Background:The Hypoglycemia Awareness Restoration Program for people with type 1 diabetes and problematic hypoglycemia with severe episodes persisting despite optimal care (HARPdoc) uniquely focusses on addressing cognitive and motivational barriers to hypoglycemia avoidance associated with impaired awareness to hypoglycemia. We aimed to compare perceptions of acceptability, feasibility, and appropriateness of HARPdoc intervention to an existing program, Blood Glucose Awareness Training (BGAT) and understand how these implementation outcomes relate to cognitive and mental health clinical outcomes. Methods:The HARPdoc trial was a hybrid randomized clinical trial delivered in the United Kingdom and United States between July 2018 and December 2019. Implementation outcomes, including perceived acceptability, appropriateness, and feasibility, were measured using published validated surveys. These surveys were completed by the people with diabetes, healthcare professionals, and relatives of participants. Clinical outcomes, including attitudes to awareness, diabetes distress, anxiety, and depression, were measured using validated self-reported questionnaires. We explored differences of perceived implementation outcomes between HARPdoc and BGAT and associations between implementation and clinical outcomes using quantile and linear regression. We also assessed whether the effect of HARPdoc on cognitive and mental health outcomes were mediated by implementation outcomes. Results:HARPdoc was perceived as more appropriate than BGAT at 12 months, with a median difference of 0.75 (95% CI 0,26,1,24) by both those involved in delivering the programs and the HARPdoc participants. All stakeholder groups also perceived HARPdoc intervention as more acceptable (MD 0.50 95% CI 0.13, 0.87), but as feasible (MD 0.00; 95% CI -0.31, 0.31) as BGAT. Each of perceived acceptability, appropriateness, and feasibility were significantly linked to improvements in clinical outcomes (feasibility- anxiety: Mean Difference: -1.07; 95% CI: -2.03, -0.10); feasibility-depression (MD: -5.25, 95% CI -9.09, -1.41)). No evidence of mediation was observed. Conclusions:HARPdoc compared to BGAT was perceived as more appropriate and acceptable and subsequently higher perceived appropriateness, acceptability and feasibility was linked to better cognitive and mental health outcomes. Our findings provide important insights for the development of an implementation blueprint and the expansion of HARPdoc and BGAT programs into routine healthcare services and highlight the need for larger, better-powered hybrid trials.

Background A substantial proportion of anorexia nervosa patients require intensive treatments, commonly inpatient or day-patient treatment. The relative merits of these treatments for adults with anorexia nervosa are unknown. Therefore, a trial investigating the clinical effectiveness and cost-effectiveness of inpatient treatment-as-usual versus a stepped-care day-patient approach in adults with anorexia nervosa (DAISIES) was commissioned. This trial terminated prematurely due to poor recruitment, mainly resulting from COVID-19’s impact on service provision. Objective We describe the rationale, methods and available outcomes of the DAISIES trial. Reasons behind the trial’s failure and implications for future research are investigated. Design A two-arm multicentre open-label parallel-group non-inferiority randomised controlled trial, evaluating the effectiveness, acceptability and cost-effectiveness of two intensive treatments for adults with severe anorexia nervosa. Setting Specialist eating-disorder services in the United Kingdom with inpatient and/or day-patient treatment facilities. Participants Adults (age 17 +) with severe anorexia nervosa (body mass index ≤ 16 kg/m 2 ) requiring intensive treatment and (optionally) their carers. Intended sample size: 386. Interventions Inpatient treatment-as-usual and a stepped-care day-patient treatment approach (with the option of initial inpatient treatment for medical stabilisation). Main outcome measures The primary outcome was body mass index at 12 months post randomisation. Qualitative interviews conducted during the trial included semistructured interviews to investigate patients’, families’ and clinicians’ views on treatments. Results During the 16-month recruitment period (November 2020 to March 2022), 53 patients were approached. Of these, 15 were enrolled and randomly allocated to the inpatient treatment-as-usual ( n = 7) or day-patient treatment ( n = 8) treatment arms. All participants were female with a mean (standard deviation) age of 24.8 (9.1) years and a mean (standard deviation) body mass index of 14.4 (1.6) kg/m 2 . Patients’ body mass indexes had increased similarly in both groups at 12 months. Participants perceived the stepped-care day-patient treatment approach to be more acceptable than inpatient treatment-as-usual. Qualitative interviews with patients, carers and clinicians suggested valued (e.g. multidisciplinary provision of care) and disliked (e.g. perceived over-focus on weight gain) aspects of treatment. Investigation of the reasons behind the trial’s failure revealed strong treatment preferences among patients as the most common reason for non-participation, alongside the impact of COVID-19 on service provision. Limitations The main trial questions could not be answered due to low participant numbers. Conclusions No conclusions can be drawn concerning the clinical and cost-effectiveness of inpatient treatment-as-usual or stepped-care day-patient treatment. The day-patient treatment approach was perceived more positively by patients and carers. Service-related (e.g. reduced clinician time for research), patient-related (e.g. treatment preferences) and wider systemic factors (e.g. reduced service capacity and patient throughput nationally during COVID-19) seem to have contributed to the failure of the DAISIES trial. Future work Despite the trial’s failure, the need to investigate the effectiveness and experience of intensive treatments of adult anorexia nervosa remains. Alternative trial designs incorporating patient preferences and investigating community-based intensive treatment options have potential to improve acceptability and recruitment. Funding This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number HTA 17/123/03.

