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The adoption of cross-dressing by male characters in Italian comedy films of the 1910s has previously received little critical attention. Far from being isolated representations of queer behaviour, cross-dressing was more prolific both on-screen (and off) than was previously thought. Within the early comedy canon lie the male-female cross-dressing films where the narrative is suspended to allow the audience to gaze upon the cross-dressed character. These films offer audiences a trans-perspective as their gaze is directed by the cross-dressed character to the transgendered body. The queerness of these films lies not only is the visibility of the queer characters but also in the productivity of the queerness. The film itself becomes queer as the narrative economy is replaced by a luxuriating of the queer body. For the spectator a conflict occurs as the cross-dressed character’s visibility, through the materialisation of the body, disrupts the perception of a trans-corpo-reality. Exposure of the cross-dressed character ruptures the heteronormative construction of the cinematic space. In the early Italian comedy films, knowledge of the cross-dressing comic star is the visibility that threatens the transgender character. The queerness of the cross-dressed character in Italian comedy films opens up temporalities and suggests the possibility of different modes of living, and of reading film texts. This paper argues that the popularisation of the cross-dressed male served as a transgressive force that provided an articulation of social tolerance in Italy at a time when gender roles were undergoing renegotiation.

Background Smartphone apps have potential for delivering interventions and supporting self-management in bipolar disorder (BD), however clinical trials of mental health apps have high dropout rates and low sustained use in real-world contexts. To support the development of app-based interventions, we explored use of and attitudes towards apps amongst people with BD, specifically concerns about privacy and preferences for various app features. Methods An international web-based survey was used to investigate concerns about privacy and the perceived importance of various app features among people with BD. Quantitative findings were summarised using descriptive statistics. Qualitative content analysis was used to investigate free-text responses. Results A total of 919 people completed the survey; 97.5% reported using smartphone apps in general. Concerns regarding data security were prevalent. Commonly prioritised mHealth features included content quality/accuracy, ease and flexibility of use, cost, and data security. The ability to share data with others, rewards for use, inter-app connectivity, and peer support were endorsed as important by fewer than half of respondents. Qualitative findings suggested that sustained app use could be supported by novel and positive content, customisation, meaningful use of data, interactivity, and perceived real-world benefits. Conclusions The findings of the present study offer important design considerations for the development and evaluation of future app-based interventions for BD. Importantly, some features that have previously been suggested as clinically beneficial or likely to support engagement were perceived ambivalently, emphasising the need for in-depth consultation with potential end users during app development.

Background : Studies exploring disability in bipolar disorder (BD) have primarily assessed clinical samples of full-threshold BD-I and BD-II alongside so-called objective criteria such as unemployment or receipt of government disability payments. This study extends research on disability by examining externally determined and self-identified disability in a community sample and by including subthreshold BD (BDS). Methods : Data were extracted from the USA Collaborative Psychiatric Epidemiology Surveys about individuals who met recognized criteria for BD-I, BD-II and BDS who had completed self-ratings of physical and mental disability, comorbidities, and health risk factors (e.g., obesity). Rates of disability were estimated, and logistic regression analyses were used to determine demographic and clinical variables associated with externally determined and self-identified of disability. Results : Of 408 individuals who met eligibility criteria (BD-I = 100; BD-II=104; BDS=204), 35% met criteria for externally determined disability, about 40% self-reported mental disability and about 23% self-reported physical disability. The odds were three-fold (Odds Ratio (OR): 3.05; 95% Confidence Intervals (CI): 1.69, 5.53) that someone with self-identified physical disability would meet criteria for externally determined disability, but associations with mental disability were non-significant (OR: 1.06; 95% CI: 0.63, 1.80). Regression analyses demonstrated that mental disability was associated with being a current or past smoker and physical disability was associated with BD-I. Limitations : the adequacy of the assessments of disability and definition of BDS can be questioned. Conclusions : Future clinical and community studies need to consider both externally determined and self-identified disability across the entire Bd spectrum.

