Publications by authors named "Simon Gilbody"

261 Publications

Antidepressant medication to prevent depression relapse in primary care: the ANTLER RCT.

Health Technol Assess 2021 Nov;25(69):1-62

Division of Psychiatry, University College London, London, UK.

Background: There has been a steady increase in the number of primary care patients receiving long-term maintenance antidepressant treatment, despite limited evidence of a benefit of this treatment beyond 8 months.

Objective: The ANTidepressants to prevent reLapse in dEpRession (ANTLER) trial investigated the clinical effectiveness and cost-effectiveness of antidepressant medication in preventing relapse in UK primary care.

Design: This was a Phase IV, double-blind, pragmatic, multisite, individually randomised parallel-group controlled trial, with follow-up at 6, 12, 26, 39 and 52 weeks. Participants were randomised using minimisation on centre, type of antidepressant and baseline depressive symptom score above or below the median using Clinical Interview Schedule - Revised (two categories). Statisticians were blind to allocation for the outcome analyses.

Setting: General practices in London, Bristol, Southampton and York.

Participants: Individuals aged 18-74 years who had experienced at least two episodes of depression and had been taking antidepressants for ≥ 9 months but felt well enough to consider stopping their medication. Those who met an , Tenth Revision, diagnosis of depression or with other psychiatric conditions were excluded.

Intervention: At baseline, participants were taking citalopram 20 mg, sertraline 100 mg, fluoxetine 20 mg or mirtazapine 30 mg. They were randomised to either remain on their current medication or discontinue medication after a tapering period.

Main Outcome Measures: The primary outcome was the time, in weeks, to the beginning of the first depressive episode after randomisation. This was measured by a retrospective Clinical Interview Schedule - Revised that assessed the onset of a depressive episode in the previous 12 weeks, and was conducted at 12, 26, 39 and 52 weeks. The depression-related resource use was collected over 12 months from medical records and patient-completed questionnaires. Quality-adjusted life-years were calculated using the EuroQol-5 Dimensions, five-level version.

Results: Between 9 March 2017 and 1 March 2019, we randomised 238 participants to antidepressant continuation (the maintenance group) and 240 participants to antidepressant discontinuation (the discontinuation group). The time to relapse of depression was shorter in the discontinuation group, with a hazard ratio of 2.06 (95% confidence interval 1.56 to 2.70;  < 0.0001). By 52 weeks, relapse was experienced by 39% of those who continued antidepressants and 56% of those who discontinued antidepressants. The secondary analysis revealed that people who discontinued experienced more withdrawal symptoms than those who remained on medication, with the largest difference at 12 weeks. In the discontinuation group, 37% (95% confidence interval 28% to 45%) of participants remained on their randomised medication until the end of the trial. In total, 39% (95% confidence interval 32% to 45%) of participants in the discontinuation group returned to their original antidepressant compared with 20% (95% confidence interval 15% to 25%) of participants in maintenance group. The health economic evaluation demonstrated that participants randomised to discontinuation had worse utility scores at 3 months (-0.037, 95% confidence interval -0.059 to -0.015) and fewer quality-adjusted life-years over 12 months (-0.019, 95% confidence interval -0.035 to -0.003) than those randomised to continuation. The discontinuation pathway, besides giving worse outcomes, also cost more [extra £2.71 per patient over 12 months (95% confidence interval -£36.10 to £37.07)] than the continuation pathway, although the cost difference was not significant.

Conclusions: Patients who discontinue long-term maintenance antidepressants in primary care are at increased risk of relapse and withdrawal symptoms. However, a substantial proportion of patients can discontinue antidepressants without relapse. Our findings will give patients and clinicians an estimate of the likely benefits and harms of stopping long-term maintenance antidepressants and improve shared decision-making. The participants may not have been representative of all people on long-term maintenance treatment and we could study only a restricted range of antidepressants and doses. Identifying patients who will not relapse if they discontinued antidepressants would be clinically important.

Trial Registration: Current Controlled Trials ISRCTN15969819 and EudraCT 2015-004210-26.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 25, No. 69. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta25690DOI Listing
November 2021

Cost-Utility Analysis of Discontinuing Antidepressants in England Primary Care Patients Compared with Long-Term Maintenance: The ANTLER Study.

Appl Health Econ Health Policy 2021 Nov 8. Epub 2021 Nov 8.

Research Department of Primary Care and Population Health, University College London, London, UK.

Background: Depression is a common mental health condition with considerable negative impact on health and well-being. Although antidepressants are recommended as first-line treatment, there is limited evidence regarding the cost effectiveness of long-term maintenance antidepressants for preventing relapse.

Objectives: Our objective was to calculate the mean incremental costs and quality-adjusted life-years (QALYs) over 12 months of discontinuing long-term antidepressant medication in well patients compared with maintenance, using patient-level trial data.

Methods: We conducted a cost-utility analysis of 478 participants from 150 UK general practices recruited to a randomised, double-blind trial (ANTLER). QALYs were calculated from EQ-5D-5L and 12-Item Short Form survey (SF-12) results, with primary analysis using the EQ-5D-5L value set for England. Resource use was collected from primary care patient electronic medical records and self-completed questionnaires capturing mental-health-related resource use. Costs were calculated by applying standard UK unit costs to resource use. Adjustments were made for baseline variables.

Results: Participants randomised to discontinuation had significantly worse utility scores at 3 months (- 0.032; 95% confidence interval [CI] - 0.053 to - 0.011) but no significant difference in QALYs (- 0.011; 95% CI - 0.026 to 0.003) or costs (£3.11; 95% CI - 41.28 to 47.50) at 12 months. The probability that discontinuation was cost effective compared with maintenance was 12.9% at a threshold of £20,000 per QALY gained.

Conclusions: Discontinuation of antidepressants was unlikely to be cost effective compared with maintenance for currently well patients on long-term antidepressants. However, this analysis provides no information on the wider impact of antidepressants. Our findings provide information on the potential impact of discontinuing long-term maintenance antidepressants and facilitate improving guidance for shared patient-clinician decision making.

Trial Registration: EudraCT number 2015-004210-26; ISRCTN number ISRCTN15969819.
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http://dx.doi.org/10.1007/s40258-021-00693-xDOI Listing
November 2021

A systematic review of behavioural smoking cessation interventions for people with severe mental ill health-what works?

Addiction 2021 Oct 25. Epub 2021 Oct 25.

Department of Health Sciences and Closing the Gap Network, University of York, York, UK.

Background And Aims: People with severe mental ill health smoke more and suffer greater smoking-related morbidity and mortality. Little is known about the effectiveness of behavioural interventions for smoking cessation in this group. This review evaluated randomized controlled trial evidence to measure the effectiveness of behavioural smoking cessation interventions (both digital and non-digital) in people with severe mental ill health.

Design: Systematic review and random-effects meta-analysis. We searched between inception and January 2020 in Medline, EMBASE, PsycINFO, CINAHL, Health Management Information Consortium and CENTRAL databases.

Setting And Participants: Randomized controlled trials (RCTs) assessing the effects of behavioural smoking cessation and reduction interventions in adults with severe mental ill health, conducted in any country, in either in-patient or community settings and published in English.

Measurements: The primary outcome was biochemically verified smoking cessation. Smoking reduction and changes in mental health symptoms and body mass index (BMI) were included as secondary outcomes. Narrative data synthesis and meta-analysis were conducted and the quality of included studies was appraised using the risk of bias 2 (RoB2) tool.