Background Despite the higher prevalence of intimate partner violence perpetration by men who misuse substances, the role of substance use in intimate partner violence is unclear. Evidence about what works to reduce intimate partner violence by men who misuse substances is lacking. Objectives To (1) understand the role of substance use in intimate partner violence perpetration, (2) develop a perpetrator intervention for men in substance use treatment and (3) test the feasibility and (4) effectiveness of delivering the intervention to men receiving substance use treatment. Design Objective 1: mixed-methods intervention development, including a qualitative meta-ethnography, narrative interviews with 14 men and their female (ex)-partners and a systematic review and meta-analysis of 9 perpetrator intervention trials. Objective 2: the ADVANCE 16-week group perpetrator intervention delivered in person, was developed and adapted for digitally supported remote delivery (ADVANCE-D) during the pandemic. Objective 3: a multicentre feasibility randomised controlled trial of ADVANCE plus substance use treatment as usual compared to treatment as usual only and a multicentre non-randomised controlled feasibility study of ADVANCE-D were conducted. Objective 4: a multicentre effectiveness and cost-effectiveness randomised controlled trial of ADVANCE was planned. Setting and participants Six community substance use treatment services in England (London, the West Midlands and the Southwest). Adult men receiving substance use treatment who had perpetrated intimate partner violence, their female (ex)-partners and staff delivering/supporting ADVANCE/ADVANCE-D delivery. Interventions The ADVANCE comprises 2–4 individual sessions and 1- to 2-hour weekly groups. ADVANCE-D includes 1 individual session, 7 fortnightly video groups and 12 website sessions, each followed by a coaching call. Main outcome measures The feasibility randomised controlled trial and non-randomised feasibility study measured eligibility, consent, recruitment, attendance (men) and follow-up rates and experiences of receiving or delivering ADVANCE/ADVANCE-D. These feasibility studies also assessed whether the following outcomes could be measured in a future effectiveness trial: intimate partner violence perpetration (men)/victimisation (women), substance use (men), self-management (men), and for men and women, mental health, health and social care service use, criminal justice contacts and quality of life. The primary outcome for the effectiveness trial was men’s self-reported intimate partner violence perpetration in the previous 4 months, 12 months post randomisation, using the Abusive Behaviour Inventory. Review methods Systematic searches of databases identified qualitative studies for the meta-ethnography and (non)-randomised controlled trials for the systematic review. Meta-analyses were conducted where comparable data existed. Study inclusion and data extraction processes were conducted as per Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Results The meta-ethnography and narrative interviews identified the complex interplay between substance use and intimate partner violence perpetration in the context of intoxication, withdrawal, acquiring drugs, impact on relationships and wider dynamics of power, control and psychological vulnerabilities. Little evidence emerged for effective interventions to reduce intimate partner violence for men who misuse substances. Meta-analysis showed that integrated substance use and intimate partner violence perpetrator interventions were non-superior to substance use treatment as usual in reducing intimate partner violence (combined mean difference 0.1, 95% confidence interval 0.37 to 0.57; p = 0.68). One hundred and four men were randomly allocated to receive ADVANCE + substance use treatment as usual (n = 54) or treatment as usual only (n = 50), and at 16 weeks post randomisation, 49% (51/104) were followed up. Of (ex)-partners, 26% (27/104) were recruited and 63% (17/27) were followed up. Median rate of intervention session attendance was 28.6% (lower quartile 0 – upper quartile 50). Self-reported intimate partner violence perpetration reduced at follow-up among men allocated to ADVANCE (estimated group difference on Revised Abusive Behaviour Inventory: −1.31, 95% confidence interval −4.06 to 1.43). Progression to a definitive trial was supported, but the trial was suspended due to COVID-19. ADVANCE was adapted for remote digitally supported delivery. Of men screened to participate in the non-randomised controlled feasibility study of ADVANCE-D, 46% (57/125) were eligible and deemed suitable to participate by staff. Forty-five men were recruited, 40 were offered ADVANCE-D and 25 (25/45; 55.6%) were followed up. Of sessions offered, 68% of core sessions, 44% of website practice sessions and 33% of coaching calls were attended/completed. Mean number of sessions attended was 11.4 (standard deviation 9.1). Twenty-one (ex)-partners were recruited, and 11 were (52.4%) followed up. Reductions in intimate partner violence perpetrated or experienced were reported by 8/11 men and 17/25 women, respectively; however, outcomes measured lacked statistical power to show a difference. Limitations The COVID-19 restrictions precluded undertaking the randomised controlled trial. Conclusions Delivering ADVANCE and ADVANCE-D to men in substance use treatment services was feasible, acceptable and safe. Promising findings were reported. Definitive trials are needed. Future work Evaluation and implementation of ADVANCE and ADVANCE-D in other settings and populations will be considered. Trial registration The trial is registered as ISRCRTN79435190 and ISRCTN66619273. The review was registered in PROSPERO as CRD42107056596. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: RP-PG-1214-20009) and is published in full in Programme Grants for Applied Research; Vol. 13, No. 10. See the NIHR Funding and Awards website for further award information. Plain language summary Intimate partner violence includes physical, sexual, financial and psychological abuse from an (ex)-partner. Men in alcohol or drug (substance) treatment report high rates of intimate partner violence towards their (ex)-partners. We reviewed existing research and conducted interviews with men and their female (ex)-partners and found that intoxication, withdrawal and craving affected men’s use of abusive behaviour. Little evidence exists that shows what interventions reduce intimate partner violence by men who use substances. We developed ADVANCE, a group intervention for men in substance use treatment consisting of individual and group sessions delivered by trained staff. To find out whether it would be possible to conduct a large study exploring the effectiveness and cost-effectiveness of ADVANCE, we first conducted a feasibility study. One hundred and fourteen men were allocated by chance to receive ADVANCE (n = 54) or their usual substance use treatment only (n = 50). Women’s support workers offered men’s (ex)-partners support and the opportunity to participate in the research. Interviews and focus groups after the intervention showed that men, (ex)-partners and staff found ADVANCE acceptable. Men who received ADVANCE reduced their use of intimate partner violence towards their (ex)-partners. We could not progress to the larger effectiveness study due to COVID-19; instead, ADVANCE was adapted to be delivered remotely (ADVANCE-D). ADVANCE-D included individual and group video sessions, self-directed website sessions and coaching calls. Forty men were offered ADVANCE-D. Again, (ex)-partners were offered support and invited to participate in the research. Men completed 48% of sessions offered. Men and staff rated ADVANCE-D highly. Men and (ex)-partners reported a reduction in using and experiencing intimate partner violence, respectively. Men also reduced their substance use. The research showed promising findings, including that trained staff from substance use services can deliver both ADVANCE and ADVANCE-D safely. A trial is needed to determine whether ADVANCE-D works and is cost-effective in a larger sample, followed up over a longer term. Scientific summary Background Intimate partner violence (IPV) perpetration involves any behaviour by an intimate partner causing physical, sexual or psychological harm, including aggression, sexual coercion, psychological