Background: Psilocybin, the primary psychoactive component of psychedelic ‘magic mushrooms’, may have potential for treating depressive symptoms, and consequent applications for bipolar disorder (BD). Knowledge of the risks and benefits of psilocybin in BD is limited to case studies. Aim: To support the design of clinical trials, we surveyed experiences of psilocybin use in people with BD. Methods: An international web-based survey was used to explore experiences of psilocybin use in people with a self-reported diagnosis of BD. Quantitative findings were summarised using descriptive statistics. Qualitative content analysis was used to investigate free-text responses, with a focus on positive experiences of psilocybin use. Results: A total of 541 people completed the survey (46.4% female, mean 34.1 years old). One-third (32.2%; n = 174) of respondents described new/increasing symptoms after psilocybin trips, prominently manic symptoms, difficulties sleeping and anxiety. No differences in rates of adverse events overall were observed between individuals with BD I compared to BD II. Use of emergency medical services was rare ( n = 18; 3.3%), and respondents (even those who experienced adverse effects) indicated that psilocybin use was more helpful than harmful. Quantitative findings elaborated on perceived benefits, as well as the potential for psilocybin trips to contain both positively and negatively received elements. Conclusions: The subjective benefits of psilocybin use for mental health symptoms reported by survey participants encourage further investigation of psilocybin-based treatments for BD. Clinical trials should incorporate careful monitoring of symptoms, as data suggest that BD symptoms may emerge or intensify following psilocybin use.

Cet article se penche sur les performances comiques féminines dans les comédies burlesques italiennes du début des années 1910. Alors que les comédiens de l’époque étaient habituellement des acteurs français et espagnols, les comédiennes étaient fermement ancrées dans la culture italienne ; elles étaient non seulement de nationalité italienne, mais leurs performances comiques prenaient souvent place au sein d’espaces domestiques typiquement italiens. À travers une analyse de la série Lea (Società Italiana Cines, 1910-1916) avec Armanda (Lea) Giunchi, cet article étudie les performances des comédiennes de l’époque en tant que lieu de remise en question l’identité nationale italienne. Ces comédies centrées sur des actrices étaient plus audacieuses dans leurs représentations de genre que les comédies masculines ou que le film de diva italien. L’étude de cette féminité moderne caractérisée par un (més)usage comique du corps permet également d’explorer ce que signifiait être italienne au début du xxe siècle. This paper explores female comic performance in Italian slapstick comedies of the early 1910s. While male slapstick comedians were usually French and Spanish comedy actors, female comics were firmly rooted in Italian culture; they were Italian born and often situated their comedy in typical Italian domestic spaces. Using the Lea series (Società Italiana Cines, 1910-1916) starring Armanda (Lea) Giunchi as a case study, this paper considers female comic performances as sites through which to interrogate Italian national identity. These female-centric comedies were far more “risk-taking” in terms of their representation of gender than either the male comedy films or the Italian diva genre. Thus, the conception of modern femininity characterised by the Italian female comic’s use, or misuse, of her body becomes a critical lens through which to analyse the conflict surrounding what it meant to be Italian at the beginning of the twentieth century.

Objectives: To study the end-user experiences of participants randomised to receive a blended digital intervention for relapse prevention in schizophrenia in the context of a cluster randomised controlled feasibility trial.Design: A qualitative interview design with thematic analysis was used.Method: A subsample of EMPOWER participants comprising 16 patients, 5 mental health staff and one carer were interviewed one-on-one.Results: Two overarching themes were constructed that were relevant for understanding end-user experiences within the EMPOWER trial: Affordances and Change Processes. Affordances described the processes underpinning how and why participants interacted with or avoided the various components of the intervention. Affordances spanned all EMPOWER components, including self-monitoring, peer support workers, clinical triaging, self-management messages and diary function. The affordances were Access to Social Connection, Access to Digital, Access to Mental Health Support, the Ability to Gauge Mental Health and Access to Mental Health Information. The affordances framework helped explain the multitude of engagement trajectories featured within the qualitative interviews. If participants sustained usage, affordances acted as a springboard for change processes, including increased self-confidence that patients could self-manage, noticing patterns and changes, and using EMPOWER as a conversation starter.Conclusions: The implementation process of EMPOWER was emergent and was best described by the intervention offering a range of affordances which could act as implementation barriers or facilitators depending on individual needs and wants. Affordances may present a sound theoretical framework for explaining end-user experiences.

