An exploration of service use pattern changes and cost analysis following implementation of community perinatal mental health teams in pregnant women with a history of specialist mental healthcare in England: a national population-based cohort study.

BACKGROUND: The National Health Service in England pledged >£365 million to improve access to mental healthcare services via Community Perinatal Mental Health Teams (CPMHTs) and reduce the rate of perinatal relapse in women with severe mental illness. This study aimed to explore changes in service use patterns following the implementation of CPMHTs in pregnant women with a history of specialist mental healthcare in England, and conduct a cost-analysis on these changes. METHODS: This study used a longitudinal cohort design based on existing routine administrative data. The study population was all women residing in England with an onset of pregnancy on or after 1st April 2016 and who gave birth on or before 31st March 2018 with pre-existing mental illness (N = 70,323). Resource use and costs were compared before and after the implementation of CPMHTs. The economic perspective was limited to secondary mental health services, and the time horizon was the perinatal period (from the start of pregnancy to 1-year post-birth, ~ 21 months). RESULTS: The percentage of women using community mental healthcare services over the perinatal period was higher for areas with CPMHTs (30.96%, n=9,653) compared to areas without CPMHTs (24.72%, n=9,615). The overall percentage of women using acute care services (inpatient and crisis resolution teams) over the perinatal period was lower for areas with CPMHTs (4.94%, n=1,540 vs. 5.58%, n=2,171), comprising reduced crisis resolution team contacts (4.41%, n=1,375 vs. 5.23%, n=2,035) but increased psychiatric admissions (1.43%, n=445 vs. 1.13%, n=441). Total mental healthcare costs over the perinatal period were significantly higher for areas with CPMHTs (fully adjusted incremental cost £111, 95% CI £29 to £192, p-value 0.008). CONCLUSIONS: Following implementation of CPMHTs, the percentage of women using acute care decreased while the percentage of women using community care increased. However, the greater use of inpatient admissions alongside greater use of community care resulted in a significantly higher mean cost of secondary mental health service use for women in the CPMHT group compared with no CPMHT. Increased costs must be considered with caution as no data was available on relevant outcomes such as quality of life or satisfaction with services.

Evaluation of intensive community care services for young people with psychiatric emergencies: study protocol for a multi-centre parallel-group, single-blinded randomized controlled trial with an internal pilot phase.

BACKGROUND: Over 3000 young people under the age of 18 are admitted to Tier 4 Child and Adolescent Mental Health Services (CAMHS) inpatient units across the UK each year. The average length of hospital stay for young people across all psychiatric units in the UK is 120 days. Research is needed to identify the most effective and efficient ways to care for young people (YP) with psychiatric emergencies. This study aims to evaluate the clinical effectiveness and cost-effectiveness of intensive community care service (ICCS) compared to treatment as usual (TAU) for young people with psychiatric emergencies. METHODS: This is a multicentre two-arm randomized controlled trial (RCT) with an internal pilot phase. Young people aged 12 to < 18 considered for admission at participating NHS organizations across the UK will be randomized 1:1 to either TAU or ICCS. The primary outcome is the time to return to or start education, employment, or training (EET) at 6 months post-randomization. Secondary outcomes will include evaluations of mental health and overall well-being and patient satisfaction. Service use and costs and cost-effectiveness will also be explored. Intention-to-treat analysis will be adopted. The trial is expected to be completed within 42 months, with an internal pilot phase in the first 12 months to assess the recruitment feasibility. A process evaluation using visual semi-structured interviews will be conducted with 42 young people and 42 healthcare workers. DISCUSSION: This trial is the first well-powered randomized controlled trial evaluating the clinical and cost-effectiveness of ICCS compared to TAU for young people with psychiatric emergencies in Great Britain. TRIAL REGISTRATION: ISRCTN ISRCTN42999542, Registration on April 29, 2020.

Gender, marginalised groups, and young people's mental health: a longitudinal analysis of trajectories.