abuse, financial abuse and controlling behaviours. While IPV can be perpetrated in all relationships, this research programme focused on IPV perpetrated by men towards a female (ex)-partner. No single factor explains why some men are more likely to perpetrate IPV; however, substance use, especially misuse and dependence, is a substantial and consistent risk factor. Rates of IPV perpetration by men in substance use treatment are around four times higher than in the general population. Around 6 in 10 men receiving substance use treatment had perpetrated any IPV in the past year. Despite this, the role of substance use in IPV perpetration remains poorly understood. There is a lack of evidence about what works to reduce IPV perpetration for men who misuse substances. Men in substance use treatment are rarely referred to perpetrator programmes, and when they are, they tend not to engage or complete. There remains a need for further research. Objectives The research programme included two work packages (WPs) to generate evidence [WP1(i), WP1(ii), WP2] to develop [WP3(i)] and test the feasibility [WP4(i)] and effectiveness (WP5) of the ADVANCE group intervention to reduce IPV by men attending substance use treatment and increase well-being and safety for their (ex)-partners. Due to COVID, ADVANCE was adapted for digitally supported delivery [WP3(ii)] and the feasibility of remote delivery was explored [WP4(ii)]. WPs are presented in the order they were completed. Research questions How does substance use feature in survivors’ and perpetrators’ narratives of IPV perpetration? [WP1(i)] What contributes to IPV perpetrated by men in substance use treatment? [WP1(ii)] What relationship/support needs do male IPV perpetrators in substance use treatment and their (ex)-partners have? [WP1(ii)] What are the core components of an evidence-based ADVANCE integrated group perpetrator intervention for men in substance use treatment? [WP3(i)] Is it feasible and acceptable to conduct an effectiveness trial of the ADVANCE intervention for men in substance use treatment? [WP4(i)] What are the experiences of participants receiving and staff delivering ADVANCE? [WP4(i)] What is the effectiveness and cost-effectiveness of ADVANCE plus substance use treatment as usual (TAU) compared to TAU alone to reduce IPV perpetration for men in substance use treatment? (WP5) Can the ADVANCE group intervention be adapted for digitally supported remote delivery (ADVANCE-D)? [WP3(ii)] Is it feasible and acceptable to deliver ADVANCE-D remotely to men in substance use treatment? [WP4(ii)] What are the experiences of participants receiving and staff delivering ADVANCE-D? [WP4(ii)] Methods Work package 1(i) A meta-ethnography of qualitative studies explored how substance use featured in survivors’ and perpetrators’ narratives of IPV perpetration. Three databases were searched for qualitative studies published in English that included narratives of heterosexual adult IPV survivors and/or perpetrators and explored the role of substance use in IPV perpetration. Data were coded for relevant participant quotes and meanings (first order), study authors’ (second order) and meta-ethnographers’ (third order) interpretations. Work package 1(ii) Free association narrative interviews (FANIs) were conducted with men receiving substance use treatment who had ever perpetrated IPV towards an (ex)-partner from six community-based substance use treatment services in England. Men were asked to provide their (ex)-partners’ contact details for researchers to invite them to be interviewed. Participants were prompted to tell the stories of their substance use, relationships, IPV and intervention experiences. Interviews were transcribed verbatim. Timelines tracked the sequence of events through participants’ lives. Case studies were written up as ‘pen portraits’ to capture the complexity each interview revealed. Thematic analysis identified the main ways substance use featured in male and female attributions and explanations for IPV. Where both partners were interviewed, men’s and women’s accounts were compared. Work package 2 A systematic narrative review with meta-analysis explored the effectiveness of perpetrator interventions for men who use substances. Seven databases and clinical trials registry were searched for randomised controlled trials (RCTs) and non-RCTs of IPV interventions compared to TAU or an intervention of a lesser intensity or frequency among adult heterosexual men where at least 60% of the sample misused substances. Outcome measures included perpetrator and/or survivor reports of IPV, and/or substance use, and/or marital satisfaction/conflict. Where at least two studies had comparable data, a comparison was made between intervention and TAU groups. Work package 3(i) Findings from WP1, WP2 and expert opinion from practitioners and people with lived experience (PWLE) informed the development of the ADVANCE integrated perpetrator and substance use intervention. The Capability, Opportunity, Motivation – Behaviour framework for behaviour change was used to develop the intervention. Key stakeholders, including Learning Alliance groups (consisting of professionals and academics) and a patient and public involvement (PPI) group, were consulted throughout the development to inform the process. Work package 4(i) A multicentre, parallel-group individually randomised feasibility trial and formative evaluation of ADVANCE was conducted. Target was to recruit 108 men from substance use treatment in England who had perpetrated IPV in the past 12 months and their (ex)-partners. Contingency management was used to encourage attendance. Eligibility, suitability, consent, recruitment, attendance, retention and follow-up rates were estimated. Pre-specified criteria assessed the feasibility of progression to a defini tive trial: ≥ 60% of eligible male participants recruited, intervention acceptable to staff and male participants, ≥ 70% of participants followed up and levels of substance use and IPV perpetrated by men allocated to ADVANCE did not increase from average baseline level at 16 weeks post randomisation. In-depth interviews or focus groups explored the intervention’s acceptability to participants, facilitators and linked women’s support workers. Pre–post differences in IPV, substance use (men only), mental health, self-management (men only), health and social care service use, criminal justice contacts and quality of life (QoL) were determined for men and women 16 weeks post randomisation. Inferential analyses estimated intervention effects. Work package 5 A multicentre, parallel-group individually RCT, with nested process evaluation of ADVANCE + TAU compared to TAU only was planned. The primary outcome was self-reported IPV perpetration by men in substance use treatment measured using the Abusive Behaviour Inventory (ABI) in the previous 4 months at 12 months post randomisation. Men who had perpetrated IPV in the past 12 months (n = 378) would have been randomly allocated on a 2 : 1 basis to ADVANCE (n = 252) or TAU (n = 126). (Ex)-partners would have been invited to participate in the research. Linear mixed modelling would have assessed the effect of the intervention using the ABI. Incremental cost-effectiveness and cost–utility analysis of ADVANCE over and above TAU would have been undertaken. Analysis of qualitative data was planned using the framework approach. This WP was not undertaken due to COVID-19. Work package 3(ii) The ADVANCE was adapted for digitally supported remote delivery (ADVANCE-D) in response to COVID-19 restrictions based on expert-opinion, PPI and best available evidence. Work package 4(ii) A non-randomised multicentre feasibility study of delivering ADVANCE-D with embedded process evaluation was conducted. Target was to recruit 60 men from substance use treatment in Scotland, England and Wales who had perpetrated IPV towards a female (ex)-partner in the past 12 months, and their (ex)-partners. Men were supplied with a tablet and data contingent on attendance. All (ex)-partners were given a smartphone and data to view the ADVANCE-D website and access safety messages. Eligibility, suitability, consent, recruitment, attendance, retention and follow-up rates were estimated. Pre–post differences in IPV perpetration [victimisation for (ex)-partners], substance use, mental health, self-management (men only), health and social care service