Maintenance or Discontinuation of Antidepressants in Primary Care.

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.).

Factors that influence participation in physical activity for people with bipolar disorder: a synthesis of qualitative evidence.

BACKGROUND: Mental health problems contribute significantly to the overall disease burden worldwide and are major causes of disability, suicide, and ischaemic heart disease. People with bipolar disorder report lower levels of physical activity than the general population, and are at greater risk of chronic health conditions including cardiovascular disease and obesity. These contribute to poor health outcomes. Physical activity has the potential to improve quality of life and physical and mental well-being. OBJECTIVES: To identify the factors that influence participation in physical activity for people diagnosed with bipolar disorder from the perspectives of service users, carers, service providers, and practitioners to help inform the design and implementation of interventions that promote physical activity. SEARCH METHODS: We searched MEDLINE, PsycINFO, and eight other databases to March 2021. We also contacted experts in the field, searched the grey literature, and carried out reference checking and citation searching to identify additional studies. There were no language restrictions. SELECTION CRITERIA: We included qualitative studies and mixed-methods studies with an identifiable qualitative component. We included studies that focused on the experiences and attitudes of service users, carers, service providers, and healthcare professionals towards physical activity for bipolar disorder. DATA COLLECTION AND ANALYSIS: We extracted data using a data extraction form designed for this review. We assessed methodological limitations using a list of predefined questions. We used the "best fit" framework synthesis based on a revised version of the Health Belief Model to analyse and present the evidence. We assessed methodological limitations using the CASP Qualitative Checklist. We used the GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative research) guidance to assess our confidence in each finding. We examined each finding to identify factors to inform the practice of health and care professionals and the design and development of physical activity interventions for people with bipolar disorder. MAIN RESULTS: We included 12 studies involving a total of 592 participants (422 participants who contributed qualitative data to an online survey, 170 participants in qualitative research studies). Most studies explored the views and experiences of physical activity of people with experience of bipolar disorder. A number of studies also reported on personal experiences of physical activity components of lifestyle interventions. One study included views from family carers and clinicians. The majority of studies were from high-income countries, with only one study conducted in a middle-income country. Most participants were described as stable and had been living with a diagnosis of bipolar disorder for a number of years. We downgraded our confidence in several of the findings from high confidence to moderate or low confidence, as some findings were based on only small amounts of data, and the findings were based on studies from only a few countries, questioning the relevance of these findings to other settings. We also had very few perspectives of family members, other carers, or health professionals supporting people with bipolar disorder. The studies did not include any findings from service providers about their perspectives on supporting this aspect of care. There were a number of factors that limited people's ability to undertake physical activity. Shame and stigma about one's physical appearance and mental health diagnosis were discussed. Some people felt their sporting skills/competencies had been lost when they left school. Those who had been able to maintain exercise through the transition into adulthood appeared to be more likely to include physical activity in their regular routine. Physical health limits and comorbid health conditions limited activity. This included bipolar medication, being overweight, smoking, alcohol use, poor diet and sleep, and these barriers were linked to negative coping skills. Practical problems included affordability, accessibility, transport links, and the weather. Workplace or health schemes that offered discounts were viewed positively. The lack of opportunity for exercise within inpatient mental health settings was a problem. Facilitating factors included being psychologically stable and ready to adopt new lifestyle behaviours. There were positive benefits of being active outdoors and connecting with nature. Achieving balance, rhythm, and routine helped to support mood management. Fitting physical activity into a regular routine despite fluctuating mood or motivation appeared to be beneficial if practised at the right intensity and pace. Over- or under-exercising could be counterproductive and accelerate depressive or manic moods. Physical activity also helped to provide a structure to people's daily routines and could lead to other positive lifestyle benefits. Monitoring physical or other activities could be an effective way to identify potential triggers or early warning signs. Technology was helpful for some. People who had researched bipolar disorder and had developed a better understanding of the condition showed greater confidence in managing their care or providing care to others. Social support from friends/family or health professionals was an enabling factor, as was finding the right type of exercise, which for many people was walking. Other benefits included making social connections, weight loss, improved quality of life, and better mood regulation. Few people had been told of the benefits of physical activity. Better education and training of health professionals could support a more holistic approach to physical and mental well-being. Involving mental health professionals in the multidisciplinary delivery of physical activity interventions could be beneficial and improve care. Clear guidelines could help people to initiate and incorporate lifestyle changes. AUTHORS' CONCLUSIONS: There is very little research focusing on factors that influence participation in physical activity in bipolar disorder. The studies we identified suggest that men and women with bipolar disorder face a range of obstacles and challenges to being active. The evidence also suggests that there are effective ways to promote managed physical activity. The research highlighted the important role that health and care settings, and professionals, can play in assessing individuals' physical health needs and how healthy lifestyles may be promoted. Based on these findings, we have provided a summary of key elements to consider for developing physical activity interventions for bipolar disorder.