Findings: We included 12 individual studies (16 articles) involving 1861 participants. The first meta-analysis (three studies, 921 participants) demonstrated effectiveness of bespoke face-to-face interventions compared with usual care across all time-points [medium-term: relative risk (RR) = 2.29, 95% confidence interval (CI) = 1.38-3.81; long-term: RR = 1.58, 95% CI = 1.09-2.30]. The second (three studies, 275 participants) did not demonstrate any difference in effectiveness of bespoke digital on-line interventions compared with standard digital on-line interventions (medium-term: RR = 0.87, 95% CI = 0.17-4.46). A narrative overview revealed mixed results when comparing bespoke face-to-face interventions with other active interventions. The methodological quality of studies was mixed, with the majority having some concerns mainly around risk of selective reporting.

Conclusions: Face-to-face bespoke smoking cessation interventions for adults with severe mental ill health appear to be effective when compared with treatment as usual, but evidence is equivocal when compared with other active interventions. There is limited evidence comparing bespoke digital interventions with generic interventions, and we found no studies comparing them with usual treatment.
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http://dx.doi.org/10.1111/add.15724DOI Listing
October 2021

Health risk behaviours among people with severe mental ill health during the COVID-19 pandemic: Analysis of linked cohort data.

PLoS One 2021 14;16(10):e0258349. Epub 2021 Oct 14.

Mental Health and Addiction Research Group, University of York, Heslington, United Kingdom.

Background: People with severe mental ill health (SMI) experience a mortality gap of 15-20 years. COVID-19 has amplified population health inequalities, and there is concern that people with SMI will be disproportionately affected. Understanding how health risk behaviours have changed during the pandemic is important when developing strategies to mitigate future increases in health inequalities.

Methods: We sampled from an existing cohort of people with SMI. Researchers contacted participants by phone or post to invite them to take part in a survey about how the pandemic had affected them. We asked people about their health risk behaviours and how these had changed during the pandemic. We created an index of changed behaviours, comprising dietary factors, smoking, lack of exercise, and drinking patterns. By creating data linkages, we compared their responses during pandemic restrictions to responses they gave prior to the pandemic.

Outcomes: 367 people provided health risk data. The mean age of the participants was 50.5 (range = 20 to 86, SD ± 15.69) with 51.0% male and 77.4% white British. 47.5% of participants reported taking less physical activity during the pandemic and of those who smoke 54.5% reported smoking more heavily. Self-reported deterioration in physical health was significantly associated with an increase in health risk behaviours (adjusted OR for physical health 1.59, 95%CI 1.22-2.07; adjusted OR for Age 0.99, 95%CI 0.98-1.00).

Interpretation: COVID-19 is likely to amplify health inequalities for people with SMI. Health services should target health risk behaviours for people with SMI to mitigate the immediate and long lasting impacts of the COVID-19 pandemic.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0258349PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8516268PMC
October 2021

Nature-based outdoor activities for mental and physical health: Systematic review and meta-analysis.

SSM Popul Health 2021 Dec 1;16:100934. Epub 2021 Oct 1.

York Environmental Sustainability Institute, University of York, York, YO10 5NG, UK.

Mental health problems are associated with lower quality of life, increased unscheduled care, high economic and social cost, and increased mortality. Nature-based interventions (NBIs) that support people to engage with nature in a structured way are asset-based solutions to improve mental health for community based adults. However, it is unclear which NBIs are most effective, or what format and dose is most efficacious. We systematically reviewed the controlled and uncontrolled evidence for outdoor NBIs. The protocol was registered at PROSPERO (CRD42020163103). Studies that included adults (aged ≥18 years) in community-based settings with or without mental and/or physical health problems were eligible for inclusion. Eligible interventions were structured outdoor activities in green and/or blue space for health and wellbeing. We searched ASSIA, CENTRAL, Embase, Greenfile, MEDLINE, PsycINFO, and Web of Science in October 2019; the search was updated in September 2020. We screened 14,321 records and included 50 studies. Sixteen studies were randomised controlled trials (RCTs); 18 were controlled studies; and 16 were uncontrolled before and after studies. Risk of bias for RCTs was low to moderate; and moderate to high for controlled and uncontrolled studies. Random effects meta-analysis of RCTs showed that NBIs were effective for improving depressive mood -0.64 (95% CI: 1.05 to -0.23), reducing anxiety -0.94 (95% CI: 0.94 to -0.01), improving positive affect 0.95 (95% CI: 0.59 to 1.31), and reducing negative affect -0.52 (95% CI: 0.77 to -0.26). Results from controlled and uncontrolled studies largely reflected findings from RCTs. There was less evidence that NBIs improved physical health. The most effective interventions were offered for between 8 and 12 weeks, and the optimal dose ranged from 20 to 90 min. NBIs, specifically gardening, green exercise and nature-based therapy, are effective for improving mental health outcomes in adults, including those with pre-existing mental health problems.
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http://dx.doi.org/10.1016/j.ssmph.2021.100934DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8498096PMC
December 2021

Behavioural activation to prevent depression and loneliness among socially isolated older people with long-term conditions: The BASIL COVID-19 pilot randomised controlled trial.

PLoS Med 2021 10 12;18(10):e1003779. Epub 2021 Oct 12.

Department of Health Sciences, University of York, York, United Kingdom.

Background: Older adults, including those with long-term conditions (LTCs), are vulnerable to social isolation. They are likely to have become more socially isolated during the Coronavirus Disease 2019 (COVID-19) pandemic, often due to advice to "shield" to protect them from infection. This places them at particular risk of depression and loneliness. There is a need for brief scalable psychosocial interventions to mitigate the psychological impacts of social isolation. Behavioural activation (BA) is a credible candidate intervention, but a trial is needed.

Methods And Findings: We undertook an external pilot parallel randomised trial (ISRCTN94091479) designed to test recruitment, retention and engagement with, and the acceptability and preliminary effects of the intervention. Participants aged ≥65 years with 2 or more LTCs were recruited in primary care and randomised by computer and with concealed allocation between June and October 2020. BA was offered to intervention participants (n = 47), and control participants received usual primary care (n = 49). Assessment of outcome was made blind to treatment allocation. The primary outcome was depression severity (measured using the Patient Health Questionnaire 9 (PHQ-9)). We also measured health-related quality of life (measured by the Short Form (SF)-12v2 mental component scale (MCS) and physical component scale (PCS)), anxiety (measured by the Generalised Anxiety Disorder 7 (GAD-7)), perceived social and emotional loneliness (measured by the De Jong Gierveld Scale: 11-item loneliness scale). Outcome was measured at 1 and 3 months. The mean age of participants was aged 74 years (standard deviation (SD) 5.5) and they were mostly White (n = 92, 95.8%), and approximately two-thirds of the sample were female (n = 59, 61.5%). Remote recruitment was possible, and 45/47 (95.7%) randomised to the intervention completed 1 or more sessions (median 6 sessions) out of 8. A total of 90 (93.8%) completed the 1-month follow-up, and 86 (89.6%) completed the 3-month follow-up, with similar rates for control (1 month: 45/49 and 3 months 44/49) and intervention (1 month: 45/47and 3 months: 42/47) follow-up. Between-group comparisons were made using a confidence interval (CI) approach, and by adjusting for the covariate of interest at baseline. At 1 month (the primary clinical outcome point), the median number of completed sessions for people receiving the BA intervention was 3, and almost all participants were still receiving the BA intervention. The between-group comparison for the primary clinical outcome at 1 month was an adjusted between-group mean difference of -0.50 PHQ-9 points (95% CI -2.01 to 1.01), but only a small number of participants had completed the intervention at this point. At 3 months, the PHQ-9 adjusted mean difference (AMD) was 0.19 (95% CI -1.36 to 1.75). When we examined loneliness, the adjusted between-group difference in the De Jong Gierveld Loneliness Scale at 1 month was 0.28 (95% CI -0.51 to 1.06) and at 3 months -0.87 (95% CI -1.56 to -0.18), suggesting evidence of benefit of the intervention at this time point. For anxiety, the GAD adjusted between-group difference at 1 month was 0.20 (-1.33, 1.73) and at 3 months 0.31 (-1.08, 1.70). For the SF-12 (physical component score), the adjusted between-group difference at 1 month was 0.34 (-4.17, 4.85) and at 3 months 0.11 (-4.46, 4.67). For the SF-12 (mental component score), the adjusted between-group difference at 1 month was 1.91 (-2.64, 5.15) and at 3 months 1.26 (-2.64, 5.15). Participants who withdrew had minimal depressive symptoms at entry. There were no adverse events. The Behavioural Activation in Social Isolation (BASIL) study had 2 main limitations. First, we found that the intervention was still being delivered at the prespecified primary outcome point, and this fed into the design of the main trial where a primary outcome of 3 months is now collected. Second, this was a pilot trial and was not designed to test between-group differences with high levels of statistical power. Type 2 errors are likely to have occurred, and a larger trial is now underway to test for robust effects and replicate signals of effectiveness in important secondary outcomes such as loneliness.