use, criminal justice contacts and QoL were explored at the end of the 16-week intervention. In both WP4(i) and WP4(ii), summary statistics quantified parameters. Paired t-tests or Wilcoxon signed-rank test compared pre- and post-intervention outcomes. The framework approach was used to analyse longitudinal qualitative data. Cross-cutting work package Two Learning Alliances of key stakeholders developed local cross-sector solutions and transferred knowledge from ADVANCE into practice. PWLE of IPV and/or substance use were consulted at all research stages. Results Work package 1(i) Twenty-six studies were included in the meta-ethnography. Five themes were identified across studies, supporting the complex interplay between substance use and IPV perpetration in the context of intoxication, withdrawal and craving. The impact of addiction and IPV on relationships was highlighted, including women describing emotional instability associated with the perpetrators’ substance use and financial abuse as perpetrators stole or used household resources to acquire substances. IPV linked to substance use was played out in relation to unequal gender relations, where male perpetrators sought to dominate and control their female partners. IPV was explained by both survivors and perpetrators as a shared response to anxiety or depression and anger, often from emotional insecurities shaped by negative childhood experiences, and mediated by substances. Work package 1(ii) Thirty-seven men and 14 of their (ex)-partners were interviewed. Men and women’s explanations of their abusive behaviour had similarities. Men tended to describe IPV as one-off incidents, arising from specific disputes or perceived sexual betrayal, whereas women described patterns of abuse and sexual jealousy. Men often described their behaviour as ‘protective’, whereas their (ex)-partners described the same experience as controlling and overbearing. The psycho-pharmacological effects of substance use were rarely the only explanation for IPV. Intoxication, craving, withdrawal and substance acquisition were key contexts in which controlling behaviours increased, conflicts escalated and seemingly erratic behaviours were commonplace. Work package 2 Nine RCTs were included in the review (n = 1014 men). Interventions were grouped into integrated IPV and substance use interventions (five trials), IPV interventions with adjunct substance use interventions (two trials) and stand-alone IPV interventions (two trials). Individual RCTs reported reductions in short-term substance use outcomes (≤ 3 months; two trials) and IPV perpetration at different time points (three trials) in interventions compared with TAU. Meta-analysis with integrated IPV and substance use interventions showed no difference in substance use (three trials) or IPV outcomes (four trials) versus substance use TAU. It was not possible to conduct meta-analysis for the other two intervention groups. Work package 3(i) The 16-week ADVANCE integrated group intervention focuses on developing participants’ strengths and healthy, non-abusive relationships. It comprises 2–4 pre-group individual sessions with a keyworker to establish personal goals and build genuine motivation to facilitate change, followed by 12 × 2-hour group sessions delivered by two trained facilitators. Integrated support services (ISSs) are offered to survivors. The main targets for change were personal goal planning; self-regulation, which refers to the ability to manage disruptive emotions and impulses; and attitudes and beliefs supporting IPV. ADVANCE incorporates an understanding of gendered power dynamics and reflects the complex links between substance use and IPV by highlighting individual risks for IPV perpetration, including substance use, poor emotional regulation and poor stress-coping. Work package 4(i) Over three temporal cycles, 104 male perpetrators were randomly allocated to receive ADVANCE + TAU (n = 54) or TAU only (n = 50). The overall median rate of intervention session attendance (of 14 compulsory sessions) was 28.6% (range 14.3–64.3% by the third cycle). Twenty-seven (ex)-partners were recruited, and 63% (17/27) were followed up. The methods were not designed to assess the effectiveness of ADVANCE. Three of the five pre-specified progression criteria were met: 71% (104/147) of eligible male participants were recruited, and there was no worsening of substance use or IPV perpetrated by men in the intervention arm 16 weeks post randomisation. The estimated group difference indicated improvement in IPV, controlling behaviours and depression and anxiety symptoms for men allocated to ADVANCE. The progression criteria of following up > 70% of men was not met, as only 49% (51/104) were followed up. Overall, the formative evaluation supported the intervention’s acceptability to staff and male participants (progression criteria partially met). Therapeutic alliance and session satisfaction were rated highly. Findings supported progression to a RCT (WP5). Work package 5 No participants had been recruited when the RCT was paused due to the pandemic. It proved impossible to restart the trial. A variation to contract was approved to adapt ADVANCE for digitally supported remote delivery [WP3(ii)] and change the study design [WP4(ii)]. Work package 3(ii) The ADVANCE-D comprises eight core sessions (an individual session, a ‘welcome’ video group and six fortnightly video groups) delivered by two trained facilitators and 12 weekly self-directed website sessions to recap and practice skills learnt in the group, followed by a one-to-one video/phone coaching session with a facilitator. Linked support is offered to (ex)-partners. Work package 4(ii) Sixty-five per cent (45/69) of eligible men were recruited, and 25 men were followed up (25/49; 55.6%). Twenty-one (ex)-partners were recruited, and 11 (52.4%) were followed up. Forty men were offered ADVANCE-D, 39 (97.5%) of whom attended at least one session. Forty-eight per cent of the total sessions offered were completed [mean 11.4; standard deviation (SD) 9.1]. Therapeutic alliance and website session satisfaction were rated highly. This study was designed to explore whether it was feasible to deliver ADVANCE-D remotely, not to assess the programme’s effectiveness. Of those followed up, 8/11 men and 17/25 women reported a reduction in abusive behaviour perpetrated and experienced, and 10/25 of men and 5/11 women reported a reduction in controlling behaviours used and experienced, respectively. Both men and women reported reductions in men using children against women, and in depression and anxiety symptoms. Of the men followed up, 7/24 reported they had increased their alcohol-free days, and 11/25 had increased their drug-free days in the past month. The process evaluation confirmed it was feasible and acceptable to deliver ADVANCE-D remotely to men in substance use treatment. Cross-cutting work package Research and intervention development was informed by the Learning Alliances and PWLE. Twenty Learning Alliance meetings were held. There are 68 subscribers to the ADVANCE blog (133 published posts). ADVANCE_PRGM has 237 followers. Findings were presented at 9 national and 35 international conferences. Eleven open access manuscripts were published. Two dissemination events were held: including 35 in person and 179 online attendees. Limitations The systematic review included only nine trials, with a low number suitable for inclusion in the meta-analysis (WP2). Recruitment was lower than planned [WP4(ii)], and the RCT of ADVANCE was not undertaken due to COVID-19 (WP5). Conclusions The ADVANCE Programme is a targeted perpetrator intervention for men in substance use treatment, usually excluded from Domestic Abuse Perpetrator Programmes. Both the group and digitally supported ADVANCE programmes can be delivered safely by trained staff in substance use treatment. With the correct risk and case management in place, alongside linked support for (ex)-partners, this research has shown promising findings, including reductions in IPV. Trial registration The trial is registered as ISRCRTN79435190 and ISRCTN66619273. The review was registered in PROSPERO as CRD42107056596. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: RP-PG-1214-20009) and is published in full in Programme Grants for Applied Research; Vol. 13, No. 10. See the NIHR Funding and Awards website for further award information.