Background Smartphone apps have recognized potential for improving access to evidence-based care in the treatment of bipolar disorder (BD). Healthcare providers are well-positioned to play a role in guiding patients to access safe, evidence-supported, and trustworthy apps. However, little is known about whether and how clinicians use apps with people with BD: understanding practices and attitudes of healthcare providers is essential to support the implementation of mHealth interventions in a real-world context. Methods A web-based survey was used to explore clinicians’ attitudes towards, and use of apps when working with people with BD. Descriptive statistics were used to summarize quantitative findings. Free text responses were investigated using qualitative content analysis. Results Eighty healthcare providers completed the survey. Approximately half of the respondents reported discussing or recommending apps in clinical practice with BD populations. Recommended apps were most commonly related to mood, sleep, and exercise. Barriers to discussing apps included a lack of healthcare provider knowledge/confidence, concerns about patients’ ability to access apps, and beliefs that patients lacked interest in apps. Conclusion Although research suggests that people with BD are interested in using apps, uptake of such technology among clinicians is more limited. A lack of clinician knowledge regarding apps, combined with concerns about the digital divide and patient interest, may account for this relatively limited integration of apps into the management of BD. These findings emphasise the importance of considering the information needs of healthcare providers when planning dissemination strategies for app-based interventions for BD.

Non-response to first-line treatment for major depressive disorder (MDD) is common; for such individuals, quality of life (QoL) impairments can be severe. Identifying predictors of QoL changes may support the management of cases with persistent depressive symptoms despite adequate initial pharmacological/psychological treatment. The present study aimed to explore predictors of domain-specific QoL improvement following adjunctive aripiprazole treatment for inadequate response to initial antidepressant therapy. We evaluated secondary QoL outcomes from a CAN-BIND (Canadian Biomarker Integration Network in Depression) study in patients with MDD who did not respond to an initial 8 weeks of escitalopram and received a further 8 weeks of adjunctive aripiprazole (n = 96). Physical, psychological, social, and environmental QoL domains were assessed using the World Health Organization QoL Scale Brief Version (WHOQOL-BREF). Clinician-rated depressive symptoms were assessed using the Montgomery–Asberg Depression Rating Scale (MADRS). Functioning was measured with the Sheehan Disability Scale (SDS). Satisfaction with medication was assessed with a single item from the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF). Exploratory t-tests were used to describe domain score changes. A hierarchical linear regression was used to explore demographic, clinical, and treatment-related predictors of improvement. Across domains, QoL improved with adjunctive aripiprazole treatment. Satisfaction with medication and MADRS and SDS scores similarly improved. Symptom reduction was a predictor for positive change to physical and psychological QoL; functioning improvements were predictive of increases to all QoL domains. Satisfaction with medication predicted improvements to physical and psychological domains, whereas number of medication trials was a predictor of worsening QoL in the physical domain. The final model explained the most variance in psychological (68%) and physical (67%) QoL. Less variance was explained for environmental (43%) and social QoL (33%), highlighting a need for further exploration of predictors in these domains. Strategies such as functional remediation may have potential to support QoL for individuals with persistent depressive symptoms. ClinicalTrials.gov identifier: NCT016557.

Introduction Many individuals with major depressive disorder (MDD) do not respond to initial antidepressant monotherapy. Adjunctive aripiprazole is recommended for treatment non-response; however, the impacts on quality of life (QoL) for individuals who receive this second-line treatment strategy have not been described. Methods We evaluated secondary QoL outcomes in patients with MDD (n=179). After 8 weeks of escitalopram, non-responders ( Results Escitalopram responders experienced the most QoL improvements in the first treatment phase. For non-responders, QoL improved with a large effect during adjunctive aripiprazole treatment. At the endpoint, 47% of patients achieving symptomatic remission still had impaired QoL. Discussion Individuals who were treated with adjunctive aripiprazole after non-response to escitalopram experienced improved QoL, but a substantial degree of QoL impairment persisted. Since QoL deficits may predict MDD recurrence, attention to ways to support this outcome is required.

