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.

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.

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.

How should we implement collaborative care for older people with depression? A qualitative study using normalisation process theory within the CASPER plus trial.

BACKGROUND: Depression in older people may have a prevalence as high as 20%, and is associated with physical co-morbidities, loss, and loneliness. It is associated with poorer health outcomes and reduced quality of life, and is under-diagnosed and under-treated. Older people may find it difficult to speak to their GPs about low mood, and GPs may avoid identifying depression due to limited consultation time and referral options for older patients. METHODS: A qualitative study nested within a randomised controlled trial for older people with moderate to severe depression: the CASPER plus Trial (Care for Screen Positive Elders). We interviewed patient participants, GPs, and case managers (CM) to explore patients' and professionals' views on collaborative care developed for older people, and how this model could be implemented at scale. Transcripts were analysed thematically using normalization process theory. RESULTS: Thirty-three interviews were conducted. Across the three data-sets, four main themes were identified based on the main principles of the Normalization Process Theory: understanding of collaborative care, interaction between patients and professionals, liaison between GPs and case managers, and the potential for implementation. CONCLUSIONS: A telephone-delivered intervention, incorporating behavioural activation, is acceptable to older people with depression, and is deliverable by case managers. The collaborative care framework makes sense to case managers and has the potential to optimize patient outcomes, but implementation requires integration in day to day general practice. Increasing GPs' understanding of collaborative care might improve liaison and collaboration with case managers, and facilitate the intervention through better support of patients. The CASPER plus model, delivering therapy to older adults with depression by telephone, offers the potential for implementation in a resource-poor health service.

Effect of Collaborative Care vs Usual Care on Depressive Symptoms in Older Adults With Subthreshold Depression: The CASPER Randomized Clinical Trial.

Importance: There is little evidence to guide management of depressive symptoms in older people. Objective: To evaluate whether a collaborative care intervention can reduce depressive symptoms and prevent more severe depression in older people. Design, Setting, and Participants: Randomized clinical trial conducted from May 24, 2011, to November 14, 2014, in 32 primary care centers in the United Kingdom among 705 participants aged 65 years or older with Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) subthreshold depression; participants were followed up for 12 months. Interventions: Collaborative care (n=344) was coordinated by a case manager who assessed functional impairments relating to mood symptoms. Participants were offered behavioral activation and completed an average of 6 weekly sessions. The control group received usual primary care (n=361). Main Outcomes and Measures: The primary outcome was self-reported depression severity at 4-month follow-up on the 9-item Patient Health Questionnaire (PHQ-9; score range, 0-27). Included among 10 prespecified secondary outcomes were the PHQ-9 score at 12-month follow-up and the proportion meeting criteria for depressive disorder (PHQ-9 score ≥10) at 4- and 12-month follow-up. Results: The 705 participants were 58% female with a mean age of 77 (SD, 7.1) years. Four-month retention was 83%, with higher loss to follow-up in collaborative care (82/344 [24%]) vs usual care (37/361 [10%]). Collaborative care resulted in lower PHQ-9 scores vs usual care at 4-month follow-up (mean score with collaborative care, 5.36 vs with usual care, 6.67; mean difference, -1.31; 95% CI, -1.95 to -0.67; P < .001). Treatment differences remained at 12 months (mean PHQ-9 score with collaborative care, 5.93 vs with usual care, 7.25; mean difference, -1.33; 95% CI, -2.10 to -0.55). The proportions of participants meeting criteria for depression at 4-month follow-up were 17.2% (45/262) vs 23.5% (76/324), respectively (difference, -6.3% [95% CI, -12.8% to 0.2%]; relative risk, 0.83 [95% CI, 0.61-1.27]; P = .25) and at 12-month follow-up were 15.7% (37/235) vs 27.8% (79/284) (difference, -12.1% [95% CI, -19.1% to -5.1%]; relative risk, 0.65 [95% CI, 0.46-0.91]; P = .01). Conclusions and Relevance: Among older adults with subthreshold depression, collaborative care compared with usual care resulted in a statistically significant difference in depressive symptoms at 4-month follow-up, of uncertain clinical importance. Although differences persisted through 12 months, findings are limited by attrition, and further research is needed to assess longer-term efficacy. Trial Registration: isrctn.org Identifier: ISRCTN02202951.