BACKGROUND: Individuals from marginalised groups experience higher levels of mental health difficulties and lower levels of wellbeing which may be due to the exposure to stress and adversity. This study explores trajectories of mental health over time for young women and girls and young people with other marginalised identities. METHODS: We conducted a secondary analysis on N = 14,215 children and young people (7,501 or 52.8% female, 6,571 or 46.2% male, and 81 or 0.6% non-binary or questioning) who completed a survey at age 11 to 12 years and at least one other annual survey aged 12 to 13 years and/or aged 13 to 14 years. We used group-based trajectory models to examine mental health difficulties. RESULTS: Except for behavioural difficulties, young women's and girls' trajectories showed that they consistently had higher levels of mental health difficulties compared to young men and boys. A similar pattern was shown for non-binary and questioning children and young people. Children and young people with economic disadvantage and/or special education needs, and/or for whom there were welfare concerns, were generally more likely to experience higher levels of mental health difficulties. CONCLUSIONS: This information could inform public policy, guidance and interventions.

Community perinatal mental health teams and associations with perinatal mental health and obstetric and neonatal outcomes in pregnant women with a history of secondary mental health care in England: a national population-based cohort study.

BACKGROUND: Women with a pre-existing severe mental disorder have an increased risk of relapse after giving birth. We aimed to evaluate associations of the gradual regional implementation of community perinatal mental health teams in England from April, 2016, with access to mental health care and with mental health, obstetric, and neonatal outcomes. METHODS: For this cohort study, we used the national dataset of secondary mental health care provided by National Health Service England, including mental health-care episodes from April 1, 2006, to March 31, 2019, linked at patient level to the Hospital Episode Statistics, and birth notifications from the Personal Demographic Service. We included women (aged ≥18 years) with an onset of pregnancy from April 1, 2016, who had given birth to a singleton baby up to March 31, 2018, and who had a pre-existing mental disorder, defined as contacts with secondary mental health care in the 10 years immediately before pregnancy. The primary outcome was acute relapse, defined as psychiatric hospital admission or crisis resolution team contact in the postnatal period (first year after birth). Secondary outcomes included any secondary mental health care in the perinatal period (pregnancy and postnatal period) and obstetric and neonatal outcomes. Outcomes were compared according to whether a community perinatal mental health team was available before pregnancy, with odds ratios (ORs) adjusted for time trends and maternal characteristics (adjORs). FINDINGS: Of 807 798 maternity episodes in England, we identified 780 026 eligible women with a singleton birth, of whom 70 323 (9·0%) had a pre-existing mental disorder. A postnatal acute relapse was found in 1117 (3·6%) of 31 276 women where a community perinatal mental health team was available and in 1745 (4·5%) of 39 047 women where one was unavailable (adjOR 0·77, 95% CI 0·64-0·92; p=0·0038). Perinatal access to any secondary mental health care was found in 9888 (31·6%) of 31 276 women where a community perinatal mental health team was available and 10 033 (25·7%) of 39 047 women where one was not (adjOR 1·35, 95% CI 1·23-1·49; p<0·0001). Risk of stillbirth and neonatal death was higher where a community perinatal mental health team was available (165 [0·5%] of 30 980 women) than where it was not (151 [0·4%] of 38 693 women; adjOR 1·34, 95% CI 1·09-1·66; p=0·0063), as was the risk of a baby small for gestational age (2227 [7·2%] of 31 030 women vs 2542 [6·6%] of 38 762 women; adjOR 1·10, 1·02-1·20; p=0·016), whereas preterm birth risk was lower (3167 [10·1%] of 31 206 women vs 4341 [11·1%] of 38 961; adjOR 0·86, 0·74-0·99; p=0·032). INTERPRETATION: The regional availability of community perinatal mental health teams reduced the postnatal risk of acute relapse and increased the overall use of secondary mental health care. Community perinatal mental health teams should have close links with maternity services to avoid intensive psychiatric support overshadowing obstetric and neonatal risks. FUNDING: The National Institute for Health and Care Research.

Obstetric and neonatal outcomes in pregnant women with and without a history of specialist mental health care: a national population-based cohort study using linked routinely collected data in England.