Background Condition-specific quality of life (QoL) instruments are more representative of the priorities of people with lived experience. As such, the development of the first and only bipolar disorder (BD) specific measurement instrument, the Quality of Life in Bipolar Disorder (QoL.BD) questionnaire, marked an important step forward for the literature. The present systematic review aims to characterise applications of the QoL.BD in the BD literature and review empirical findings obtained from studies using this measure. Methods A systematic search identified 37 peer-reviewed publications which reported original empirical data using the QoL.BD in a BD population. No restrictions were placed on language/study type. Results Adaptations to the QoL.BD displayed appropriate psychometric properties. Although clinical trials were typically underpowered, promising effect sizes for a number of treatment modalities were reported. QoL.BD scores were moderately correlated with depressive symptoms; a number of candidate predictors were identified. Limitations Due to resource limitations, the present review used one database (Google Scholar), and a single author reviewed articles for eligibility. On balance the risks of missing relevant studies were deemed minimal. Conclusion A sizeable, international body of evidence now exists regarding the measurement, presentation, and treatment of condition-specific aspects of QoL in BD. Key avenues for future research include large scale, randomized control clinical trials using the QoL.BD as a primary outcome, and granular exploration of potential correlates of QoL.BD domain scores. Finally, longer follow-up periods are required to inform understanding of the dynamic relationship between clinical variables and condition-specific aspects of QoL in BD.

Curriculum models and training activities in medical education have been markedly enhanced to prepare physicians to address the health needs of diverse populations and to advance health equity. While different teaching and experiential learning activities in the public health and population health sciences have been implemented, there is no existing framework to measure the effectiveness of public and population health (PPH) education in medical education programs. In 2015, the Association of American Medical Colleges established the Expert Panel on Public and Population Health in Medical Education, which convened 20 U.S. medical faculty members whose goal was to develop an evaluation framework adapted from the New World Kirkpatrick Model. Institutional leaders can use this framework to assess the effectiveness of PPH curricula for learners, faculty, and community partners. It may also assist institutions with identifying opportunities to improve the integration of PPH content into medical education programs. In this article, the authors present outcomes metrics and practical curricular or institutional illustrations at each Kirkpatrick training evaluation level to assist institutions with the measurement of (1) reaction to the PPH education content, (2) learning accomplished, (3) application of knowledge and skills to practice, and (4) outcomes achieved as a result of PPH education and practice. A fifth level was added to measure the benefit of PPH curricula on the health system and population health. The framework may assist with developing a locally relevant evaluation to further integrate and support PPH education at U.S. medical schools and teaching hospitals.

Objective To investigate the anxiolytic properties of a standardized extract of Sceletium tortuosum (trademarked-Zembrin® ). Methods Two studies utilized a placebo-controlled, double-blind, between-subject experimental design to investigate the effects of a single dose of Sceletium tortuosum (25 mg, Zembrin® ) on laboratory stress/anxiety responding in 20 young healthy volunteers. To elicit feelings of stress/anxiety, participants completed 20 min of the multitasking framework in study 1 and a 5-min simulated public speaking task in study 2. Study 1 measured subjective experiences of mood at baseline, prestress induction, and poststress induction. Study 2 measured subjective experiences of anxiety and physiological indicators of stress (heart rate [HR] and galvanic skin response) at baseline, prestress induction, during stress induction, and poststress induction. Results A series of analysis of covariances (baseline entered as the covariate) revealed no treatment effect in study 1; however, study 2 revealed subjective anxiety levels to be significantly lower in the Zembrin® group at the prestress induction point and a significant interaction between treatment and time on HR. Taken together, results indicate that a single dose of Zembrin® can ameliorate laboratory stress/anxiety responding in healthy volunteers. Conclusion We provide the first tentative behavioral evidence to support the anxiolytic properties of Sceletium tortuosum (25 mg Zembrin® ).