Factors associated with low fruit and vegetable consumption among people with severe mental ill health.

Severe mental ill health (SMI) is associated with excess mortality, and poor diet is one associated modifiable risk factor. This study investigated factors associated with low consumption of fruit and vegetables among people with SMI (N = 9914). A total of 8.4% of participants ate no portions per day, while only 15% ate 5 + portions. Individuals who never consumed fruit and vegetables or ate < 5 portions per day were more likely to be male, younger than 65, unemployed, experience poorer general health, or perceive health as unimportant. Poor diet is common among people with SMI and tailored dietary improvement interventions are required.

How do schools influence the emotional and behavioural health of their pupils? A multi-level analysis of 135 schools in the Born in Bradford inner city multi-ethnic birth cohort.

PURPOSE: To estimate variation in emotional and behavioural problems between primary schools in Bradford, an ethnically diverse and relatively deprived city in the UK. METHODS: We did a cross-sectional analysis of data collected from 2017 to 2021 as part of the 'Born In Bradford' birth cohort study. We used multilevel linear regression in which the dependent variable was the Strengths and Difficulties Questionnaire (SDQ) total score, with a random intercept for schools. We adjusted for pupil-level characteristics including age, ethnicity, socioeconomic status, and parental mental health. RESULTS: The study included 5,036 participants from 135 schools. Participants were aged 7-11 years and 56% were of Pakistani heritage. The mean SDQ score was 8.84 out of a maximum 40. We estimated that the standard deviation in school-level scores was 1.41 (95% CI 1.11-1.74) and 5.49% (95% CI 3.19-9.37%) of variation was explained at school level. After adjusting for pupil characteristics, the standard deviation of school-level scores was 1.04 (95% CI 0.76-1.32) and 3.51% (95% CI 1.75-6.18%) of variation was explained at school level. Simulation suggested that a primary school with 396 pupils at the middle of the distribution has 63 pupils (95% CI 49-78) with a 'raised' SDQ score of 15 + /40; and shifting a school from the lower to the upper quartile would prevent 26 cases (95% CI 5-46). CONCLUSION: The prevalence of emotional and behavioural problems varies between schools. This is partially explained by pupil characteristics; though residual variation in adjusted scores may suggest that schools have a differential impact on mental wellbeing.

Health-risk behaviours among people with severe mental ill health: understanding modifiable risk in the Closing the Gap Health Study.