BACKGROUND: Pregnant women with pre-existing mental illnesses have increased risks of adverse obstetric and neonatal outcomes compared with pregnant women without pre-existing mental illnesses. We aimed to estimate these differences in risks according to the highest level of pre-pregnancy specialist mental health care, defined as psychiatric hospital admission, crisis resolution team (CRT) contact, or specialist community care only, and the timing of the most recent care episode in the 7 years before pregnancy. METHODS: Hospital and birth registration records of women with singleton births between April 1, 2014, and March 31, 2018 in England were linked to records of babies and records from specialist mental health services provided by the England National Health Service, a publicly funded health-care system. We compared the risks of adverse pregnancy outcomes, including fetal and neonatal death, preterm birth, and babies being born small for gestational age (SGA; birthweight <10th percentile), and composite indicators for neonatal adverse outcomes and maternal morbidity, between women with and without a history of contact with specialist mental health care. We calculated odds ratios adjusted for maternal characteristics (aORs), using logistic regression. FINDINGS: Of 2 081 043 included women (mean age 30·0 years; range 18-55 years; 77·7% White, 11·4% South Asian, 4·7% Black, and 6·2% mixed or other ethnic background), 151 770 (7·3%) had at least one pre-pregnancy specialist mental health-care contact. 7247 (0·3%) had been admitted to a psychiatric hospital, 29 770 (1·4%) had CRT contact, and 114 753 (5·5%) had community care only. With a pre-pregnancy mental health-care contact, risk of stillbirth or neonatal death within 7 days of birth was not significantly increased (0·45-0·49%; aOR 1·11, 95% CI 0·99-1·24): risk of preterm birth (<37 weeks) increased (6·5-9·8%; aOR 1·53, 1·35-1·73), as did risk of SGA (6·2- 7·5%; aOR 1·34, 1·30-1·37) and neonatal adverse outcomes (6·4-8·4%; aOR 1·37, 1·21-1·55). With a pre-pregnancy mental health-care contact, risk of maternal morbidity increased slightly from 0·9% to 1·0% (aOR 1·18, 1·12-1·25). Overall, risks were highest for women who had a psychiatric hospital admission any time or a mental health-care contact in the year before pregnancy. INTERPRETATION: Information about the level and timing of pre-pregnancy specialist mental health-care contacts helps to identify women at increased risk of adverse obstetric and neonatal outcomes. These women are most likely to benefit from dedicated community perinatal mental health teams working closely with maternity services to provide integrated care. FUNDING: National Institute for Health Research.

A survey and stakeholder consultation of Independent Domestic Violence Advisor (IDVA) programmes in English maternity services.

BACKGROUND: Healthcare-based Independent Domestic Violence Advisors (hIDVA) are evidence-based programmes that provide emotional and practical support to service users experiencing domestic abuse. hIDVA programmes are found to improve health outcomes for service users and are increasingly delivered across a range of healthcare settings. However, it is unclear how hIDVA programmes are implemented across maternity services and the key facilitators and barriers to their implementation. The aim of this study was to identify; how many English National Health Service (NHS) Trusts with maternity services have a hIDVA programme; which departments within the Trust they operate in; what format, content, and variation in hIDVA programmes exist; and key facilitators and barriers of implementation in maternity services. METHODS: A national survey of safeguarding midwives (Midwives whose role specifically tasks them to protect pregnant women from harm including physical, emotional, sexual and financial harm and neglect) within all maternity services across England; descriptive statistics were used to summarise responses. A World Café event (a participatory method, which aims to create a café atmosphere to facilitate informal conversation) with 38 national key stakeholders to examine barriers and facilitators to hIDVA programme implementation. RESULTS: 86/124 Trusts (69%) with a maternity service responded to the survey; 59(69%) of respondents reported that they had a hIDVA programme, and 47(55%) of the hIDVA programmes operated within maternity services. Key facilitators to implementation of hIDVA programmes included training of NHS staff about the hIDVA role and regular communication between Trust staff and hIDVA staff; hIDVA staff working directly from the Trust; co-creation of hIDVA programmes with experts by experience; governance and middle- and senior-management support. Key barriers included hIDVA staff having a lack of access to a private space for their work, insecure funding for hIDVA programmes and issues with recruitment and retention of hIDVA staff. CONCLUSIONS: Despite hIDVA programmes role in improving the health outcomes of service users experiencing domestic abuse, increased funding and staff training is needed to successfully implement hIDVA staff in maternity services. Integrated Care Board commissioning of acute and mental health trust services would benefit from ensuring hIDVA programmes and clinician DVA training are prioritised.

Prevalence of HIV in mental health service users: a retrospective cohort study.

