Zerrin Atakan¹  Khalida Ismail^1,10  Daniel Stahl³  Fiona Gaughran² 

[1] Section of Neuroimaging, Department of Psychosis Studies, Institute of Psychiatry, King’s College London, 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;Department of Biostatistics, Institute of Psychiatry, King’s College London, London, UK;Early Intervention in Psychosis Service, Sussex Partnership NHS Foundation Trust, Worthing, West Sussex, UK;Institute of Psychiatry, King’s College London, London, UK;Division of Ambulatory Care & Local Networks, King’s College Hospital NHS Foundation Trust, London, UK;Centre for the Economics of Mental and Physical Health (CEMPH), Institute of Psychiatry at 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;King’s College Hospital NHS Foundation Trust, London, UK

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

Others  :  1123931
DOI  :  10.1186/1471-244X-13-263

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

【 摘 要 】

Background

Cardiovascular 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.

Methods

Impact 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.

Discussion

The 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 registration

ISRCTN58667926.

【 授权许可】

   
2013 Gaughran et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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