BACKGROUND: People with severe mental ill health (SMI) experience some of the largest health inequalities of any sector within society. For these inequalities to be reduced, an understanding of the behavioural determinants of health in this population is needed. AIMS: Utilising data from the Closing the Gap Health Study, we aimed to assess the extent to which people with SMI report health-risk factors and behaviours, their interest in modifying them, and the factors associated with being motivated to modify these behaviours. METHOD: Adult (≥18 years old) participants were recruited via primary and secondary care in the English National Health Service. To be eligible, participants needed to have a documented diagnosis of schizophrenia, psychotic disorders or bipolar disorder. Data were collected by survey on demographics, general physical health, diet, physical activity, alcohol, smoking and body mass index. RESULTS: Between April 2016 and March 2020, n = 9914 participants were recruited. Among people with SMI, high rates of obesity (37.5%), infrequent physical activity (62.0%), not meeting current guidelines (≥5) for the consumption of fruit and vegetables (85.0%) and smoking (42.2%) were observed. However, most participants were motivated to reduce health-risk behaviours. Perceiving the importance of health-promoting behaviours, being of poorer general health and being female were significantly associated with being motivated to modify health-risk behaviours. CONCLUSIONS: Despite experiencing poor physical and mental health outcomes compared with the general population, and contrary to popular misconceptions, people with SMI perceive health as important and are motivated to make behavioural changes to improve health.

One session treatment (OST) is equivalent to multi-session cognitive behavioral therapy (CBT) in children with specific phobias (ASPECT): results from a national non-inferiority randomized controlled trial.

BACKGROUND: 5%-10% children and young people (CYP) experience specific phobias that impact daily functioning. Cognitive Behaviour Therapy (CBT) is recommended but has limitations. One Session Treatment (OST), a briefer alternative incorporating CBT principles, has demonstrated efficacy. The Alleviating Specific Phobias Experienced by Children Trial (ASPECT) investigated the non-inferiority of OST compared to multi-session CBT for treating specific phobias in CYP. METHODS: ASPECT was a pragmatic, multi-center, non-inferiority randomized controlled trial in 26 CAMHS sites, three voluntary agency services, and one university-based CYP well-being service. CYP aged 7-16 years with specific phobia were randomized to receive OST or CBT. Clinical non-inferiority and a nested cost-effectiveness evaluation was assessed 6-months post-randomization using the Behavioural Avoidance Task (BAT). Secondary outcome measures included the Anxiety Disorder Interview Schedule, Child Anxiety Impact Scale, Revised Children's Anxiety Depression Scale, goal-based outcome measure, and EQ-5DY and CHU-9D, collected blind at baseline and six-months. RESULTS: 268 CYPs were randomized to OST (n = 134) or CBT (n = 134). Mean BAT scores at 6 months were similar across groups in both intention-to-treat (ITT) and per-protocol (PP) populations (CBT: 7.1 (ITT, n = 76), 7.4 (PP, n = 57), OST: 7.4 (ITT, n = 73), 7.6 (PP, n = 56), on the standardized scale-adjusted mean difference for CBT compared to OST -0.123, 95% CI -0.449 to 0.202 (ITT), mean difference -0.204, 95% CI -0.579 to 0.171 (PP)). These findings were wholly below the standardized non-inferiority limit of 0.4, suggesting that OST is non-inferior to CBT. No between-group differences were found on secondary outcomes. OST marginally decreased mean service use costs and maintained similar mean Quality Adjusted Life Years compared to CBT. CONCLUSIONS: One Session Treatment has similar clinical effectiveness to CBT for specific phobias in CYP and may be a cost-saving alternative.

Promoting and Maintaining Changes in Smoking Behavior for Patients Following Discharge from a Smoke-free Mental Health Inpatient Stay: Development of a Complex Intervention Using the Behavior Change Wheel.