Revealing hidden depression in older people: a qualitative study within a randomised controlled trial.

BACKGROUND: The prevalence of depressive symptoms in older people may be as high as 20 %. Depression in older people is associated with loss, loneliness and physical co-morbidities; it is known to be under-diagnosed and under-treated. Older people may find it difficult to speak to their GPs about low mood, and GPs may avoid identifying depression due to limited consultation time and referral options for older patients. METHODS: A nested qualitative study in a randomised controlled trial for older people with moderate to severe depression: the CASPER Plus Trial (Collaborative Care for Screen Positive Elders). We interviewed GPs, case managers (CM) and patient participants to explore perspectives and experiences of delivering and receiving a psychosocial intervention, developed specifically for older adults in primary care, within a collaborative care framework. Transcripts were analysed thematically using principles of constant comparison. RESULTS: Thirty three interviews were conducted and, across the three data-sets, four main themes were identified: revealing hidden depression, reducing the 'blind spots', opportunity to talk outside the primary care consultation and 'moving on' from depression. CONCLUSIONS: Depression in older people is commonly hidden, and may coexist with physical conditions that are prioritised by both patients and GPs. Being invited to participate in a trial about depression may allow older people to disclose their feelings, name the problem, and seek help. Offering older people an opportunity to talk outside the primary care consultation is valued by patients and GPs. A psychosocial intervention delivered by a case manager in the primary care setting may fill the gap in the care of older people with depression. TRIAL REGISTRATION: Current Controlled Trials ISRCTN45842879 .

Behavioural activation to mitigate the psychological impacts of COVID-19 restrictions on older people in England and Wales (BASIL+): a pragmatic randomised controlled trial.

BACKGROUND: Older adults were more likely to be socially isolated during the COVID-19 pandemic, with increased risk of depression and loneliness. We aimed to investigate whether a behavioural activation intervention delivered via telephone could mitigate depression and loneliness in at-risk older people during the COVID-19 pandemic. METHODS: BASIL+ (Behavioural Activation in Social Isolation) was a pragmatic randomised controlled trial conducted among patients recruited from general practices in England and Wales, and was designed to assess the effectiveness of behavioural activation in mitigating depression and loneliness among older people during the COVID-19 pandemic. Eligible participants were aged 65 years and older, socially isolated, with a score of 5 or higher on the Patient Health Questionnaire-9 (PHQ-9), and had multiple long-term conditions. Participants were allocated in a 1:1 ratio to the intervention (behavioural activation) or control groups by use of simple randomisation without stratification. Behavioural activation was delivered by telephone; participants were offered up to eight weekly sessions with trained BASIL+ Support Workers. Behavioural activation was adapted to maintain social connections and encourage socially reinforcing activities. Participants in the control group received usual care with existing COVID-19 wellbeing resources. The primary clinical outcome was self-reported depression severity, assessed by the PHQ-9, at 3 months. Outcomes were assessed masked to allocation and analysis was by treatment allocation. This trial is registered with the ISRCTN registry (ISRCTN63034289). FINDINGS: Between Feb 8, 2021, and Feb 28, 2022, 449 eligible participants were identified and 435 from 26 general practices were recruited and randomly assigned (1:1) to the behavioural activation intervention (n=218) or to the control group (usual care with signposting; n=217). The mean age of participants was 75·7 years (SD 6·7); 270 (62·1%) of 435 participants were female, and 418 (96·1%) were White. Participants in the intervention group attended an average of 5·2 (SD 2·9) of eight remote behavioural activation sessions. The adjusted mean difference in PHQ-9 scores between the control and intervention groups at 3 months was -1·65 (95% CI -2·54 to -0·75, p=0·0003). No adverse events were reported that were attributable to the behavioural activation intervention. INTERPRETATION: Behavioural activation is an effective and potentially scalable intervention that can reduce symptoms of depression and emotional loneliness in at-risk groups in the short term. The findings of this trial add to the range of strategies to improve the mental health of older adults with multiple long-term conditions. These results can be helpful to policy makers beyond the pandemic in reducing the global burden of depression and addressing the health impacts of loneliness, particularly in at-risk groups. FUNDING: UK National Institute for Health and Care Research.