BACKGROUND Quality of life (QoL) is increasingly recognised as a key outcome of self-management interventions for bipolar disorder (BD). Mobile phone applications (apps) can increase access to evidence-based self-management strategies and provide real-time support. However, while individuals with lived experience desire support with monitoring and improving broader health domains, existing BD apps largely target mood symptoms only. Further, evidence from the broader mHealth literature has shown that the desires and goals of end-users are not adequately taken into account during app development, and as a result engagement with mental health apps is suboptimal. To capitalise on the potential of apps to optimise wellness in BD, there is a need for interventions developed in consultation with real-world users that are designed to support QoL self-monitoring and self-management. Objective: This mixed methods pilot study is designed to evaluate the beta version of the newly developed PolarUs app, which aims to support QoL self-monitoring and self-management in people with BD. Developed using a community-based participatory research framework, the PolarUs app builds on the web-based adaptation of a BD-specific QoL self-assessment measure, and integrates material from a web-based portal providing information on evidence-informed self-management strategies in BD. OBJECTIVE The primary objectives of this project are to: (1) evaluate PolarUs app feasibility (via behavioral usage metrics); (2) evaluate PolarUs impact (via the Brief Quality of Life in Bipolar Disorders, QoL.BD scale, our primary outcomes measure); and (3) explore engagement with the PolarUs app (via both quantitative and qualitative methods). METHODS Study participants will be North American residents (N=150) aged 18-65 years with a DSM-5 diagnosis of BD-I, BD-II or BD not otherwise specified (NOS) as assessed by a structured diagnostic interview. An embedded mixed-methods research design will be adopted; qualitative interviews with a purposefully selected sub-sample (~n=30) of participants will be conducted to explore in more depth feasibility, impact and engagement with the PolarUs app over the 12-week study period. RESULTS At the time of publication of this protocol, the development of the beta version of the PolarUs app is complete. Participant enrollment is expected to begin in February 2022. Data collection is expected to be completed by December 2022. CONCLUSIONS Beyond contributing knowledge on the feasibility and impacts of a novel app to support QoL and self-management in BD, this study is also expected to provide new knowledge on engagement with mHealth apps. Furthermore, it is expected to function as a case study of successful co-design between individuals living with BD, clinicians who specialise in the treatment of BD, and BD researchers, providing a template for future use of community-based participatory research frameworks in mHealth intervention development. Results will be used to further refine the PolarUs app and inform the design of a larger clinical trial.

Background: \ud Early warning signs monitoring by service users with schizophrenia has shown promise in preventing relapse but the quality of evidence is low. We aimed to establish the feasibility of undertaking a definitive randomised controlled trial to determine the effectiveness of a blended digital intervention for relapse prevention in schizophrenia.\ud \ud Methods: \ud This multicentre, feasibility, cluster randomised controlled trial aimed to compare Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) with treatment as usual in community mental health services (CMHS) in Glasgow and Melbourne. CMHS were the unit of randomisation, selected on the basis of those that probably had five or more care coordinators willing to participate. Participants were eligible if they were older than 16 years, had a schizophrenia or related diagnosis confirmed via case records, were able to provide informed consent, had contact with CMHS, and had had a relapse within the previous 2 years. Participants were randomised within stratified clusters to EMPOWER or to continue their usual approach to care. EMPOWER blended a smartphone for active monitoring of early warning signs with peer support to promote self-management and clinical triage to promote access to relapse prevention. Main outcomes were feasibility, acceptability, usability, and safety, which was assessed through face-to-face interviews. App usage was assessed via the smartphone and self-report. Primary end point was 12 months. Participants, research assistants and other team members involved in delivering the intervention were not masked to treatment conditions. Assessment of relapse was done by an independent adjudication panel masked to randomisation group. The study is registered at ISRCTN (99559262).\ud \ud Findings: \ud We identified and randomised eight CMHS (six in Glasgow and two in Melbourne) comprising 47 care coordinators. We recruited 86 service users between Jan 19 and Aug 8, 2018; 73 were randomised (42 [58%] to EMPOWER and 31 [42%] to treatment as usual). There were 37 (51%) men and 36 (49%) women. At 12 months, main outcomes were collected for 32 (76%) of service users in the EMPOWER group and 30 (97%) of service users in the treatment as usual group. Of those randomised to EMPOWER, 30 (71%) met our a priori criterion of more than 33% adherence to daily monitoring that assumed feasibility. Median time to discontinuation of these participants was 31·5 weeks (SD 14·5). There were 29 adverse events in the EMPOWER group and 25 adverse events in the treatment as usual group. There were 13 app-related adverse events, affecting 11 people, one of which was serious. Fear of relapse was lower in the EMPOWER group than in the treatment as usual group at 12 months (mean difference –7·53 (95% CI –14·45 to 0·60; Cohen's d –0·53).\ud \ud Interpretation: \ud A trial of digital technology to monitor early warning signs blended with peer support and clinical triage to detect and prevent relapse appears to be feasible, safe, and acceptable. A further main trial is merited.\ud \ud Funding: \ud UK National Institute for Health Research Health Technology Assessment programme and the Australian National Health and Medical Research Council.

