scholarly journals Structured lifestyle education to support weight loss for people with schizophrenia, schizoaffective disorder and first episode psychosis: the STEPWISE RCT

2018 ◽  
Vol 22 (65) ◽  
pp. 1-160 ◽  
Author(s):  
Richard IG Holt ◽  
Daniel Hind ◽  
Rebecca Gossage-Worrall ◽  
Michael J Bradburn ◽  
David Saxon ◽  
...  
Keyword(s):  
Mental Health ◽  
Physical Activity ◽  
Health Care ◽  
Cost Effectiveness ◽  
Health Technology ◽  
First Episode Psychosis ◽  
Incremental Cost Effectiveness Ratio ◽  
First Episode ◽  
Cost Effectiveness Ratio ◽  
Episode Psychosis

Background Obesity is twice as common in people with schizophrenia as in the general population. The National Institute for Health and Care Excellence guidance recommends that people with psychosis or schizophrenia, especially those taking antipsychotics, be offered a healthy eating and physical activity programme by their mental health care provider. There is insufficient evidence to inform how these lifestyle services should be commissioned. Objectives To develop a lifestyle intervention for people with first episode psychosis or schizophrenia and to evaluate its clinical effectiveness, cost-effectiveness, delivery and acceptability. Design A two-arm, analyst-blind, parallel-group, randomised controlled trial, with a 1 : 1 allocation ratio, using web-based randomisation; a mixed-methods process evaluation, including qualitative case study methods and logic modelling; and a cost–utility analysis. Setting Ten community mental health trusts in England. Participants People with first episode psychosis, schizophrenia or schizoaffective disorder. Interventions Intervention group: (1) four 2.5-hour group-based structured lifestyle self-management education sessions, 1 week apart; (2) multimodal fortnightly support contacts; (3) three 2.5-hour group booster sessions at 3-monthly intervals, post core sessions. Control group: usual care assessed through a longitudinal survey. All participants received standard written lifestyle information. Main outcome measures The primary outcome was change in weight (kg) at 12 months post randomisation. The key secondary outcomes measured at 3 and 12 months included self-reported nutrition (measured with the Dietary Instrument for Nutrition Education questionnaire), objectively measured physical activity measured by accelerometry [GENEActiv (Activinsights, Kimbolton, UK)], biomedical measures, adverse events, patient-reported outcome measures and a health economic assessment. Results The trial recruited 414 participants (intervention arm: 208 participants; usual care: 206 participants) between 10 March 2015 and 31 March 2016. A total of 341 participants (81.6%) completed the trial. A total of 412 participants were analysed. After 12 months, weight change did not differ between the groups (mean difference 0.0 kg, 95% confidence interval –1.59 to 1.67 kg; p = 0.964); physical activity, dietary intake and biochemical measures were unchanged. Glycated haemoglobin, fasting glucose and lipid profile were unchanged by the intervention. Quality of life, psychiatric symptoms and illness perception did not change during the trial. There were three deaths, but none was related to the intervention. Most adverse events were expected and related to the psychiatric illness. The process evaluation showed that the intervention was acceptable, with participants valuing the opportunity to interact with others facing similar challenges. Session feedback indicated that 87.2% of participants agreed that the sessions had met their needs. Some indicated the desire for more ongoing support. Professionals felt that the intervention was under-resourced and questioned the long-term sustainability within current NHS settings. Professionals would have preferred greater access to participants’ behaviour data to tailor the intervention better. The incremental cost-effectiveness ratio from the health-care perspective is £246,921 per quality-adjusted life-year (QALY) gained and the incremental cost-effectiveness ratio from the societal perspective is £367,543 per QALY gained. Conclusions Despite the challenges of undertaking clinical research in this population, the trial successfully recruited and retained participants, indicating a high level of interest in weight management interventions; however, the STEPWISE intervention was neither clinically effective nor cost-effective. Further research will be required to define how overweight and obesity in people with schizophrenia should be managed. The trial results suggest that lifestyle programmes for people with schizophrenia may need greater resourcing than for other populations, and interventions that have been shown to be effective in other populations, such as people with diabetes mellitus, are not necessarily effective in people with schizophrenia. Trial registration Current Controlled Trials ISRCTN19447796. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 65. See the NIHR Journals Library website for further project information.