Acceptability of a behavioural intervention to mitigate the psychological impacts of COVID-19 restrictions in older people with long-term conditions: a qualitative study.

OBJECTIVES: The COVID-19 pandemic heightened the need to address loneliness, social isolation and associated incidence of depression among older adults. Between June and October 2020, the Behavioural Activation in Social IsoLation (BASIL) pilot study investigated the acceptability and feasibility of a remotely delivered brief psychological intervention (behavioural cctivation) to prevent and reduce loneliness and depression in older people with long-term conditions during the COVID-19 pandemic. DESIGN: An embedded qualitative study was conducted. Semi-structured interviews generated data that was analysed inductively using thematic analysis and then deductively using the theoretical framework of acceptability (TFA). SETTING: NHS and third sector organisations in England. PARTICIPANTS: Sixteen older adults and nine support workers participating in the BASIL pilot study. RESULTS: Acceptability of the intervention was high across all constructs of the TFA: Older adults and BASIL Support Workers described a positive Affective Attitude towards the intervention linked to altruism, however the activity planning aspect of the intervention was limited due to COVID-19 restrictions. A manageable Burden was involved with delivering and participating in the intervention. For Ethicality, older adults valued social contact and making changes, support workers valued being able to observe those changes. The intervention was understood by older adults and support workers, although less understanding in older adults without low mood (Intervention Coherence). Opportunity Cost was low for support workers and older adults. Behavioural Activation was perceived to be useful in the pandemic and likely to achieve its aims (Perceived Effectiveness), especially if tailored to people with both low mood and long-term conditions. Self-efficacy developed over time and with experience for both support workers and older adults. CONCLUSIONS: Overall, BASIL pilot study processes and the intervention were acceptable. Use of the TFA provided valuable insights into how the intervention was experienced and how the acceptability of study processes and the intervention could be enhanced ahead of the larger definitive trial (BASIL+).

Self-Help Plus for refugees and asylum seekers: an individual participant data meta-analysis.

QUESTION: Refugees and asylum seekers are at high risk of mental disorders due to various stressors before, during and after forceful displacement. The WHO Self-Help Plus (SH+) intervention was developed to manage psychological distress and a broad range of mental health symptoms in vulnerable populations. This study aimed to examine the effects and moderators of SH+ compared with Enhanced Care as Usual (ECAU) in reducing depressive symptoms among refugees and asylum seekers. STUDY SELECTION AND ANALYSIS: Three randomised trials were identified with 1795 individual participant data (IPD). We performed an IPD meta-analysis to estimate the effects of SH+, primarily on depressive symptoms and second on post-traumatic stress, well-being, self-identified problems and functioning. Effects were also estimated at 5-6 months postrandomisation (midterm). FINDINGS: There was no evidence of a difference between SH+ and ECAU+ in reducing depressive symptoms at postintervention. However, SH+ had significantly larger effects among participants who were not employed (ß=1.60, 95% CI 0.20 to 3.00) and had lower mental well-being levels (ß=0.02, 95% CI 0.001 to 0.05). At midterm, SH+ was significantly more effective than ECAU in improving depressive symptoms (ß=-1.13, 95% CI -1.99 to -0.26), self-identified problems (ß=-1.56, 95% CI -2.54 to -0.59) and well-being (ß=6.22, 95% CI 1.60 to 10.90). CONCLUSIONS: Although SH+ did not differ significantly from ECAU in reducing symptoms of depression at postintervention, it did present benefits for particularly vulnerable participants (ie, unemployed and with lower mental well-being levels), and benefits were also evident at midterm follow-up. These results are promising for the use of SH+ in the management of depressive symptoms and improvement of well-being and self-identified problems among refugees and asylum seekers.

