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Making remote measurement technology work in multiple sclerosis, epilepsy and depression: survey of healthcare professionalsBACKGROUND: Epilepsy, multiple sclerosis (MS) and depression are long term, central nervous system disorders which have a significant impact on everyday life. Evaluating symptoms of these conditions is problematic and typically involves repeated visits to a clinic. Remote measurement technology (RMT), consisting of smartphone apps and wearables, may offer a way to improve upon existing methods of managing these conditions. The present study aimed to establish the practical requirements that would enable clinical integration of data from patients' RMT, according to healthcare professionals. METHODS: This paper reports findings from an online survey of 1006 healthcare professionals currently working in the care of people with epilepsy, MS or depression. The survey included questions on types of data considered useful, how often data should be collected, the value of RMT data, preferred methods of accessing the data, benefits and challenges to RMT implementation, impact of RMT data on clinical practice, and requirement for technical support. The survey was presented on the JISC online surveys platform. RESULTS: Among this sample of 1006 healthcare professionals, respondents were positive about the benefits of RMT, with 73.2% indicating their service would be likely or highly likely to benefit from the implementation of RMT in patient care plans. The data from patients' RMT devices should be made available to all nursing and medical team members and could be reviewed between consultations where flagged by the system. However, results suggest it is also likely that RMT data would be reviewed in preparation for and during a consultation with a patient. Time to review information is likely to be one of the greatest barriers to successful implementation of RMT in clinical practice. CONCLUSIONS: While further work would be required to quantify the benefits of RMT in clinical practice, the findings from this survey suggest that a wide array of clinical team members treating epilepsy, MS and depression would find benefit from RMT data in the care of their patients. Findings presented could inform the implementation of RMT and other digital interventions in the clinical management of a range of neurological and mental health conditions.
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Sleep deprivation as a treatment for major depressive episodes: A systematic review and meta-analysisSummary Sleep deprivation, alone or in combination with pharmacological treatment and as part of a chronotherapy package, is of potential use for people with major depressive episodes, however the evidence base is still conflicting. The aim of this systematic review and meta-analysis is to assess the clinical effects of sleep deprivation in comparison to any other intervention for the acute and long-term treatment of mood disorders. We searched electronic databases and trial registries (last update: 16th October 2021) for published and unpublished randomised controlled trials recruiting participants with a major depressive episode in unipolar or bipolar affective disorder. The clinical outcomes of interest were the reduction in depressive symptoms at different timepoints and the number of participants experiencing at least one side effect. Overall, 29 trials (1246 participants) were included. We did not find any difference in change in symptoms or all-cause discontinuation between interventions including SD compared to a control of the same intervention except without SD. In the included studies there were no available data for adverse events. Using the most methodologically rigorous approach, we did not find evidence that the addition of sleep deprivation to treatment packages leads to enhanced depressive outcomes.
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Psychological treatments for depression and anxiety in dementia and mild cognitive impairmentBACKGROUNDExperiencing anxiety and depression is very common in people living with dementia and mild cognitive impairment (MCI). There is uncertainty about the best treatment approach. Drug treatments may be ineffective and associated with adverse effects. Guidelines recommend psychological treatments. In this updated systematic review, we investigated the effectiveness of different psychological treatment approaches.OBJECTIVESPrimary objective To assess the clinical effectiveness of psychological interventions in reducing depression and anxiety in people with dementia or MCI. Secondary objectives To determine whether psychological interventions improve individuals' quality of life, cognition, activities of daily living (ADL), and reduce behavioural and psychological symptoms of dementia, and whether they improve caregiver quality of life or reduce caregiver burden.SEARCH METHODSWe searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group's register, MEDLINE, Embase, four other databases, and three trials registers on 18 February 2021.SELECTION CRITERIAWe included randomised controlled trials (RCTs) that compared a psychological intervention for depression or anxiety with treatment as usual (TAU) or another control intervention in people with dementia or MCI.DATA COLLECTION AND ANALYSISA minimum of two authors worked independently to select trials, extract data, and assess studies for risk of bias. We classified the included psychological interventions as cognitive behavioural therapies (cognitive behavioural therapy (CBT), behavioural activation (BA), problem-solving therapy (PST)); 'third-wave' therapies (such as mindfulness-based cognitive therapy (MBCT)); supportive and counselling therapies; and interpersonal therapies. We compared each class of intervention with control. We expressed treatment effects as standardised mean differences or risk ratios. Where possible, we pooled data using a fixed-effects model. We used GRADE methods to assess the certainty of the evidence behind each result.MAIN RESULTSWe included 29 studies with 2599 participants. They were all published between 1997 and 2020. There were 15 trials of cognitive behavioural therapies (4 CBT, 8 BA, 3 PST), 11 trials of supportive and counselling therapies, three trials of MBCT, and one of interpersonal therapy. The comparison groups received either usual care, attention-control education, or enhanced usual care incorporating an active control condition that was not a specific psychological treatment. There were 24 trials of people with a diagnosis of dementia, and five trials of people with MCI. Most studies were conducted in community settings. We considered none of the studies to be at low risk of bias in all domains. Cognitive behavioural therapies (CBT, BA, PST) Cognitive behavioural therapies are probably slightly better than treatment as usual or active control conditions for reducing depressive symptoms (standardised mean difference (SMD) -0.23, 95% CI -0.37 to -0.10; 13 trials, 893 participants; moderate-certainty evidence). They may also increase rates of depression remission