OBJECTIVES:This study compared whether different addiction treatment educational experiences were associated with physicians' attitudes toward patients with opioid use disorder (OUD) and perceived efficacy of medications for opioid use disorder (MOUD). METHODS:Ohio physicians (n = 2757) with and without a waiver to prescribe buprenorphine (Drug Addiction Treatment Act 2000 [DATA 2000] waiver) were surveyed regarding their attitudes toward treating patients with OUD and on the effectiveness of MOUD. We divided physicians into 3 groups: physicians with DATA 2000 waivers, non-waivered physicians with experiential training, and non-waivered physicians without experiential training. We defined experiential training as educational experience directly working with individuals with OUD including those in recovery. Analysis of variance was used to detect statistically significant group differences. RESULTS:We found significant main effect differences in attitudes toward patients with OUD and perceived efficacy of MOUD between groups (P ≤ .01) for all but one attitude. Post hoc comparisons revealed waivered physicians had the most favorable attitudes. Among physicians without a waiver, those with experiential training had significantly more favorable attitudes toward treating OUD and perceived MOUD to be more effective, including items such as "OUD are treatable illnesses" and "medication assisted treatment is a crucial part of treatment for OUD." CONCLUSION:The results suggest that physicians with DATA 2000 waiver and experiential training, as compared to physicians without either a waiver or experiential training in OUD, are associated with less stigmatizing views of treating patients with OUD and prescribing MOUD. While legislation in December 2022 eliminated DATA 2000 waiver training requirement, these findings suggest an ongoing need for training opportunities.