scholarly journals Structured lifestyle education for people with schizophrenia, schizoaffective disorder and first-episode psychosis (STEPWISE): randomised controlled trial

2018 ◽  
Vol 214 (2) ◽  
pp. 63-73 ◽  
Author(s):  
Richard I. G. Holt ◽  
Rebecca Gossage-Worrall ◽  
Daniel Hind ◽  
Michael J. Bradburn ◽  
Paul McCrone ◽  
...  
Keyword(s):  
Mental Health ◽  
Physical Activity ◽  
Health Research ◽  
Controlled Trial ◽  
First Episode Psychosis ◽  
First Episode ◽  
Episode Psychosis ◽  
Randomised Controlled ◽  
The University ◽  
Lifestyle Education

BackgroundObesity is a major challenge for people with schizophrenia.AimsWe assessed whether STEPWISE, a theory-based, group structured lifestyle education programme could support weight reduction in people with schizophrenia.MethodIn this randomised controlled trial (study registration: ISRCTN19447796), we recruited adults with schizophrenia, schizoaffective disorder or first-episode psychosis from ten mental health organisations in England. Participants were randomly allocated to the STEPWISE intervention or treatment as usual. The 12-month intervention comprised four 2.5 h weekly group sessions, followed by 2-weekly maintenance contact and group sessions at 4, 7 and 10 months. The primary outcome was weight change after 12 months. Key secondary outcomes included diet, physical activity, biomedical measures and patient-related outcome measures. Cost-effectiveness was assessed and a mixed-methods process evaluation was included.ResultsBetween 10 March 2015 and 31 March 2016, we recruited 414 people (intervention 208, usual care 206) with 341 (84.4%) participants completing the trial. At 12 months, weight reduction did not differ between groups (mean difference 0.0 kg, 95% CI −1.6 to 1.7, P = 0.963); physical activity, dietary intake and biochemical measures were unchanged. STEPWISE was well-received by participants and facilitators. The healthcare perspective incremental cost-effectiveness ratio was £246 921 per quality-adjusted life-year gained.ConclusionsParticipants were successfully recruited and retained, indicating a strong interest in weight interventions; however, the STEPWISE intervention was neither clinically nor cost-effective. Further research is needed to determine how to manage overweight and obesity in people with schizophrenia.Declaration of interestR.I.G.H. received fees for lecturing, consultancy work and attendance at conferences from the following: Boehringer Ingelheim, Eli Lilly, Janssen, Lundbeck, Novo Nordisk, Novartis, Otsuka, Sanofi, Sunovion, Takeda, MSD. M.J.D. reports personal fees from Novo Nordisk, Sanofi-Aventis, Lilly, Merck Sharp & Dohme, Boehringer Ingelheim, AstraZeneca, Janssen, Servier, Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceuticals International Inc.; and, grants from Novo Nordisk, Sanofi-Aventis, Lilly, Boehringer Ingelheim, Janssen. K.K. has received fees for consultancy and speaker for Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Servier and Merck Sharp & Dohme. He has received grants in support of investigator and investigator-initiated trials from Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Pfizer, Boehringer Ingelheim and Merck Sharp & Dohme. K.K. has received funds for research, honoraria for speaking at meetings and has served on advisory boards for Lilly, Sanofi-Aventis, Merck Sharp & Dohme and Novo Nordisk. D.Sh. is expert advisor to the NICE Centre for guidelines; board member of the National Collaborating Centre for Mental Health (NCCMH); clinical advisor (paid consultancy basis) to National Clinical Audit of Psychosis (NCAP); views are personal and not those of NICE, NCCMH or NCAP. J.P. received personal fees for involvement in the study from a National Institute for Health Research (NIHR) grant. M.E.C. and Y.D. report grants from NIHR Health Technology Assessment, during the conduct of the study; and The Leicester Diabetes Centre, an organisation (employer) jointly hosted by an NHS Hospital Trust and the University of Leicester and who is holder (through the University of Leicester) of the copyright of the STEPWISE programme and of the DESMOND suite of programmes, training and intervention fidelity framework that were used in this study. S.R. has received honorarium from Lundbeck for lecturing. F.G. reports personal fees from Otsuka and Lundbeck, personal fees and non-financial support from Sunovion, outside the submitted work; and has a family member with professional links to Lilly and GSK, including shares. F.G. is in part funded by the National Institute for Health Research Collaboration for Leadership in Applied Health Research & Care Funding scheme, by the Maudsley Charity and by the Stanley Medical Research Institute and is supported by the by the Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London.

