Caregiving and mental health needs in the significant others of women receiving inpatient and home treatment for acute severe postpartum mental illness.

To examine the mental health and caregiving needs of significant others (including partners, parents, friends) to women who received acute psychiatric care either as inpatients or at home during the perinatal period. Cross-sectional survey of 98 significant others of 279 women who participated in a quasi-experimental cohort study of services for mothers with acute severe postpartum mental health diagnoses. Significant others completed an adapted General Health Questionnaire-12 (GHQ) and Involvement Evaluation Questionnaire (IEQ) to indicate their mental health needs and service use as well as caregiving activities. The mean age of significant others was 38.9 years (range 24-69). 81.6% were male and 81.6% were intimate partners to the women. High levels of unmet mental health needs were detected in significant others, with a majority (51.0%) having a score > 2 on the GHQ-12 indicating caseness for a psychiatric disorder. In those with GHQ-12 caseness indicated, few were receiving help for their difficulties: 22.5% received support from their general practitioner, and 14.3% received help from a social worker, psychologist, psychiatrist or outpatient department. 18.4% received medication for GHQ-12 symptoms. The median sumscore of IEQ surveying caregiving activities in significant others was 18/108. We did not find evidence of differences in GHQ-12 or IEQ scores for significant others to women who received inpatient care versus care at home. Significant others to women with acute severe postpartum psychiatric illness have high levels of unmet mental health needs during the weeks after women are discharged from acute care. Services need to address these needs to optimise outcomes for the whole family.

Experience and perpetration of intimate partner violence and abuse by gender of respondent and their current partner before and during COVID-19 restrictions in 2020: a cross-sectional study in 13 countries.

BACKGROUND: Intimate partner violence and abuse (IPVA) includes controlling behaviours, psychological, physical, sexual and financial abuse. Globally, surveys and emergency services have recorded an increase in IPVA since restrictions were imposed to limit COVID-19 transmission. Most studies have only included heterosexual women. METHODS: Data from the Global Drug Survey (an annual, anonymous, online survey collecting data on drug use) Special Edition were analysed to explore the impact of COVID-19 on people's lives, including their intimate relationships. Five relationship groupings were created using respondents' lived gender identity: women partnered with men (46.9%), women partnered with women (2.1%), men partnered with men (2.9%), men partnered with women (47.2%), and partnerships where one or both partners were non-binary (1%). Self-reported experience and perpetration of IPVA in the past 30 days before (February) and during COVID-19 restrictions (May or June) in 2020 (N = 35,854) was described and compared for different relationship groupings using Fishers Exact Tests. Changes in IPVA during restrictions were assessed using multivariable logistic regression. RESULTS: During restrictions, 17.8 and 16.6% of respondents had experienced or perpetrated IPVA respectively; 38.2% of survivors and 37.6% of perpetrators reported this had increased during restrictions. Greater proportions of non-binary respondents or respondents with a non-binary partner reported experiencing or perpetrating IPVA (p < .001) than other relationship groupings. 22.0% of respondents who were non-binary or had a non-binary partner, 19.5% of men partnered with men, 18.9% of men partnered with women, 17.1% of women partnered with women and 16.6% of women partnered with men reported experiencing IPVA. Respondents with higher psychological distress, poor coping with pandemic-related changes, relationship tension and changes (increases or increases and decreases) in alcohol consumption reported increased experience of IPVA during restrictions. CONCLUSIONS: This study confirmed that IPVA can occur in all intimate relationships, regardless of gender of the perpetrator or survivor. Non-binary respondents or respondents with non-binary partners reported the highest use and experience of IPVA. Most IPVA victim support services have been designed for heterosexual, cisgender women. IPVA support services and perpetrator programmes must be tailored to support all perpetrators and survivors during the pandemic and beyond, regardless of their sexual or gender identity.

Characteristics of adults with type 1 diabetes and treatment-resistant problematic hypoglycaemia: a baseline analysis from the HARPdoc RCT.