Objectives: To understand patient and therapist experiences of time-intensive and weekly exposure-based therapy for anxiety disorders delivered during pregnancy.Design: A qualitative study using semi-structured interviews with patients and therapists who had taken part in a feasibility trial of predominantly online time-intensive versus weekly CBT in pregnancy. Setting UK therapists and patients in a primary care setting Participants In-depth interviews were conducted with 45 women who had participated in the trial and 6 therapists who had delivered the treatments. Analysis: Data were analysed using reflexive thematic analysis. Results: Five themes were developed from the data that showed convergence from therapist and patient perspectives. These were: ‘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 isolated 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 can be 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 connection, suggesting a hybrid model of delivery is the ideal.

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.

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.

BackgroundExposure-based cognitive-behaviour therapies (CBT) are effective but their acceptability in pregnancy is untested, despite affecting 15% of women. Time-intensive delivery of CBT (INT-CBT) may accelerate treatment response. AimsTo test the acceptability and feasibility of a trial of INT-CBT for antenatal anxiety disordersMethodThis multi-centre parallel-group trial recruited pregnant women with anxiety disorders from maternity and mental health settings and randomised (1:1) to INT-CBT or standard weekly CBT (WCBT). Participants received 12 hours of individual therapy using remote delivery (95%). Outcomes were assessed: at baseline; during treatment at week 2 and 6, and at 1 month and 3 months postpartum (by blinded assessors), alongside a qualitative interview. Pre-specified primary feasibility outcomes were evaluated and adjusted mean difference estimated for the proposed study primary outcome.ResultsAll feasibility outcomes were met. Of 135 screened, 59 women were recruited and randomised into the trial (29 INT-CBT :30 WCBT). 93% completed treatment and 81% provided data at 3m postpartum. No adverse effects were attributable to treatment. Women randomised to INT-CBT showed a reduction in anxiety (GAD-7) after two weeks of treatment (aMD=-4.17, 95%CI -6.03 to -2.31). There were differences in late pregnancy aMD=-1.72 (95%CI -3.99, 0.56), 1-month postpartum aMD=-2.13 (95%CI -5.14, 0.89), 3-month postpartum aMD=-0.11 (95%CI -3.23, 3.00). Women described the momentum of INT-CBT as helpful to drive change.ConclusionsExposure-based therapies are acceptable to pregnant women. INT-CBT may reduce anxiety quickly and should be tested in a confirmatory trial examining longer term outcomes.

Mothers with severe postpartum psychiatric diagnoses are more likely to have children’s social care involvement with their infants, but little is known about the needs or experiences of this group of women. With input from a lived experience advisory group, we carried out secondary analysis of data collected from 278 mother-infant dyads where the mother accessed acute psychiatric care in England or Wales postnatally. We explored the characteristics, needs, and service use experiences of mother-infant dyads with (n = 99) and without (n = 179) children’s social care involvement. We found that mothers with social care involvement were often experiencing wider adversity and inequity across multiple areas of their lives. These mothers were also less satisfied with their mental health care and had more unmet needs after discharge from acute services. We built multivariable logistic regression models to examine factors associated with children’s social care involvement during the acute admission and one year later. We found that having social care involvement during an acute postpartum admission was associated with being deprived, reporting a maternal history of childhood trauma, experiencing domestic abuse, having a diagnosis of personality disorder or schizophrenia, and having a history of previous psychiatric admissions. At one-year follow-up, factors associated with children’s social care involvement included deprivation, experiencing childhood trauma, having been single at the time of the postpartum admission, and having been readmitted to acute psychiatric services following the postpartum admission. Our findings suggest that mothers with children’s social services involvement in the context of an acute postpartum psychiatric diagnosis may have high levels of support needs, but services may struggle to meet their needs fully. We argue that an increased focus on supporting mothers with histories of trauma, adversity, and deprivation, along with greater collaboration between mental health, children’s social care, and third sector services may help improve experiences and outcomes.