Conclusions: In this study, we observed that BA is a credible intervention to mitigate the psychological impacts of COVID-19 isolation for older adults. We demonstrated that it is feasible to undertake a trial of BA. The intervention can be delivered remotely and at scale, but should be reserved for older adults with evidence of depressive symptoms. The significant reduction in loneliness is unlikely to be a chance finding, and replication will be explored in a fully powered randomised controlled trial (RCT).

Trial Registration: ISRCTN94091479.
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http://dx.doi.org/10.1371/journal.pmed.1003779DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8509874PMC
October 2021

Use of the Internet and Digital Devices Among People With Severe Mental Ill Health During the COVID-19 Pandemic Restrictions.

Front Psychiatry 2021 24;12:732735. Epub 2021 Sep 24.

Mental Health and Addiction Research Group, Department of Health Sciences, University of York, York, United Kingdom.

Restrictions due to the COVID-19 pandemic have led to everyday reliance on digitalisation of life, including access to health care services. People with severe mental ill health (SMI-e.g., bipolar or psychosis spectrum disorders) are at greater risk for digital exclusion and it is unknown to what extent they adapted to online service delivery. This study explored use of the Internet and digital devices during the pandemic restrictions and its association with physical and mental health changes. Three hundred sixty seven adults with an SMI diagnosis completed a survey (online or offline) and provided information on access to Internet connexion and devices, internet knowledge, online activities, and barriers to using the Internet. They also self-reported changes in mental and physical health since the beginning of the pandemic restrictions. During the pandemic restrictions 61.6% were limited or non-users of the Internet. The majority had access to the Internet and digital devices but around half reported knowledge deficits. Most common activities were accessing information and entertainment (88.9%), staying in touch with friends and families (84.8%), and purchasing goods (other than food) (84.3%). Most common barriers were finding the Internet "not interesting" (28.3%) or "too difficult" (27.9%), as well as "security concerns" (22.1-24.3%). Using the Internet "a lot" (vs. "just a bit or not at all") during the pandemic was associated with younger age (18-30: Adj ORs 4.76; 31-45: 6.39; < 0.001; vs. 66+), having a diagnosis of bipolar disorder (compared to psychosis; Adj OR = 3.88, < 0.001), or reporting a decline in mental health (compared to no decline; Adj OR = 1.92, = 0.01). Most people with SMI were limited or non-users of the Internet during the pandemic, which seems to be mainly attributable to lack of interest and skills, rather than lack of devices or connectivity. Older adults with psychosis should be the focus of interventions to support digital engagement in people with SMI.
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http://dx.doi.org/10.3389/fpsyt.2021.732735DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8499705PMC
September 2021

Assessment of cytokines, microRNA and patient related outcome measures in conversion disorder/functional neurological disorder (CD/FND): The CANDO clinical feasibility study.

Brain Behav Immun Health 2021 May 24;13:100228. Epub 2021 Feb 24.

Background: Conversion disorder/functional neurological disorder (CD/FND) occurs often in neurological settings and can lead to long-term distress, disability and demand on health care services. Systemic low-grade inflammation might play a role, however, the pathogenic mechanism is still unknown.

Aim: 1) To explore the feasibility to establish and assess a cohort of CD/FND with motor symptoms, involving persons with lived experience (PPI). 2) To generate proof of concept regarding a possible role for cytokines, microRNA, cortisol levels and neurocognitive symptoms in patients with motor CD/FND.

Method: Feasibility study.

Results: The study showed active involvement of patients despite high clinical illness burden and disability, neurocognitive symptoms, childhood adverse experiences (ACE) and current life events. The study provided valuable knowledge regarding the feasibility of conducting a study in these patients that will inform future study phases. In the sample there were elevated levels of IL6, IL12, IL17A, IFNg, TNFa and VEGF-a, suggesting systemic low-grade inflammation. Also, microRNAs involved in inflammation and vascular inflammation were correlated with TNFa and VEGFa respectively, suggesting proof of concept for an epigenetic mechanism. Owing to the COVID-19 outbreak, the patient sample was limited to 15 patients.

Conclusion: It is a novelty that this study is conducted in the clinical setting. This innovative, translational study explores stress-related SLI in CD/FND patients and the feasibility of a larger project aiming to develop new treatments for this vulnerable population. Given the positive findings, there is scope to conduct further research into the mechanism of disease in CD/FND.
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http://dx.doi.org/10.1016/j.bbih.2021.100228DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8474571PMC
May 2021

Maintenance or Discontinuation of Antidepressants in Primary Care.

N Engl J Med 2021 09;385(14):1257-1267

From the Division of Psychiatry, Faculty of Brain Sciences (Gemma Lewis, L.D., M.K., P.L., F.B., M.B., Glyn Lewis), the Research Department of Primary Care and Population Health and Priment Clinical Trials Unit (L.M., R.H., I.N., C.S.C.), and the Institute of Clinical Trials and Methodology (N.F.), University College London, London, the Department of Health Sciences and Hull York Medical School, University of York, York (S.G., S.B., J.P.), Primary Care Population Sciences and Medical Education, Faculty of Medicine, University of Southampton, Southampton (T.K., M.M., A.H.), and Population Health Sciences (D.K.) and the Centre for Academic Mental Health (N.W., A.B.), Bristol Medical School, University of Bristol, Bristol - all in the United Kingdom; and the Department of Family Medicine, McMaster University, Hamilton, ON, Canada (D.M.).

Background: Patients with depression who are treated in primary care practices may receive antidepressants for prolonged periods. Data are limited on the effects of maintaining or discontinuing antidepressant therapy in this setting.

Methods: We conducted a randomized, double-blind trial involving adults who were being treated in 150 general practices in the United Kingdom. All the patients had a history of at least two depressive episodes or had been taking antidepressants for 2 years or longer and felt well enough to consider stopping antidepressants. Patients who had received citalopram, fluoxetine, sertraline, or mirtazapine were randomly assigned in a 1:1 ratio to maintain their current antidepressant therapy (maintenance group) or to taper and discontinue such therapy with the use of matching placebo (discontinuation group). The primary outcome was the first relapse of depression during the 52-week trial period, as evaluated in a time-to-event analysis. Secondary outcomes were depressive and anxiety symptoms, physical and withdrawal symptoms, quality of life, time to stopping an antidepressant or placebo, and global mood ratings.