AIMS/HYPOTHESIS: Problematic hypoglycaemia still complicates insulin therapy for some with type 1 diabetes. This study describes baseline emotional, cognitive and behavioural characteristics in participants in the HARPdoc trial, which evaluates a novel intervention for treatment-resistant problematic hypoglycaemia. METHODS: We documented a cross-sectional baseline description of 99 adults with type 1 diabetes and problematic hypoglycaemia despite structured education in flexible insulin therapy. The following measures were included: Hypoglycaemia Fear Survey II (HFS-II); Attitudes to Awareness of Hypoglycaemia questionnaire (A2A); Hospital Anxiety and Depression Index; and Problem Areas In Diabetes. k-mean cluster analysis was applied to HFS-II and A2A factors. Data were compared with a peer group without problematic hypoglycaemia, propensity-matched for age, sex and diabetes duration (n = 81). RESULTS: The HARPdoc cohort had long-duration diabetes (mean ± SD 35.8 ± 15.4 years), mean ± SD Gold score 5.3 ± 1.2 and a median (IQR) of 5.0 (2.0-12.0) severe hypoglycaemia episodes in the previous year. Most individuals had been offered technology and 49.5% screened positive for anxiety (35.0% for depression and 31.3% for high diabetes distress). The cohort segregated into two clusters: in one (n = 68), people endorsed A2A cognitive barriers to hypoglycaemia avoidance, with low fear on HFS-II factors; in the other (n = 29), A2A factor scores were low and HFS-II high. Anxiety and depression scores were significantly lower in the comparator group. CONCLUSIONS/INTERPRETATION: The HARPdoc protocol successfully recruited people with treatment-resistant problematic hypoglycaemia. The participants had high anxiety and depression. Most of the cohort endorsed unhelpful health beliefs around hypoglycaemia, with low fear of hypoglycaemia, a combination that may contribute to persistence of problematic hypoglycaemia and may be a target for adjunctive psychological therapies.

Effectiveness and cost-effectiveness of psychiatric mother and baby units: quasi-experimental study.

BACKGROUND: Psychiatric mother and baby units (MBUs) are recommended for severe perinatal mental illness, but effectiveness compared with other forms of acute care remains unknown. AIMS: We hypothesised that women admitted to MBUs would be less likely to be readmitted to acute care in the 12 months following discharge, compared with women admitted to non-MBU acute care (generic psychiatric wards or crisis resolution teams (CRTs)). METHOD: Quasi-experimental cohort study of women accessing acute psychiatric care up to 1 year postpartum in 42 healthcare organisations across England and Wales. Primary outcome was readmission within 12 months post-discharge. Propensity scores were used to account for systematic differences between MBU and non-MBU participants. Secondary outcomes included assessment of cost-effectiveness, experience of services, unmet needs, perceived bonding, observed mother-infant interaction quality and safeguarding outcome. RESULTS: Of 279 women, 108 (39%) received MBU care, 62 (22%) generic ward care and 109 (39%) CRT care only. The MBU group (n = 105) had similar readmission rates to the non-MBU group (n = 158) (aOR = 0.95, 95% CI 0.86-1.04, P = 0.29; an absolute difference of -5%, 95% CI -14 to 4%). Service satisfaction was significantly higher among women accessing MBUs compared with non-MBUs; no significant differences were observed for any other secondary outcomes. CONCLUSIONS: We found no significant differences in rates of readmission, but MBU advantage might have been masked by residual confounders; readmission will also depend on quality of care after discharge and type of illness. Future studies should attempt to identify the effective ingredients of specialist perinatal in-patient and community care to improve outcomes.

Factors associated with re-admission in the year after acute postpartum psychiatric treatment.

PURPOSE: To examine factors associated with being re-admitted in the year after discharge from acute postpartum psychiatric treatment. METHODS: Secondary data analysis of information collected from mothers who were admitted to acute psychiatric services in the year after childbirth between 2013 and 2017. We carried out univariable analyses and multivariable hierarchical logistic regression to examine risk factors for women's re-admission to acute psychiatric care (inpatient or community crisis care) in the year following discharge. RESULTS: Sixty-seven (24.1%) of 278 women were re-admitted in the year after discharge from acute care; the median number of days to re-admission was 86 (IQR 35-214), and women who were re-admitted accessed a median of two further acute services (IQR 1-3). In adjusted analyses, reporting a history of childhood trauma (aOR 1.02; 95% CI 1.00- 1.03, p = 0.036), a higher level of difficulties in the mother-infant bond (aOR 1.03; 95% CI 1.01-1.06, p = 0.009) and younger age (aOR 0.95; 95% CI 0.90-1.00, p = 0.066) were associated with re-admission. CONCLUSION: This study confirms that the role of childhood adverse experiences on mental health is relevant for outcomes in women experiencing acute postpartum psychiatric episodes. Ongoing parent-infant bonding difficulties are also independently associated with re-admission. Perinatal mental health services therefore need to offer evidence-based interventions to address histories of trauma and to support parent-infant bonding to optimise mental health in women following discharge from acute psychiatric services. However, further research is needed to explore what other factors, not measured in our study, are also influential to re-admission.