BACKGROUND:Exposure-based cognitive-behaviour therapies (CBT) are effective but their acceptability in pregnancy is untested. Time-intensive delivery of CBT (INT-CBT) may accelerate treatment response. This feasibility trial aimed to explore this. METHODS:This multi-centre parallel-group trial recruited pregnant women with anxiety-related disorders via maternity and mental health settings and randomised (1:1) to INT-CBT (8-10 treatment hours over two weeks) or standard weekly one-hour CBT sessions (WCBT). Both groups also received late pregnancy and postpartum follow-ups. Participants received 10-12 total hours of individual therapy using remote delivery (95 %). Outcomes were assessed: at baseline; after two weeks of treatment, late pregnancy, at 1 and 3 months postpartum (by blinded assessors), alongside a qualitative interview. Pre-specified primary feasibility outcomes regarding acceptability, recruitment and retention were evaluated. The secondary outcome of adjusted mean difference was estimated for the proposed primary outcome. RESULTS:All feasibility outcomes were met. Of 135 screened, 59 women were randomised into the trial (29 INT-CBT:30 WCBT). 93 % completed treatment and 81 % provided data at 3 m postpartum. No adverse effects were attributable to treatment. Women receiving INT-CBT showed a reduction in anxiety (GAD-7) after two weeks of treatment compared to WCBT (aMD = -4.17, 95%CI -6.03 to -2.31) with narrower difference at 3-month postpartum aMD = -0.11 (95%CI -3.23, 3.00). Women described the momentum of INT-CBT as helpful to drive change. CONCLUSIONS:Exposure-based therapies are acceptable to pregnant women. INT-CBT may reduce anxiety quickly and should be tested in a confirmatory trial examining longer term outcomes. There may be limitations to generalisability from sampling and COVID. TRIAL REGISTRATION:doi:https://doi.org/10.1186/ISRCTN81203286 prospectively registered 27/6/2019.

BACKGROUND:Anorexia nervosa (AN) is a serious and disabling mental disorder with a high disease burden. In a proportion of cases, intensive hospital-based treatments, i.e. inpatient or day patient treatment, are required, with day patient treatment often being used as a 'step-down' treatment after a period of inpatient treatment. Demand for such treatment approaches has seen a sharp rise. Despite this, the relative merits of these approaches for patients, their families, and the NHS and wider society are relatively unknown. This paper describes the rationale for, and protocol of, a two-arm multi-centre open-label parallel group non-inferiority randomised controlled trial, evaluating the effectiveness and cost-effectiveness of these two intensive treatments for adults with severe AN: inpatient treatment as usual and a stepped care day patient approach (the combination of day patient treatment with the option of initial inpatient treatment for medical stabilisation). The main aim of this trial is to establish whether, in adults with severe AN, a stepped care day patient approach is non-inferior to inpatient treatment as usual in relation to improving body mass index (BMI) at 12 months post-randomisation. METHODS:386 patients with a Diagnostic and Statistical Manual 5th edition diagnosis of severe AN or related disorder, with a BMI of ≤16 kg/m2 and in need of intensive treatment will be randomly allocated to either inpatient treatment as usual or a stepped care day patient approach. Patients in both groups will receive treatment until they reach a healthy weight or get as close to this point as possible. Assessments will be conducted at baseline (prior to randomisation), and at 6 and 12 months post-randomisation, with additional monthly symptom monitoring. The primary outcome will be BMI at the 12-month post-randomisation assessment. Other outcomes will include psychosocial adjustment; treatment motivation, expectations and experiences; cost-effectiveness; and carer burden. DISCUSSION:The results of this study will provide a rigorous evaluation of two intensive treatment approaches which will inform future national and international treatment guidelines and service provision. TRIAL REGISTRATION:ISRCTN ISRCTN10166784 . Registered 28 February 2020. ISRCTN is a primary registry of the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) network and includes all items from the WHO Trial Registration Data Set.

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. 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). 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. 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.

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.

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.

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.