OBJECTIVE: To examine the prevalence of HIV in a cohort of people who have used secondary mental health services in the UK. DESIGN: Retrospective cohort study. SETTING: Routinely collected clinical data from secondary mental health services in South London, UK available for research through the Clinical Record Interactive Search tool at the National Institute for Health and Care Research Maudsley Biomedical Research Centre were matched with pseudonymised national HIV surveillance data held by the UK Health Security Agency using a deterministic matching algorithm. PARTICIPANTS: All adults aged 16+ who presented for the first time to mental health services in the South London and Maudsley (SLaM) National Health Service Trust between 1 January 2007 and 31 December 2018 were included. PRIMARY OUTCOME: Point prevalence of HIV. RESULTS: There were 181 177 people who had contact with mental health services for the first time between 2007 and 2018 in SLaM. Overall, 2.47% (n=4481) of those had a recorded HIV diagnosis in national HIV surveillance data at any time (before, during or after contact with mental health services), 24.73 people per 1000. HIV point prevalence was highest in people with a diagnosed substance use disorder at 3.77% (n=784). A substantial percentage of the sample did not have a formal mental health diagnosis (27%), but even with those excluded, the point prevalence remained high at 2.31%. Around two-thirds of people had their diagnosis of HIV before contact with mental health services (67%; n=1495). CONCLUSIONS: The prevalence of HIV in people who have had contact with mental health services was approximately 2.5 times higher than the general population in the same geographical area. Future work should investigate risk factors and disparities in HIV outcomes between those with and without mental health service contact.

Clinical Effectiveness and Cost-Effectiveness of Supported Mindfulness-Based Cognitive Therapy Self-help Compared With Supported Cognitive Behavioral Therapy Self-help for Adults Experiencing Depression: The Low-Intensity Guided Help Through Mindfulness (LIGHTMind) Randomized Clinical Trial.

Importance: Depression is prevalent. Treatment guidelines recommend practitioner-supported cognitive behavioral therapy self-help (CBT-SH) for mild to moderate depression in adults; however, dropout rates are high. Alternative approaches are required. Objective: To determine if practitioner-supported mindfulness-based cognitive therapy self-help (MBCT-SH) is superior to practitioner-supported CBT-SH at reducing depressive symptom severity at 16 weeks postrandomization among patients with mild to moderate depression and secondarily to examine if practitioner-supported MBCT-SH is cost-effective compared with practitioner-supported CBT-SH. Design, Setting, and Participants: This was an assessor- and participant-blinded superiority randomized clinical trial with 1:1 automated online allocation stratified by center and depression severity comparing practitioner-supported MBCT-SH with practitioner-supported CBT-SH for adults experiencing mild to moderate depression. Recruitment took place between November 24, 2017, and January 31, 2020. The study took place in 10 publicly funded psychological therapy services in England (Improving Access to Psychological Therapies [IAPT]). A total of 600 clients attending IAPT services were assessed for eligibility, and 410 were enrolled. Participants met diagnostic criteria for mild to moderate depression. Data were analyzed from January to October 2021. Interventions: Participants received a copy of either an MBCT-SH or CBT-SH workbook and were offered 6 support sessions with a trained practitioner. Main Outcomes and Measures: The preregistered primary outcome was Patient Health Questionnaire (PHQ-9) score at 16 weeks postrandomization. The primary analysis was intention-to-treat with treatment arms masked. Results: Of 410 randomized participants, 255 (62.2%) were female, and the median (IQR) age was 32 (25-45) years. At 16 weeks postrandomization, practitioner-supported MBCT-SH (n = 204; mean [SD] PHQ-9 score, 7.2 [4.8]) led to significantly greater reductions in depression symptom severity compared with practitioner-supported CBT-SH (n = 206; mean [SD] PHQ-9 score, 8.6 [5.5]), with a between-group difference of -1.5 PHQ-9 points (95% CI, -2.6 to -0.4; P = .009; d = -0.36). The probability of MBCT-SH being cost-effective compared with CBT-SH exceeded 95%. However, although between-group effects on secondary outcomes were in the hypothesized direction, they were mostly nonsignificant. Three serious adverse events were reported, all deemed not study related. Conclusions and Relevance: In this randomized clinical trial, practitioner-supported MBCT-SH was superior to standard recommended treatment (ie, practitioner-supported CBT-SH) for mild to moderate depression in terms of both clinical effectiveness and cost-effectiveness. Findings suggest that MBCT-SH for mild to moderate depression should be routinely offered to adults in primary care services. Trial Registration: isrctn.org Identifier: ISRCTN13495752.

Assessing the feasibility of a web-based outcome measurement system in child and adolescent mental health services - myHealthE a randomised controlled feasibility pilot study.

BACKGROUND: Interest in internet-based patient reported outcome measure (PROM) collection is increasing. The NHS myHealthE (MHE) web-based monitoring system was developed to address the limitations of paper-based PROM completion. MHE provides a simple and secure way for families accessing Child and Adolescent Mental Health Services to report clinical information and track their child's progress. This study aimed to assess whether MHE improves the completion of the Strengths and Difficulties Questionnaire (SDQ) compared with paper collection. Secondary objectives were to explore caregiver satisfaction and application acceptability. METHODS: A 12-week single-blinded randomised controlled feasibility pilot trial of MHE was conducted with 196 families accessing neurodevelopmental services in south London to examine whether electronic questionnaires are completed more readily than paper-based questionnaires over a 3-month period. Follow up process evaluation phone calls with a subset (n = 8) of caregivers explored system satisfaction and usability. RESULTS: MHE group assignment was significantly associated with an increased probability of completing an SDQ-P in the study period (adjusted hazard ratio (HR) 12.1, 95% CI 4.7-31.0; p = <.001). Of those caregivers' who received the MHE invitation (n = 68) 69.1% completed an SDQ using the platform compared to 8.8% in the control group (n = 68). The system was well received by caregivers, who cited numerous benefits of using MHE, for example, real-time feedback and ease of completion. CONCLUSIONS: MHE holds promise for improving PROM completion rates. Research is needed to refine MHE, evaluate large-scale MHE implementation, cost effectiveness and explore factors associated with differences in electronic questionnaire uptake.

Antidepressant and antipsychotic treatment of Psychotic Major Depression in a British mental healthcare setting.

BACKGROUND: Evidence from treatment trials shows that the most effective pharmacological treatment for Psychotic Major Depression (PMD) is combined antidepressant and antipsychotic pharmacotherapy. AIM: This study investigates the use of antidepressant and antipsychotic treatment for PMD in clinical practice and examines how treatment profiles correlate with demographic and clinical symptoms. METHOD: Anonymised electronic health records of 2,837 individuals with PMD were followed up for 12-months post-diagnosis in a historic open cohort design. The use of antidepressants and antipsychotics, alone or in combination, were described using frequency statistics. Demographic and clinical characteristics associated with each treatment were assessed using logistic regression analyses. RESULTS: Antidepressant and antipsychotic combination pharmacotherapy was the most used treatment for PMD with 69.9% users, compared to antidepressant monotherapy (10.9%) and antipsychotic monotherapy (10.3%). The remaining 8.9% of individuals did not receive antidepressant or antipsychotic treatment. The presence of delusions was strongly associated with the use of antipsychotics, both alone (odds ratio =3.99, 95% confidence intervals = 2.72-5.83, p<.001) and in combination with antidepressants (OR = 2.7, 95% CI = 2.09-3.67, p<.001), rather than antidepressant treatment alone. CONCLUSIONS: Combined antidepressant and antipsychotic pharmacotherapy is the most common treatment of PMD in clinical practice, showing that clinical practice is in line with evidence from treatment research.

Cognitive bias modification for paranoia (CBM-pa): a randomised controlled feasibility study in patients with distressing paranoid beliefs.

BACKGROUND: Cognitive Bias Modification for paranoia (CBM-pa) is a novel, theory-driven psychological intervention targeting the biased interpretation of emotional ambiguity associated with paranoia. Study objectives were (i) test the intervention's feasibility, (ii) provide effect size estimates, (iii) assess dose-response and (iv) select primary outcomes for future trials. METHODS: In a double-blind randomised controlled trial, sixty-three outpatients with clinically significant paranoia were randomised to either CBM-pa or an active control (text reading) between April 2016 and September 2017. Patients received one 40 min session per week for 6 weeks. Assessments were given at baseline, after each interim session, post-treatment, and at 1- and 3-months post-treatment. RESULTS: A total of 122 patients were screened and 63 were randomised. The recruitment rate was 51.2%, with few dropouts (four out of 63) and follow-up rates were 90.5% (1-month) and 93.7% (3-months). Each session took 30-40 min to complete. There was no statistical evidence of harmful effects of the intervention. Preliminary data were consistent with efficacy of CBM-pa over text-reading control: patients randomised to the intervention, compared to control patients, reported reduced interpretation bias (d = -0.48 to -0.76), improved symptoms of paranoia (d = -0.19 to -0.38), and lower depressed and anxious mood (d = -0.03 to -0.29). The intervention effect was evident after the third session. CONCLUSIONS: CBM-pa is feasible for patients with paranoia. A fully powered randomised control trial is warranted.

Mental health service use among pregnant and early postpartum women.

PURPOSE: To explore the proportion and characteristics of women with a mental disorder who have contact with mental health services during pregnancy and the postnatal period in a maternity service in London. METHODS: Data from the WEll-being in pregNancy stuDY (WENDY), a prospective cohort study, were used. Women were recruited at their first appointment for antenatal care and assessed for mental disorders using the Structured Clinical Interview DSM-IV Axis I/II Disorders for Research. Clinical, sociodemographic and psychosocial characteristics were collected. Mental health service use data were collected for the period from study entry to 3 months postpartum. RESULTS: Two hundred women met diagnostic criteria for a mental disorder. Fifty-five (34%) of these had at least one contact with mental health services. Moderate depression (OR 7.44, CI 2.03-27.28, p < 0.01), severe depression (OR 10.5, CI 2.68-41.12, p < 0.01), past psychiatric hospital admission (OR 3.76, CI 1.05-13.44, p < 0.05), symptoms of anxiety (OR 3.95, CI 1.86-8.37, p < 0.001) and perceived low levels of social support (OR 0.43, CI 0.18-1.01, p = 0.05) were associated with an increased likelihood of contact with mental health services in univariate analyses. However, only moderate (OR 5.92, CI 1.31-26.78, p = 0.02) and severe depression (OR 6.04, CI 1.08-33.72, p = 0.04) remained significant in the multivariate regressions analyses. CONCLUSION: Only a third of women with a diagnosable mental disorder at their first antenatal appointment had any contact with mental health services during pregnancy or up to 3 months postpartum. Further research is warranted to elicit perinatal women's views about the potential barriers to accessing professional mental health care.

Cost-effectiveness of screening tools for identifying depression in early pregnancy: a decision tree model.

BACKGROUND: Although the effectiveness of screening tools for detecting depression in pregnancy has been investigated, there is limited evidence on the cost-effectiveness. This is vital in providing full information to decision makers. This study aimed to explore the cost-effectiveness of different screening tools to identify depression in early pregnancy compared to no screening. METHODS: A decision tree was developed to model the identification and treatment pathways of depression from the first antenatal appointment to 3-months postpartum using the Whooley questions, the Edinburgh Postnatal Depression Scale (EPDS) and the Whooley questions followed by the EPDS, compared to no screening. The economic evaluation took an NHS and Personal Social Services perspective. Model parameters were taken from a combination of sources including a cross-sectional survey investigating the diagnostic accuracy of screening tools, and other published literature. Cost-effectiveness was assessed in terms of the incremental cost per quality adjusted life years (QALYs). Cost-effectiveness planes and cost-effectiveness acceptability curves were produced using a net-benefit approach based on Monte Carlo simulations of cost-outcome data. RESULTS: In a 4-way comparison, the Whooley, EPDS and Whooley followed by the EPDS each had a similar probability of being cost-effective at around 30% for willingness to pay values from £20,000-30,000 per QALY compared to around 20% for the no screen option. CONCLUSIONS: All three screening approaches tested had a higher probability of being cost-effective than the no-screen option. In the absence of a clear cost-effectiveness advantage for any one of the three screening options, the choice between the screening approaches could be made on other grounds, such as clinical burden of the screening options. Limitations include data availability and short time horizon, thus further research is needed. CLINICAL TRIALS REGISTRATION: N/A.

Treating common mental disorder including psychotic experiences in the primary care improving access to psychological therapies programme (the TYPPEX study): protocol for a stepped wedge cluster randomised controlled trial with nested economic and process evaluation of a training package for therapists.

INTRODUCTION: At least one in four people treated by the primary care improving access to psychological therapies (IAPT) programme in England experiences distressing psychotic experiences (PE) in addition to common mental disorder (CMD). These individuals are less likely to achieve recovery. IAPT services do not routinely screen for nor offer specific treatments for CMD including PE. The Tailoring evidence-based psychological therapY for People with common mental disorder including Psychotic EXperiences study will evaluate the clinical and cost-effectiveness of an enhanced training for cognitive behavioural therapists that aims to address this clinical gap. METHODS AND ANALYSIS: This is a multisite, stepped-wedge cluster randomised controlled trial. The setting will be IAPT services within three mental health trusts. The participants will be (1) 56-80 qualified IAPT cognitive behavioural therapists and (2) 600 service users who are triaged as appropriate for cognitive behavioural therapy in an IAPT service and have PE according to the Community Assessment of Psychic Experiences-Positive 15-items Scale. IAPT therapists will be grouped into eight study clusters subsequently randomised to the control-intervention sequence. We will obtain pseudonymous clinical outcome data from IAPT clinical records for eligible service users. We will invite service users to complete health economic measures at baseline, 3, 6, 9 and 12-month follow-up. The primary outcome will be the proportion of patients with common mental disorder psychotic experiences who have recovered by the end of treatment as measured by the official IAPT measure for recovery. ETHICS AND DISSEMINATION: The study received the following approvals: South Central-Berkshire Research Ethics Committee on 28 April 2020 (REC reference 20/SC/0135) and Health Research Authority (HRA) on 23 June 2020. An amendment was approved by the Ethics Committee on 01 October 2020 and HRA on 27 October 2020. Results will be made available to patients and the public, the funders, stakeholders in the IAPT services and other researchers. TRIAL REGISTRATION NUMBER: ISRCTN93895792.

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).

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.

Out of pocket expenses in obsessive compulsive disorder.

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

Rethinking the course of psychotic disorders: modelling long-term symptom trajectories.

BACKGROUND: The clinical course of psychotic disorders is highly variable. Typically, researchers have captured different course types using broad pre-defined categories. However, whether these adequately capture symptom trajectories of psychotic disorders has not been fully assessed. Using data from AESOP-10, we sought to identify classes of individuals with specific symptom trajectories over a 10-year follow-up using a data-driven approach. METHOD: AESOP-10 is a follow-up, at 10 years, of 532 incident cases with a first episode of psychosis initially identified in south-east London and Nottingham, UK. Using extensive information on fluctuations in the presence of psychotic symptoms, we fitted growth mixture models to identify latent trajectory classes that accounted for heterogeneity in the patterns of change in psychotic symptoms over time. RESULTS: We had sufficient data on psychotic symptoms during the follow-up on 326 incident patients. A four-class quadratic growth mixture model identified four trajectories of psychotic symptoms: (1) remitting-improving (58.5%); (2) late decline (5.6%); (3) late improvement (5.4%); (4) persistent (30.6%). A persistent trajectory, compared with remitting-improving, was associated with gender (more men), black Caribbean ethnicity, low baseline education and high disadvantage, low premorbid IQ, a baseline diagnosis of non-affective psychosis and long DUP. Numbers were small, but there were indications that those with a late decline trajectory more closely resembled those with a persistent trajectory. CONCLUSION: Our current approach to categorising the course of psychotic disorders may misclassify patients. This may confound efforts to elucidate the predictors of long-term course and related biomarkers.

Recovery From Severe Mental Health Problems: A Systematic Review of Service User and Informal Caregiver Perspectives.

Introduction: The recovery approach aims to have users' perspectives at the heart of service development and research; it is a holistic perspective that considers social needs, personal growth and inclusion. In the last decade recovery-oriented research and practice has increased greatly, however, a comprehensive model of recovery considering exclusively the perspectives of people with lived experience has not been devised. Aims: This review aimed to develop a framework and contextualize service users' and informal caregivers' understanding of recovery from severe mental health problems. Methods: We systematically searched 6 databases including key terms related to knowledge, experience and narratives AND mental health AND personal recovery. The search was supplemented with reference sourcing through gray literature, reference tracking and expert consultation. Data analysis consisted of a qualitative meta-synthesis using constant comparative methods. Results: Sixty-two studies were analyzed. A pattern emerged regarding the recovery paradigms that the studies used to frame their findings. The resulting recovery framework included the domains Social recovery; Prosperity (Legal, political, and economic recovery); Individual Recovery; and Clinical Recovery Experience (SPICE). Service users' definitions of recovery tended to prioritize social aspects, particularly being accepted and connecting with others, while caregivers focused instead on clinical definitions of recovery such as symptom remission. Both groups emphasized individual aspects such as becoming self-sufficient and achieving personal goals, which was strongly linked with having economic means for independence. Conclusions: The recovery model provided by this review offers a template for further research in the field and a guide for policy and practice. Predominant definitions of recovery currently reflect understandings of mental health which focus on an individual perspective, while this review found an important emphasis on socio-political aspects. At the same time, only a small number of studies took place in low-income countries, focused on minoritized populations, or included caregivers' perspectives. These are important gaps in the literature that require further attention. Systematic Review Registration: The review protocol was registered on PROSPERO (CRD42017076450); https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=76450.