Anti-stigma training and positive changes in mental illness stigma outcomes in medical students in ten countries: a mediation analysis on pathways via empathy development and anxiety reduction.

PURPOSE: Studies of mental illness stigma reduction interventions have been criticised for failing to evaluate behavioural outcomes and mechanisms of action. This project evaluates training for medical students entitled 'Responding to Experienced and Anticipated Discrimination' (READ), developed to focus on skills in addition to attitudes and knowledge. We aimed to (i) evaluate the effectiveness of READ with respect to knowledge, attitudes, and clinical communication skills in responding to mental illness-related discrimination, and (ii) investigate whether its potential effectiveness was mediated via empathy or/and intergroup anxiety. METHODS: This is an international multisite non-randomised pre- vs post-controlled study. Eligible medical students were currently undertaking their rotational training in psychiatry. Thirteen sites across ten countries (n = 570) were included in the final analysis. RESULTS: READ was associated with positive changes in knowledge (mean difference 1.35; 95% CI 0.87 to 1.82), attitudes (mean difference - 2.50; 95% CI - 3.54 to - 1.46), skills (odds ratio 2.98; 95% CI 1.90 to 4.67), and simulated patient perceived empathy (mean difference 3.05; 95% CI 1.90 to 4.21). The associations of READ with knowledge, attitudes, and communication skills but not with simulated patient perceived empathy were partly mediated through student reported empathy and intergroup anxiety. CONCLUSION: This is the first study to identify mediating effects of reduced intergroup anxiety and increased empathy in an evaluation of anti-stigma training that includes behavioural measures in the form of communication skills and perceived empathy. It shows the importance of both mediators for all of knowledge, skills, and attitudes, and hence of targeting both in future interventions.

Mothers' experiences of acute perinatal mental health services in England and Wales: a qualitative analysis.

BACKGROUND/OBJECTIVE: Perinatal mental health services are a current NHS priority and services are being increased for women. There is limited research on mothers' perspectives of these services and most research focuses on mother and baby units (MBUs). This study explored women's views of their experiences of generic wards, MBUs and crisis resolution teams. METHODS: A qualitative thematic analysis was conducted on written feedback on a service-user-designed questionnaire. One hundred and thirty-nine women recruited across 42 mental health trusts made comments. RESULTS: Two key themes were identified: support networks and staff authority. Support networks included subthemes relating to families, peers and staff. The theme of staff authority incorporated subthemes about communication, confidence in staff and service-user autonomy. All themes contributed to whether mothers felt safe in these services. Mothers reported the benefits of positive, non-coercive relationships with family and staff for their recovery. The findings highlight that the challenges women face in perinatal settings reflect the literature on general psychiatric services, particularly around coercion. CONCLUSIONS: Specific implications for mothers accessing perinatal mental health services: 1) integrated mental health care and support with babies; 2) support with separation from babies for mothers in acute wards; 3) improvement of women's relationships with social services across all services.

Characteristics and mortality rates among patients requiring intermediate care: a national cohort study using linked databases.