Background: It is unclear how best to identify and treat women with mental disorders in pregnancy and the year after birth (i.e. the perinatal period). Objectives: (1) To investigate how best to identify depression at antenatal booking [work package (WP) 1]. (2) To estimate the prevalence of mental disorders in early pregnancy (WP1). (3) To develop and examine the efficacy of a guided self-help intervention for mild to moderate antenatal depression delivered by psychological well-being practitioners (WP1). (4) To examine the psychometric properties of the perinatal VOICE (Views On Inpatient CarE) measure of service satisfaction (WP3). (5) To examine the clinical effectiveness and cost-effectiveness of services for women with acute severe postnatal mental disorders (WPs 1–3). (6) To investigate women’s and partners’/significant others’ experiences of different types of care (WP2). Design: Objectives 1 and 2 – a cross-sectional survey stratified by response to Whooley depression screening questions. Objective 3 – an exploratory randomised controlled trial. Objective 4 – an exploratory factor analysis, including test–retest reliability and validity assessed by association with the Client Satisfaction Questionnaire contemporaneous satisfaction scores. Objective 5 – an observational cohort study using propensity scores for the main analysis and instrumental variable analysis using geographical distance to mother and baby unit. Objective 6 – a qualitative study. Setting: English maternity services and generic and specialist mental health services for pregnant and postnatal women. Participants: Staff and users of mental health and maternity services. Interventions: Guided self-help, mother and baby units and generic care. Main outcome measures: The following measures were evaluated in WP1(i) – specificity, sensitivity, positive predictive value, likelihood ratio, acceptability and population prevalence estimates. The following measures were evaluated in WP1(ii) – participant recruitment rate, attrition and adverse events. The following measure was evaluated in WP2 – experiences of care. The following measures were evaluated in WP3 – psychometric indices for perinatal VOICE and the proportion of participants readmitted to acute care in the year after discharge. Results: WP1(i) – the population prevalence estimate was 11% (95% confidence interval 8% to 14%) for depression and 27% (95% confidence interval 22% to 32%) for any mental disorder in early pregnancy. The diagnostic accuracy of two depression screening questions was as follows: a weighted sensitivity of 0.41, a specificity of 0.95, a positive predictive value of 0.45, a negative predictive value of 0.93 and a likelihood ratio (positive) of 8.2. For the Edinburgh Postnatal Depression Scale, the diagnostic accuracy was as follows: a weighted sensitivity of 0.59, a specificity of 0.94, a positive predictive value of 0.52, a negative predictive value of 0.95 and a likelihood ratio (positive) of 9.8. Most women reported that asking about depression at the antenatal booking appointment was acceptable, although this was reported as being less acceptable for women with mental disorders and/or experiences of abuse. Cost-effectiveness analysis suggested that both the Whooley depression screening questions and the Edinburgh Postnatal Depression Scale were more cost-effective than with the Whooley depression screening questions followed by the Edinburgh Postnatal Depression Scale or no-screen option. WP1(ii) – 53 women with depression in pregnancy were randomised. Twenty-six women received modified guided self-help [with 18 (69%) women attending four or more sessions] and 27 women received usual care. Three women were lost to follow-up (follow-up for primary outcome: 92%). At 14 weeks post randomisation, women receiving guided self-help reported fewer depressive symptoms than women receiving usual care (adjusted effect size −0.64, 95% confidence interval −1.30 to 0.06). Costs and quality-adjusted life-years were similar, resulting in a 50% probability of guided self-help being cost-effective compared with usual care at National Institute for Health and Care Excellence cost per quality-adjusted life-year thresholds. The slow recruitment rate means that a future definitive larger trial is not feasible. WP2 – qualitative findings indicate that women valued clinicians with specialist perinatal expertise across all services, but for some women generic services were able to provide better continuity of care. Involvement of family members and care post discharge from acute services were perceived as poor across services, but there was also ambivalence among some women about increasing family involvement because of a complex range of factors. WP3(i) – for the perinatal VOICE, measures from exploratory factor analysis suggested that two factors gave an adequate fit (comparative fit index = 0.97). Items loading on these two dimensions were (1) those concerning aspects of the service relating to the care of the mother and (2) those relating to care of the baby. The factors were positively correlated (0.49; p < 0.0001). Total scores were strongly associated with service (with higher satisfaction for mother and baby units, 2 degrees of freedom; p < 0.0001) and with the ‘gold standard’ Client Service Questionnaire total score (test–retest intraclass correlation coefficient 0.784, 95% confidence interval 0.643 to 0.924; p < 0.0001). WP3(ii) – 263 of 279 women could be included in the primary analysis, which shows that the odds of being readmitted to acute care was 0.95 times higher for women who were admitted to a mother and baby unit than for those not admitted to a mother and baby unit (0.95, 95% confidence interval 0.86 to 1.04; p = 0.29). Sensitivity analysis using an instrumental variable found a markedly more significant effect of admission to mother and baby units (p < 0.001) than the primary analysis. Mother and baby units were not found to be cost-effective at 1 month post discharge because of the costs of care in a mother and baby unit. Cost-effectiveness advantages may exist if the cost of mother and baby units is offset by savings from reduced readmissions in the longer term. Limitations: Policy and service changes had an impact on recruitment. In observational studies, residual confounding is likely. Conclusions: Services adapted for the perinatal period are highly valued by women and may be more effective than generic services. Mother and baby units have a low probability of being cost-effective in the short term, although this may vary in the longer term. Future work: Future work should include examination of how to reduce relapses, including in after-care following discharge, and how better to involve family members. Trial registration: This trial is registered as ISRCTN83768230 and as study registration UKCRN ID 16403. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 10, No. 5. See the NIHR Journals Library website for further project information.

Abstract 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)

Introduction Severe hypoglycaemia (SH), when blood glucose falls too low to support brain function, is the most feared acute complication of insulin therapy for type 1 diabetes mellitus (T1DM). 10% of people with T1DM contribute nearly 70% of all episodes, with impaired awareness of hypoglycaemia (IAH) a major risk factor. People with IAH may be refractory to conventional approaches to reduce SH, with evidence for cognitive barriers to hypoglycaemia avoidance. This paper describes the protocol for the Hypoglycaemia Awareness Restoration Programme for People with Type 1 Diabetes and Problematic Hypoglycaemia Persisting Despite Optimised Self-care (HARPdoc) study, a trial to assess the impact on hypoglycaemia experience of a novel intervention that addresses cognitive barriers to hypoglycaemia avoidance, compared with an existing control intervention, recommended by the National Institute of Health and Care Excellence. Methods and analysis A randomised parallel two-arm trial of two group therapies: HARPdoc versus Blood Glucose Awareness Training, among 96 adults with T1DM and problematic hypoglycaemia, despite attendance at education with or without technology use, in four centres providing specialist T1DM services. The primary outcome will be the SH rate at 12 and/or 24 months after randomisation to either course. Secondary outcomes include rates of SH requiring parenteral therapy, involving unconsciousness or needing emergency services; hypoglycaemia awareness status, overall diabetes control and quality of life measures. An implementation study to evaluate how the interventions are delivered and how implementation impacts on clinical effectiveness is planned as a parallel study, with its own protocol. Ethics and dissemination The protocol was approved by the London Dulwich Research Ethics Committee, the Health Research Authority, National Health Service R&D and the Institutional Review Board of the Joslin Diabetes Center in the USA. Study findings will be disseminated to study participants and through peer-reviewed publications and conference presentations, including user groups. Trial registration number NCY02940873; Pre-results.

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.