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

BACKGROUND AND AIMS: People with severe mental ill health smoke more and suffer greater smoking-related morbidity and mortality. Little is known about the effectiveness of behavioural interventions for smoking cessation in this group. This review evaluated randomized controlled trial evidence to measure the effectiveness of behavioural smoking cessation interventions (both digital and non-digital) in people with severe mental ill health. DESIGN: Systematic review and random-effects meta-analysis. We searched between inception and January 2020 in Medline, EMBASE, PsycINFO, CINAHL, Health Management Information Consortium and CENTRAL databases. SETTING AND PARTICIPANTS: Randomized controlled trials (RCTs) assessing the effects of behavioural smoking cessation and reduction interventions in adults with severe mental ill health, conducted in any country, in either in-patient or community settings and published in English. MEASUREMENTS: The primary outcome was biochemically verified smoking cessation. Smoking reduction and changes in mental health symptoms and body mass index (BMI) were included as secondary outcomes. Narrative data synthesis and meta-analysis were conducted and the quality of included studies was appraised using the risk of bias 2 (RoB2) tool. FINDINGS: We included 12 individual studies (16 articles) involving 1861 participants. The first meta-analysis (three studies, 921 participants) demonstrated effectiveness of bespoke face-to-face interventions compared with usual care across all time-points [medium-term: relative risk (RR) = 2.29, 95% confidence interval (CI) = 1.38-3.81; long-term: RR = 1.58, 95% CI = 1.09-2.30]. The second (three studies, 275 participants) did not demonstrate any difference in effectiveness of bespoke digital on-line interventions compared with standard digital on-line interventions (medium-term: RR = 0.87, 95% CI = 0.17-4.46). A narrative overview revealed mixed results when comparing bespoke face-to-face interventions with other active interventions. The methodological quality of studies was mixed, with the majority having some concerns mainly around risk of selective reporting. CONCLUSIONS: Face-to-face bespoke smoking cessation interventions for adults with severe mental ill health appear to be effective when compared with treatment as usual, but evidence is equivocal when compared with other active interventions. There is limited evidence comparing bespoke digital interventions with generic interventions, and we found no studies comparing them with usual treatment.

The feasibility and acceptability of a brief psychological intervention for adults with long-term health conditions and subthreshold depression delivered via community pharmacies: a mixed methods evaluation-the Community Pharmacies Mood Intervention Study (CHEMIST).

BACKGROUND: Adults with long-term health conditions (LTCs) are more likely to experience depressive symptoms which can worsen health outcomes and quality of life, and increase healthcare costs. Subthreshold depression may go undetected and/or untreated. The Community Pharmacies Mood Intervention Study (CHEMIST) explored whether community pharmacies represent a suitable setting to offer brief psychological support to people with LTCs and comorbid subthreshold depression. METHODS: A feasibility intervention study with a nested mixed methods evaluation was employed. Adults with subthreshold depression and a minimum of one LTC were recruited from community pharmacies/local general practices and offered a brief psychological support intervention ('Enhanced Support Intervention' (ESI)), based on behavioural activation within a Collaborative Care framework. The intervention included up to six sessions supported by pharmacy staff ('ESI facilitators') trained to deliver the ESI within the community pharmacy setting. Recruitment, retention rates and engagement with the ESI were assessed. Semi-structured, one-to-one interviews with pharmacy staff and study participants, and a focus group with pharmacy staff, explored experiences and acceptability of the study and the ESI. Themes were mapped onto constructs of the Theoretical Framework of Acceptability. RESULTS: Recruitment of ESI participants was challenging and slower than anticipated despite the varied methods of recruitment employed; although, this was useful in identifying barriers and enabling factors for participation. Engagament with the ESI was good with n=17 (71%) recruited participants commencing the ESI. The ESI was found to be acceptable to participants and ESI facilitators. Retention rate at 4 months was good n=20 (87.0%). The main barriers to identifying potential participants for pharmacy staff were lack of time, resources and limited experience in research. The ESI training and support manual were acceptable to ESI facilitators. The ESI and supporting patient workbook were acceptable to people with LTCs and subthreshold depression. CONCLUSIONS: Community pharmacies were viewed as an acceptable setting in which to deliver preventative brief psychological support to people with LTCs at risk of depression. This feasibility study provided important data to inform the design of a pilot randomised controlled trial in this setting and highlighted important considerations for future pharmacy-based research. TRIAL REGISTRATION: ISRCTN11290592.