at the end of treatment (risk ratio (RR) 1.84, 95% CI 1.18 to 2.88; 2 studies, with one study contributing 2 independent comparisons, 146 participants; low-certainty evidence). We were very uncertain about the effect of cognitive behavioural therapies on anxiety at the end of treatment (SMD -0.03, 95% CI -0.36 to 0.30; 3 trials, 143 participants; very low-certainty evidence). Cognitive behavioural therapies probably improve patient quality of life (SMD 0.31, 95% CI 0.13 to 0.50; 7 trials, 459 participants; moderate-certainty evidence) and activities of daily living at end of treatment compared to treatment as usual or active control (SMD -0.25, 95% CI -0.40 to -0.09; 7 trials, 680 participants; moderate-certainty evidence). Supportive and counselling interventions Meta-analysis showed that supportive and counselling interventions may have little or no effect on depressive symptoms in people with dementia compared to usual care at end of treatment (SMD - .05, 95% CI -0.18 to 0.07; 9 trials, 994 participants; low-certainty evidence). We were very uncertain about the effects of these treatments on anxiety, which was assessed only in one small pilot study. Other interventions There were very few data and very low-certainty evidence on MBCT and interpersonal therapy, so we were unable to draw any conclusions about the effectiveness of these interventions.AUTHORS' CONCLUSIONSCBT-based treatments added to usual care probably slightly reduce symptoms of depression for people with dementia and MCI and may increase rates of remission of depression. There may be important effect modifiers (degree of baseline depression, cognitive diagnosis, or content of the intervention). CBT-based treatments probably also have a small positive effect on quality of life and activities of daily living. Supportive and counselling interventions may not improve symptoms of depression in people with dementia. Effects of both types of treatment on anxiety symptoms are very uncertain. We are also uncertain about the effects of other types of psychological treatments, and about persistence of effects over time. To inform clinical guidelines, future studies should assess detailed components of these interventions and their implementation in different patient populations and in different settings.
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Feasibility, acceptability and costs of nurse-led Alpha-Stim cranial electrostimulation to treat anxiety and depression in university studentsBACKGROUND: Only a relatively low proportion of university students seek help for anxiety and depression disorders, partly because they dislike current drug and psychological treatment options and would prefer home-based care. The aim of this study is to determine the feasibility, acceptability and cost utility of Alpha-Stim cranial electrostimulation (CES) delivered through a nurse led primary care clinic as a daily treatment for anxiety and depression symptoms by the student at home in contrast to usual primary care. METHOD: Feasibility and acceptability of a nurse led clinic offering Alpha-Stim CES in terms of the take up and completion of the six-week course of Alpha-Stim CES. Change in score on the GAD-7 and PHQ-9 as measures of anxiety and depression symptoms at baseline and at 8 weeks following a course of Alpha-Stim CES. Similar evaluation in a non-randomised control group attending a family doctor over the same period. Cost-utility analysis of the nurse led Alpha-Stim CES and family doctor pathways with participants failing to improve following further NICE Guideline clinical care (facilitated self-help and cognitive behaviour therapy). RESULTS: Of 47 students (mean age 22.1, years, 79% female opting for Alpha-Stim CES at the nurse-led clinic 46 (97.9%) completed a 6-week daily course. Forty-seven (47) students comprised a comparison group receiving usual family doctor care. Both Alpha-Stim CES and usual family doctor care were associated with large effect size reductions in GAD-7 and PHQ-9 scores from baseline to 8 weeks. There were no adverse effects and only one participant showed a clinically important deterioration in the Alpha-Stim group. In the cost utility analysis, Alpha-Stim CES was a cheaper option than usual family doctor care under all deterministic or probabilistic assumptions. CONCLUSION: Nurse delivered Alpha-Stim CES may be a feasible, acceptable and cheaper way of providing greater choice and home-based care for some university students seeking help from primary care with new presentations of anxiety and depression.
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A randomised controlled trial investigating the clinical and cost-effectiveness of Alpha-Stim AID cranial electrotherapy stimulation (CES) in patients seeking treatment for moderate severity depression in primary care (Alpha-Stim-D Trial)BACKGROUNDMajor depression is the second leading cause of years lost to disability worldwide and is a leading contributor to suicide. However, first-line antidepressants are only fully effective for 33%, and only 40% of those offered psychological treatment attend for two sessions or more. Views gained from patients and primary care professionals are that greater treatment uptake might be achieved if people with depression could be offered alternative and more accessible treatment options. Although there is evidence that the Alpha-Stim Anxiety Insomnia and Depression (AID) device is safe and effective for anxiety and depression symptoms in people with anxiety disorders, there is much less evidence of efficacy in major depression without anxiety. This study investigates the effectiveness of the Alpha-Stim AID device, a cranial electrotherapy stimulation (CES) treatment that people can safely use independently at home. The device provides CES which has been shown to increase alpha oscillatory brain activity, associated with relaxation.METHODSThe aim of this study is to investigate the clinical and cost-effectiveness of Alpha-Stim AID in treatment-seeking patients (aged 16 years upwards) with moderate to moderately severe depressive symptoms in primary care. The study is a multi-centre parallel-group, double-blind, non-commercial, randomised controlled superiority trial. The primary objective of the study is to examine the clinical efficacy of active daily use of 8 weeks of Alpha-Stim AID versus sham Alpha-Stim AID on depression symptoms at 16 weeks (8 weeks after the end of treatment) in people with moderate severity depression. The primary outcome is the 17-item Hamilton Depression Rating Scale at 16 weeks. All trial and treatment procedures are carried out remotely using videoconferencing, telephone and postal delivery considering the COVID-19 pandemic restrictions.DISCUSSIONThis study is investigating whether participants using the Alpha-Stim AID device display a reduction in depressive symptoms that can be maintained over 8 weeks post-treatment. The findings will help to determine whether Alpha-Stim AID should be recommended, including being made available in the NHS for patients with depressive symptoms.TRIAL REGISTRATIONISRTCN ISRCTN11853110 . Registered on 14 August 2020.