Background Major Depressive Disorder (MDD) is characterized by objective and subjective cognitive deficits. Discrepancies between objective and subjective cognitive performance can reflect under- to over-estimations of cognitive abilities, and these discrepancies are referred to as cognitive self-appraisals. Despite evidence that low self-appraisals are associated with depression, the modifiability of self-appraisals and their association with treatment outcome remains unclear. The current study examined whether self-appraisals change following antidepressant treatment. Furthermore, we investigated the association of self-appraisals with treatment outcome. Methods As part of the CAN-BIND-1 clinical trial, 154 patients with MDD completed measures of objective and subjective cognitive abilities, depressive symptoms, and functional outcomes (work productivity, psychosocial functioning, and quality of life) at baseline and post-escitalopram treatment. Self-appraisals were calculated based on discrepancies between objective and subjective cognitive abilities, with higher scores indicating overestimation of cognitive abilities. Results Baseline self-appraisals were not predictive of treatment outcomes. However, self-appraisals increased from pre- to post-treatment. Moreover, pre-post treatment increases in self-appraisals were associated with positive treatment response and remission, decreases in depressive symptoms, and improvements in work productivity, psychosocial functioning, and quality of life. Limitations The pre-post intervention design precluded examining the temporal precedence of change in self-appraisals versus depressive symptoms and functional outcomes. Conclusions Findings are the first to demonstrate that self-appraisals are treatment-sensitive and are associated with treatment outcomes and recovery from MDD. Cognitive self-appraisals may represent a key marker of treatment response and a valuable target for assessment and intervention, as well as a potential mechanism underlying risk and recovery.

Luca Cottini’s The Art of Objects offers a unique and engaging approach to the study of early Italian industrialisation examined through the lens of the mass consumption of iconic artefacts. Cottin...

Background Hepatitis B virus (HBV) screening during pregnancy is standard of care to prevent vertical transmission to infants, yet the mothers themselves may not receive appropriate follow-up. Goals Using a national database, we sought to determine rates of maternal peripartum follow-up with a HBV specialist and identify factors associated with a lack of follow-up. Materials and methods We identified women who delivered in 2000 to 2012 and were diagnosed with HBV according to International Classification of Diseases-9 codes using a national database (Optum) derived from commercial insurance claims with ∼46 million members ages 0 to 64 in all 50 states. Our primary outcome was follow-up during or after pregnancy with a HBV specialist (gastroenterology/infectious diseases). Results The prevalence of HBV was 0.27% (2558/959,747 pregnancies), and median follow-up was 45 months. Only 21% of women had peripartum HBV specialist follow-up. On multivariable regression, predictors of peripartum follow-up at 1-year included younger age [odds ratio (OR), 0.97/y; 95% confidence interval (CI), 0.94, 0.99], Asian race/ethnicity (OR, 1.56 vs. white; 95% CI, 1.13, 2.17), and residing in the Northeast (OR, 1.70; 95% CI, 1.09, 2.66) and Midwest (OR, 1.73; 95% CI, 1.07, 2.81) versus West. Predictors of testing for HBV DNA and alanine aminotransferase at 1 year included Asian race (OR, 1.72; 95% CI, 1.23, 2.41), a primary care physician visit within 2 years of delivery (OR, 1.63; 95% CI, 1.19, 2.22), and peripartum HBV specialist follow-up within 1 year (OR, 15.68; 95% CI, 11.38, 21.60). Conclusions Maternal HBV specialist follow-up rates were extremely low in this large, diverse cohort representing all United States regions. Referral to a HBV specialist was the strongest predictor of appropriate postpartum HBV laboratory testing. Follow-up rates may be even lower in uninsured populations.

The lived experience of people with mood disorders may be leveraged to inform priorities for research, define key treatment outcomes, and support decision-making in clinical care. The aim of this mixed-methods project was to provide insight into how people with depression and bipolar disorder experience the impact of symptoms, their treatment preferences, and their definitions of wellness.The project was implemented in two phases. In Phase 1, community-based participatory research was used to develop a web-based survey enquiring about living with a mood disorder, treatment experiences, and wellness priorities. In Phase 2, a series of focus groups were conducted to explore aspects of wellness in greater detail.Respondents (n= 6153) described the symptoms of mood disorders as having a significant, chronic impact on their lives. A holistic approach to treatment was desired by participants, but not necessarily experienced. Qualitative findings were used to further describe four highly ranked wellness priorities identified in the survey: ability to act independently or according to my own will; purpose in life; getting through the day; and contentment.Experience of a mood disorder was self-reported, and no formal confirmation of diagnosis occurred. Although the survey could not incorporate all possible wellness definitions, this was supplemented by qualitative focus groups.The present findings provide important insights from the perspectives of individuals with lived experience of mood disorders. Implications of this for research and clinical practice are discussed, particularly with regards to measurement-based care and use of wellness-oriented clinical outcome assessments.