Behavioural Activation for Social IsoLation (BASIL+) trial (Behavioural activation to mitigate depression and loneliness among older people with long-term conditions): Protocol for a fully-powered pragmatic randomised controlled trial.

INTRODUCTION: Depression is a leading mental health problem worldwide. People with long-term conditions are at increased risk of experiencing depression. The COVID-19 pandemic led to strict social restrictions being imposed across the UK population. Social isolation can have negative consequences on the physical and mental wellbeing of older adults. In the Behavioural Activation in Social IsoLation (BASIL+) trial we will test whether a brief psychological intervention (based on Behavioural Activation), delivered remotely, can mitigate depression and loneliness in older adults with long-term conditions during isolation. METHODS: We will conduct a two-arm, parallel-group, randomised controlled trial across several research sites, to evaluate the clinical and cost-effectiveness of the BASIL+ intervention. Participants will be recruited via participating general practices across England and Wales. Participants must be aged ≥65 with two or more long-term conditions, or a condition that may indicate they are within a 'clinically extremely vulnerable' group in relation to COVID-19, and have scored ≥5 on the Patient Health Questionnaire (PHQ9), to be eligible for inclusion. Randomisation will be 1:1, stratified by research site. Intervention participants will receive up to eight intervention sessions delivered remotely by trained BASIL+ Support Workers and supported by a self-help booklet. Control participants will receive usual care, with additional signposting to reputable sources of self-help and information, including advice on keeping mentally and physically well. A qualitative process evaluation will also be undertaken to explore the acceptability of the BASIL+ intervention, as well as barriers and enablers to integrating the intervention into participants' existing health and care support, and the impact of the intervention on participants' mood and general wellbeing in the context of the COVID-19 restrictions. Semi-structured interviews will be conducted with intervention participants, participant's caregivers/supportive others and BASIL+ Support Workers. Outcome data will be collected at one, three, and 12 months post-randomisation. Clinical and cost-effectiveness will be evaluated. The primary outcome is depressive symptoms at the three-month follow up, measured by the PHQ9. Secondary outcomes include loneliness, social isolation, anxiety, quality of life, and a bespoke health services use questionnaire. DISCUSSION: This study is the first large-scale trial evaluating a brief Behavioural Activation intervention in this population, and builds upon the results of a successful external pilot trial. TRIAL REGISTRATION: ClinicalTrials.Gov identifier ISRCTN63034289, registered on 5th February 2021.

Can we mitigate the psychological impacts of social isolation using behavioural activation? Long-term results of the UK BASIL urgent public health COVID-19 pilot randomised controlled trial and living systematic review.

BACKGROUND: Behavioural and cognitive interventions remain credible approaches in addressing loneliness and depression. There was a need to rapidly generate and assimilate trial-based data during COVID-19. OBJECTIVES: We undertook a parallel pilot RCT of behavioural activation (a brief behavioural intervention) for depression and loneliness (Behavioural Activation in Social Isolation, the BASIL-C19 trial ISRCTN94091479). We also assimilate these data in a living systematic review (PROSPERO CRD42021298788) of cognitive and/or behavioural interventions. METHODS: Participants (≥65 years) with long-term conditions were computer randomised to behavioural activation (n=47) versus care as usual (n=49). Primary outcome was PHQ-9. Secondary outcomes included loneliness (De Jong Scale). Data from the BASIL-C19 trial were included in a metanalysis of depression and loneliness. FINDINGS: The 12 months adjusted mean difference for PHQ-9 was -0.70 (95% CI -2.61 to 1.20) and for loneliness was -0.39 (95% CI -1.43 to 0.65).The BASIL-C19 living systematic review (12 trials) found short-term reductions in depression (standardised mean difference (SMD)=-0.31, 95% CI -0.51 to -0.11) and loneliness (SMD=-0.48, 95% CI -0.70 to -0.27). There were few long-term trials, but there was evidence of some benefit (loneliness SMD=-0.20, 95% CI -0.40 to -0.01; depression SMD=-0.20, 95% CI -0.47 to 0.07). DISCUSSION: We delivered a pilot trial of a behavioural intervention targeting loneliness and depression; achieving long-term follow-up. Living meta-analysis provides strong evidence of short-term benefit for loneliness and depression for cognitive and/or behavioural approaches. A fully powered BASIL trial is underway. CLINICAL IMPLICATIONS: Scalable behavioural and cognitive approaches should be considered as population-level strategies for depression and loneliness on the basis of a living systematic review.