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Association between mirtazapine use and serious self-harm in people with depression: an active comparator cohort study using UK electronic health recordsBackground Studies report an increased risk of self-harm or suicide in people prescribed mirtazapine compared with other antidepressants.Objectives To compare the risk of serious self-harm in people prescribed mirtazapine versus other antidepressants as second-line treatments.Design and setting Cohort study using anonymised English primary care electronic health records, hospital admission data and mortality data with study window 1 January 2005 to 30 November 2018.Participants 24 516 people diagnosed with depression, aged 18–99 years, initially prescribed a selective serotonin reuptake inhibitor (SSRI) and then prescribed mirtazapine, a different SSRI, amitriptyline or venlafaxine.Main outcome measures Hospitalisation or death due to deliberate self-harm. Age–sex standardised rates were calculated and survival analyses were performed using inverse probability of treatment weighting to account for baseline covariates.Results Standardised rates of serious self-harm ranged from 3.8/1000 person-years (amitriptyline) to 14.1/1000 person-years (mirtazapine). After weighting, the risk of serious self-harm did not differ significantly between the mirtazapine group and the SSRI or venlafaxine groups (HRs (95% CI) 1.18 (0.84 to 1.65) and 0.85 (0.51 to 1.41) respectively). The risk was significantly higher in the mirtazapine than the amitriptyline group (3.04 (1.36 to 6.79)) but was attenuated after adjusting for dose.Conclusions There was no evidence for a difference in risk between mirtazapine and SSRIs or venlafaxine after accounting for baseline characteristics. The higher risk in the mirtazapine versus the amitriptyline group might reflect residual confounding if amitriptyline is avoided in people considered at risk of self-harm.Clinical implications Addressing baseline risk factors and careful monitoring might improve outcomes for people at risk of serious self-harm.No data are available. Data used in the study were provided under licence by CPRD (www.cprd.com) and cannot be shared by the authors. All code lists and the statistical code (in the form of Stata do-files) used to prepare and analyse the data are available on Zenodo.org (https://doi.org/10.5281/zenodo.4779024).
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The risk of all-cause and cause-specific mortality in people prescribed mirtazapine: an active comparator cohort study using electronic health recordsBACKGROUNDStudies have reported an increased risk of mortality among people prescribed mirtazapine compared to other antidepressants. The study aimed to compare all-cause and cause-specific mortality between adults prescribed mirtazapine or other second-line antidepressants.METHODSThis cohort study used English primary care electronic medical records, hospital admission records, and mortality data from the Clinical Practice Research Datalink (CPRD), for the period 01 January 2005 to 30 November 2018. It included people aged 18-99 years with depression first prescribed a selective serotonin reuptake inhibitor (SSRI) and then prescribed mirtazapine (5081), a different SSRI (15,032), amitriptyline (3905), or venlafaxine (1580). Follow-up was from starting to stopping the second antidepressant, with a 6-month wash-out window, censoring at the end of CPRD follow-up or 30 November 2018. Age-sex standardised rates of all-cause mortality and death due to circulatory system disease, cancer, or respiratory system disease were calculated. Survival analyses were performed, accounting for baseline characteristics using inverse probability of treatment weighting.RESULTSThe cohort contained 25,598 people (median age 41 years). The mirtazapine group had the highest standardised mortality rate, with an additional 7.8 (95% confidence interval (CI) 5.9-9.7) deaths/1000 person-years compared to the SSRI group. Within 2 years of follow-up, the risk of all-cause mortality was statistically significantly higher in the mirtazapine group than in the SSRI group (weighted hazard ratio (HR) 1.62, 95% CI 1.28-2.06). No significant difference was found between the mirtazapine group and the amitriptyline (HR 1.18, 95% CI 0.85-1.63) or venlafaxine (HR 1.11, 95% CI 0.60-2.05) groups. After 2 years, the risk was significantly higher in the mirtazapine group compared to the SSRI (HR 1.51, 95% CI 1.04-2.19), amitriptyline (HR 2.59, 95% CI 1.38-4.86), and venlafaxine (HR 2.35, 95% CI 1.02-5.44) groups. The risks of death due to cancer (HR 1.74, 95% CI 1.06-2.85) and respiratory system disease (HR 1.72, 95% CI 1.07-2.77) were significantly higher in the mirtazapine than in the SSRI group.CONCLUSIONSMortality was higher in people prescribed mirtazapine than people prescribed a second SSRI, possibly reflecting residual differences in other risk factors between the groups. Identifying these potential health risks when prescribing mirtazapine may help reduce the risk of mortality.