Results: A total of 1466 patients underwent screening. Of these patients, 478 were enrolled in the trial (238 in the maintenance group and 240 in the discontinuation group). The average age of the patients was 54 years; 73% were women. Adherence to the trial assignment was 70% in the maintenance group and 52% in the discontinuation group. By 52 weeks, relapse occurred in 92 of 238 patients (39%) in the maintenance group and in 135 of 240 (56%) in the discontinuation group (hazard ratio, 2.06; 95% confidence interval, 1.56 to 2.70; P<0.001). Secondary outcomes were generally in the same direction as the primary outcome. Patients in the discontinuation group had more symptoms of depression, anxiety, and withdrawal than those in the maintenance group.

Conclusions: Among patients in primary care practices who felt well enough to discontinue antidepressant therapy, those who were assigned to stop their medication had a higher risk of relapse of depression by 52 weeks than those who were assigned to maintain their current therapy. (Funded by the National Institute for Health Research; ANTLER ISRCTN number, ISRCTN15969819.).
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http://dx.doi.org/10.1056/NEJMoa2106356DOI Listing
September 2021

Relationship between Green and Blue Spaces with Mental and Physical Health: A Systematic Review of Longitudinal Observational Studies.

Int J Environ Res Public Health 2021 08 26;18(17). Epub 2021 Aug 26.

Department of Health Sciences, University of York, York YO10 4DD, UK.

There is growing interest in the ways natural environments influence the development and progression of long-term health conditions. Vegetation and water bodies, also known as green and blue spaces, have the potential to affect health and behaviour through the provision of aesthetic spaces for relaxation, socialisation and physical activity. While research has previously assessed how green and blue spaces affect mental and physical wellbeing, little is known about the relationship between these exposures and health outcomes over time. This systematic review summarised the published evidence from longitudinal observational studies on the relationship between exposure to green and blue space with mental and physical health in adults. Included health outcomes were common mental health conditions, severe mental health conditions and noncommunicable diseases (NCDs). An online bibliographic search of six databases was completed in July 2020. After title, abstract and full-text screening, 44 eligible studies were included in the analysis. Depression, diabetes and obesity were the health conditions most frequently studied in longitudinal relationships. The majority of exposures included indicators of green space availability and urban green space accessibility. Few studies addressed the relationship between blue space and health. The narrative synthesis pointed towards mixed evidence of a protective relationship between exposure to green space and health. There was high heterogeneity in exposure measures and adjustment for confounding between studies. Future policy and research should seek a standardised approach towards measuring green and blue space exposures and employ theoretical grounds for confounder adjustment.
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http://dx.doi.org/10.3390/ijerph18179010DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8431638PMC
August 2021

Long-Term Cost-Effectiveness of Smoking Cessation Interventions in People With Mental Disorders: A Dynamic Decision Analytical Model.

Value Health 2021 Sep 3;24(9):1263-1272. Epub 2021 Jun 3.

Department of Health Sciences, University of York, Heslington, York, UK.

Objectives: People with mental disorders are more likely to smoke than the general population. The objective of this study is to develop a decision analytical model that estimates long-term cost-effectiveness of smoking cessation interventions in this population.

Methods: A series of Markov models were constructed to estimate average lifetime smoking-attributable inpatient cost and expected quality-adjusted life-years. The model parameters were estimated using a variety of data sources. The model incorporated uncertainty through probabilistic sensitivity analysis using Monte Carlo simulations. It also generated tables presenting incremental cost-effectiveness ratios of the proposed interventions with varying incremental costs and incremental quit rates. We used data from 2 published trials to demonstrate the model's ability to make projections beyond the observational time frame.

Results: The average smoker's smoking-attributable inpatient cost was 3 times higher and health utility was 5% lower than ex-smokers. The intervention in the trial with a statistically insignificant difference in quit rate (19% vs 25%; P=.2) showed a 45% to 49% chance of being cost-effective compared with the control at willingness-to-pay thresholds of £20 000 to £30 000/quality-adjusted life-years. The second trial had a significant outcome (quit rate 35.9% vs 15.6%; P<.001), and the corresponding probability of the intervention being cost-effective was 65%.

Conclusions: This model provides a consistent platform for clinical trials to estimate the potential lifetime cost-effectiveness of smoking cessation interventions for people with mental disorders and could help commissioners direct resources to the most cost-effective programs. However, direct comparisons of results between trials must be interpreted with caution owing to their different designs and settings.
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http://dx.doi.org/10.1016/j.jval.2021.04.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8404974PMC
September 2021

Still 'being bothered about Billy': managing the physical health of people with severe mental illness.

Br J Gen Pract 2021 08 29;71(709):373-376. Epub 2021 Jul 29.

University of Manchester, Manchester, UK; Honorary Research Consultant, Psychosis Research Unit (PRU), Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK; Honorary Senior Research Fellow, School of Medicine, Keele University, Keele, UK.

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http://dx.doi.org/10.3399/bjgp21X716741DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8312669PMC
August 2021

Can We Prevent Depression in At-Risk Older Adults Using Self-Help? The UK SHARD Trial of Behavioral Activation.

Am J Geriatr Psychiatry 2021 Jun 19. Epub 2021 Jun 19.

Department of Health Sciences (SG, SB, AM, DE, DM, DB, DH, AK, KB), University of York, UK.

Background: Treatment of established depression is the dominant approach to care of older adults, but prevention holds much promise. Self-help interventions are a feasible preventive approach, since they are scalable and low cost. There are few trials in this area. Behavioral Activation (BA) is a credible candidate psychological approach, which has been shown to work in therapist led care but not been trialled in a self-help form.

Aim: To test the effectiveness of an unguided self-help intervention based on BA for older adults.

Methods: We compared a self-help intervention based on BA for older people (n = 172) to usual care (n = 160) in a pragmatic randomized controlled trial. Outcomes were depression status and severity (PHQ9) and health related quality of life (SF12). The primary timepoint of the primary outcome was depression at 4 months, with longer term follow up at 12 months to test sustained impact of the primary outcome.

Results: At 4 months adjusted PHQ-9 scores for BA self-help were 0.79 lower (95% CI: -1.70 to 0.13; p = 0.09) and the proportion of participants with case-level depression was significantly reduced (BA 31/137 (22.6%) versus usual care 41/141 (29.1%); Odds Ratio 0.48; 95% CI: 0.26-0.92; p = 0.03). There was no PHQ-9 difference at 12 months or for health related quality of life at any point (4 or 12 months).

Discussion: Self-help using BA for older people at risk of depression is a feasible and scalable intervention with potential short-term benefits in preventing depression.
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http://dx.doi.org/10.1016/j.jagp.2021.06.006DOI Listing
June 2021

Home environmental assessments and modification delivered by occupational therapists to reduce falls in people aged 65 years and over: the OTIS RCT.

Health Technol Assess 2021 07;25(46):1-118

York Trials Unit, Department of Health Sciences, University of York, York, UK.

Background: Falls and fall-related fractures are highly prevalent among older people and are a major contributor to morbidity and costs to individuals and society. Only one small pilot trial has evaluated the effectiveness of a home hazard assessment and environmental modification in the UK. This trial reported a reduction in falls as a secondary outcome, and no economic evaluation was undertaken. Therefore, the results need to be confirmed and a cost-effectiveness analysis needs to be undertaken.

Objective: To determine the clinical effectiveness and cost-effectiveness of a home hazard assessment and environmental modification delivered by occupational therapists for preventing falls among community-dwelling people aged ≥ 65 years who are at risk of falling, relative to usual care.

Design: This was a pragmatic, multicentre, modified cohort randomised controlled trial with an economic evaluation and a qualitative study.