Remote data collection during COVID-19 restrictions: an example from a refugee and asylum-seeker participant group in the UK.

This article describes how one trial site of the Refugee Emergency: Defining and Implementing Novel Evidence-based psychosocial interventions (RE-DEFINE) study, designed to evaluate a Self Help+ intervention with Arabic-speaking refugees and asylum seekers currently living in the UK and experiencing stress, was adapted to accommodate social distancing rules and working from home during the COVID-19 restrictions. Digital divide, risk and safety management, acceptability of remote data collection and practical considerations are described. The adaptions to methods have practical implications for researchers looking for more flexible approaches in response to continuing restrictions resulting from COVID-19, and the authors believe that others could adopt such an approach. The need for a further acceptability study focusing on human and economic costs and benefits of telephone and video as an alternative to face-to-face data collection is indicated. TRIALS REGISTRATION: Refugee Emergency - Defining and Implementing Novel Evidence-based psychosocial interventions RE-DEFINE. (Trials registration numbers NCT03571347 , NCT03587896 ) https://doi.org/10.1136/bmjopen-2019-030259 (2019).

Self-help plus for refugees and asylum seekers; study protocol for a series of individual participant data meta-analyses.

Background: Refugees and asylum seekers face various stressors due to displacement and are especially vulnerable to common mental disorders. To effectively manage psychological distress in this population, innovative interventions are required. The World Health Organization (WHO) Self-Help Plus (SH+) intervention has shown promising outcomes in reducing symptoms of common mental disorders among refugees and asylum seekers. However, individual participant differences in response to SH+ remain largely unknown. The Individual Participant Data (IPD) meta-analysis synthesizes raw datasets of trials to provide cutting-edge evidence of outcomes that cannot be examined by conventional meta-analytic approaches. Objectives: This protocol outlines the methods of a series of IPD meta-analyses aimed at examining the effects and potential moderators of SH+ in (a) reducing depressive symptoms at post-intervention and (b) preventing the six-month cumulative incidence of mental disorders in refugees and asylum seekers. Method: RCTs on SH+ have been identified through WHO and all authors have agreed to share the datasets of the trials. The primary outcomes of the IPD meta-analyses are (a) reduction in depressive symptoms at post-intervention, and (b) prevention of six-month cumulative incidence of mental disorders. Secondary outcomes include post-traumatic stress disorder symptoms, well-being, functioning, quality of life, and twelve-month cumulative incidence of mental disorders. One-stage IPD meta-analyses will be performed using mixed-effects linear/logistic regression. Missing data will be handled by multiple imputation. Conclusions: These results will enrich current knowledge about the response to SH+ and will facilitate its targeted dissemination. The results of these IPD meta-analyses will be published in peer-reviewed journals.