BACKGROUND: Adults increasingly live and die with chronic progressive conditions into advanced age. Many live with multimorbidity and an uncertain illness trajectory with points of marked decline, loss of function and increased risk of end of life. Intermediate care units support mainly older adults in transition between hospital and home to regain function and anticipate and plan for end of life. This study examined the patient characteristics and the factors associated with mortality over 1 year post-admission to an intermediate care unit to inform priorities for care. METHODS: A national cohort study of adults admitted to intermediate care units in England using linked individual-level Hospital Episode Statistics and death registration data. The main outcome was mortality within 1 year from admission. The cohort was examined as two groups with significant differences in mortality between main diagnosis of a non-cancer condition and cancer. Data analysis used Kaplan-Meier curves to explore mortality differences between the groups and a time-dependant Cox proportional hazards model to determine mortality risk factors. RESULTS: The cohort comprised 76,704 adults with median age 81 years (IQR 70-88) admitted to 220 intermediate care units over 1 year in 2016. Overall, 28.0% died within 1 year post-admission. Mortality varied by the main diagnosis of cancer (total n = 3680, 70.8% died) and non-cancer condition (total n = 73,024, 25.8% died). Illness-related factors had the highest adjusted hazard ratios [aHRs]. At 0-28 days post-admission, risks were highest for non-cancer respiratory conditions (pneumonia (aHR 6.17 [95%CI 4.90-7.76]), chronic obstructive pulmonary disease (aHR 5.01 [95% CI 3.78-6.62]), dementia (aHR 5.07 [95% CI 3.80-6.77]) and liver disease (aHR 9.75 [95% CI 6.50-14.6]) compared with musculoskeletal disorders. In cancer, lung cancer showed largest risk (aHR 1.20 [95%CI 1.04-1.39]) compared with cancer 'other'. Risks increased with high multimorbidity for non-cancer (aHR 2.57 [95% CI 2.36-2.79]) and cancer (aHR 2.59 [95% CI 2.13-3.15]) (reference: lowest). CONCLUSIONS: One in four patients died within 1 year. Indicators for palliative care assessment are respiratory conditions, dementia, liver disease, cancer and rising multimorbidity. The traditional emphasis on rehabilitation and recovery in intermediate care units has changed with an ageing population and the need for greater integration of palliative care.

Evaluation of anti-stigma social marketing campaigns in Ghana and Kenya: Time to Change Global.

BACKGROUND: Launched in 2018, Time to Change Global is a new anti-stigma programme to tackle stigma and discrimination towards people with mental health problems in low- and middle-income countries. Our aim was to evaluate pre-post changes in stigma within the target populations for the social marketing campaigns ran in Ghana and Kenya carried out as components of the wider Time to Change Global programme. METHODS: Using data collected before and after each campaign in Accra and Nairobi, we investigated pre-post differences in stigma-related outcome measures: mental health-related knowledge (MAKS), mental health-related attitudes (CAMI), and desire for social distance (RIBS), with regression analyses. Other covariates were included in the models to control for differences in participant demographics. RESULTS: A significant positive change in a stigma related outcome was found at each site. Reported in standard deviation units, desire for social distance from people with mental health problems in Accra was lower after the launch of the campaign, measured as an increase in intended contact (ß = 0.29, 95% CI = 0.14 to 0.43, p < 0.001). In Nairobi, the stigma related knowledge score was higher in the post campaign sample (ß = 0.21, 95% CI = 0.07 to 0.34, p = 0.003). CONCLUSION: The increase in intended contact in the absence of other changes seen in Ghana, is consistent with the early results for Time to Change England. The estimate for the magnitude of this change is the same as Time to Change England for the general population between 2009 and 19, a very promising result for a short term public mental health campaign. The different results observed between sites may be due to campaign as well as population differences.

ADVANCE integrated group intervention to address both substance use and intimate partner abuse perpetration by men in substance use treatment: a feasibility randomised controlled trial.

BACKGROUND: Substance use is a risk factor for intimate partner abuse (IPA) perpetration. Delivering perpetrator interventions concurrently with substance use treatment shows promise. METHODS: The feasibility of conducting an efficacy and cost-effectiveness trial of the ADVANCE 16-week intervention to reduce IPA by men in substance use treatment was explored. A multicentre, parallel group individually randomised controlled feasibility trial and formative evaluation was conducted. Over three temporal cycles, 104 men who had perpetrated IPA towards a female (ex) partner in the past year were randomly allocated to receive the ADVANCE intervention + substance use treatment as usual (TAU) (n = 54) or TAU only (n = 50) and assessed 16-weeks post-randomisation. Participants' (ex) partners were offered support and 27 provided outcome data. Thirty-one staff and 12 men who attended the intervention participated in focus groups or interviews that were analysed using the framework approach. Pre-specified criteria assessed the feasibility of progression to a definitive trial: 1) ≥ 60% of eligible male participants recruited; 2) intervention acceptable to staff and male participants; 3) ≥ 70% of participants followed-up and 4) levels of substance use and 5) IPA perpetrated by men in the intervention arm did not increase from average baseline level at 16-weeks post-randomisation. RESULTS: 70.7% (104/147) of eligible men were recruited. The formative evaluation confirmed the intervention's acceptability. Therapeutic alliance and session satisfaction were rated highly. The overall median rate of intervention session attendance (of 14 compulsory sessions) was 28.6% (range 14.3-64.3% by the third cycle). 49.0% (51/104) of men and 63.0% (17/27) of their (ex) partners were followed-up 16-weeks post-randomisation. This increased to 100% of men and women by cycle three. At follow-up, neither substance use nor IPA perpetration had worsened for men in the intervention arm. CONCLUSIONS: It was feasible to deliver the ADVANCE intervention in substance use treatment services, although it proved difficult to collect data from female (ex)partners. While some progression criteria were met, others were not, although improvements were demonstrated by the third cycle. Lessons learned will be implemented into the study design for a definitive trial of the ADVANCE intervention. TRIAL REGISTRATION: ISRCTN79435190 prospectively registered 22nd May 2018.