Background: Fear of relapse is an independent risk factor for future relapse events indicating its importance in clinical management and early warning signs-based relapse prevention monitoring.Methods: 25 participants who were taking part in a clinical trial of relapse prevention in schizophrenia responded to daily ecological momentary assessment prompts assessing common early warning signs of relapse and self-reported positive experiences like feeling supported by others. We conducted multilevel vector auto-regression using common symptoms assessed in early warning signs monitoring relapse prevention while controlling for positive self-reported experiences like feeling supported by others to estimate three networks (to explore concurrent, temporal and mean levels across the whole time period).Results: Reporting fear of relapse was positively associated (within the same cross-sectional time window) with hearing voices, alongside anxiety, negative affect and sleep change. Fear of relapse appeared to predict anxiety and negative affect on the next consecutive day. Experiencing fear of relapse on one day meant being more likely to also experience fear of relapse again at the next consecutive time point. However, none of the common early warning signs predicted fear of relapse within the temporal window and all observed relationships were small. Discussion: Early warning signs themselves appear poor predictors of experiencing fear of relapse but because fear of relapse predicts later anxiety and negative affect (even to a small degree) it may be a valuable intervention target within the daily life of people diagnosed with schizophrenia.

BACKGROUND Web-based resources can support people with bipolar disorder (BD) to improve their knowledge and self-management. However, publicly available resources are heterogeneous in terms of their quality and ease of use. Characterizing digital health literacy (the skillset that enable people to navigate and make use of health information in a web-based context) in BD will support the development of educational resources. OBJECTIVE The aim of this study was to develop understanding of digital health literacy and its predictors in people with BD. METHODS A web-based survey was used to explore self-reported digital health literacy (as measured by the e-Health Literacy Scale [eHEALS]) in people with BD. Multiple regression analysis was used to evaluate potential predictors, including demographic/clinical characteristics and technology use. RESULTS A total of 919 respondents (77.9% female; mean age 36.9 years) completed the survey. Older age (β=0.09; P=.01), postgraduate education (β=0.11; P=.01), and current use of self-management apps related to BD (β=0.13; P CONCLUSIONS Levels of self-reported digital health literacy were comparable or higher than other studies in the general population and specific physical/mental health conditions. However, individuals with BD who are younger, have completed less education, or are less familiar with mental health apps may require extra support to safely and productively navigate web-based health resources. Relevant educational initiatives are discussed. Future studies should evaluate skill development interventions for less digitally literate groups.

Background Bright light therapy has been shown to improve depressive symptoms in patients with nonseasonal major depressive disorder (MDD) but there are few studies examining functional outcomes. Methods We examined secondary functional outcomes in the 8-week randomized, placebo-sham-controlled LIFE-D trial comparing light therapy, fluoxetine, and the combination in patients with nonseasonal MDD. Functional assessments included the Sheehan Disability Scale (SDS) and, for employed participants, the Lam Employment Absence and Productivity Scale (LEAPS). Analysis of covariance (ANCOVA) was conducted with SDS and LEAPS change scores from baseline to week 8 as dependent variables, treatment modality (light, fluoxetine) as an independent variable, and baseline SDS and LEAPS scores as covariates. Results Of 122 randomized participants, SDS data were available for 105 and LEAPS data for 70. For the SDS, there were no interaction effects, but there was a significant small- to medium-sized main effect of light treatment on total SDS scores with corresponding significant effects in the Social Life and Family Life domains, but not in the Work/Study domain. There were no significant interaction or main effects with LEAPS scores. Conclusion Light therapy significantly improved social and family life functioning in patients with MDD. However, work functioning was not significantly improved despite large effect sizes; these results were limited by low statistical power because of small sample sizes. Future studies should use longer treatment durations and be powered to detect clinically relevant differences in functional outcomes.