Antecedentes: Los refugiados y solicitantes de asilo enfrentan numerosos estresores debido al desplazamiento y son especialmente vulnerables a trastornos de salud mental comunes. Para poder manejar efectivamente el malestar psicológico en esta población, se requieren intervenciones innovadoras. La intervención Self- Help Plus (SH+) de la Organización Mundial de la Salud (OMS) ha mostrado resultados prometedores en la reducción de síntomas de trastornos de salud mental comunes entre refugiados y solicitantes de asilo. Sin embargo, las diferencias individuales de los participantes en respuesta a SH+ permanecen mayormente desconocida. El meta-análisis de Datos de Participantes Individuales (IPD) sintetiza bases de datos puros para proveer evidencia de resultados de vanguardia que no puede ser examinada mediante enfoques meta-analíticos convencionales.Objetivos: Este protocolo delinea los métodos de una serie de meta-análisis de IPD enfocados en examinar los efectos y potenciales moderadores de SH+ en (a) reducir síntomas depresivos en la post-intervención y (b) prevenir la incidencia acumulada de trastornos mentales en refugiados y solicitantes de asilo durante seis meses.Método: Se identificaron RCT sobre SH+ a través de la OMS y todos los autores acordaron compartir la base de datos de sus ensayos. Los resultados primarios de los meta-análisis de IPD son (a) reducción en síntomas depresivos después de la intervención, y (b) prevención de la incidencia acumulada de trastornos mentales en refugiados y solicitantes de asilo durante 6 meses. Entre los resultados secundarios de incluyó síntomas de trastorno de estrés postraumático, bienestar, funcionamiento, calidad de vida e incidencia acumulada de trastornos de salud mental durante 12 meses. Se realizaran meta-análisis de IPD de una etapa usando regresión linear/logística de efectos mixtos. Los datos faltantes se manejaran mediante imputación múltiple.Conclusiones: Estos resultados enriquecerán el conocimiento actual sobre la respuesta a SH+ y facilitarán su diseminación en su público objetivo. Los resultados de estos meta-análisis de IPD serán publicados en revistas revisadas por pares.

Challenges and solutions to nicotine replacement therapy access: observations from SCIMITAR.

BACKGROUND: Given that smoking results in poor physical and mental health, reducing tobacco harm is of high importance. Recommendations published by the National Institute for Health and Care Excellence to reduce smoking harms included provision of support, use of nicotine containing products and commissioning of smoking cessation services. AIMS: This report explores the difficulties in obtaining such support, as observed in a recently conducted randomised controlled trial in patients with severe mental ill health, and outlines suggestions to improve facilitation of provision. METHOD: Data collected during the Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR+) (trial Registration ISRCTN72955454), was reviewed to identify the difficulties experienced, across the trial, with regards to access and provision of nicotine replacements therapy (NRT). Actions taken to facilitate access and provision of NRT were collated to outline how provision could be better facilitated. RESULTS: Access to NRT varied across study settings and in some instances proved impossible for patients to access. Difficulty in access was irrespective of a diagnosis of severe mental ill health. Where NRT was provided, this was not always provided in accordance with NICE guidelines. CONCLUSIONS: Availability of smoking cessation support, and NRT provision would benefit from being made clearer, simpler and more easily accessible so as to enhance smoking cessation rates.

E-cigarette use and associated factors among smokers with severe mental illness.

INTRODUCTION: Smoking is more prevalent among people with severe mental illness (SMI) than the general population. E-cigarettes could provide an effective means of helping people to quit smoking. The aim of this paper is to explore the use of e-cigarettes and factors related to their use in people smokers with SMI. METHODS: This is a cross sectional study including adult smokers with a documented diagnosis of SMI (ICD-10) recruited to the SCIMITAR + trial (2015-2016) from primary and secondary care. At baseline, participants were asked for demographic information and about their use of e-cigarettes. Data was were analysed to explore factors associated with e-cigarette use. After testing bivariate associations, logistic regressions were conducted. RESULTS: Among 526 participants, 58.7% were male, mean age 46 years (SD 12.1), the majority (70.3%) had tried an e-cigarette. Among those who had ever tried an e-cigarette, over half (54.6%) reported the reason was to quit smoking, while 13.9% reported that the reason was to reduce smoking. Having an educational qualification of GCSE or higher (odds ratio 2.17, 95% CI 1.22 to 3.86, p = 0.008) and having made a quit attempt in the past six months (OR 1.66, 95% CI 1.04 to 2.63, p = 0.032) was associated with ever having tried an e-cigarette. CONCLUSIONS: Ever use of an e-cigarette was associated with education levels and recent quit attempts. Future trials could explore the effectiveness of e-cigarettes as a cessation aid in this participant group.

Cost-effectiveness of a specialist smoking cessation package compared with standard smoking cessation services for people with severe mental illness in England: a trial-based economic evaluation from the SCIMITAR+ study.