Relationships between types of UK national newspapers, illness classification, and stigmatising coverage of mental disorders.

BACKGROUND: Media coverage on mental health problems has been found to vary by newspaper type, and stigma disproportionately affects people with mental illness by diagnosis. OBJECTIVE: This study investigated the relationships between types of UK national newspaper (tabloid vs. broadsheet), illness classification (SMI-severe mental illnesses vs. CMD-common mental disorders), and stigmatising coverage of mental disorders, and whether these relationships changed over the course of the Time to Change anti-stigma programmes in England and Wales. METHODS: Secondary analysis of data from a study of UK newspaper coverage of mental illness was performed. Relevant articles from nine UK national newspapers in 2008-11, 2013, 2016 and 2019 were retrieved. A structured coding framework was used for content analysis. The odds an article was stigmatising in a tabloid compared to a broadsheet, and about SMI compared to CMD, were calculated. Coverage of CMD and SMI by newspaper type was compared using the content elements categorised as stigmatising or anti-stigmatising. RESULTS: 2719 articles were included for analysis. Articles in tabloids had 1.32 times higher odds of being stigmatising than articles in broadsheet newspapers (OR 1.32, 95% CI 1.12-1.55). Odds of stigmatising coverage was 1.72 times higher for articles on SMI than CMD (OR 1.72, 95% CI 1.39-2.13). Different patterns in reporting were observed when results were stratified by years for all analyses. A few significant associations were observed for the portrays of stigmatising elements between tabloid and broadsheet newspapers regarding SMI or CMD. CONCLUSIONS: Tailored interventions are needed for editors and journalists of different newspaper types, to include specific strategies for different diagnoses.

Mental illness stigma after a decade of Time to Change England: inequalities as targets for further improvement.

BACKGROUND: England's Time to Change programme to reduce mental health-related stigma and discrimination included a social marketing campaign using traditional and social media, and targeted middle-income groups aged 25-45 between 2009 and 2016. From 2017, the same age group on low to middle incomes were targeted, and the content focused on men's mental health, by changing the advertising and adapting the 'key messages'. This study investigates changes in stigma-related public knowledge, attitudes and desire for social distance in England since Time to Change began in 2008-19 and for 2017-19. METHODS: Using data from a face-to-face survey of a nationally representative quota sample of adults for England, we evaluated longitudinal trends in outcomes with regression analyses and made assumptions based on a simple random sample. The pre-existing survey used a measure of attitudes; measures of knowledge and desire for social distance were added in 2009. RESULTS: Reported in standard deviation units (95% CI), the improvement for knowledge for 2009-19 was 0.25 (0.19, 0.32); for attitudes, 2008-19, 0.32 (0.26, 0.39) and for desire for social distance, 2009-19 0.29 (0.23, 0.36). Significant interactions between year and both region and age suggest greater improvements in London, where stigma is higher, and narrowing of age differences. There were significant improvements between 2017 and 2019 in knowledge [0.09 (0.02, 0.16)] and attitudes [0.08 (0.02, 0.14)] but not social distance. CONCLUSION: The positive changes support the effectiveness of Time to Change but cannot be definitively attributed to it. Inequalities in stigma by demographic characteristics present targets for research and intervention.

Time to Change's social marketing campaign for a new target population: results from 2017 to 2019.