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Connectivity-guided theta burst transcranial magnetic stimulation versus repetitive transcranial magnetic stimulation for treatment-resistent moderate to severe depression: Magnetic resonance imaging protocol and SARS-CoV-2-induced changes for a randomized double-blind controlled trialBackground: Depression is a substantial health and economic burden. In approximately one-third of patients, depression is resistant to first-line treatment; therefore, it is essential to find alternative treatments. Transcranial magnetic stimulation (TMS) is a neuromodulatory treatment involving the application of magnetic pulses to the brain that is approved in the United Kingdom and the United States in treatment-resistant depression. This trial aims to compare the clinical effectiveness, cost-effectiveness, and mechanism of action of standard treatment repetitive TMS (rTMS) targeted at the F3 electroencephalogram site with a newer treatment—a type of TMS called theta burst stimulation (TBS) targeted based on measures of functional brain connectivity. This protocol outlines brain imaging acquisition and analysis for the Brain Imaging Guided Transcranial Magnetic Stimulation in Depression (BRIGhTMIND) study trial that is used to create personalized TMS targets and answer the proposed mechanistic hypotheses. Objective: The aims of the imaging arm of the BRIGhTMIND study are to identify functional and neurochemical brain signatures indexing the treatment mechanisms of rTMS and connectivity-guided intermittent theta burst TMS and to identify imaging-based markers predicting response to treatment. Methods: The study is a randomized double-blind controlled trial with 1:1 allocation to either 20 sessions of TBS or standard rTMS. Multimodal magnetic resonance imaging (MRI) is acquired for each participant at baseline (before TMS treatment) with T1-weighted and task-free functional MRI during rest used to estimate TMS targets. For participants enrolled in the mechanistic substudy, additional diffusion-weighted sequences are acquired at baseline and at posttreatment follow-up 16 weeks after treatment randomization. Core data sets of T1-weighted and task-free functional MRI during rest are acquired for all participants and are used to estimate TMS targets. Additional sequences of arterial spin labeling, magnetic resonance spectroscopy, and diffusion-weighted images are acquired depending on the recruitment site for mechanistic evaluation. Standard rTMS treatment is targeted at the F3 electrode site over the left dorsolateral prefrontal cortex, whereas TBS treatment is guided using the coordinate of peak effective connectivity from the right anterior insula to the left dorsolateral prefrontal cortex. Both treatment targets benefit from the level of MRI guidance, but only TBS is provided with precision targeting based on functional brain connectivity. Results: Recruitment began in January 2019 and is ongoing. Data collection is expected to continue until January 2023. Conclusions: This trial will determine the impact of precision MRI guidance on rTMS treatment and assess the neural mechanisms underlying this treatment in treatment-resistant depressed patients.
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Association between mirtazapine use and serious self-harm in people with depression: an active comparator cohort study using UK electronic health recordsBackground Studies report an increased risk of self-harm or suicide in people prescribed mirtazapine compared with other antidepressants.Objectives To compare the risk of serious self-harm in people prescribed mirtazapine versus other antidepressants as second-line treatments.Design and setting Cohort study using anonymised English primary care electronic health records, hospital admission data and mortality data with study window 1 January 2005 to 30 November 2018.Participants 24 516 people diagnosed with depression, aged 18–99 years, initially prescribed a selective serotonin reuptake inhibitor (SSRI) and then prescribed mirtazapine, a different SSRI, amitriptyline or venlafaxine.Main outcome measures Hospitalisation or death due to deliberate self-harm. Age–sex standardised rates were calculated and survival analyses were performed using inverse probability of treatment weighting to account for baseline covariates.Results Standardised rates of serious self-harm ranged from 3.8/1000 person-years (amitriptyline) to 14.1/1000 person-years (mirtazapine). After weighting, the risk of serious self-harm did not differ significantly between the mirtazapine group and the SSRI or venlafaxine groups (HRs (95% CI) 1.18 (0.84 to 1.65) and 0.85 (0.51 to 1.41) respectively). The risk was significantly higher in the mirtazapine than the amitriptyline group (3.04 (1.36 to 6.79)) but was attenuated after adjusting for dose.Conclusions There was no evidence for a difference in risk between mirtazapine and SSRIs or venlafaxine after accounting for baseline characteristics. The higher risk in the mirtazapine versus the amitriptyline group might reflect residual confounding if amitriptyline is avoided in people considered at risk of self-harm.Clinical implications Addressing baseline risk factors and careful monitoring might improve outcomes for people at risk of serious self-harm.No data are available. Data used in the study were provided under licence by CPRD (www.cprd.com) and cannot be shared by the authors. All code lists and the statistical code (in the form of Stata do-files) used to prepare and analyse the data are available on Zenodo.org (https://doi.org/10.5281/zenodo.4779024).
