Multidisciplinary Lifestyle-enhancing Treatment for People With Severe Mental Illness in Sheltered Housing Facilities
Multidisciplinary Lifestyle-enhancing Treatment for Long-term Severe Mentally Ill Inpatients: Sheltered Housing
Introduction and rationale:
Unhealthy eating habits and lack of physical activity are risk factors for many diseases (including metabolic syndrome) and contribute to a shortened lifespan of 15-30 years in people with severe mental illness (SMI). Literature, mainly including short-term hospitalized or outpatients, show strong positive effects of activation on both physical and mental health. However, studies in long-term care are limited. In recent years, implementation of a lifestyle enhancing treatment intervention in clinical settings in "GGz Centraal" has demonstrated to be effective. The question is whether this kind of lifestyle intervention in sheltered housing is applicable and effective.
Objectives:
This research aims to develop an appropriate lifestyle intervention for patients living in sheltered housing services of GGz Centraal, based on input of patients and directly involved. Does applying this lifestyle treatment result in a positive effect in health and quality of life of patients and what is the influence of contextual factors, personal- and disease characteristics?
Study design:
In this intervention study, we use an experimental design. Municipal locations are paired based on the number of participants to generate equal cluster sizes. These paired clusters are randomly allocated to the control or intervention arm by means of a random number generator by an independent person (not involved in this project). At the start of the lifestyle treatment patients in the experimental and control group are invited to participate in the baseline screening. After twelve months, following a post-test on all outcome measures.
Treatment intervention:
The intervention in this study consists of formulating a lifestyle intervention, by patients and directly involved, aimed at enhancing a more active and healthier lifestyle . After formulation of the plan (based on psycho education, nutrition and physical activity), it wil be executed for a twelve month period.
Hypothesis:
Hypotheses is that lifestyle enhancing treatment is associated with improved metabolic health, quality of life and reduced use of medication. Furthermore we expect that movement disorders and disease severity will be negative related in becoming more active.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Sample size calculation:
To calculate the sample size we use the effect size on decrease in waist circumference in the previous intervention study (d =0.51) and the same analysis (multiple regression with correction for baseline value's on age, diagnosis and disease severity). To be able to detect the same effect in the current study with a minimum 80% power as a benchmark for a fair test and a significant level of 95% (α = 0.05), a minimum sample of 124 people is required (2 groups of 62). Taking into account a response rate of 73% from the first measurement a sample size of 168 patients is required.
Analyses:
We use multilevel regression to analyze the intervention effect. Possible clustering of data within the residential locations (and thus care teams) is taken into account by using a two-level structure with the first level residential location and the patients as the second. The intervention variable is set as an independent variable against difference scores of outcome variables (T2 minus T1) and corrected for the baseline value of the outcome to prevent regression to the centre. As we are unable to randomize patients individually in the current configuration on personal and disease characteristics (gender, age, diagnosis, disease severity at the start of intervention), these factors will be corrected for in the analyses if they differ significantly(p<0.05) between intervention and control group, analysed using independent t-tests and chi-squared tests. Characteristics that differ significantly will be included as covariates in the analysis described above. Multicollinearity will be checked with correlation coefficients and collinearity statistics (tolerance and Variance Inflation Factors (VIF) values).
Missing data:
Patients who are hospitalized for more than two months will be excluded from analyses.