Setting: Eight NHS trusts in primary and secondary care in England.

Participants: In total, 1331 participants were randomised (intervention group,  = 430; usual-care group,  = 901) via a secure, remote service. Blinding was not possible.

Interventions: All participants received a falls prevention leaflet and routine care from their general practitioner. The intervention group were additionally offered one home environmental assessment and modifications recommended or provided to identify and manage personal fall-related hazards, delivered by an occupational therapist.

Main Outcome Measures: The primary outcome was the number of falls per participant during the 12 months from randomisation. The secondary outcomes were the proportion of fallers and multiple fallers, time to fall, fear of falling, fracture rate, health-related quality of life and cost-effectiveness.

Results: The primary analysis included all 1331 randomised participants and indicated weak evidence of a difference in fall rate between the two groups, with an increase in the intervention group relative to usual care (adjusted incidence rate ratio 1.17, 95% confidence interval 0.99 to 1.38;  = 0.07). A similar proportion of participants in the intervention group (57.0%) and the usual-care group (56.2%) reported at least one fall over 12 months. There were no differences in any of the secondary outcomes. The base-case cost-effectiveness analysis from an NHS and Personal Social Services perspective found that, on average per participant, the intervention was associated with additional costs (£18.78, 95% confidence interval £16.33 to £21.24), but was less effective (mean quality-adjusted life-year loss -0.0042, 95% confidence interval -0.0041 to -0.0043). Sensitivity analyses demonstrated uncertainty in these findings. No serious, related adverse events were reported. The intervention was largely delivered as intended, but recommendations were followed to a varying degree.

Limitations: Outcome data were self-reported by participants, which may have led to inaccuracies in the reported falls data.

Conclusions: We found no evidence that an occupational therapist-delivered home assessment and modification reduced falls in this population of community-dwelling participants aged ≥ 65 years deemed at risk of falling. The intervention was more expensive and less effective than usual care, and therefore it does not provide a cost-effective alternative to usual care.

Future Work: An evaluation of falls prevention advice in a higher-risk population, perhaps those previously hospitalised for a fall, or given by other professional staff could be justified.

Trial Registration: Current Controlled Trials ISRCTN22202133.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 25, No. 46. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta25460DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8287374PMC
July 2021

The development and validation of a prognostic model to PREDICT Relapse of depression in adult patients in primary care: protocol for the PREDICTR study.

Diagn Progn Res 2021 Jul 2;5(1):12. Epub 2021 Jul 2.

Department of Health Sciences, University of York, York, England.

Background: Most patients who present with depression are treated in primary care by general practitioners (GPs). Relapse of depression is common (at least 50% of patients treated for depression will relapse after a single episode) and leads to considerable morbidity and decreased quality of life for patients. The majority of patients will relapse within 6 months, and those with a history of relapse are more likely to relapse in the future than those with no such history. GPs see a largely undifferentiated case-mix of patients, and once patients with depression reach remission, there is limited guidance to help GPs stratify patients according to risk of relapse. We aim to develop a prognostic model to predict an individual's risk of relapse within 6-8 months of entering remission. The long-term objective is to inform the clinical management of depression after the acute phase.

Methods: We will develop a prognostic model using secondary analysis of individual participant data drawn from seven RCTs and one longitudinal cohort study in primary or community care settings. We will use logistic regression to predict the outcome of relapse of depression within 6-8 months. We plan to include the following established relapse predictors in the model: residual depressive symptoms, number of previous depressive episodes, co-morbid anxiety and severity of index episode. We will use a "full model" development approach, including all available predictors. Performance statistics (optimism-adjusted C-statistic, calibration-in-the-large, calibration slope) and calibration plots (with smoothed calibration curves) will be calculated. Generalisability of predictive performance will be assessed through internal-external cross-validation. Clinical utility will be explored through net benefit analysis.

Discussion: We will derive a statistical model to predict relapse of depression in remitted depressed patients in primary care. Assuming the model has sufficient predictive performance, we outline the next steps including independent external validation and further assessment of clinical utility and impact.

Study Registration: ClinicalTrials.gov ID: NCT04666662.
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http://dx.doi.org/10.1186/s41512-021-00101-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8254312PMC
July 2021

Mitigating the impacts of COVID-19: where are the mental health trials?

Lancet Psychiatry 2021 08 1;8(8):647-650. Epub 2021 Jun 1.

Yorkshire and Humberside Applied Research Collaboration, Bradford Institute for Health Research, Bradford, UK.

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http://dx.doi.org/10.1016/S2215-0366(21)00204-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8169044PMC
August 2021

Shared goals for mental health research: what, why and when for the 2020s.

J Ment Health 2021 May 9:1-9. Epub 2021 May 9.

Department of Experimental Psychology and Psychiatry, University of Oxford, Oxford, UK.

Mental health problems bring substantial individual, community and societal costs and the need for innovation to promote good mental health and to prevent and treat mental health problems has never been greater. However, we know that research findings can take up to 20 years to implement. One way to push the pace is to focus researchers and funders on shared, specific goals and targets. We describe a consultation process organised by the Department of Health and Social Care and convened by the Chief Medical Officer to consider high level goals for future research efforts and to begin to identify UK-specific targets to measure research impact. The process took account of new scientific methods and evidence, the UK context with a universal health care system (the NHS) and the embedded research support from the National Institute for Health Research Clinical Research Network, as well as the views of individual service users and service user organisations. The result of the consultation is a set of four overarching goals with the potential to be measured at intervals of three, five or ten years.
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http://dx.doi.org/10.1080/09638237.2021.1898552DOI Listing
May 2021

Dismantling, optimising, and personalising internet cognitive behavioural therapy for depression: a systematic review and component network meta-analysis using individual participant data.

Lancet Psychiatry 2021 06 3;8(6):500-511. Epub 2021 May 3.

Department of Clinical Psychology, Faculty of Psychology, University of Bergen, Bergen, Norway.

Background: Internet cognitive behavioural therapy (iCBT) is a viable delivery format of CBT for depression. However, iCBT programmes include training in a wide array of cognitive and behavioural skills via different delivery methods, and it remains unclear which of these components are more efficacious and for whom.

Methods: We did a systematic review and individual participant data component network meta-analysis (cNMA) of iCBT trials for depression. We searched PubMed, PsycINFO, Embase, and the Cochrane Library for randomised controlled trials (RCTs) published from database inception to Jan 1, 2019, that compared any form of iCBT against another or a control condition in the acute treatment of adults (aged ≥18 years) with depression. Studies with inpatients or patients with bipolar depression were excluded. We sought individual participant data from the original authors. When these data were unavailable, we used aggregate data. Two independent researchers identified the included components. The primary outcome was depression severity, expressed as incremental mean difference (iMD) in the Patient Health Questionnaire-9 (PHQ-9) scores when a component is added to a treatment. We developed a web app that estimates relative efficacies between any two combinations of components, given baseline patient characteristics. This study is registered in PROSPERO, CRD42018104683.

Findings: We identified 76 RCTs, including 48 trials contributing individual participant data (11 704 participants) and 28 trials with aggregate data (6474 participants). The participants' weighted mean age was 42·0 years and 12 406 (71%) of 17 521 reported were women. There was suggestive evidence that behavioural activation might be beneficial (iMD -1·83 [95% credible interval (CrI) -2·90 to -0·80]) and that relaxation might be harmful (1·20 [95% CrI 0·17 to 2·27]). Baseline severity emerged as the strongest prognostic factor for endpoint depression. Combining human and automated encouragement reduced dropouts from treatment (incremental odds ratio, 0·32 [95% CrI 0·13 to 0·93]). The risk of bias was low for the randomisation process, missing outcome data, or selection of reported results in most of the included studies, uncertain for deviation from intended interventions, and high for measurement of outcomes. There was moderate to high heterogeneity among the studies and their components.