Personality and coping in first episode psychosis linked to mental health care use

2016 ◽  
Vol 238 ◽  
pp. 218-224 ◽  
Author(s):  
Anne Neeltje Scholte-Stalenhoef ◽  
Sacha la Bastide-van Gemert ◽  
Gerard van de Willige ◽  
Rianne Dost–Otter ◽  
Ellen Visser ◽  
...  
Keyword(s):  
Mental Health ◽  
Health Care ◽  
Mental Health Care ◽  
First Episode Psychosis ◽  
Health Care Use ◽  
First Episode ◽  
Episode Psychosis ◽  
Mental Health Care Use ◽  
And Coping

scholarly journals Patterns of Health Care Utilization Before First Episode Psychosis in Racial and Ethnic Groups

2019 ◽  
Vol 29 (4) ◽  
pp. 609-616
Author(s):  
Karen J. Coleman ◽  
Bobbi Jo Yarborough ◽  
Anne Beck ◽  
Frances L. Lynch ◽  
Christine Stewart ◽  
...  
Keyword(s):  
Mental Health ◽  
Health Care ◽  
Health Care Utilization ◽  
Ethnic Groups ◽  
First Episode Psychosis ◽  
Research Network ◽  
Care Utilization ◽  
First Episode ◽  
Asian Patients ◽  
Episode Psychosis

Objective: To compare patterns of health care utilization associated with first presen­tation of psychosis among different racial and ethnic groups of patients.Design: The study was a retrospective observational design.Settings: The study was conducted in five health care systems in the western United States. All sites were also part of the Nation­al Institute of Mental Health-funded Mental Health Research Network (MHRN).Participants: Patients (n = 852) were aged 15 – 59 years (average 26.9 ± 12.2 years), 45% women, and primarily non-Hispanic White (53%), with 16% Hispanic, 10% non-Hispanic Black, 6% Asian, 1% Native Hawaiian/Pacific Islander, 1% Native Ameri­can/ Alaskan Native, and 12% unknown race/ethnicity.Methods: Data abstracted from electronic medical records and insurance claims data were organized into a research virtual data warehouse (VDW) and used for analysis.Main Outcome Measures: Variables exam­ined were patterns of health care utilization, type of comorbid mental health condition, and type of treatment received in the three years before first presentation of psychosis.Results: Compared with non-Hispanic Whites, Asian patients (16% vs 34%; P=.007) and non-Hispanic Black patients (20% vs 34%; P=.009) were less likely to have a visit with specialty mental health care before their first presentation of psychosis.Conclusions: Early detection of first episode psychosis should start with wider screening for symptoms outside of any indicators for mental health conditions for non-Hispanic Black and Asian patients. Ethn Dis. 2019;29(4):609-616; doi:10.18865/ ed.29.4.609

scholarly journals Blended Digital and Face-to-Face Care for First-Episode Psychosis Treatment in Young People: Qualitative Study (Preprint)

2020 ◽  
Author(s):  
Lee Valentine ◽  
Carla McEnery ◽  
Imogen Bell ◽  
Shaunagh O'Sullivan ◽  
Ingrid Pryor ◽  
...  
Keyword(s):  
Mental Health ◽  
Health Care ◽  
Young People ◽  
First Episode Psychosis ◽  
First Episode ◽  
Model Of Care ◽  
Face To Face ◽  
Design And Implementation ◽  
Episode Psychosis ◽  
Blended Treatment