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Primary care depression advice clinicAims and Objectives: The aim of the Depression Advice Clinic (DAC) was to provide timely specialist advice on depression management within a primary care setting for individuals suffering from treatment resistant or recurrent depression. Method(s): The clinic was located in a primary care centre and offered one-off 90 minute assessments to patients referred by their GPs. Patients were seen by a senior psychiatry trainee who conducted a comprehensive psychiatric history, examination, diagnosis and bio-psycho-social formulation. Following discussion with the supervising consultant psychiatrist a letter with recommendations for next step treatments was sent to patient and their GP. The clinic employed one full time senior trainee, a consultant psychiatrist at 12.5% full time equivalent and an administrator at 25% full time equivalent as well as incurring overheads for consultation room rental. Result(s): During the 12 month operational period 127 referrals were received and 124 assessment appointments were offered. The mean wait for assessment was 23 days (in secondary care this is closer to 70 days) and the completed assessment rate was 92% (in local audit of secondary care services this was 81%). Following initial assessment 96% patients were discharged to their GP with advice on lifestyle, self-care and next step pharmacological and psychotherapeutic management option. 4% of patients were transferred directly to secondary/ tertiary care psychiatry, for reasons including severity, risk or initiation of medications that could not be carried out in primary care (e.g. Lithium). Discussion(s): The DAC achieved its aim of providing timely assessment and advice for people suffering from persistent or recurrent depression with most patients being seen much sooner than they would have had they been referred to secondary care. There were also some surprising, and potentially significant, findings from the clinic: more men were referred to the clinic than would have been expected to be seen in secondary services and one third of patients referred with an existing diagnosis of depression had this diagnosis changed following assessment (primarily to one of the anxiety disorders). Each of the patients referred from the DAC into secondary and tertiary care disclosed that they had made plans to end their life which they had concealed form their families and GPs and that being seen in the clinic had prevented them from acting on their plans. Conclusion(s): Referral rates, completed appointment rates and stakeholder feedback suggest that the DAC was an operationally feasible way of working across primary, secondary and tertiary care, whilst also being acceptable to GPs and patients. It is estimated that the average cost per completed suicide for those of working age in England is 1.67m. Since at least three patients reported that being seen in the clinic had prevented them from ending their lives the DAC was also a cost effective way of decreasing the mortality and morbidity resulting from chronic and recurring depression.
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Depressive symptoms, social support, and health-related quality of life: A community-based study in Shanghai, ChinaBACKGROUNDDepressive symptoms erode both physical and mental aspects of health-related quality of life (HRQoL). Social support (SS) may improve HRQoL through its direct effects or buffering effects. The association among depressive symptoms, SS, and HRQoL has been studied in specific groups, but research in the general adult population remains limited. This study examined the association among depressive symptoms, SS, and HRQoL, including exploring whether SS (including its three dimensions: subjective SS, objective SS and support utilization) mediated or moderated the relationship between depressive symptoms and HRQoL among community-based adults.METHODSWe conducted a cross-sectional survey in six communities in Shanghai, China, and 1642 adult participants with complete information on depressive symptoms and/or SS, and HRQoL were included. Linear regression analysis was used to investigate the association among depressive symptoms, SS, and HRQoL. In addition, we explored the mediating and moderating role of SS in the relationship between depressive symptoms and HRQoL.RESULTSMore depressive symptoms were associated with lower physical HRQoL (B = -0.64, p < .001) and lower mental HRQoL (B = -0.83, p < .001). SS (B = 0.07, p = .02), specifically subjective SS (B = 0.09, p = .03), was positively related to mental HRQoL. After adjusting for covariates, we found no evidence for a mediating role of SS in the relationship between depressive symptoms and HRQoL, while SS (subjective SS and objective SS) moderated the association between depressive symptoms and mental HRQoL.LIMITATIONSDue to the low voluntary participation rate of employees, participants represented approximately 50% of the individuals approached, thus limiting the generalizability of our findings. Data collected through self-report scales could lead to information bias.CONCLUSIONSSS does not appear to underlie the relationship between depressive symptoms and HRQoL. However, interventions to increase SS (in particular, subjective SS and objective SS) should be studied to determine whether they may be beneficial in alleviating the adverse impact of depressive symptoms on mental HRQoL.
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Multicentre randomised controlled trial of a group psychological intervention for postnatal depression in British mothers of South Asian origin (ROSHNI-2): study protocolBackground In the UK, postnatal depression is more common in British South Asian women than White Caucasion women. Cognitive–behavioural therapy (CBT) is recommended as a first-line treatment, but there is little evidence for the adaptation of CBT for postnatal depression to ensure its applicability to different ethnic groups. Aims To evaluate the clinical and cost-effectiveness of a CBT-based positive health programme group intervention in British South Asian women with postnatal depression. Method We have designed a multicentre, two-arm, partially nested, randomised controlled trial with 4- and 12-month follow-up, comparing a 12-session group CBT-based intervention (positive health programme) plus treatment as usual with treatment as usual alone, for British South Asian women with postnatal depression. Participants will be recruited from primary care and appropriate community venues in areas of high South Asian density across the UK. It has been estimated that randomising 720 participants (360 into each group) will be sufficient to detect a clinically important difference between a 55% recovery rate in the intervention group and a 40% recovery rate in the treatment-as-usual group. An economic analysis will estimate the cost-effectiveness of the positive health programme. A qualitative process evaluation will explore barriers and enablers to study participation and examine the acceptability and impact of the programme from the perspective of British South Asian women and other key stakeholders.