If baseline or follow-up data are missing for two or more measures on physical or psychiatric health, patients are excluded from the analysis as insufficient difference scores can be calculated. Patients lacking difference scores on one outcome variable, are excluded from the analysis of that particular variable.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Gelderland
-
Ermelo, Gelderland, Holandsko, 3853LC
- Veldwijk
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Severe Mentally Ill patients,
- living in Sheltered Housing facilities
Exclusion Criteria:
- Incapacitated patients,
- without informed consent from their legal representative
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Žádný zásah: Léčba jako obvykle
|
|
|
Experimentální: Lifestyle treatment
|
Lifestyle treatment
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Metabolic Health: Waist circumference
Časové okno: 12 months
|
measured halfway between the iliac crest and lowest rib in standing position
|
12 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Metabolic Health: weight
Časové okno: 12 months
|
weight measured to the nearest 0.1kg
|
12 months
|
|
Metabolic Health: blood pressure
Časové okno: 12 months
|
measured systolic and diastolic blood pressure (mmHg)
|
12 months
|
|
Metabolic Health:Lipids
Časové okno: 12 months
|
values in blood sample
|
12 months
|
|
Metabolic Health:Fasting glucose
Časové okno: 12 months
|
values in blood sample
|
12 months
|
|
Metabolic health: HbA1c
Časové okno: 12 months
|
values in blood sample
|
12 months
|
|
Sedentary behaviour & physical activity
Časové okno: 12 months
|
measured 5 consecutive days with an accelerometer (ActiGraph GT3X+
|
12 months
|
|
Quality of Life EuroQol 5D
Časové okno: 12 months
|
measured by the EuroQol 5D (EQ-5D)
|
12 months
|
|
Quality of Life WHOQoL
Časové okno: 12 months
|
measured by the WHOQoL-Bref
|
12 months
|
|
Psychopathology BPRS-E
Časové okno: 12 months
|
Psychopathology / illness severity measured by the BPRS-E
|
12 months
|
|
Implementation fidelity
Časové okno: At follow-up (12 months)
|
A proxy for implementation fidelity using the 'descriptive norm' item of the Measurement Instrument for Determinants of Innovations
|
At follow-up (12 months)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Peter N van Harten, Prof. Dr., GGZ Centraal
Publikace a užitečné odkazy
Obecné publikace
- Santos-Lozano A, Santin-Medeiros F, Cardon G, Torres-Luque G, Bailon R, Bergmeir C, Ruiz JR, Lucia A, Garatachea N. Actigraph GT3X: validation and determination of physical activity intensity cut points. Int J Sports Med. 2013 Nov;34(11):975-82. doi: 10.1055/s-0033-1337945. Epub 2013 May 22.
- Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
- Sasaki JE, John D, Freedson PS. Validation and comparison of ActiGraph activity monitors. J Sci Med Sport. 2011 Sep;14(5):411-6. doi: 10.1016/j.jsams.2011.04.003. Epub 2011 May 25.
- Aleman A, Hijman R, de Haan EH, Kahn RS. Memory impairment in schizophrenia: a meta-analysis. Am J Psychiatry. 1999 Sep;156(9):1358-66. doi: 10.1176/ajp.156.9.1358.
- Kozey-Keadle S, Libertine A, Lyden K, Staudenmayer J, Freedson PS. Validation of wearable monitors for assessing sedentary behavior. Med Sci Sports Exerc. 2011 Aug;43(8):1561-7. doi: 10.1249/MSS.0b013e31820ce174.
- Rossler W, Salize HJ, van Os J, Riecher-Rossler A. Size of burden of schizophrenia and psychotic disorders. Eur Neuropsychopharmacol. 2005 Aug;15(4):399-409. doi: 10.1016/j.euroneuro.2005.04.009.
- Foussias G, Remington G. Negative symptoms in schizophrenia: avolition and Occam's razor. Schizophr Bull. 2010 Mar;36(2):359-69. doi: 10.1093/schbul/sbn094. Epub 2008 Jul 21.
- Acil AA, Dogan S, Dogan O. The effects of physical exercises to mental state and quality of life in patients with schizophrenia. J Psychiatr Ment Health Nurs. 2008 Dec;15(10):808-15. doi: 10.1111/j.1365-2850.2008.01317.x.
- Mas-Exposito L, Amador-Campos JA, Gomez-Benito J, Lalucat-Jo L; Research Group on Severe Mental Disorder. The World Health Organization Quality of Life Scale Brief Version: a validation study in patients with schizophrenia. Qual Life Res. 2011 Sep;20(7):1079-89. doi: 10.1007/s11136-011-9847-1. Epub 2011 Feb 3.
- van Os J, Kapur S. Schizophrenia. Lancet. 2009 Aug 22;374(9690):635-45. doi: 10.1016/S0140-6736(09)60995-8.