BACKGROUND: Since 2009 Time to Change has included among its strategies a social marketing campaign to tackle the stigma surrounding mental health problems. At the start of its third phase (2016-2021) the target group of the campaign was kept as people aged between mid-twenties and mid-forties but changed to middle-low income groups and the content was focused on men. METHODS: Participants (n = 3700) were recruited through an online market research panel, before and after each burst of the campaign. They completed an online questionnaire evaluating knowledge (Mental Health Knowledge Schedule, MAKS); attitudes (Community Attitudes toward Mental Illness, CAMI); and desire for social distance (Intended Behaviour subscale of the Reported and Intended Behaviour Scale, RIBS). Socio-demographic data and awareness of the campaign were also collected. RESULTS: For each of the 3 bursts, significant pre-post awareness differences were found (OR = 2.83, CI = 1.90-4.20, p < 0.001; OR = 1.72, CI = 1.22-2.42, p = 0.002; OR = 1.41, CI = 1.01-1.97, p = 0.043), and awareness at the end of the third burst was 33%. Demographic factors associated with awareness for one or more bursts included having children, familiarity with mental illness, male sex, being Black, Asian or other ethnic minorities and living in London or the East Midlands regions. An improvement across bursts in the "living with" subscale item of the RIBS, and in the "recover" and "advice to a friend" MAKS items were found. Familiarity with mental illness had the strongest association with all outcome measures, while the awareness of the campaign was also related with higher scores in MAKS and RIBS. CONCLUSIONS: These interim results suggest that the campaign is reaching and having an impact on its new target audience to a similar extent as did the TTC phase 1 campaign. While over the course of TTC we have found no evidence that demographic differences in stigma have widened, and indeed those by age group and region of England have narrowed, those for socioeconomic status, ethnicity and sex have so far remained unchanged. By targeting a lower socioeconomic group and creating relatively greater awareness among men and in Black and ethnic minority groups, the campaign is showing the potential to address these persistent differences in stigma.

Patient and therapist experiences of exposure therapy for anxiety-related disorders in pregnancy: qualitative analysis of a feasibility trial of intensive versus weekly CBT.

BACKGROUND: Approximately 15% of pregnant women experience anxiety disorders. Effective treatments exist but their acceptability during pregnancy, particularly exposure therapy, is not known. AIMS: To understand patient and therapist experiences of time-intensive and weekly exposure-based therapy for anxiety disorders delivered during pregnancy. Trial registration: ISRCTN81203286. METHOD: In-depth interviews were conducted with patients and therapists who had taken part in a feasibility trial of predominantly online time-intensive versus weekly cognitive-behavioural therapy in pregnancy in a primary care setting in the UK. Data were analysed using reflexive thematic analysis. RESULTS: In total, 45 women participating in the trial and 6 therapists who had delivered the treatments were interviewed. Five themes were developed from the data that showed convergence from therapist and patient perspectives: 'Acquiring tools to navigate the perinatal period'; 'Motivated yet constrained by pregnancy'; 'Having the confidence to face fears and tolerate uncertainty'; 'Momentum with the need for flexibility'; 'Being removed from the face-to-face world'. CONCLUSIONS: Exposure therapy is acceptable and helpful in pregnancy and can lead to lasting gains. Exposure is a key element of treatment and needs to be confidently conducted by therapists with perinatal knowledge and expertise. Treatments need to consider the unfolding context of pregnancy. The momentum of intensive therapy can lead to rapid improvements, but is demanding for both patients and therapists, especially fitting round other commitments. Online treatments can work well and are a good fit for perinatal women, but this needs to be balanced with the need for social connection, suggesting a hybrid model is the ideal.

Making the invisible visible: New perspectives on the intersection of human-environment interactions of clinical teams in intensive care.

Understanding human behaviour is essential to the successful adoption of new technologies, and for the promotion of safer care. This requires capturing the detail of clinical workflows to inform the design of new human-technology interactions. We are interested particularly in the possibilities for touchless technologies that can decipher human speech, gesture and motion and allow for interactions that are free of contact. Here, we employ a new approach by installing a single 360° camera into a clinical environment to analyse touch patterns and human-environment interactions across a clinical team to recommend design considerations for new technologies with the potential to reduce avoidable touch.

Impacts of changes in alcohol consumption patterns during the first 2020 COVID-19 restrictions for people with and without mental health and neurodevelopmental conditions: A cross sectional study in 13 countries.