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The impact of data from remote measurement technology on the clinical practice of healthcare professionals in depression, epilepsy and multiple sclerosis: surveyBACKGROUNDA variety of smartphone apps and wearables are available both to help patients monitor their health and to support health care professionals (HCPs) in providing clinical care. As part of the RADAR-CNS consortium, we have conducted research into the application of wearables and smartphone apps in the care of people with multiple sclerosis, epilepsy, or depression.METHODSWe conducted a large online survey study to explore the experiences of HCPs working with patients who have one or more of these conditions. The survey covered smartphone apps and wearables used by clinicians and their patients, and how data from these technologies impacted on the respondents' clinical practice. The survey was conducted between February 2019 and March 2020 via a web-based platform. Detailed statistical analysis was performed on the answers.RESULTSOf 1009 survey responses from HCPs, 1006 were included in the analysis after data cleaning. Smartphone apps are used by more than half of responding HCPs and more than three quarters of their patients use smartphone apps or wearable devices for health-related purposes. HCPs widely believe the data that patients collect using these devices impacts their clinical practice. Subgroup analyses show that views on the impact of this data on different aspects of clinical work varies according to whether respondents use apps themselves, and, to a lesser extent, according to their clinical setting and job role.CONCLUSIONSUse of smartphone apps is widespread among HCPs participating in this large European survey and caring for people with epilepsy, multiple sclerosis and depression. The majority of respondents indicate that they treat patients who use wearables and other devices for health-related purposes and that data from these devices has an impact on clinical practice.
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Screening male prisoners for depression and anxiety with the PHQ-9 and GAD-7 at NHS HealthchecK: patterns of symptoms and caseness thresholdBACKGROUNDScreening for depression and anxiety disorders has been proposed in prison populations but little is known about caseness thresholds on commonly used self-report measures in relation to core symptoms, risk factors and symptom patterns.METHODA cross-sectional prevalence survey measured depression and anxiety caseness (threshold scores > 10 and > 15 on PHQ-9 and GAD-7 and diagnostic algorithm on PHQ-9) in 1205 male prisoners aged 35-74 years eligible for an NHS Healthcheck from six English prisons. Caseness scores were compared with the presence or absence of daily core symptoms of depression and generalised anxiety disorder (GAD), demographic, prison and cardiovascular risk factors. Cluster analysis was applied to PHQ-9 and GAD-7 items in prisoners scoring > 10 on PHQ-9.RESULTS453(37.6%) and 249(20.7%) prisoners scored > 10 and > 15 respectively on PHQ-9; 216 (17.9%) had a depressive episode on the PHQ-9 algorithm; 378(31.4%) and 217(18.0%) scored > 10 and > 15 on GAD-7 respectively. Daily core items for depression were scored in 232(56.2%) and 139(74.3%) prisoners reaching > 10 and > 15 respectively on PHQ-9; daily core anxiety items in 282(74.9%) and 179(96.3%) reaching > 10 and > 15 on GAD-7. Young age, prison and previous high alcohol intake were associated with > 15 on the PHQ-9. Cluster analysis showed a cluster with core symptoms of depression, slowness, restlessness, suicidality, poor concentration, irritability or fear. Altered appetite, poor sleep, lack of energy, guilt or worthlessness belonged to other clusters and may not be indicative of depression.CONCLUSIONSIn male prisoners > 35 years, a score of > 10 on the PHQ-9 over diagnoses depressive episodes but a score of > 10 on the GAD-7 may detect cases of GAD more efficiently. Further research utilising standardised psychiatric interviews is required to determine whether the diagnostic algorithm, a higher cut-off on the PHQ-9 or the profile of symptoms on the PHQ-9 and GAD-7 used singly or in combination may be used to screen depressive episodes efficiently in prisoners.
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Recent advances in electroconvulsive therapy and physical treatments for depressionThis article gives an update for practitioners on recent developments in the use of electroconvulsive therapy (ECT) and related treatment modalities in the contemporary treatment of depression in the UK. Details are provided on new information on the efficacy and side-effects of ECT both in research studies and in the real world, together with recent research on ECT's mode of delivery. There is a focus on the safe administration of ECT in clinical practice. An update on the regulatory framework for ECT in the UK is provided, together with up-to-date information on the legal situation regarding its prescription. Finally, brief summaries of the current position for other neuromodulatory treatment modalities are given.