INTRODUCTION: Evidence suggests that smokers can successfully quit, remain abstinent or reduce smoking during a smoke-free mental health inpatient stay, provided behavioral/pharmacological support are offered. However, few evidence-based strategies to prevent the return to prehospital smoking behaviors post-discharge exist. AIMS AND METHODS: We report the development of an intervention designed to support smoking-related behavior change following discharge from a smoke-free mental health stay. We followed the Behavior Change Wheel (BCW) intervention development process. The target behavior was supporting patients to change their smoking behaviors following discharge from a smoke-free mental health stay. Using systematic reviews, we identified the barriers and enablers, classified according to the Theoretical Domains Framework (TDF). Potential intervention functions to address key influences were identified by consulting the BCW and Behavior Change Technique (BCT) taxonomy. Another systematic review identified effectiveness of BCTs in this context. Stakeholder consultations were conducted to prioritize and refine intervention content. RESULTS: Barriers and enablers to supporting smoking cessation were identified within the domains of environmental context and resources (lack of staff time); knowledge (ill-informed interactions about smoking); social influences, and intentions (lack of intention to deliver support). Potential strategies to address these influences included goal setting, problem-solving, feedback, social support, and information on health consequences. A strategy for operationalizing these techniques into intervention components was agreed upon: Pre-discharge evaluation sessions, a personalized resource folder, tailored behavioral and text message support post-discharge, and a peer interaction group, delivered by a trained mental health worker. CONCLUSIONS: The intervention includes targeted resources to support smoking-related behavior change in patients following discharge from a smoke-free mental health setting. IMPLICATIONS: Using the BCW and TDF supported a theoretically and empirically informed process to define and develop a tailored intervention that acknowledges barriers and enablers to supporting smoking cessation in mental health settings. The result is a novel complex theory- and evidence-based intervention that will be formally tested in a randomized controlled feasibility study.

An economic evaluation of universal and targeted case-finding strategies for identifying antenatal depression: a model-based analysis comparing common case-finding instruments.

Half of women with depression in the perinatal period are not identified in routine care, and missed cases reflect inequalities in other areas of maternity care. Case finding (screening) for depression in pregnant women may be a cost-effective strategy to improve identification, and targeted case finding directs finite resources towards the greatest need. We compared the cost-effectiveness of three case-finding strategies: no case finding, universal (all pregnant women), and targeted (only pregnant women with risk factors for antenatal depression, i.e. history of anxiety/depression, age < 20 years, and adverse life events). A decision tree model was developed to represent case finding (at around 20 weeks gestation) and subsequent treatment for antenatal depression (up to 40 weeks gestation). Costs include case finding and treatment. Health benefits are measured as quality-adjusted life years (QALYs). The sensitivity and specificity of case-finding instruments and prevalence and severity of antenatal depression were estimated from a cohort study of pregnant women. Other model parameters were derived from published literature and expert consultation. The most cost-effective case-finding strategy was a two-stage strategy comprising the Whooley questions followed by the PHQ-9. The mean costs were £52 (universal), £61 (no case finding), and £62 (targeted case finding). Both case-finding strategies improve health compared with no case finding. Universal case finding is cost-saving. Costs associated with targeted case finding are similar to no case finding, with greater health gains, although targeted case finding is not cost-effective compared with universal case finding. Universal case finding for antenatal depression is cost-saving compared to no case finding and more cost-effective than targeted case finding.

Development of a Supported Self-management Intervention for People With Severe Mental Illness and Type 2 Diabetes: Theory and Evidence-Based Co-design Approach.

BACKGROUND: Type 2 diabetes is 2 to 3 times more common among people with severe mental illness (SMI). Self-management is crucial, with additional challenges faced by people with SMI. Therefore, it is essential that any diabetes self-management program for people with SMI addresses the unique needs of people living with both conditions and the inequalities they experience within health care services. OBJECTIVE: We combined theory, empirical evidence, and co-design approaches to develop a type 2 diabetes self-management intervention for people with SMI. METHODS: The development process encompassed 4 steps: step 1 involved prioritizing the mechanisms of action (MoAs) and behavior change techniques (BCTs) for the intervention. Using findings from primary qualitative research and systematic reviews, we selected candidate MoAs to target in the intervention and candidate BCTs to use. Expert stakeholders then ranked these MoAs and BCTs using a 2-phase survey. The average scores were used to generate a prioritized list of MoAs and BCTs. During step 2, we presented the survey results to an expert consensus workshop to seek expert agreement with the definitive list of MoAs and BCTs for the intervention and identify potential modes of delivery. Step 3 involved the development of trigger films using the evidence from steps 1 and 2. We used animations to present the experiences of people with SMI managing diabetes. These films were used in step 4, where we used a stakeholder co-design approach. This involved a series of structured workshops, where the co-design activities were informed by theory and evidence. RESULTS: Upon the completion of the 4-step process, we developed the DIAMONDS (diabetes and mental illness, improving outcomes and self-management) intervention. It is a tailored self-management intervention based on the synthesis of the outputs from the co-design process. The intervention incorporates a digital app, a paper-based workbook, and one-to-one coaching designed to meet the needs of people with SMI and coexisting type 2 diabetes. CONCLUSIONS: The intervention development work was underpinned by the MoA theoretical framework and incorporated systematic reviews, primary qualitative research, expert stakeholder surveys, and evidence generated during co-design workshops. The intervention will now be tested for feasibility before undergoing a definitive evaluation in a pragmatic randomized controlled trial.