BACKGROUND A small number of studies have found that digital mental health interventions can be feasible and acceptable for young people experiencing first-episode psychosis; however, little research has examined how they might be blended with face-to-face approaches in order to enhance care. Blended treatment refers to the integration of digital and face-to-face mental health care. It has the potential to capitalize on the evidence-based features of both individual modalities, while also exceeding the sum of its parts. This integration could bridge the online–offline treatment divide and better reflect the interconnected, and often complementary, ways young people navigate their everyday digital and physical lives. OBJECTIVE This study aimed to gain young people’s perspectives on the design and implementation of a blended model of care in first-episode psychosis treatment. METHODS This qualitative study was underpinned by an end-user development framework and was based on semistructured interviews with 10 participants aged 19 to 28 (mean 23.4, SD 2.62). A thematic analysis was used to analyze the data. RESULTS Three superordinate themes emerged relating to young people’s perspectives on the design and implementation of a blended model of care in first-episode psychosis treatment: (1) blended features, (2) cautions, and (3) therapeutic alliance. CONCLUSIONS We found that young people were very enthusiastic about the prospect of blended models of mental health care, in so far as it was used to enhance their experience of traditional face-to-face treatment but not to replace it overall. Aspects of blended treatment that could enhance clinical care were readily identified by young people as increasing accessibility, continuity, and consolidation; accessing posttherapy support; strengthening the relationship between young person and clinician; and tracking personal data that could be used to better inform clinical decision making. Future research is needed to investigate the efficacy of blended models of care by evaluating its impact on the therapeutic alliance, clinical and social outcomes, cost-effectiveness, and engagement.

scholarly journals Blended Digital and Face-to-Face Care for First-Episode Psychosis Treatment in Young People: Qualitative Study

10.2196/18990 ◽  
2020 ◽  
Vol 7 (7) ◽  
pp. e18990 ◽  
Author(s):  
Lee Valentine ◽  
Carla McEnery ◽  
Imogen Bell ◽  
Shaunagh O'Sullivan ◽  
Ingrid Pryor ◽  
...  
Keyword(s):  
Mental Health ◽  
Health Care ◽  
Young People ◽  
First Episode Psychosis ◽  
First Episode ◽  
Model Of Care ◽  
Face To Face ◽  
Design And Implementation ◽  
Episode Psychosis ◽  
Blended Treatment

Background A small number of studies have found that digital mental health interventions can be feasible and acceptable for young people experiencing first-episode psychosis; however, little research has examined how they might be blended with face-to-face approaches in order to enhance care. Blended treatment refers to the integration of digital and face-to-face mental health care. It has the potential to capitalize on the evidence-based features of both individual modalities, while also exceeding the sum of its parts. This integration could bridge the online–offline treatment divide and better reflect the interconnected, and often complementary, ways young people navigate their everyday digital and physical lives. Objective This study aimed to gain young people’s perspectives on the design and implementation of a blended model of care in first-episode psychosis treatment. Methods This qualitative study was underpinned by an end-user development framework and was based on semistructured interviews with 10 participants aged 19 to 28 (mean 23.4, SD 2.62). A thematic analysis was used to analyze the data. Results Three superordinate themes emerged relating to young people’s perspectives on the design and implementation of a blended model of care in first-episode psychosis treatment: (1) blended features, (2) cautions, and (3) therapeutic alliance. Conclusions We found that young people were very enthusiastic about the prospect of blended models of mental health care, in so far as it was used to enhance their experience of traditional face-to-face treatment but not to replace it overall. Aspects of blended treatment that could enhance clinical care were readily identified by young people as increasing accessibility, continuity, and consolidation; accessing posttherapy support; strengthening the relationship between young person and clinician; and tracking personal data that could be used to better inform clinical decision making. Future research is needed to investigate the efficacy of blended models of care by evaluating its impact on the therapeutic alliance, clinical and social outcomes, cost-effectiveness, and engagement.

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