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A case management occupational health model to facilitate earlier return to work of NHS staff with common mental health disorders: a feasibility studyBackground: The NHS is the biggest employer in the UK. Depression and anxiety are common reasons for sickness absence among staff. Evidence suggests that an intervention based on a case management model using a biopsychosocial approach could be cost-effective and lead to earlier return to work for staff with common mental health disorders. Objective: The objective was to assess the feasibility and acceptability of conducting a trial of the clinical effectiveness and cost-effectiveness of an early occupational health referral and case management intervention to facilitate the return to work of NHS staff on sick leave with any common mental health disorder (e.g. depression or anxiety). Design: A multicentre mixed-methods feasibility study with embedded process evaluation and economic analyses. The study comprised an updated systematic review, survey of care as usual, and development of an intervention in consultation with key stakeholders. Although this was not a randomised controlled trial, the study design comprised two arms where participants received either the intervention or care as usual. Participants: Participants were NHS staff on sick leave for 7 or more consecutive days but less than 90 consecutive days, with a common mental health disorder. Intervention: The intervention involved early referral to occupational health combined with standardised work-focused case management. Control/comparator: Participants in the control arm received care as usual. Primary outcome: The primary outcome was the feasibility and acceptability of the intervention, study processes (including methods of recruiting participants) and data collection tools to measure return to work, episodes of sickness absence, workability (a worker’s functional ability to perform their job), occupational functioning, symptomatology and cost-effectiveness proposed for use in a main trial. Results: Forty articles and two guidelines were included in an updated systematic review. A total of 49 of the 126 (39%) occupational health providers who were approached participated in a national survey of care as usual. Selected multidisciplinary stakeholders contributed to the development of the work-focused case management intervention (including a training workshop). Six NHS trusts (occupational health departments) agreed to take part in the study, although one trust withdrew prior to participant recruitment, citing staff shortages. At mixed intervention sites, participants were sequentially allocated to each arm, where possible. Approximately 1938 (3.9%) NHS staff from the participating sites were on sick leave with a common mental health disorder during the study period. Forty-two sick-listed NHS staff were screened for eligibility on receipt of occupational health management referrals. Twenty-four (57%) participants were consented: 11 (46%) received the case management intervention and 13 (54%) received care as usual. Follow-up data were collected from 11 out of 24 (46%) participants at 3 months and 10 out of 24 (42%) participants at 6 months. The case management intervention and case manager training were found to be acceptable and inexpensive to deliver. Possible contamination issues are likely in a future trial if participants are individually randomised at mixed intervention sites. Harms: No adverse events were reported. Limitations: The method of identification and recruitment of eligible sick-listed staff was ineffective in practice because uptake of referral to occupational health was low, but a new targeted method has been devised. Conclusion: All study questions were addressed. Difficulties raising organisational awareness of the study coupled with a lack of change in occupational health referral practices by line managers affected the identification and recruitment of participants. Strategies to overcome these barriers in a main trial were identified. The case management intervention was fit for purpose and acceptable to deliver in the NHS.
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Safety of antidepressants in a primary care cohort of adults with obesity and depressionBACKGROUNDObesity, depressive disorders and antidepressant drugs are associated with increased mortality, cardiovascular disease, diabetes, fractures and falls. We explored outcomes associated with the most commonly prescribed antidepressants in overweight or obese people with depression.METHODS AND FINDINGSWe identified a cohort of overweight or obese adults (≥18 years) in primary care from the UK Clinical Practice Research Datalink, linked with hospital and mortality data, between 1 January 2000 and 31 December 2016 who developed incident depression to January 2019. Cox proportional hazards models and 99% confidence intervals were used to estimate hazard ratios (HR) for mortality, cardiovascular disease, diabetes, and falls/fractures associated with exposure to selective serotonin reuptake inhibitors (SSRIs), tricyclic (TCA)/other, combination antidepressants, citalopram, fluoxetine, sertraline, amitriptyline and mirtazapine, adjusting for potential confounding variables. In 519,513 adults, 32,350 (9.2 per 1,000 years) displayed incident depression and 21,436 (66.3%) were prescribed ≥1 antidepressant. Compared with no antidepressants, all antidepressant classes were associated with increased relative risks of cardiovascular disorders [SSRI HR: 1.32 (1.14-1.53), TCA/Other HR: 1.26 (1.01-1.58)], and diabetes (any type) [SSRI HR: 1.28 (1.10-1.49), TCA/Other: 1.52 (1.19-1.94)]. All commonly prescribed antidepressants except citalopram were associated with increased mortality compared with no antidepressants. However, prescription ≥1 year of ≥40mg citalopram was associated with increased mortality and falls/fractures and ≥1 year 100mg sertraline with increased falls/fractures.CONCLUSIONSIn overweight/obese people with depression, antidepressants may be overall and differentially associated with increased risks of some adverse outcomes. Further research is required to exclude indication bias and residual confounding.