Interpretation: The individual patient data cNMA revealed potentially helpful, less helpful, or harmful components and delivery formats for iCBT packages. iCBT packages aiming to be effective and efficient might choose to include beneficial components and exclude ones that are potentially detrimental. Our web app can facilitate shared decision making by therapist and patient in choosing their preferred iCBT package.

Funding: Japan Society for the Promotion of Science.
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http://dx.doi.org/10.1016/S2215-0366(21)00077-8DOI Listing
June 2021

Prognostic models for predicting relapse or recurrence of major depressive disorder in adults.

Cochrane Database Syst Rev 2021 05 6;5:CD013491. Epub 2021 May 6.

Mental Health and Addiction Research Group, Department of Health Sciences, University of York, York, UK.

Background: Relapse (the re-emergence of depressive symptoms after some level of improvement but preceding recovery) and recurrence (onset of a new depressive episode after recovery) are common in depression, lead to worse outcomes and quality of life for patients and exert a high economic cost on society. Outcomes can be predicted by using multivariable prognostic models, which use information about several predictors to produce an individualised risk estimate. The ability to accurately predict relapse or recurrence while patients are well (in remission) would allow the identification of high-risk individuals and may improve overall treatment outcomes for patients by enabling more efficient allocation of interventions to prevent relapse and recurrence.

Objectives: To summarise the predictive performance of prognostic models developed to predict the risk of relapse, recurrence, sustained remission or recovery in adults with major depressive disorder who meet criteria for remission or recovery.

Search Methods: We searched the Cochrane Library (current issue); Ovid MEDLINE (1946 onwards); Ovid Embase (1980 onwards); Ovid PsycINFO (1806 onwards); and Web of Science (1900 onwards) up to May 2020. We also searched sources of grey literature, screened the reference lists of included studies and performed a forward citation search. There were no restrictions applied to the searches by date, language or publication status .

Selection Criteria: We included development and external validation (testing model performance in data separate from the development data) studies of any multivariable prognostic models (including two or more predictors) to predict relapse, recurrence, sustained remission, or recovery in adults (aged 18 years and over) with remitted depression, in any clinical setting. We included all study designs and accepted all definitions of relapse, recurrence and other related outcomes. We did not specify a comparator prognostic model.

Data Collection And Analysis: Two review authors independently screened references; extracted data (using a template based on the CHecklist for critical Appraisal and data extraction for systematic Reviews of prediction Modelling Studies (CHARMS)); and assessed risks of bias of included studies (using the Prediction model Risk Of Bias ASsessment Tool (PROBAST)). We referred any disagreements to a third independent review author. Where we found sufficient (10 or more) external validation studies of an individual model, we planned to perform a meta-analysis of its predictive performance, specifically with respect to its calibration (how well the predicted probabilities match the observed proportions of individuals that experience the outcome) and discrimination (the ability of the model to differentiate between those with and without the outcome). Recommendations could not be qualified using the GRADE system, as guidance is not yet available for prognostic model reviews.

Main Results: We identified 11 eligible prognostic model studies (10 unique prognostic models). Seven were model development studies; three were model development and external validation studies; and one was an external validation-only study. Multiple estimates of performance measures were not available for any of the models and, meta-analysis was therefore not possible. Ten out of the 11 included studies were assessed as being at high overall risk of bias. Common weaknesses included insufficient sample size, inappropriate handling of missing data and lack of information about discrimination and calibration. One paper (Klein 2018) was at low overall risk of bias and presented a prognostic model including the following predictors: number of previous depressive episodes, residual depressive symptoms and severity of the last depressive episode. The external predictive performance of this model was poor (C-statistic 0.59; calibration slope 0.56; confidence intervals not reported). None of the identified studies examined the clinical utility (net benefit) of the developed model.

Authors' Conclusions: Of the 10 prognostic models identified (across 11 studies), only four underwent external validation. Most of the studies (n = 10) were assessed as being at high overall risk of bias, and the one study that was at low risk of bias presented a model with poor predictive performance. There is a need for improved prognostic research in this clinical area, with future studies conforming to current best practice recommendations for prognostic model development/validation and reporting findings in line with the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD) statement.
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http://dx.doi.org/10.1002/14651858.CD013491.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8102018PMC
May 2021

Cost-effectiveness of feedback-informed psychological treatment: Evidence from the IAPT-FIT trial.

Behav Res Ther 2021 07 24;142:103873. Epub 2021 Apr 24.

Department of Health Sciences and Hull York Medical School, University of York, United Kingdom; Department of Epidemiology and Biostatistics, Western University, Canada.

Background: Feedback-informed treatment (FIT) involves using computerized routine outcome monitoring technology to alert therapists to cases that are not responding well to psychotherapy, prompting them to identify and resolve obstacles to improvement. In this study, we present the first health economic evaluation of FIT, compared to usual care, to enable decision makers to judge whether this approach represents a good investment for health systems.

Methods: This randomised controlled trial included 2233 patients clustered within 77 therapists who were randomly assigned to a FIT group (n = 1176) or a usual care control group (n = 1057). Treatment response was monitored using patient-reported depression (PHQ-9) and anxiety (GAD-7) measures. Therapists in the FIT group had access to a computerized algorithm that alerted them to cases that were "not on track", compared to normative clinical data. Health service costs included the cost of training therapists to use FIT and the cost of therapy sessions in each arm. The incremental cost-effectiveness of FIT was assessed relative to usual care, using multilevel modelling.

Results: FIT was associated with an increased probability of reliable symptomatic improvement by 8.09 percentage points (95% CI: 4.16%-12.03%) which was statistically significant. The incremental cost of FIT was £15.17 (95% CI: £6.95 to £37.29) per patient and was not statistically significant. The incremental cost-effectiveness ratio (ICER) per additional case of reliable improvement was £187.4 (95% CI: £126.7 to £501.5); this confidence interval shows that the relative cost-effectiveness is between FIT being a dominant strategy (i.e. more effective and also cost-saving) to FIT being more effective at a modest incremental cost to the health system.

Conclusions: The FIT strategy increases the probability of reliable improvement in routine clinical practice and may be associated with a small (but uncertain) incremental cost. FIT is likely to be a cost-effective strategy for mental health services.
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http://dx.doi.org/10.1016/j.brat.2021.103873DOI Listing
July 2021

Cost-effectiveness of feedback-informed psychological treatment: Evidence from the IAPT-FIT trial.

Behav Res Ther 2021 07 24;142:103873. Epub 2021 Apr 24.

Department of Health Sciences and Hull York Medical School, University of York, United Kingdom; Department of Epidemiology and Biostatistics, Western University, Canada.

Background: Feedback-informed treatment (FIT) involves using computerized routine outcome monitoring technology to alert therapists to cases that are not responding well to psychotherapy, prompting them to identify and resolve obstacles to improvement. In this study, we present the first health economic evaluation of FIT, compared to usual care, to enable decision makers to judge whether this approach represents a good investment for health systems.

Methods: This randomised controlled trial included 2233 patients clustered within 77 therapists who were randomly assigned to a FIT group (n = 1176) or a usual care control group (n = 1057). Treatment response was monitored using patient-reported depression (PHQ-9) and anxiety (GAD-7) measures. Therapists in the FIT group had access to a computerized algorithm that alerted them to cases that were "not on track", compared to normative clinical data. Health service costs included the cost of training therapists to use FIT and the cost of therapy sessions in each arm. The incremental cost-effectiveness of FIT was assessed relative to usual care, using multilevel modelling.