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

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.

Healthcare resource use and costs for people with type 2 diabetes mellitus with and without severe mental illness in England: longitudinal matched-cohort study using the Clinical Practice Research Datalink.

BACKGROUND: Approximately 60 000 people in England have coexisting type 2 diabetes mellitus (T2DM) and severe mental illness (SMI). They are more likely to have poorer health outcomes and require more complex care pathways compared with those with T2DM alone. Despite increasing prevalence, little is known about the healthcare resource use and costs for people with both conditions. AIMS: To assess the impact of SMI on healthcare resource use and service costs for adults with T2DM, and explore the predictors of healthcare costs and lifetime costs for people with both conditions. METHOD: This was a matched-cohort study using data from the Clinical Practice Research Datalink linked to Hospital Episode Statistics for 1620 people with comorbid SMI and T2DM and 4763 people with T2DM alone. Generalised linear models and the Bang and Tsiatis method were used to explore cost predictors and mean lifetime costs respectively. RESULTS: There were higher average annual costs for people with T2DM and SMI (£1930 higher) than people with T2DM alone, driven primarily by mental health and non-mental health-related hospital admissions. Key predictors of higher total costs were older age, comorbid hypertension, use of antidepressants, use of first-generation antipsychotics, and increased duration of living with both conditions. Expected lifetime costs were approximately £35 000 per person with both SMI and T2DM. Extrapolating nationally, this would generate total annual costs to the National Health Service of around £250 m per year. CONCLUSIONS: Our estimates of resource use and costs for people with both T2DM and SMI will aid policymakers and commissioners in service planning and resource allocation.

Predicting relapse or recurrence of depression: systematic review of prognostic models.

BACKGROUND: Relapse and recurrence of depression are common, contributing to the overall burden of depression globally. Accurate prediction of relapse or recurrence while patients are well would allow the identification of high-risk individuals and may effectively guide the allocation of interventions to prevent relapse and recurrence. AIMS: To review prognostic models developed to predict the risk of relapse, recurrence, sustained remission, or recovery in adults with remitted major depressive disorder. METHOD: 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 2021. We included development and external validation studies of multivariable prognostic models. We assessed risk of bias of included studies using the Prediction model risk of bias assessment tool (PROBAST). RESULTS: We identified 12 eligible prognostic model studies (11 unique prognostic models): 8 model development-only studies, 3 model development and external validation studies and 1 external validation-only study. Multiple estimates of performance measures were not available and meta-analysis was therefore not necessary. Eleven out of the 12 included studies were assessed as being at high overall risk of bias and none examined clinical utility. CONCLUSIONS: Due to high risk of bias of the included studies, poor predictive performance and limited external validation of the models identified, presently available clinical prediction models for relapse and recurrence of depression are not yet sufficiently developed for deploying in clinical settings. There is a need for improved prognosis research in this clinical area and future studies should conform to best practice methodological and reporting guidelines.

How much change is enough? Evidence from a longitudinal study on depression in UK primary care.