- Vancampfort D, Stubbs B, Mitchell AJ, De Hert M, Wampers M, Ward PB, Rosenbaum S, Correll CU. Risk of metabolic syndrome and its components in people with schizophrenia and related psychotic disorders, bipolar disorder and major depressive disorder: a systematic review and meta-analysis. World Psychiatry. 2015 Oct;14(3):339-47. doi: 10.1002/wps.20252.
- Andreasen NC, Carpenter WT Jr, Kane JM, Lasser RA, Marder SR, Weinberger DR. Remission in schizophrenia: proposed criteria and rationale for consensus. Am J Psychiatry. 2005 Mar;162(3):441-9. doi: 10.1176/appi.ajp.162.3.441.
- Bassett DR Jr, Cureton AL, Ainsworth BE. Measurement of daily walking distance-questionnaire versus pedometer. Med Sci Sports Exerc. 2000 May;32(5):1018-23. doi: 10.1097/00005768-200005000-00021.
- Bech P, Larsen JK, Andersen J. The BPRS: psychometric developments. Psychopharmacol Bull. 1988;24(1):118-21. No abstract available.
- Callaghan P. Exercise: a neglected intervention in mental health care? J Psychiatr Ment Health Nurs. 2004 Aug;11(4):476-83. doi: 10.1111/j.1365-2850.2004.00751.x.
- Daumit GL, Goldberg RW, Anthony C, Dickerson F, Brown CH, Kreyenbuhl J, Wohlheiter K, Dixon LB. Physical activity patterns in adults with severe mental illness. J Nerv Ment Dis. 2005 Oct;193(10):641-6. doi: 10.1097/01.nmd.0000180737.85895.60.
- Delespaul PH; de consensusgroep EPA. [Consensus regarding the definition of persons with severe mental illness and the number of such persons in the Netherlands]. Tijdschr Psychiatr. 2013;55(6):427-38. Dutch.
- Dingemans PM, Linszen DH, Lenior ME, Smeets RM. Component structure of the expanded Brief Psychiatric Rating Scale (BPRS-E). Psychopharmacology (Berl). 1995 Dec;122(3):263-7. doi: 10.1007/BF02246547.
- Docx L, Sabbe BG, Koning J, Mentzel TQ, van Harten PN, Morrens M. [Instrumental registration of psychomotor symptoms in schizophrenia: has the time come to use the technique in clinical practice?]. Tijdschr Psychiatr. 2015;57(2):148-53. Dutch.
- Farnam CR, Zipple AM, Tyrrell W, Chittinanda P. Health status risk factors of people with severe and persistent mental illness. J Psychosoc Nurs Ment Health Serv. 1999 Jun;37(6):16-21. doi: 10.3928/0279-3695-19990601-15.
- Gerlach J, Korsgaard S, Clemmesen P, Lauersen AM, Magelund G, Noring U, Povlsen UJ, Bech P, Casey DE. The St. Hans Rating Scale for extrapyramidal syndromes: reliability and validity. Acta Psychiatr Scand. 1993 Apr;87(4):244-52. doi: 10.1111/j.1600-0447.1993.tb03366.x.
- Hafkenscheid A. Psychometric evaluation of the Nurses Observation Scale for Inpatient Evaluation in The Netherlands. Acta Psychiatr Scand. 1991 Jan;83(1):46-52. doi: 10.1111/j.1600-0447.1991.tb05510.x.
- Kane I, Lee H, Sereika S, Brar J. Feasibility of pedometers for adults with schizophrenia: pilot study. J Psychiatr Ment Health Nurs. 2012 Feb;19(1):8-14. doi: 10.1111/j.1365-2850.2011.01747.x. Epub 2011 May 25.
- Killaspy H, White S, Wright C, Taylor TL, Turton P, Kallert T, Schuster M, Cervilla JA, Brangier P, Raboch J, Kalisova L, Onchev G, Alexiev S, Mezzina R, Ridente P, Wiersma D, Visser E, Kiejna A, Piotrowski P, Ploumpidis D, Gonidakis F, Caldas-de-Almeida JM, Cardoso G, King M. Quality of longer term mental health facilities in Europe: validation of the quality indicator for rehabilitative care against service users' views. PLoS One. 2012;7(6):e38070. doi: 10.1371/journal.pone.0038070. Epub 2012 Jun 4.