Results: FIT was associated with an increased probability of reliable symptomatic improvement by 8.09 percentage points (95% CI: 4.16%-12.03%) which was statistically significant. The incremental cost of FIT was £15.17 (95% CI: £6.95 to £37.29) per patient and was not statistically significant. The incremental cost-effectiveness ratio (ICER) per additional case of reliable improvement was £187.4 (95% CI: £126.7 to £501.5); this confidence interval shows that the relative cost-effectiveness is between FIT being a dominant strategy (i.e. more effective and also cost-saving) to FIT being more effective at a modest incremental cost to the health system.

Conclusions: The FIT strategy increases the probability of reliable improvement in routine clinical practice and may be associated with a small (but uncertain) incremental cost. FIT is likely to be a cost-effective strategy for mental health services.
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http://dx.doi.org/10.1016/j.brat.2021.103873DOI Listing
July 2021

Investigating smoking and nicotine dependence among people with severe mental illness during the COVID-19 pandemic: analysis of linked data from a UK Closing the Gap cohort.

BJPsych Open 2021 Apr 23;7(3):e86. Epub 2021 Apr 23.

Mental Health and Addiction Research Group, University of York, UK.

Smoking rates are higher for people who use mental health services, which contributes substantially to health inequalities. Smoking can lead to worse COVID-19 outcomes, yet it remains unclear whether smoking has changed for people who use mental health services. We examined smoking patterns in a large clinical cohort of people with severe mental illness, before and during the pandemic. We found high levels of nicotine dependence and heavier patterns of smoking. Although some people had reported quitting, it is likely that smoking inequalities have become further entrenched. Mental health services should seek to mitigate this modifiable risk and source of poor health.
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http://dx.doi.org/10.1192/bjo.2021.45DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8082119PMC
April 2021

The contribution of depressive 'disorder characteristics' to determinations of prognosis for adults with depression: an individual patient data meta-analysis.

Psychol Med 2021 05 14;51(7):1068-1081. Epub 2021 Apr 14.

Centre for Outcomes Research and Effectiveness (CORE), Research Department of Clinical, Educational & Health Psychology, University College London, LondonWC1E 7HB, UK.

Background: This study aimed to investigate general factors associated with prognosis regardless of the type of treatment received, for adults with depression in primary care.

Methods: We searched Medline, Embase, PsycINFO and Cochrane Central (inception to 12/01/2020) for RCTs that included the most commonly used comprehensive measure of depressive and anxiety disorder symptoms and diagnoses, in primary care depression RCTs (the Revised Clinical Interview Schedule: CIS-R). Two-stage random-effects meta-analyses were conducted.

Results: Twelve (n = 6024) of thirteen eligible studies (n = 6175) provided individual patient data. There was a 31% (95%CI: 25 to 37) difference in depressive symptoms at 3-4 months per standard deviation increase in baseline depressive symptoms. Four additional factors: the duration of anxiety; duration of depression; comorbid panic disorder; and a history of antidepressant treatment were also independently associated with poorer prognosis. There was evidence that the difference in prognosis when these factors were combined could be of clinical importance. Adding these variables improved the amount of variance explained in 3-4 month depressive symptoms from 16% using depressive symptom severity alone to 27%. Risk of bias (assessed with QUIPS) was low in all studies and quality (assessed with GRADE) was high. Sensitivity analyses did not alter our conclusions.

Conclusions: When adults seek treatment for depression clinicians should routinely assess for the duration of anxiety, duration of depression, comorbid panic disorder, and a history of antidepressant treatment alongside depressive symptom severity. This could provide clinicians and patients with useful and desired information to elucidate prognosis and aid the clinical management of depression.
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http://dx.doi.org/10.1017/S0033291721001367DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8188529PMC
May 2021

Living with diabetes alongside a severe mental illness: A qualitative exploration with people with severe mental illness, family members and healthcare staff.

Diabet Med 2021 Jul 4;38(7):e14562. Epub 2021 May 4.

Department of Health Sciences, University of York, Heslington, York, UK.

Aims: Diabetes is two to three times more prevalent in people with severe mental illness, yet little is known about the challenges of managing both conditions from the perspectives of people living with the co-morbidity, their family members or healthcare staff. Our aim was to understand these challenges and to explore the circumstances that influence access to and receipt of diabetes care for people with severe mental illness.

Methods: Framework analysis of qualitative semi-structured interviews with people with severe mental illness and diabetes, family members, and staff from UK primary care, mental health and diabetes services, selected using a maximum variation sampling strategy between April and December 2018.

Results: In all, 39 adults with severe mental illness and diabetes (3 with type 1 diabetes and 36 with type 2 diabetes), nine family members and 30 healthcare staff participated. Five themes were identified: (a) Severe mental illness governs everyday life including diabetes management; (b) mood influences capacity and motivation for diabetes self-management; (c) cumulative burden of managing multiple physical conditions; (d) interacting conditions and overlapping symptoms and (e) support for everyday challenges. People living with the co-morbidity and their family members emphasised the importance of receiving support for the everyday challenges that impact diabetes management, and identified barriers to accessing this from healthcare providers.

Conclusions: More intensive support for diabetes management is needed when people's severe mental illness (including symptoms of depression) or physical health deteriorates. Interventions that help people, including healthcare staff, distinguish between symptoms of diabetes and severe mental illness are also needed.
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http://dx.doi.org/10.1111/dme.14562DOI Listing
July 2021

How can we estimate QALYs based on PHQ-9 scores? Equipercentile linking analysis of PHQ-9 and EQ-5D.

Evid Based Ment Health 2021 Mar 2. Epub 2021 Mar 2.

Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.

Background: Quality-adjusted life years (QALYs) are widely used to measure the impact of various diseases on both the quality and quantity of life and in their economic valuations. It will be clinically important and informative if we can estimate QALYs based on measurements of depression severity.

Objective: To construct a conversion table from the Patient Health Questionnaire-9 (PHQ-9), the most frequently used depression scale in recent years, to the Euro-Qol Five Dimensions Three Levels (EQ-5D-3L), one of the most commonly used instruments to assess QALYs.

Methods: We obtained individual participant data of randomised controlled trials of internet cognitive-behavioural therapy which had administered depression severity scales and the EQ-5D-3L at baseline and at end of treatment. Scores from depression scales were all converted into the PHQ-9 according to the validated algorithms. We used equipercentile linking to establish correspondences between the PHQ-9 and the EQ-5D-3L.

Findings: Individual-level data from five trials (total N=2457) were available. Subthreshold depression (PHQ-9 scores between 5 and 10) corresponded with EQ-5D-3L index values of 0.9-0.8, mild major depression (10-15) with 0.8-0.7, moderate depression (15-20) with 0.7-0.5 and severe depression (20 or higher) with 0.6-0.0. A five-point improvement in PHQ-9 corresponded approximately with an increase in EQ-5D-3L score by 0.03 and a ten-point improvement by approximately 0.25.

Conclusions And Clinical Implications: The conversion table between the PHQ-9 and the EQ-5D-3L scores will enable fine-grained assessment of burden of depression at its various levels of severity and of impacts of its various treatments.
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http://dx.doi.org/10.1136/ebmental-2020-300240DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8311092PMC
March 2021

Health of mothers of children with a life-limiting condition: a comparative cohort study.

Arch Dis Child 2021 10 2;106(10):987-993. Epub 2021 Mar 2.

Health Sciences, University of York, York, UK.

Objective: This study aimed to quantify the incidence rates of common mental and physical health conditions in mothers of children with a life-limiting condition.