BACKGROUND: The Patient Health Questionnaire (PHQ-9), the Beck Depression Inventory (BDI-II) and the Generalised Anxiety Disorder Assessment (GAD-7) are widely used in the evaluation of interventions for depression and anxiety. The smallest reduction in depressive symptoms that matter to patients is known as the Minimum Clinically Important Difference (MCID). Little empirical study of the MCID for these scales exists. METHODS: A prospective cohort of 400 patients in UK primary care were interviewed on four occasions, 2 weeks apart. At each time point, participants completed all three questionnaires and a 'global rating of change' scale (GRS). MCID estimation relied on estimated changes in symptoms according to reported improvement on the GRS scale, stratified by baseline severity on the Clinical Interview Schedule (CIS-R). RESULTS: For moderate baseline severity, those who reported improvement on the GRS had a reduction of 21% (95% confidence interval (CI) -26.7 to -14.9) on the PHQ-9; 23% (95% CI -27.8 to -18.0) on the BDI-II and 26.8% (95% CI -33.5 to -20.1) on the GAD-7. The corresponding threshold scores below which participants were more likely to report improvement were -1.7, -3.5 and -1.5 points on the PHQ-9, BDI-II and GAD-7, respectively. Patients with milder symptoms require much larger reductions as percentage of their baseline to endorse improvement. CONCLUSIONS: An MCID representing 20% reduction of scores in these scales, is a useful guide for patients with moderately severe symptoms. If treatment had the same effect on patients irrespective of baseline severity, those with low symptoms are unlikely to notice a benefit. FUNDING: Funding. National Institute for Health Research.

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

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.

Behavioral Activation in Nursing Homes to Treat Depression (BAN-Dep): Results From a Clustered, Randomized, Single-Blinded, Controlled Clinical Trial.

OBJECTIVES: To determine if behavioral activation (BA) delivered by trained staff decreases prevalence of clinically significant symptoms of depression among older adults living in residential aged care facilities (RACFs). METHODS: Clustered, randomized, single-blinded, controlled trial of BA for adults aged over 60 years living permanently in a RACF with symptoms of depression (Patient Health Questionnaire, PHQ-9 ≥ 5). BA was delivered over 8-12 weeks using a structured workbook. The proportion of residents with PHQ-9 ≥ 10 at weeks 12, 26, and 52, as well as anxiety symptoms (GAD-7), physical (PCS), and mental (MCS) quality of life, loneliness, and loss to follow-up were main outcomes of interest RESULTS: We recruited 54 RACFs (26 intervention) and 188 of their residents (89 intervention). Participants were aged 61-100 years and 132 (70.2%) were women. PHQ-9 ≥ 10 interacted with BA at week 12 (OR = 0.34, 95%CI = 0.11-1.07), but differences between the groups were not statistically significant at any time-point. GAD-7 ≥ 10 interacted with BA at week 26 (OR = 0.12, 95%CI = 0.02-0.58), but not at any other time-point. Overall, the intervention had no effect on the scores of the PHQ-9, GAD-7, PCS, MCS, and loneliness scale. Loss to follow-up was similar between groups. Adherence to all stages of the intervention was poor (36.2%). CONCLUSIONS: Disruption by the COVID-19 pandemic and staffing issues in RACFs undermined recruitment and adherence. In such a context, a BA program delivered by RACF staff was not associated with better mental health outcomes for residents over 52 weeks.

Cost and effectiveness of one session treatment (OST) for children and young people with specific phobias compared to multi-session cognitive behavioural therapy (CBT): results from a randomised controlled trial.

