Randomized Controlled Trial

. 2017 Dec 28;17(1):413.

doi: 10.1186/s12888-017-1571-0.

Randomised control trial of the effectiveness of an integrated psychosocial health promotion intervention aimed at improving health and reducing substance use in established psychosis (IMPaCT)

Fiona Gaughran^{1

2}, Daniel Stahl³, Khalida Ismail⁴, Kathryn Greenwood⁵, Zerrin Atakan⁶, Poonam Gardner-Sood⁶, Brendon Stubbs^{7

8}, David Hopkins⁹, Anita Patel¹⁰, John Lally^{6

11}, Philippa Lowe¹², Maurice Arbuthnot¹³, Diana Orr¹³, Sarah Corlett¹⁴, Jonas Eberhard^{6

15}, Anthony S David¹⁶, Robin Murray⁶, Shubulade Smith^{17

18}; IMPaCT Team

Affiliations

¹ National Psychosis Service, South London and Maudsley NHS Foundation Trust, London, UK. fiona.p.gaughran@kcl.ac.uk.
² Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, London, UK. fiona.p.gaughran@kcl.ac.uk.
³ Biostatistics Department, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, Denmark Hill, London, UK.
⁴ Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, Denmark Hill, London, UK.
⁵ Sussex Partnership NHS Foundation Trust and School of Psychology, University of Sussex, Brighton, UK.
⁶ Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, London, UK.
⁷ Health Service and Population Research Department, Institute of Psychiatry, Kings College London, London, UK.
⁸ Physiotherapy Department, South London and Maudsley NHS Foundation Trust, London, UK.
⁹ Department of Diabetic Medicine, King's College Hospital NHS Foundation Trust, King's Health Partners, London, UK.
¹⁰ Health Economics, Centre for Primary Care & Public Health, Blizard Institute, Queen Mary University of London, London, UK.
¹¹ National Psychosis Service, South London and Maudsley NHS Foundation Trust, London, UK.
¹² Carer Expert and Chair of Trustees, Rethink Mental Illness, London, UK.
¹³ , London, UK.
¹⁴ Interim Director of Public Health, London Borough Of Lambeth, London, UK.
¹⁵ Department of Clinical Sciences, Lund University, Lund, Sweden.
¹⁶ Institute of Psychiatry, Psychology and Neuroscience, Kings College London, Denmark Hill, London, UK.
¹⁷ Department of Forensic and Neurodevelopmental Science, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, Denmark Hill, London, UK.
¹⁸ Forensic Intensive Care Service, South London and Maudsley NHS Foundation Trust, London, UK.

PMID: 29284438
PMCID: PMC5745644
DOI: 10.1186/s12888-017-1571-0

Randomized Controlled Trial

Randomised control trial of the effectiveness of an integrated psychosocial health promotion intervention aimed at improving health and reducing substance use in established psychosis (IMPaCT)

Fiona Gaughran et al. BMC Psychiatry. 2017.

. 2017 Dec 28;17(1):413.

doi: 10.1186/s12888-017-1571-0.

Authors

Affiliations

¹ National Psychosis Service, South London and Maudsley NHS Foundation Trust, London, UK. fiona.p.gaughran@kcl.ac.uk.
² Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, London, UK. fiona.p.gaughran@kcl.ac.uk.
³ Biostatistics Department, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, Denmark Hill, London, UK.
⁴ Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, Denmark Hill, London, UK.
⁵ Sussex Partnership NHS Foundation Trust and School of Psychology, University of Sussex, Brighton, UK.
⁶ Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, London, UK.
⁷ Health Service and Population Research Department, Institute of Psychiatry, Kings College London, London, UK.
⁸ Physiotherapy Department, South London and Maudsley NHS Foundation Trust, London, UK.
⁹ Department of Diabetic Medicine, King's College Hospital NHS Foundation Trust, King's Health Partners, London, UK.
¹⁰ Health Economics, Centre for Primary Care & Public Health, Blizard Institute, Queen Mary University of London, London, UK.
¹¹ National Psychosis Service, South London and Maudsley NHS Foundation Trust, London, UK.
¹² Carer Expert and Chair of Trustees, Rethink Mental Illness, London, UK.
¹³ , London, UK.
¹⁴ Interim Director of Public Health, London Borough Of Lambeth, London, UK.
¹⁵ Department of Clinical Sciences, Lund University, Lund, Sweden.
¹⁶ Institute of Psychiatry, Psychology and Neuroscience, Kings College London, Denmark Hill, London, UK.
¹⁷ Department of Forensic and Neurodevelopmental Science, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, Denmark Hill, London, UK.
¹⁸ Forensic Intensive Care Service, South London and Maudsley NHS Foundation Trust, London, UK.