Methods: Comparative national longitudinal cohort study using linked primary and secondary care data from the Clinical Practice Research Datalink in England. Maternal-child dyads were identified in these data. Maternal physical and mental health outcomes were identified in the primary and secondary care datasets using previously developed diagnostic coding frameworks. Incidence rates of the outcomes were modelled using Poisson regression, adjusting for deprivation, ethnicity and age and accounting for time at risk.

Results: A total of 35 683 mothers; 8950 had a child with a life-limiting condition, 8868 had a child with a chronic condition and 17 865 had a child with no long-term condition.The adjusted incidence rates of all of the physical and mental health conditions were significantly higher in the mothers of children with a life-limiting condition when compared with those mothers with a child with no long-term condition (eg, depression: incidence rate ratio (IRR) 1.21, 95% CI 1.13 to 1.30; cardiovascular disease: IRR 1.73, 95% CI 1.27 to 2.36; death in mothers: IRR 1.59, 95% CI 1.16 to 2.18).

Conclusion: This study clearly demonstrates the higher incidence rates of common and serious physical and mental health problems and death in mothers of children with a life-limiting condition. Further research is required to understand how best to support these mothers, but healthcare providers should consider how they can target this population to provide preventative and treatment services.
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http://dx.doi.org/10.1136/archdischild-2020-320655DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8461446PMC
October 2021

Supporting smoking cessation and preventing relapse following a stay in a smoke-free setting: a meta-analysis and investigation of effective behaviour change techniques.

Addiction 2021 11 6;116(11):2978-2994. Epub 2021 Mar 6.

Department of Health Sciences, University of York, Heslington, York, YO10 5DD, UK.

Background And Aims: Admission to a smoke-free setting presents a unique opportunity to encourage smokers to quit. However, risk of relapse post-discharge is high, and little is known about effective strategies to support smoking cessation following discharge. We aimed to identify interventions that maintain abstinence following a smoke-free stay and determine their effectiveness, as well as the probable effectiveness of behaviour change techniques (BCTs) used in these interventions.

Methods: Systematic review and meta-analyses of studies of adult smokers aged ≥ 18 years who were temporarily or fully abstinent from smoking to comply with institutional smoke-free policies. Institutions included prison, inpatient mental health, substance misuse or acute hospital settings. A Mantel-Haenszel random-effects meta-analysis of randomized controlled trials (RCTs) was conducted using biochemically verified abstinence (7-day point prevalence or continuous abstinence). BCTs were defined as 'promising' in terms of probable effectiveness (if BCT was present in two or more long-term effective interventions) and feasibility (if BCT was also delivered in ≥ 25% of all interventions).

Results: Thirty-seven studies (intervention n = 9041, control n = 6195) were included: 23 RCTs (intervention n = 6593, control n = 5801); three non-randomized trials (intervention n = 845, control n = 394) and 11 cohort studies (n = 1603). Meta-analysis of biochemically verified abstinence at longest follow-up (4 weeks-18 months) found an overall effect in favour of intervention [risk ratio (RR) = 1.27, 95% confidence interval (CI) = 1.08-1.49, I  = 42%]. Nine BCTs (including 'pharmacological support', 'goal-setting (behaviour)' and 'social support') were characterized as 'promising' in terms of probable effectiveness and feasibility.

Conclusions: A systematic review and meta-analyses indicate that behavioural and pharmacological support is effective in maintaining smoking abstinence following a stay in a smoke-free institution. Several behaviour change techniques may help to maintain smoking abstinence up to 18 months post-discharge.
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http://dx.doi.org/10.1111/add.15452DOI Listing
November 2021

Impact of severe mental illness on healthcare use and health outcomes for people with type 2 diabetes: a longitudinal observational study in England.

Br J Gen Pract 2021 08 29;71(709):e565-e573. Epub 2021 Jul 29.

Department of Health Sciences, University of York, York.

Background: People with severe mental illnesses (SMIs) have reduced life expectancy compared with the general population. Diabetes is a contributor to this disparity, with higher prevalence and poorer outcomes in people with SMI.

Aim: To determine the impact of SMI on healthcare processes and outcomes for people with type 2 diabetes (T2DM).

Design And Setting: Retrospective, observational, matched, nested, case-control study conducted in England using patient records from the Clinical Practice Research Datalink, linked to Hospital Episode Statistics.

Method: A range of healthcare processes (primary care consultations, physical health checks, and metabolic measurements) and outcomes (prevalence and hospitalisation for cardiovascular disease [CVD], and mortality risk) were compared for 2192 people with SMI and T2DM (cases) with 7773 people who had diabetes alone (controls). Sociodemographics, comorbidity, and medication prescription were covariates in regression models.

Results: When compared with results for participants with T2DM only, SMI was associated with increased risk of all-cause mortality (hazard ratio [HR] 1.919, 95% confidence interval [CI] = 1.602 to 2.300) and CVD-specific mortality (HR 2.242, 95% CI = 1.547 to 3.250), higher primary care physician consultation rates (incidence rate ratio [IRR] 1.149, 95% CI = 1.111 to 1.188), more-frequent checks of blood pressure (IRR 1.024, 95% CI = 1.003 to 1.046) and cholesterol (IRR 1.038, 95% CI = 1.019 to 1.058), lower prevalence of angina (odds ratio 0.671, 95% CI = 0.450 to 1.001), more emergency admissions for angina (IRR 1.532, 95% CI = 1.069 to 2.195), and fewer elective admissions for ischaemic heart disease (IRR 0.682, 95% CI = 0.508 to 0.915).

Conclusion: Monitoring of metabolic measurements was comparable for people with T2DM who did, and did not, have SMI. Increased mortality rates observed in people with SMI may be attributable to underdiagnosis of CVD and delays in treatment.
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http://dx.doi.org/10.3399/BJGP.2020.0884DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8252859PMC
August 2021

Is social support pre-treatment associated with prognosis for adults with depression in primary care?

Acta Psychiatr Scand 2021 05 16;143(5):392-405. Epub 2021 Feb 16.

Centre for Outcomes Research and Effectiveness (CORE), Research Department of Clinical, Educational & Health Psychology, University College London, London, UK.

Objective: Depressed patients rate social support as important for prognosis, but evidence for a prognostic effect is lacking. We aimed to test the association between social support and prognosis independent of treatment type, and the severity of depression, and other clinical features indicating a more severe illness.

Methods: Individual patient data were collated from all six eligible RCTs (n = 2858) of adults seeking treatment for depression in primary care. Participants were randomized to any treatment and completed the same baseline assessment of social support and clinical severity factors. Two-stage random effects meta-analyses were conducted.

Results: Social support was associated with prognosis independent of randomized treatment but effects were smaller when adjusting for depressive symptoms and durations of depression and anxiety, history of antidepressant treatment, and comorbid panic disorder: percentage decrease in depressive symptoms at 3-4 months per z-score increase in social support = -4.14(95%CI: -6.91 to -1.29). Those with a severe lack of social support had considerably worse prognoses than those with no lack of social support: increase in depressive symptoms at 3-4 months = 14.64%(4.25% to 26.06%).

Conclusions: Overall, large differences in social support pre-treatment were associated with differences in prognostic outcomes. Adding the Social Support scale to clinical assessments may be informative, but after adjusting for routinely assessed clinical prognostic factors the differences in prognosis are unlikely to be of a clinically important magnitude. Future studies might investigate more intensive treatments and more regular clinical reviews to mitigate risks of poor prognosis for those reporting a severe lack of social support.
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Source
http://dx.doi.org/10.1111/acps.13285DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7610633PMC
May 2021
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