- Kruisdijk F, Deenik J, Tenback D, Tak E, Beekman AJ, van Harten P, Hopman-Rock M, Hendriksen I. Accelerometer-measured sedentary behaviour and physical activity of inpatients with severe mental illness. Psychiatry Res. 2017 Aug;254:67-74. doi: 10.1016/j.psychres.2017.04.035. Epub 2017 Apr 22.
- Millier A, Schmidt U, Angermeyer MC, Chauhan D, Murthy V, Toumi M, Cadi-Soussi N. Humanistic burden in schizophrenia: a literature review. J Psychiatr Res. 2014 Jul;54:85-93. doi: 10.1016/j.jpsychires.2014.03.021. Epub 2014 Apr 4.
- Ozemek C, Kirschner MM, Wilkerson BS, Byun W, Kaminsky LA. Intermonitor reliability of the GT3X+ accelerometer at hip, wrist and ankle sites during activities of daily living. Physiol Meas. 2014 Feb;35(2):129-38. doi: 10.1088/0967-3334/35/2/129. Epub 2014 Jan 7.
- Sallis JF, Saelens BE. Assessment of physical activity by self-report: status, limitations, and future directions. Res Q Exerc Sport. 2000 Jun;71(2 Suppl):S1-14. No abstract available. Erratum In: Res Q Exerc Sport 2000 Dec;71(4):409.
- Soundy A, Roskell C, Stubbs B, Vancampfort D. Selection, use and psychometric properties of physical activity measures to assess individuals with severe mental illness: a narrative synthesis. Arch Psychiatr Nurs. 2014 Apr;28(2):135-51. doi: 10.1016/j.apnu.2013.12.002. Epub 2013 Dec 19.
- Stanton R, Happell B. Exercise for mental illness: a systematic review of inpatient studies. Int J Ment Health Nurs. 2014 Jun;23(3):232-42. doi: 10.1111/inm.12045. Epub 2013 Sep 30.
- Stubbs B, Firth J, Berry A, Schuch FB, Rosenbaum S, Gaughran F, Veronesse N, Williams J, Craig T, Yung AR, Vancampfort D. How much physical activity do people with schizophrenia engage in? A systematic review, comparative meta-analysis and meta-regression. Schizophr Res. 2016 Oct;176(2-3):431-440. doi: 10.1016/j.schres.2016.05.017. Epub 2016 Jun 1.
- Tenback DE, van Kessel F, Jessurun J, Pijl YJ, Heerdink ER, van Harten PN. [Risk factors for inactivity in patients in long-term care with severe mental illness]. Tijdschr Psychiatr. 2013;55(2):83-91. Dutch.
- Thornicroft G, Tansella M. The balanced care model for global mental health. Psychol Med. 2013 Apr;43(4):849-63. doi: 10.1017/S0033291712001420. Epub 2012 Jul 11.
- Vancampfort D, Probst M, Scheewe T, Maurissen K, Sweers K, Knapen J, De Hert M. Lack of physical activity during leisure time contributes to an impaired health related quality of life in patients with schizophrenia. Schizophr Res. 2011 Jul;129(2-3):122-7. doi: 10.1016/j.schres.2011.03.018. Epub 2011 Apr 14.
- Vancampfort D, Rosenbaum S, Schuch F, Ward PB, Richards J, Mugisha J, Probst M, Stubbs B. Cardiorespiratory Fitness in Severe Mental Illness: A Systematic Review and Meta-analysis. Sports Med. 2017 Feb;47(2):343-352. doi: 10.1007/s40279-016-0574-1.
- Walker ER, McGee RE, Druss BG. Mortality in mental disorders and global disease burden implications: a systematic review and meta-analysis. JAMA Psychiatry. 2015 Apr;72(4):334-41. doi: 10.1001/jamapsychiatry.2014.2502. Erratum In: JAMA Psychiatry. 2015 Jul;72(7):736. JAMA Psychiatry. 2015 Dec;72(12):1259.
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