BACKGROUND: The initial period of COVID-19-related restrictions affected substance use in some population groups. We explored how changes in alcohol use at the beginning of the pandemic impacted the health and wellbeing of people with and without mental health and neurodevelopmental conditions (MHDCs). METHODS: Data came from the Global Drug Survey Special Edition on COVID-19 conducted in May-June 2020. Measured were; changes in drinking compared to February 2020 (pre-COVID-19 restrictions), reasons for changes, and impact on physical health, mental health, relationships, finances, work/study, and enjoyment. This study included 38,141 respondents (median age = 32 IQR 25-45; 51.9% cis man; 47.8% cis woman; 1.2% trans/non-binary; 30.2% with MHDCs e.g. depression 20.0%, anxiety 16.3%, ADHD 3.8%, PTSD 3.3%). RESULTS: A third (35.3%) of respondents with MHDCs and 17.8% without MHDCs indicated that increased drinking affected their mental health negatively (p<.001); 44.2% of respondents with MHDCS compared to 32.6% without MHDCs said it affected their physical health negatively (p<.001). Reduced drinking was associated with better mental health among a fifth (21.1%) of respondents with MHDCS and 14.4% without MHDCs (p<.001). Age, relationship status, living arrangements, employment, coping and distress were significant predictors of increases in drinking. CONCLUSION: Among people with MHDCS, reduced alcohol consumption was associated with better mental health, while the negative effects of increased drinking were more pronounced when compared to people without MHDCS. When supporting people in reducing alcohol consumption during uncertain times, people with MHDCS may need additional support, alongside those experiencing greater levels of distress.

Multisite randomised controlled trial of trauma-focused cognitive behaviour therapy for psychosis to reduce post-traumatic stress symptoms in people with co-morbid post-traumatic stress disorder and psychosis, compared to treatment as usual: study protocol for the STAR (Study of Trauma And Recovery) trial.

BACKGROUND: People with psychosis have high rates of trauma, with a post-traumatic stress disorder (PTSD) prevalence rate of approximately 15%, which exacerbates psychotic symptoms such as delusions and hallucinations. Pilot studies have shown that trauma-focused (TF) psychological therapies can be safe and effective in such individuals. This trial, the largest to date, will evaluate the clinical effectiveness of a TF therapy integrated with cognitive behaviour therapy for psychosis (TF-CBTp) on post-traumatic stress symptoms in people with psychosis. The secondary aims are to compare groups on cost-effectiveness; ascertain whether TF-CBTp impacts on a range of other meaningful outcomes; determine whether therapy effects endure; and determine acceptability of the therapy in participants and therapists. METHODS: Rater-blind, parallel arm, pragmatic randomised controlled trial comparing TF-CBTp + treatment as usual (TAU) to TAU only. Adults (N = 300) with distressing post-traumatic stress and psychosis symptoms from five mental health Trusts (60 per site) will be randomised to the two groups. Therapy will be manualised, lasting 9 months (m) with trained therapists. We will assess PTSD symptom severity (primary outcome); percentage who show loss of PTSD diagnosis and clinically significant change; psychosis symptoms; emotional well-being; substance use; suicidal ideation; psychological recovery; social functioning; health-related quality of life; service use, a total of four times: before randomisation; 4 m (mid-therapy); 9 m (end of therapy; primary end point); 24 m (15 m after end of therapy) post-randomisation. Four 3-monthly phone calls will be made between 9 m and 24 m assessment points, to collect service use over the previous 3 months. Therapy acceptability will be assessed through qualitative interviews with participants (N = 35) and therapists (N = 5-10). An internal pilot will ensure integrity of trial recruitment and outcome data, as well as therapy protocol safety and adherence. Data will be analysed following intention-to-treat principles using generalised linear mixed models and reported according to Consolidated Standards of Reporting Trials-Social and Psychological Interventions Statement. DISCUSSION: The proposed intervention has the potential to provide significant patient benefit in terms of reductions in distressing symptoms of post-traumatic stress, psychosis, and emotional problems; enable clinicians to implement trauma-focused therapy confidently in this population; and be cost-effective compared to TAU through reduced service use. TRIAL REGISTRATION: ISRCTN93382525 (03/08/20).

A parallel randomised controlled trial of the Hypoglycaemia Awareness Restoration Programme for adults with type 1 diabetes and problematic hypoglycaemia despite optimised self-care (HARPdoc).