AIMS: To evaluate the cost-effectiveness of a specialist smoking cessation package for people with severe mental illness DESIGN: Incremental cost-effectiveness analysis was undertaken from the UK National Health Service and Personal Social Services perspective over a 12-month time horizon. Total costs, including smoking cessation, health-care and social services costs and quality-adjusted life years (QALYs), derived from the five-level EuroQol 5-dimension (EQ-5D-5 L), collected from a randomized controlled trial, were used as outcome measures. The bootstrap technique was employed to assess the uncertainty. SETTING: Sixteen primary care and 21 secondary care mental health sites in England. PARTICIPANTS: Adult smokers with bipolar affective disorder, schizoaffective disorder or schizophrenia and related illnesses (n = 526). INTERVENTION AND COMPARATOR: A bespoke smoking cessation (BSC) package for people with severe mental illness offered up to 12 individual sessions with a mental health smoking cessation practitioner versus usual care (UC). Of the participants who were randomized, 261 were in UC group and 265 were in BSC group. MEASUREMENTS: BSC intervention cost was estimated from the treatment log. Costs of UC, health-care and social services and EQ-5D-5 L were collected at baseline, 6- and 12-month follow-ups. Incremental costs and incremental QLAYs were estimated using regression adjusting for respective baseline values and other baseline covariates. FINDINGS: The mean total cost in the BSC group was £270 [95% confidence interval (CI) = -£1690 to £1424] lower than in the UC group, while the mean QALYs were 0.013 (95% CI = -0.008 to 0.045) higher, leading to BSC dominating UC (76% probability of cost-effective at £20 000/QALY). CONCLUSIONS: A bespoke smoking cessation package for people with severe mental illness is likely to be cost-effective over 12 months compared with usual care provided by the UK's National Health Service and personal social services.

The effectiveness of a contingent financial incentive to improve trial follow up; a randomised study within a trial (SWAT).

Objectives To evaluate the effectiveness of a contingent financial incentive (£10 note in addition to a routinely provided £10 voucher) versus no contingent financial incentive, on improving the retention rate in a randomised controlled trial (RCT). Methods A two arm 'Study within a Trial' (SWAT) embedded within a host RCT (SCIMITAR+). Participants were randomised to the SWAT using a 2:1 (intervention:control) allocation ratio. The primary outcome measure was the proportion of participants completing a CO breath measurement at the first SCIMITAR+ follow up time point (6 months). Secondary outcomes were withdrawing from follow-up after contact and time from assessment due date to completion.  Analyses were conducted using logistic or Cox Proportional Hazards regression as appropriate. Results A total of 434 participants were randomised into this SWAT. Completion of the CO breath measurement at 6 months was 88.5% (n=247) in the intervention arm of the SWAT and 85.4% (n=123) in the control arm (Difference 3.1%, OR 1.29, 95% CI 0.71-2.33, p=0.41). There was also no evidence of a difference in the proportion of participants withdrawing from follow-up after contact (intervention n=7 (2.5%), control n=5 (3.5%); OR 0.76, 95% CI 0.23-2.44, p=0.64), nor in terms of proximity of 6-month visit completion to due date (HR 1.07, 95% CI 0.86-1.33, p=0.55). Conclusion It is unclear if contingent financial incentives increased rates of face-to-face follow-up completion within the SCIMITAR+ trial population. However, the sample size of this SWAT was constrained by the size of the host trial and power was limited. This SWAT adds to the body of evidence for initiatives to increase response rates in trials.

Standard smoking cessation services in sites participating in the SCIMITAR+ trial for people with severe mental ill health.

Aims and methodThe SCIMITAR+ trial was commissioned to evaluate the effectiveness of a bespoke smoking cessation intervention for people with severe mental ill health compared with usual services. It is difficult to define what constitutes usual care in smoking cessation services. We aimed to define what this was during the trial. Twenty-two National Health Service healthcare providers participated in a bespoke survey asking about usual care in their area. RESULTS: All sites offered smoking cessation support; however, service provider and service type varied substantially. In some cases services were not streamlined, meaning that people received smoking cessation counselling from one organisation and smoking cessation medication from another.Clinical implicationsTo better implement the National Institute for Health and Care Excellence guideline PH48, clearer referral pathways need to be implemented and communicated to patients, staff and carers. People with severe mental ill health need to be able to access services that combine nicotine replacement therapy and behavioural support in a streamlined manner.Declaration of interestNone.