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Cognitive-behavioural therapy for a variety of conditions: an overview of systematic reviews and panoramic meta-analysisBackground: Cognitive-behavioural therapy aims to increase quality of life by changing cognitive and behavioural factors that maintain problematic symptoms. A previous overview of cognitive-behavioural therapy systematic reviews suggested that cognitive-behavioural therapy was effective for many conditions. However, few of the included reviews synthesised randomised controlled trials. Objectives: This project was undertaken to map the quality and gaps in the cognitive-behavioural therapy systematic review of randomised controlled trial evidence base. Panoramic meta-analyses were also conducted to identify any across-condition general effects of cognitive-behavioural therapy. Data sources: The overview was designed with cognitive-behavioural therapy patients, clinicians and researchers. The Cochrane Library, MEDLINE, EMBASE, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, Child Development & Adolescent Studies, Database of Abstracts of Reviews of Effects and OpenGrey databases were searched from 1992 to January 2019. Review methods: Study inclusion criteria were as follows: (1) fulfil the Centre for Reviews and Dissemination criteria; (2) intervention reported as cognitive-behavioural therapy or including one cognitive and one behavioural element; (3) include a synthesis of cognitive-behavioural therapy trials; (4) include either health-related quality of life, depression, anxiety or pain outcome; and (5) available in English. Review quality was assessed with A MeaSurement Tool to Assess systematic Reviews (AMSTAR)-2. Reviews were quality assessed and data were extracted in duplicate by two independent researchers, and then mapped according to condition, population, context and quality. The effects from high-quality reviews were pooled within condition groups, using a random-effect panoramic meta-analysis. If the across-condition heterogeneity was I-2 < 75%, we pooled across conditions. Subgroup analyses were conducted for age, delivery format, comparator type and length of follow-up, and a sensitivity analysis was performed for quality. Results: A total of 494 reviews were mapped, representing 68% (27/40) of the categories of the International Classification of Diseases, Eleventh Revision, Mortality and Morbidity Statistics. Most reviews (71%, 351/494) were of lower quality. Research on older adults, using cognitive-behavioural therapy preventatively, ethnic minorities and people living outside Europe, North America or Australasia was limited. Out of 494 reviews, 71 were included in the primary panoramic meta-analyses. A modest effect was found in favour of cognitive-behavioural therapy for health-related quality of life (standardised mean difference 0.23, 95% confidence interval 0.05 to 0.41, prediction interval -0.05 to 0.50, I-2 = 32%), anxiety (standardised mean difference 0.30, 95% confidence interval 0.18 to 0.43, prediction interval -0.28 to 0.88, I-2 = 62%) and pain (standardised mean difference 0.23, 95% confidence interval 0.05 to 0.41, prediction interval -0.28 to 0.74, I-2 = 64%) outcomes. All condition, subgroup and sensitivity effect estimates remained consistent with the general effect. A statistically significant interaction effect was evident between the active and non-active comparator groups for the health-related quality-of-life outcome. A general effect for depression outcomes was not produced as a result of considerable heterogeneity across reviews and conditions. Limitations: Data extraction and analysis were conducted at the review level, rather than returning to the individual trial data. This meant that the risk of bias of the individual trials could not be accounted for, but only the quality of the systematic reviews that synthesised them. Conclusion: Owing to the consistency and homogeneity of the highest-quality evidence, it is proposed that cognitive-behavioural therapy can produce a modest general, across-condition benefit in health-related quality-of-life, anxiety and pain outcomes. Future work: Future research should focus on how the modest effect sizes seen with cognitive-behavioural therapy can be increased, for example identifying alternative delivery formats to increase adherence and reduce dropout, and pursuing novel methods to assess intervention fidelity and quality. Study registration: This study is registered as PROSPERO CRD42017078690.
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A direct-to-public peer support program (Big White Wall) versus web-based information to aid the self-management of depression and anxiety: Results and challenges of an automated randomized controlled trialBackground: Effective help for depression and anxiety reaches a small proportion of people who might benefit from it. The scale of the problem suggests the need for effective, safe web-based public health services delivered directly to the public. One model, the Big White Wall (BWW), offers peer support at low cost. As these interventions are delivered digitally, we tested whether a randomized controlled trial (RCT) intervention could also be fully delivered and evaluated digitally. Objective: This study aims to determine the reach, feasibility, acceptability, baseline costs, and outcomes of a public health campaign for an automated RCT of the BWW, providing digital peer support and information, compared with a standard website used by the National Health Service Moodzone (MZ), to people with probable mild-to-moderate depression and anxiety disorder. The primary outcome was the change in self-rated well-being at 6 weeks, measured using the Warwick-Edinburgh Mental Well-Being Scale. Methods: An 18-month campaign was conducted across Nottinghamshire, the United Kingdom (target population 914,000) to advertise the trial directly to the public through general marketing, web-based and social media sources, health services, other public services, and third-sector groups. The population reach of this campaign was examined by the number of people accessing the study website and self-registering to the study. A pragmatic, parallel-group, single-blind RCT was then conducted using a fully automated trial website in which eligible participants were randomized to receive either 6 months of access to BWW or signposted to MZ. Those eligible for participation were aged >16 years with probable mild-to-moderate depression or anxiety disorders. Results: Of 6483 visitors to the study website, 1510 (23.29%) were eligible. Overall, 790 of 1510 (52.32%) visitors participated. Of 790 visitors, 397 (50.3%) were randomized to BWW and 393 (49.7%) to MZ. Their mean age was 38 (SD 13.8) years, 81.0% (640/790) were female, 93.4% (738/790) were White, and 47.4% (271/572) had no contact with health services in the previous 3 months. We estimated 3-month productivity losses of £1001.01 (95% CI 868.75-1133.27; US $1380.79; 95% CI 1198.35-1563.23) per person for those employed. Only 16.6% (131/790) participants completed the primary outcome assessment. There were no differences in the primary or secondary outcomes between the 2 groups. Conclusions: Most participants reached and those eligible for this trial of digital interventions were White women not in recent contact with health services and whose productivity losses represent a significant annual societal burden. A fully automated RCT recruiting directly from the public failed to recruit and retain sufficient participants to test the clinical effectiveness of this digital intervention, primarily because it did not personally engage participants and explain how these unfamiliar interventions might benefit them.
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Dismantling, optimising, and personalising internet cognitive behavioural therapy for depression: a systematic review and component network meta-analysis using individual participant dataBACKGROUND: 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.