BACKGROUND: In the UK, around 93,000 (0.8%) children and young people (CYP) are experiencing specific phobias that have a substantial impact on daily life. The current gold-standard treatment-multi-session cognitive behavioural therapy (CBT) - is effective at reducing specific phobia severity; however, CBT is time consuming, requires specialist CBT therapists, and is often at great cost and limited availability. A briefer variant of CBT called one session treatment (OST) has been found to offer similar clinical effectiveness for specific phobia as multi-session CBT. The aim of this study was to assess the cost-effectiveness of OST compared to multi-session CBT for CYP with specific phobias through the Alleviating Specific Phobias Experienced by Children Trial (ASPECT), a two-arm, pragmatic, multi-centre, non-inferiority randomised controlled trial. METHODS: CYP aged seven to 16 years with specific phobias were recruited nationally via Health and Social Care pathways, remotely randomised to the intervention group (OST) or the control group (CBT-based therapies) and analysed (n = 267). Resource use based on NHS and personal social services perspective and quality adjusted life years (QALYs) measured by EQ-5D-Y were collected at baseline and at six-month follow-up. Incremental cost-effectiveness ratio (ICER) was calculated, and non-parametric bootstrapping was conducted to capture the uncertainty around the ICER estimates. The results were presented on a cost-effectiveness acceptability curve (CEAC). A set of sensitivity analyses (including taking a societal perspective) were conducted to assess the robustness of the primary findings. RESULTS: After adjustment and bootstrapping, on average CYP in the OST group incurred less costs (incremental cost was -£302.96 (95% CI -£598.86 to -£28.61)) and maintained similar improvement in QALYs (QALYs gained 0.002 (95% CI - 0.004 to 0.008)). The CEAC shows that the probability of OST being cost-effective was over 95% across all the WTP thresholds. Results of a set of sensitivity analyses were consistent with the primary outcomes. CONCLUSION: Compared to CBT, OST produced a reduction in costs and maintained similar improvement in QALYs. Results from both primary and sensitivity analyses suggested that OST was highly likely to be cost saving. TRIAL REGISTRATION: ISRCTN19883421 (30/11/2016).

Out of pocket expenses in obsessive compulsive disorder.

BACKGROUND: Despite anecdotal evidence that the out of pocket costs of OCD can be substantial in some cases, there is no evidence on how many people they affect, or the magnitude of these costs. AIMS: This paper explores the type and quantity of out of pocket expenses reported by a large sample of adults with OCD. METHODS: Data on out of pocket expenses were collected from participants taking part in the OCTET multi-centre randomised controlled trial. Participants were aged 18+, meeting DSM-IV criteria for OCD, and scoring 16+ on the Yale Brown Obsessive Compulsive Scale. Individual-level resource use data including a description and estimated cost of out of pocket expenses were measured using an adapted version of the Adult Service Use Schedule (AD-SUS): a questionnaire used to collect data on resource use. RESULTS: Forty-five percent (208/465) reported out of pocket expenses due to their OCD. The mean cost of out of pocket expenses was £19.19 per week (SD £27.56 SD), range £0.06-£224.00. CONCLUSIONS: Future economic evaluations involving participants with OCD should include out of pocket expenses, but careful consideration of alternative approaches to the collection and costing of this data is needed.

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

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.

The digital divide: amplifying health inequalities for people with severe mental illness in the time of COVID-19.

During COVID-19, health provision and information resources have been increasingly provided via digital means (e.g. websites, apps) and this will become a standard practice beyond the pandemic. People with severe mental illness face profound health inequalities (e.g. a >20-year mortality gap). Digital exclusion puts this population at risk of heightened or compounded inequalities. This has been referred to as the 'digital divide'. For any new digital means introduced in clinical practice to augment healthcare service provision, issues of accessibility, acceptability and usability should be addressed by researchers and developers early in the design phase, and prior to full implementation, to prevent digital exclusion.

Smoking cessation in severe mental illness: combined long-term quit rates from the UK SCIMITAR trials programme.

Smoking contributes to health inequalities for people with severe mental illness (SMI). Although smoking cessation interventions are effective in the short term, there are few long-term trial-based estimates of abstinence. The SCIMITAR trials programme includes the largest trial to date of a smoking cessation intervention for people with SMI, but this was underpowered to detect anticipated long-term quit rates. By pooling pilot and full-trial data we found that quit rates were maintained at 12 months (OR = 1.67, 95% CI 1.02-2.73, P = 0.04). Policymakers can now be confident that bespoke smoking cessation interventions produce successful short- and long-term quitting.