Impaired awareness of hypoglycaemia (IAH) is a major risk for severe hypoglycaemia in insulin treatment of type 1 diabetes (T1D). To explore the hypothesis that unhelpful health beliefs create barriers to regaining awareness, we conducted a multi-centre, randomised, parallel, two-arm trial (ClinicalTrials.gov NCT02940873) in adults with T1D and treatment-resistant IAH and severe hypoglycaemia, with blinded analysis of 12-month recall of severe hypoglycaemia at 12 and/or 24 months the primary outcome. Secondary outcomes included cognitive and emotional measures. Adults with T1D, IAH and severe hypoglycaemia despite structured education in insulin adjustment, +/- diabetes technologies, were randomised to the "Hypoglycaemia Awareness Restoration Programme despite optimised self-care" (HARPdoc, n = 49), a psychoeducation programme uniquely focussing on changing cognitive barriers to avoiding hypoglycaemia, or the evidence-based "Blood Glucose Awareness Training" (BGAT, n = 50), both delivered over six weeks. Median [IQR] severe hypoglycaemia at baseline was 5[2-12] per patient/year, 1[0-5] at 12 months and 0[0-2] at 24 months, with no superiority for HARPdoc (HARPdoc vs BGAT incident rate ratios [95% CI] 1.25[0.51, 3.09], p = 0.62 and 1.26[0.48, 3.35], p = 0.64 respectively), nor for changes in hypoglycaemia awareness scores or fear. Compared to BGAT, HARPdoc significantly reduced endorsement of unhelpful cognitions (Estimated Mean Difference for Attitudes to Awareness scores at 24 months, -2.07 [-3.37,-0.560], p = 0.01) and reduced scores for diabetes distress (-6.70[-12.50,-0.89], p = 0.02); depression (-1.86[-3.30, -0.43], p = 0.01) and anxiety (-1.89[-3.32, -0.47], p = 0.01). Despite positive impact on cognitive barriers around hypoglycaemia avoidance and on diabetes-related and general emotional distress scores, HARPdoc was not more effective than BGAT at reducing severe hypoglycaemia.

The feasibility of delivering the ADVANCE digital intervention to reduce intimate partner abuse by men receiving substance use treatment: protocol for a non-randomised multi-centre feasibility study and embedded process evaluation.

BACKGROUND: Compared to men in the general population, men in substance use treatment are more likely to perpetrate intimate partner abuse (IPA). The ADVANCE group intervention for men in substance use treatment is tailored to address substance use and IPA in an integrated way. In a feasibility trial pre-COVID, men who received the ADVANCE intervention via face-to-face group delivery showed reductions in IPA perpetration. Due to COVID-19, ADVANCE was adapted for remote digital delivery. METHODS/DESIGN: This mixed-methods non-randomised feasibility study, with a nested process evaluation, will explore the feasibility and acceptability of delivering the ADVANCE digital intervention to men in substance use treatment who have perpetrated IPA towards a female partner in the past year. Sixty men will be recruited from seven substance use treatment services in Great Britain. The ADVANCE digital intervention comprises a preparatory one-to-one session with a facilitator to set goals, develop a personal safety plan, and increase motivation and a preparatory online group to prepare men for taking part in the intervention. The core intervention comprises six fortnightly online group sessions and 12 weekly self-directed website sessions to recap and practise skills learned in the online group sessions. Each website session is followed by a one-to-one video/phone coaching session with a facilitator. Men will also receive their usual substance use treatment. Men's female (ex) partners will be invited to provide outcome data and offered support from integrated safety services (ISS). Outcome measures for men and women will be sought post intervention (approximately 4 months post male baseline interview). Feasibility parameters to be estimated include eligibility, suitability, consent, recruitment, attendance, retention and follow-up rates. In-depth interviews or focus groups will explore the intervention's acceptability to participants, facilitators and ISS workers. A secondary focus of the study will estimate pre-post-differences in outcome measures covering substance use, IPA, mental health, self-management, health and social care service use, criminal justice contacts and quality of life. DISCUSSION: Findings will inform the design of a multicentre randomised controlled trial evaluating the efficacy and cost-effectiveness of the ADVANCE digital intervention for reducing IPA. TRIAL REGISTRATION: The feasibility study was prospectively registered: ISRCTN66619273 .