PMID: 29284438
PMCID: PMC5745644
DOI: 10.1186/s12888-017-1571-0

Abstract

Background: People with psychosis have a reduced life expectancy of 10-20 years, largely due to cardiovascular disease. This trial aimed to determine the effectiveness of a modular health promotion intervention (IMPaCT Therapy) in improving health and reducing cardiovascular risk in psychosis.

Methods: A multicentre, two arm, parallel cluster RCT was conducted across five UK mental health NHS trusts. Community care coordinators (CC) were randomly assigned to training and supervision in delivering IMPaCT Therapy or treatment as usual (TAU) to current patients with psychosis (cluster). The primary outcome was the physical and mental health subscales of the Short form-36 (SF-36) questionnaire.

Results: Of 104 care coordinators recruited, 52 (with 213 patients) were randomised to deliver IMPaCT therapy and 52 (with 193 patients) randomised to TAU. Of 406 patients, 318 (78%) and 301 (74%) attended 12- and 15-month follow-up respectively. IMPaCT therapy showed no significant effect on the physical or mental health component SF-36 scores versus TAU at 12 or 15 months. No effect was observed for cardiovascular risk indicators, except for HDL cholesterol, which improved more with IMPACT therapy than TAU (Treatment effect (95% CI); 0.085 (0.007 to 0.16); p = 0.034). The 22% of patients who received >180 min of IMPACT Therapy in addition to usual care achieved a greater reduction in waist circumference than did controls, which was clinically significant.

Conclusion: Training and supervising community care coordinators to use IMPaCT therapy in patients with psychosis is insufficient to significantly improve physical or mental health quality of life. The search for effective, pragmatic interventions deliverable in health care services continues.

Trial registration: The trial was retrospectively registered with ISRCTN registry on 23/4/2010 at ISRCTN58667926 ; recruitment started on 01/03/2010 with first randomization on 09.08.2010 ISRCTN58667926 .

Keywords: Health promotion intervention; Mortality; Psychosis; Quality of life; Schizophrenia.

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Conflict of interest statement

Ethics approval and consent to participate

Ethical approval was obtained from the joint South London and Maudsley and the Institute of Psychiatry NHS Ethics Committee (REC Ref no 09/HO80/41). Once participants were identified, they were approached by trained researchers who explained the trial and gave out an information leaflet regarding the study for consideration. The researcher then met the potential participant to answer any further questions they may have and learn if they wished to consent. Potential participants lacking capacity were ineligible for inclusion in the trial. Participants gave written informed consent, having been informed that their decision whether or not to participate in the study was purely voluntary and, in the case of patient participants, would have no effect on their clinical care. Participants were also told that they were free to withdraw their consent at any time, without their clinical care being affected.

Consent for publication

Not applicable.

Competing interests

FG has received honoraria for advisory work and lectures or CME activity support from Roche, BMS, Lundbeck, Otsaka, Janssen and Sunovion, is a collaborator on a NHS Innovations project co-funded by Janssen and has a family member with professional links to Lilly and GSK, including shares.

KI, speaker fees for Eli Lilly, Janssen, Sanofi.

RM Honoraria for lectures from Lundbeck, Janssen, and Sunovion.

JE is an employee of Lundbeck.

All other authors declare they have no conflict of interest.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

**Fig. 2**
Mean Physical health and mental health component score (95% Confidence interval) at baseline, 12 and 15 months follow-up for Treatment as usual (TAU) and Health intervention programme group (HPI)

See this image and copyright information in PMC

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Randomised control trial of the effectiveness of an integrated psychosocial health promotion intervention aimed at improving health and reducing substance use in established psychosis (IMPaCT)

Affiliations

Randomised control trial of the effectiveness of an integrated psychosocial health promotion intervention aimed at improving health and reducing substance use in established psychosis (IMPaCT)

Authors

Affiliations

Abstract

Conflict of interest statement

Ethics approval and consent to participate

Consent for publication

Competing interests

Publisher’s Note

Figures

References

Publication types

MeSH terms

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical