Designing a Library of Lived Experience for Mental Health: integrated realist synthesis and experience-based co-design study in UK mental health services.

OBJECTIVE: Living Library events involve people being trained as living 'Books', who then discuss aspects of their personal experiences in direct conversation with attendees, referred to as 'Readers'. This study sought to generate a realist programme theory and a theory-informed implementation guide for a Library of Lived Experience for Mental Health (LoLEM). DESIGN: Integrated realist synthesis and experience-based co-design. SETTING: Ten online workshops with participants based in the North of England. PARTICIPANTS: Thirty-one participants with a combination of personal experience of using mental health services, caring for someone with mental health difficulties and/or working in mental health support roles. RESULTS: Database searches identified 30 published and grey literature evidence sources which were integrated with data from 10 online co-design workshops conducted over 12 months. The analysis generated a programme theory comprising five context-mechanism-outcome (CMO) configurations. Findings highlight how establishing psychological safety is foundational to productive Living Library events (CMO 1). For Readers, direct conversations humanise others' experiences (CMO 2) and provide the opportunity to flexibly explore new ways of living (CMO 3). Through participation in a Living Library, Books may experience personal empowerment (CMO 4), while the process of self-authoring and co-editing their story (CMO 5) can contribute to personal development. This programme theory informed the co-design of an implementation guide highlighting the importance of tailoring event design and participant support to the contexts in which LoLEM events are held. CONCLUSIONS: The LoLEM has appeal across stakeholder groups and can be applied flexibly in a range of mental health-related settings. Implementation and evaluation are required to better understand the positive and negative impacts on Books and Readers. TRIAL REGISTRATION NUMBER: PROSPERO CRD42022312789.

Improving Peer Online Forums (iPOF): protocol for a realist evaluation of peer online mental health forums to inform practice and policy.

INTRODUCTION: Peer online mental health forums are commonly used and offer accessible support. Positive and negative impacts have been reported by forum members and moderators, but it is unclear why these impacts occur, for whom and in which forums. This multiple method realist study explores underlying mechanisms to understand how forums work for different people. The findings will inform codesign of best practice guidance and policy tools to enhance the uptake and effectiveness of peer online mental health forums. METHODS AND ANALYSIS: In workstream 1, we will conduct a realist synthesis, based on existing literature and interviews with approximately 20 stakeholders, to generate initial programme theories about the impacts of forums on members and moderators and mechanisms driving these. Initial theories that are relevant for forum design and implementation will be prioritised for testing in workstream 2.Workstream 2 is a multiple case study design with mixed methods with several online mental health forums differing in contextual features. Quantitative surveys of forum members, qualitative interviews and Corpus-based Discourse Analysis and Natural Language Processing of forum posts will be used to test and refine programme theories. Final programme theories will be developed through novel triangulation of the data.Workstream 3 will run alongside workstreams 1 and 2. Key stakeholders from participating forums, including members and moderators, will be recruited to a Codesign group. They will inform the study design and materials, refine and prioritise theories, and codesign best policy and practice guidance. ETHICS AND DISSEMINATION: Ethical approval was granted by Solihull Research Ethics Committee (IRAS 314029). Findings will be reported in accordance with RAMESES (Realist And MEta-narrative Evidence Syntheses: Evolving Standards) guidelines, published as open access and shared widely, along with codesigned tools. TRIAL REGISTRATION NUMBER: ISRCTN 62469166; the protocol for the realist synthesis in workstream one is prospectively registered at PROSPERO CRD42022352528.

Designing a library of lived experience for mental health (LoLEM): protocol for integrating a realist synthesis and experience based codesign approach.

INTRODUCTION: People with lived expertise in managing mental health challenges can be an important source of knowledge and support for other people facing similar challenges, and for carers to learn how best to help. However, opportunities for sharing lived expertise are limited. Living libraries support people with lived expertise to be 'living books', sharing their experiences in dialogue with 'readers' who can ask questions. Living libraries have been piloted worldwide in health-related contexts but without a clear model of how they work or rigorous evaluation of their impacts. We aim to develop a programme theory about how a living library could be used to improve mental health outcomes, using this theory to codesign an implementation guide that can be evaluated across different contexts. METHODS AND ANALYSIS: We will use a novel integration of realist synthesis and experience-based codesign (EBCD) to produce a programme theory about how living libraries work and a theory and experience informed guide to establishing a library of lived experience for mental health (LoLEM). Two workstreams will run concurrently: (1) a realist synthesis of literature on living libraries, combined with stakeholder interviews, will produce several programme theories; theories will be developed collaboratively with an expert advisory group of stakeholders who have hosted or taken part in a living library and will form our initial analysis framework; a systematic search will identify literature about living libraries; data will be coded into our analysis framework, and we will use retroductive reasoning to explain living libraries' impacts across multiple contexts. Individual stakeholder interviews will help refine and test theories; (2) data from workstream 1 will inform 10 EBCD workshops with people with experience of managing mental health difficulties and health professionals to produce a LoLEM implementation guide; data from this process will also inform the theory in workstream 1. ETHICS AND DISSEMINATION: Ethical approval was granted by Coventry and Warwick National Health Service Research Ethics Committee on 29 December 2021 (reference number 305975). The programme theory and implementation guide will be published as open access and shared widely through a knowledge exchange event, a study website, mental health provider and peer support networks, peer reviewed journals and a funders report. PROSPERO REGISTRATION DETAILS: CRD42022312789.

A pilot randomised controlled trial to assess the feasibility and acceptability of recovery-focused therapy for older adults with bipolar disorder.

BACKGROUND: Despite increasing evidence for the effectiveness of individual psychological interventions for bipolar disorder, research on older adults is lacking. We report the first randomised controlled trial of psychological therapy designed specifically for older adults with bipolar disorder. AIMS: To evaluate the feasibility and acceptability of recovery-focused therapy, designed in collaboration with older people living with bipolar disorder. METHOD: A parallel, two-armed, randomised controlled trial comparing treatment as usual with up to 14 sessions of recovery-focused therapy plus treatment as usual, for older adults with bipolar disorder. RESULTS: Thirty-nine participants (67% female, mean age 67 years) were recruited over a 17-month period. Feasibility and acceptability of recruitment, retention (>80% observer-rated outcomes at both 24 and 48 weeks) and intervention processes were demonstrated. The majority of participants started therapy when offered, adhered to the intervention (68% attended all sessions and 89% attended six or more sessions) and reported positive benefits. Clinical assessment measures provide evidence of a signal for effectiveness on a range of outcomes including mood symptoms, time to relapse and functioning. No trial-related serious adverse events were identified. CONCLUSIONS: Recovery-focused therapy is feasible, acceptable and has the potential to improve a range of outcomes for people living with bipolar disorder in later life. A large-scale trial is warranted to provide a reliable estimate of its clinical and cost-effectiveness.

Directly or Indirectly? The Role of Social Support in the Psychological Pathways Underlying Suicidal Ideation in People with Bipolar Disorder.

Contemporary theories of suicide, such as the Schematic Appraisals Model (SAMS), hypothesize that negative perceptions of social support are implicated in the pathways to suicidal experiences. The SAMS predicts that perceived social support influences suicidal ideation through appraisals of defeat and entrapment. However, such pathways have not been investigated in people who have bipolar disorder. This prospective four-month study tested the influence of perceived social support on later suicidal ideation via changes in defeat, entrapment, and hopelessness, in a sample of eighty euthymic participants with bipolar disorder (N = 62 at follow-up). Linear regression models tested the extent to which perceived social support at baseline predicted changes in suicidal ideation at four months directly and indirectly via changes in defeat, entrapment, and hopelessness. Perceived social support did not directly predict changes in suicidal ideation, but there was a significant indirect mediational pathway between perceived social support at baseline and changes in suicidal ideation over time, via changes in defeat, entrapment and hopelessness, supporting the SAMS. Psychological interventions which target negative perceptions of social support early, in tandem with addressing defeat, entrapment, and hopelessness over time, present a potentially effective approach to counter suicidal ideation in people who experience bipolar disorder.

Recovery beyond clinical improvement - Recovery outcomes measured for people with bipolar disorder between 1980 and 2020.

BACKGROUND: Outcome measurement in bipolar disorder (BD) traditionally focused on clinical improvement without considering other domains. Improvement trajectories in clinical and social-functional domains are different and can simultaneously appear in one while not in other domains. Measuring personal recovery (PR) has become a priority internationally. This review explored the shift in research investigating operational recovery definitions and underpinning factors of recovery in BD over the past four decades. METHODS: Studies defining recovery domains (other than clinical recovery) in BD were systematically reviewed; operational recovery definitions and factors assessed in association with recovery were thematically categorised and integrated in a narrative synthesis. RESULTS: Thirty-three studies, comprising 3638 participants from 19 countries were included. Identified operational recovery definition themes included i) PR ii) social-functional (SFR), and iii) occupational-residential (ORR) recovery. Examined factors were grouped as demographic, clinical and psychosocial factors. Predominantly demographic factors were linked to ORR and clinical factors to SFR. Depressive symptomatology was the only clinical factor associated with PR. Research investigating psychosocial factors in PR is emerging and has showed that resilience and appraisals of mood seem to be associated with PR. LIMITATIONS: Studies not available in English or examining functioning without defining recovery were excluded. CONCLUSIONS: Earlier operational recovery definitions of ORR and SFR were often arbitrary and inconsistent, and predominantly focused on clinical and demographic underpinning factors. While research attempts to follow the significant policy shifts towards personalised care by measuring what matters to individuals and exploring broader underpinning psychosocial factors, it is still lagging behind.

Mindfulness-based online intervention to improve quality of life in late-stage bipolar disorder: A randomized clinical trial.

Objective: Adjunctive psychological interventions improve outcomes in bipolar disorder (BD), but people in latter stages likely have different clinical needs. The objective here was to test the hypothesis that for people with ≥10 episodes of BD, a brief online mindfulness-based intervention (ORBIT 2.0) improves quality of life (QoL) relative to a Psychoeducation control. Method: A rater-masked, pragmatic superiority randomized clinical trial compared ORBIT 2.0 with active control. Both interventions were 5-week coach-supported programs with treatment as usual continued. Inclusion criteria included age 18-65 years, confirmed diagnosis of BD, and history of ≥10 episodes. Measures were collected at baseline, postintervention, and 3- and 6-month follow-ups. The main outcome was QoL, measured on the Brief Quality of Life in Bipolar Disorder (Brief QoL.BD) at 5 weeks, using intention-to-treat analyses. Results: Among N = 302 randomized participants, the primary hypothesis was not supported (Treatment × Time ß = -0.69, 95% CI [-2.69, 1.31], p = .50). The main effect of Time was not significant in either condition, indicating no improvement in either group. Recruitment was feasible, the platform was safe, both interventions were highly acceptable, but usage was suboptimal. Post hoc analyses found both interventions effective for participants not in remission from depression at baseline. Conclusions: In people with late-stage BD, an online mindfulness-based intervention was not superior to psychoeducational control in improving QoL. Online delivery was found to be safe and acceptable. Future interventions may need to be higher intensity, address engagement challenges, and target more symptomatic individuals. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Developing a recovery-focused therapy for older people with bipolar disorder: a qualitative focus group study.

OBJECTIVES: As awareness of bipolar disorder (BD) increases and the world experiences a rapid ageing of the population, the number of people living with BD in later life is expected to rise substantially. There is no current evidence base for the effectiveness of psychological interventions for older adults with BD. This focus group study explored a number of topics to inform the development and delivery of a recovery-focused therapy (RfT) for older adults with BD. DESIGN: A qualitative focus group study. SETTING: Three focus groups were conducted at a university in the North West of England. PARTICIPANTS: Eight people took part in the focus groups; six older adults with BD, one carer and one friend. RESULTS: Participant's responses clustered into six themes: (1) health-related and age-related changes in later life, (2) the experience of BD in later life, (3) managing and coping with BD in later life, (4) recovery in later life, (5) seeking helping in the future and (6) adapting RfT for older people. CONCLUSIONS: Participants reported a range of health-related and age-related changes and strategies to manage their BD. Participants held mixed views about using the term 'recovery' in later life. Participants were in agreement that certain adaptations were needed for delivering RfT for older adults, based on their experience of living with BD in later life. The data collected as part of the focus groups have led to a number of recommendations for delivering RfT for older adults with BD in a randomised controlled trial (Clinical Trial Registration: ISRCTN13875321).

Psychological therapy for mood instability within bipolar spectrum disorder: a randomised, controlled feasibility trial of a dialectical behaviour therapy-informed approach (the ThrIVe-B programme).

BACKGROUND: A subgroup of those with bipolar spectrum disorders experience ongoing mood fluctuations outside of full episodes. We conducted a randomised, controlled feasibility study of a Dialectical Behavioural Therapy-informed approach for bipolar mood fluctuations (Therapy for Inter-episode mood Variability in Bipolar [ThrIVe-B]). Our study aimed to examine the feasibility and acceptability of a future definitive trial evaluating the clinical and cost effectiveness of the ThrIVe-B programme. Participants were required to meet diagnostic criteria for a bipolar spectrum disorder and report frequent mood swings outside of acute episodes. They were randomised to treatment as usual (control arm) or the ThrIVe-B intervention plus treatment as usual (intervention arm). Follow-up points were at 3, 6, 9 and 15 months after baseline, with 9 months as the primary end point. To evaluate feasibility and acceptability we examined recruitment and retention rates, completion rates for study measures, adverse events and feedback from participants on their experience of study participation and therapy. RESULTS: Of the target 48 participants, 43 were recruited (22 in the intervention arm; 21 in the control arm), with a recruitment rate of 3.9 participants per month. At 9 months 74% of participants engaged in research follow-up assessment, exceeding the pre-specified criterion of 60%. There were no serious concerns about the safety of the research procedures or the intervention. On one of the four candidate primary outcome measures, the 95% CI for the between-group mean difference score excluded the null effect and included the minimal clinically important difference, favouring the intervention arm, whilst on no measure was there evidence of deterioration in the intervention arm relative to the control arm. Attendance of the intervention (50% attending at least half of the mandatory sessions) was below the pre-specified continuation criterion of 60%, and qualitative feedback from participants indicated areas that may have hampered or facilitated engagement. CONCLUSIONS: It is broadly feasible to conduct a trial of this design within the population of people with frequent bipolar mood swings. Changes should be made to the therapy to increase uptake, such as simplifying content and considering individual rather than group delivery. Trial registration ISRCTN: ISRCTN54234300. Registered 14th July 2017, http://www.isrctn.com/ISRCTN54234300.

Personal recovery in bipolar disorder: Systematic review and "best fit" framework synthesis of qualitative evidence - a POETIC adaptation of CHIME.

BACKGROUND: Personal recovery, living a satisfying, hopeful life alongside symptoms, has become an increasingly valued aim across mental health care agendas internationally. However, there is little understanding of how people experience personal recovery alongside the mood challenges characteristic of a bipolar disorder diagnosis. Personal recovery frameworks have been developed for populations with mixed psychiatric diagnoses, predominantly psychotic disorders. METHODS: This systematic review of qualitative data used the widely adopted personal recovery processes Connectedness, Hope and optimism, Identity, Meaning and purpose, Empowerment (CHIME) in a "best fit" framework synthesis to understand personal recovery experiences in bipolar disorder. Included studies were coded with deductive framework analysis based on the CHIME processes and inductive thematic analysis for aspects beyond the a priori framework. RESULTS: A comprehensive search of six literature databases led to inclusion of twelve articles published 2010-2020. Deductive coding supported the fit with the CHIME framework but revealed difficulties, losses, and tensions within and across recovery processes. The proposed framework for personal recovery in bipolar disorder, Purpose and meaning, Optimism and hope, Empowerment, Tensions, Identity, Connectedness (POETIC), organises all CHIME processes around these tensions. LIMITATIONS: Diversity among study participants was limited with majority middle-aged, female, Western participants. CONCLUSIONS: The compact POETIC personal recovery framework tailored for bipolar disorder is directly applicable to clinical practice with personal recovery objectives. It highlights the need for professionals to introduce personal recovery in a realistic and balanced way to address recent criticism by service user organisations of personal recovery as overly optimistic.

A qualitative exploration of how people with bipolar disorder consider risk-taking in everyday decisions.

BACKGROUND: Difficulties with decision making and risk taking in individuals with bipolar disorder (BD) have been associated with mood episodes. However, there is limited information about these experiences during euthymia, the mood state where people with BD spent the majority of their time. AIMS: To examine how individuals with BD consider risk in everyday decisions during their euthymic phase. METHOD: We conducted a qualitative study that used semi-structured audio recorded interviews. Eight euthymic participants with confirmed BD were interviewed, and we used interpretative phenomenological analysis to analyse the data. RESULTS: We identified four themes. The first theme, 'Who I really am', involves the relationship between individual identity and risks taken. The second theme, 'Taking back control of my life', explored the relationship between risks taken as participants strove to keep control of their lives. The third theme, 'Fear of the "what ifs"', represents how the fear of negative consequences from taking risks impacts risk decisions. Finally, the fourth theme, 'The role of family and friends', highlights the important role that a supporting network can play in their lives in the context of taking risks. CONCLUSIONS: The study highlights aspects that can impact on an individual with BD's consideration of risk during euthymia. Identity, control, fear and support all play a role when a person considers risk in their decision-making process, and they should be taken into consideration when exploring risk with individuals with BD in clinical settings, and inform the design of future interventions.

Psychological factors in personal and clinical recovery in bipolar disorder.

BACKGROUND: Research into bipolar disorder (BD) has primarily focused upon clinical recovery (CR), i.e. symptom reduction, and overlooked personally meaningful recovery outcomes emphasized by service users. Personal recovery (PR) has been a major focus in the formulation of mental health policies and guidelines, and yet, research into factors influencing PR in BD is in its infancy. METHODS: This study compared psychological associates of concurrent PR and CR, and determined psychological factors in PR prospectively at 6 months. RESULTS: 107 participants completed baseline assessments, of whom 84% completed follow-up at 6 months. Controlling for potential confounders, multiple linear and ordinal regression models showed that some psychological factors underpinned both CR and PR at baseline: worse PR and CR outcomes were associated with higher negative self-dispositional appraisals and dysfunctional attitudes. Better PR, but worse CR ([hypo]mania related) were associated with higher adaptive coping. Additionally, better PR (but not CR) was associated with higher concurrent risk taking at baseline and predicted at follow-up by higher levels of baseline rumination. Better CR ([hypo]mania related), but not PR, was associated with lower impulsivity, but higher BAS processes. LIMITATIONS: Psychological and clinical factors were not measured at follow up and may have changed over time. Participants were a convenience sample. CONCLUSIONS: Understanding psychological factors driving recovery in BD is essential for refining the conceptual framework of PR, and informing psychological models and related interventions for BD. The identified differences in psychological factors highlight the importance of more individualised, PR focused therapeutic approaches.

A web-based, peer-supported self-management intervention to reduce distress in relatives of people with psychosis or bipolar disorder: the REACT RCT.

BACKGROUND: Relatives caring for people with severe mental health problems find information and emotional support hard to access. Online support for self-management offers a potential solution. OBJECTIVE: The objective was to determine the clinical effectiveness and cost-effectiveness of an online supported self-management tool for relatives: the Relatives' Education And Coping Toolkit (REACT). DESIGN AND SETTING: This was a primarily online (UK), single-blind, randomised controlled trial, comparing REACT plus a resource directory and treatment as usual with the resource directory and treatment as usual only, by measuring user distress and other well-being measures at baseline and at 12 and 24 weeks. PARTICIPANTS: A total of 800 relatives of people with severe mental health problems across the UK took part; relatives who were aged ≥ 16 years, were experiencing high levels of distress, had access to the internet and were actively seeking help were recruited. INTERVENTION: REACT comprised 12 psychoeducation modules, peer support through a group forum, confidential messaging and a comprehensive resource directory of national support. Trained relatives moderated the forum and responded to messages. MAIN OUTCOME MEASURE: The main outcome was the level of participants' distress, as measured by the General Health Questionnaire-28 items. RESULTS: Various online and offline strategies, including social media, directed potential participants to the website. Participants were randomised to one of two arms: REACT plus the resource directory (n = 399) or the resource directory only (n = 401). Retention at 24 weeks was 75% (REACT arm, n = 292; resource directory-only arm, n = 307). The mean scores for the General Health Questionnaire-28 items reduced substantially across both arms over 24 weeks, from 40.2 (standard deviation 14.3) to 30.5 (standard deviation 15.6), with no significant difference between arms (mean difference -1.39, 95% confidence interval -3.60 to 0.83; p = 0.22). At 12 weeks, the General Health Questionnaire-28 items scores were lower in the REACT arm than in the resource directory-only arm (-2.08, 95% confidence interval -4.14 to -0.03; p = 0.027), but this finding is likely to be of limited clinical significance. Accounting for missing data, which were associated with higher distress in the REACT arm (0.33, 95% confidence interval -0.27 to 0.93; p = 0.279), in a longitudinal model, there was no significant difference between arms over 24 weeks (-0.56, 95% confidence interval -2.34 to 1.22; p = 0.51). REACT cost £142.95 per participant to design and deliver (£62.27 for delivery only), compared with £0.84 for the resource directory only. A health economic analysis of NHS, health and Personal Social Services outcomes found that REACT has higher costs (£286.77), slightly better General Health Questionnaire-28 items scores (incremental General Health Questionnaire-28 items score adjusted for baseline, age and gender: -1.152, 95% confidence interval -3.370 to 1.065) and slightly lower quality-adjusted life-year gains than the resource directory only; none of these differences was statistically significant. The median time spent online was 50.8 minutes (interquartile range 12.4-172.1 minutes) for REACT, with no significant association with outcome. Participants reported finding REACT a safe, confidential environment (96%) and reported feeling supported by the forum (89%) and the REACT supporters (86%). No serious adverse events were reported. LIMITATIONS: The sample comprised predominantly white British females, 25% of participants were lost to follow-up and dropout in the REACT arm was not random. CONCLUSIONS: An online self-management support toolkit with a moderated group forum is acceptable to relatives and, compared with face-to-face programmes, offers inexpensive, safe delivery of National Institute for Health and Care Excellence-recommended support to engage relatives as peers in care delivery. However, currently, REACT plus the resource directory is no more effective at reducing relatives' distress than the resource directory only. FUTURE WORK: Further research in improving the effectiveness of online carer support interventions is required. TRIAL REGISTRATION: Current Controlled Trials ISRCTN72019945. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 32. See the NIHR Journals Library website for further project information.

Relatives of people with severe mental health problems need better access to information and emotional support. The Relatives' Education And Coping Toolkit (REACT) is a website designed to do this. It includes lots of information presented in text and video, an online forum for relatives to share knowledge and experience, a messaging system where they can ask questions in confidence and a comprehensive directory of contact details for national organisations offering relevant support. Trained relatives support the forum and messaging. In the UK, we recruited 800 relatives of people with severe mental health problems: all were aged ≥ 16 years, had high levels of distress, had access to the internet and wanted help. We divided them into two equal groups: one group received REACT (including the resource directory), whereas the other group received the resource directory only. To ensure that there were no differences between groups at the start, relatives were allocated to the two groups randomly, so they had an equal chance of being in either group. We followed up with both groups at 12 and 24 weeks, and received data from approximately three-quarters of the participants. This trial found that REACT was acceptable, safe and inexpensive to deliver (£62.27 per relative), compared with face-to-face interventions, and that relatives using it felt well supported. However, once we accounted for missing data (relatives who dropped out of the trial or did not complete the follow-up questionnaires), there were no significant differences between the groups. There was no evidence that REACT increased relatives' quality of life or saved money for the NHS.

Methodological Challenges in Web-Based Trials: Update and Insights From the Relatives Education and Coping Toolkit Trial.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2017-016965.

Clinical effectiveness of a web-based peer-supported self-management intervention for relatives of people with psychosis or bipolar (REACT): online, observer-blind, randomised controlled superiority trial.

BACKGROUND: The Relatives Education And Coping Toolkit (REACT) is an online supported self-management toolkit for relatives of people with psychosis or bipolar designed to improve access to NICE recommended information and emotional support. AIMS: Our aim was to determine clinical and cost-effectiveness of REACT including a Resource Directory (RD), versus RD-only. METHODS: A primarily online, observer-blind randomised controlled trial comparing REACT (including RD) with RD only (registration ISRCTN72019945). Participants were UK relatives aged > = 16, with high distress (assessed using the GHQ-28), and actively help-seeking, individually randomised, and assessed online. Primary outcome was relatives' distress (GHQ-28) at 24 weeks. Secondary outcomes were wellbeing, support, costs and user feedback. RESULTS: We recruited 800 relatives (REACT = 399; RD only = 401) with high distress at baseline (GHQ-28 REACT mean 40.3, SD 14.6; RD only mean 40.0, SD 14.0). Median time spent online on REACT was 50.8 min (IQR 12.4-172.1) versus 0.5 min (IQR 0-1.6) on RD only. Retention to primary follow-up (24 weeks) was 75% (REACT n = 292 (73.2%); RD-only n = 307 (76.6%)). Distress decreased in both groups by 24 weeks, with no significant difference between the two groups (- 1.39, 95% CI -3.60, 0.83, p = 0.22). Estimated cost of delivering REACT was £62.27 per person and users reported finding it safe, acceptable and convenient. There were no adverse events or reported side effects. CONCLUSIONS: REACT is an inexpensive, acceptable, and safe way to deliver NICE-recommended support for relatives. However, for highly distressed relatives it is no more effective in reducing distress (GHQ-28) than a comprehensive online resource directory. TRIAL REGISTRATION: ISRCTN72019945 prospectively registered 19/11/2015.

IMPlementation of An online Relatives' Toolkit for psychosis or bipolar (IMPART study): iterative multiple case study to identify key factors impacting on staff uptake and use.

BACKGROUND: Despite the potential of digital health interventions to improve the delivery of psychoeducation to people with mental health problems and their relatives, and substantial investment in their development, there is little evidence of successful implementation into clinical practice. We report the first implementation study of a digital health intervention: Relatives Education And Coping Toolkit (REACT), into routine mental healthcare. Our main aim was to identify critical factors affecting staff uptake and use of this online self-management tool for relatives of people with psychosis or bipolar. METHODS: A mixed-methods, theory-driven (Normalisation Process Theory), iterative multiple case study approach using qualitative analysis of interviews with staff and quantitative reporting of uptake. Carer researchers were part of the research team. RESULTS: In all, 281 staff and 159 relatives from Early Intervention teams across six catchment areas (cases) in England registered on REACT; 129 staff took part in qualitative interviews. Staff were positive about REACT helping services improve support and meet clinical targets. Implementation was hindered by: high staff caseloads and difficulties prioritising carers; perception of REACT implementation as research; technical difficulties using REACT; poor interoperability with trust computer systems and care pathways; lack of access to mobile technology and training; restricted forum populations; staff fears of risk, online trolling, and replacement by technology; and uncertainty around REACT's long-term availability. CONCLUSIONS: Digital health interventions, such as REACT, should be iteratively developed, evaluated, adapted and implemented, in partnership with the services they aim to support, and as part of a long term national strategy to co-develop integrated technology-enabled mental healthcare. Implementation strategies must instil a sense of ownership for staff and ensure they have adequate IT training, appropriate governance protocols for online working, and adequate mobile technologies. Wider contextual factors including adequate funding for mental health services and prioritisation of carer support, also need to be addressed for successful implementation of carer focussed digital interventions. TRIAL REGISTRATION: Study registration: ISCTRN 16267685.

Measuring social and occupational functioning of people with bipolar disorder: A systematic review.

Previous literature has focused on impaired social and occupational functioning in Bipolar Disorder (BD), however this ignores people who may be functioning well or even exceptionally. This paper presents the first systematic review of how functioning is measured and the range of functioning observed in BD to aid applied research and practice in this area. Identified measures from studies reporting use of a social and/or occupational functioning measure in BD were organised according to frequency of use over the last 10 years, resulting in six measures (Global Assessment of Functioning (GAF), Functioning Assessment Short Test (FAST), Social and Occupational Functioning Scale (SOFAS), Social Adjustment Scale (SAS)), Social Functioning Scale (SFS) and LIFE-Range of Impaired Functioning (LIFE-RIFT). Descriptive statistics of sample scores were extracted and pooled to provide cross-study values for each measure. Around 16% of individuals with BD can be estimated to function at a high level, defined as those falling within two standard deviations of the mean score on each measure. Evidence of a ceiling effect for some measures suggests that BD functioning may have been underestimated during measure development. Future research is needed to further understand higher functioning in people with BD, and factors which may support this.

Qualitative investigation of relatives' and service users' experience of mental healthcare for suicidal behaviour in bipolar disorder.

OBJECTIVE: People with bipolar disorder are known to be at high risk of engaging in suicidal behaviours, and those who die by suicide have often been in recent contact with mental health services. The objective of this study was to explore suicidal behaviour in bipolar disorder and how this is monitored and managed by mental health services. AIMS: To identify themes within relatives' and service users' accounts of mental healthcare, related to management and prevention of suicidal behaviour in bipolar disorder. DESIGN: Thematic analysis of 22 semistructured interviews. PARTICIPANTS: Participants were aged 18 years or over, fluent in written and spoken English, and either had bipolar disorder with a history of suicidal behaviour, or were relatives of people with bipolar disorder who had died by suicide. SETTING: England, UK. PRIMARY OUTCOME: Themes identified from participants' accounts of mental healthcare for suicidal behaviours in bipolar disorder. RESULTS: Two main themes were identified. 'Access to care' was characterised by a series or cycle of potential barriers to care (eg, gate-keepers, lack of an accurate diagnosis) which had the potential to increase risk of suicidal behaviour if failure to access care continued over time. 'Problems with communication' captured the importance of maintaining open routes of communication between all parties involved in care to ensure successful monitoring and management of suicidal behaviours in bipolar disorder. CONCLUSIONS: Mental health services need to be accessible and respond rapidly to people with suicidal behaviour in bipolar disorder. Open communication and inclusion of relatives in care, where appropriate, could help closer monitoring of changes in symptoms that indicate increased risk.

Feasibility and acceptability of integrated psychological therapy versus treatment as usual for people with bipolar disorder and co-morbid alcohol use: A single blind randomised controlled trial.

BACKGROUND: Alcohol use is a common problem in bipolar disorder (BD) and evidence indicates more promising outcomes for alcohol use than other substances. No trials have evaluated individual integrated motivational interviewing and cognitive behaviour therapy (MI-CBT) for problematic alcohol use in BD. We therefore assessed the feasibility and acceptability of a novel MI-CBT intervention for alcohol use in BD. METHODS: A single blind RCT was conducted to compare MI-CBT plus treatment as usual (TAU) with TAU only. MI-CBT was delivered over 20 sessions with participants followed up at 3, 6, 9 and 12 months post-randomisation. Primary outcomes were the feasibility and acceptability of MI-CBT (recruitment to target, retention to follow-up and therapy, acceptability of therapy and absence of adverse events). We also conducted preliminary analyses of alcohol and mood outcomes (frequency and severity of alcohol use and time to mood relapse). RESULTS: 44 participants were recruited with 75% retention to 6 and 12 months follow-up. Therapy participants attended a mean of 17.6 (SD 4.5) sessions. Therapy alliance and treatment fidelity were acceptable. Qualitative interviews indicated the intervention was experienced as collaborative, and helpful, in addressing mood and alcohol issues, although risk of overconfidence following therapy was also identified. Clinical outcomes did not differ between arms at 12 months follow-up. LIMITATIONS: As a feasibility and acceptability trial any secondary results should be treated with caution. CONCLUSIONS: Integrated MI-CBT is feasible and acceptable, but lack of clinical impact, albeit in a feasibility study, suggests need for further development. Potential adaptations are discussed.

Improving access to psychological therapies (IAPT) for people with bipolar disorder: Summary of outcomes from the IAPT demonstration site.

Access to structured psychological therapy recommended for bipolar disorder (BD) is poor. The UK NHS Improving Access to Psychological Therapies initiative commissioned a demonstration site for BD to explore the outcomes of routine delivery of psychological therapy in clinical practice, which this report summarises. All clinically diagnosed patients with BD who wanted a psychological intervention and were not in acute mood episode were eligible. Patients were offered a 10-session group intervention (Mood on Track) which delivered NICE congruent care. Outcomes were evaluated using an open (uncontrolled), pre-post design. Access to psychological therapy increased compared to preceding 6 years by 54%. 202 people began treatment; 81% completed >5 sessions; median 9 sessions (range 6-11). Pre-post outcomes included personal recovery (primary outcome), quality of life, work and social functioning, mood and anxiety symptoms (secondary outcomes). Personal recovery significantly improved from pre to post-therapy; medium effect-size (d = 0.52). Secondary outcomes all improved (except mania symptoms) with smaller effect sizes (d = 0.20-0.39). Patient satisfaction was high. Use of crisis services, and acute admissions were reduced compared to pre-treatment. It is possible to deliver group psychological therapy for bipolar disorder in a routine NHS setting. Improvements were observed in personal recovery, symptoms and wider functioning with high patient satisfaction and reduced service use.