Curriculum models and training activities in medical education have been markedly enhanced to prepare physicians to address the health needs of diverse populations and to advance health equity. While different teaching and experiential learning activities in the public health and population health sciences have been implemented, there is no existing framework to measure the effectiveness of public and population health (PPH) education in medical education programs. In 2015, the Association of American Medical Colleges established the Expert Panel on Public and Population Health in Medical Education, which convened 20 U.S. medical faculty members whose goal was to develop an evaluation framework adapted from the New World Kirkpatrick Model. Institutional leaders can use this framework to assess the effectiveness of PPH curricula for learners, faculty, and community partners. It may also assist institutions with identifying opportunities to improve the integration of PPH content into medical education programs. In this article, the authors present outcomes metrics and practical curricular or institutional illustrations at each Kirkpatrick training evaluation level to assist institutions with the measurement of (1) reaction to the PPH education content, (2) learning accomplished, (3) application of knowledge and skills to practice, and (4) outcomes achieved as a result of PPH education and practice. A fifth level was added to measure the benefit of PPH curricula on the health system and population health. The framework may assist with developing a locally relevant evaluation to further integrate and support PPH education at U.S. medical schools and teaching hospitals.

BACKGROUND Recruitment processes for clinical trials of digital interventions for psychosis are seldom described in detail in the literature. Although trial staff have expertise in describing barriers to and facilitators of recruitment, a specific focus on understanding recruitment from the point of view of trial staff is rare, and because trial staff are responsible for meeting recruitment targets, a lack of research on their point of view is a key limitation. OBJECTIVE The primary aim of this study was to understand recruitment from the point of view of trial staff and discover what they consider important. METHODS We applied pluralistic ethnographic methods, including analysis of trial documents, observation, and focus groups, and explored the recruitment processes of the EMPOWER (Early Signs Monitoring to Prevent Relapse in Psychosis and Promote Well-being, Engagement, and Recovery) feasibility trial, which is a digital app–based intervention for people diagnosed with schizophrenia. RESULTS Recruitment barriers were categorized into 2 main themes: service characteristics (lack of time available for mental health staff to support recruitment, staff turnover, patient turnover [within Australia only], management styles of community mental health teams, and physical environment) and clinician expectations (filtering effects and resistance to research participation). Trial staff negotiated these barriers through strategies such as emotional labor (trial staff managing feelings and expressions to successfully recruit participants) and trying to build relationships with clinical staff working within community mental health teams. CONCLUSIONS Researchers in clinical trials for digital psychosis interventions face numerous recruitment barriers and do their best to work flexibly and to negotiate these barriers and meet recruitment targets. The recruitment process appeared to be enhanced by trial staff supporting each other throughout the recruitment stage of the trial.

BACKGROUND Recruitment processes for clinical trials of digital interventions for psychosis are seldom described in detail within the literature. While trial staff have expertise in describing barriers and facilitators to recruitment a specific focus on understanding recruitment from the point of view of trial staff is rare. OBJECTIVE The primary aim of this study was to understand recruitment from the point of view of trial staff and discover what they considered to be important. METHODS We applied pluralistic ethnographic methods including analysis of trial documents, observation and focus groups explored the recruitment processes of the EMPOWER feasibility trial (ISRCTN: 99559262) RESULTS Recruitment barriers fell into two main themes; service characteristics (lack of time available to mental health staff to support recruitment, staff turnover, patient turnover (within Australia only), management styles of community mental health teams, physical environment) and clinician expectations (filtering effects and resistance to research participation). Trial staff negotiated these barriers through strategies such as emotional labour (trial staff managing feelings and expressions in order to successfully recruit participants) and trying to build relationships with clinical staff working within community mental health teams. CONCLUSIONS Researchers in clinical trials for digital psychosis interventions face numerous recruitment barriers and do their best to work flexibly negotiate these barriers and meet recruitment targets. The recruitment process appeared to be enhanced by trial staff supporting each other throughout the recruitment stage of the trial. CLINICALTRIAL ISRCTN: 99559262 INTERNATIONAL REGISTERED REPORT RR2-10.2196/15634

Objective: The goal of this study was to validate the French version of the Quality of Life in Bipolar Disorder (QoL.BD) scale, a condition-specific measure for bipolar disorder (BD). Method: The QoL.BD scale was translated into French in accordance with the recommendations for transcultural adaptation. It was administered to 125 participants with BD living in Quebec, Canada. Construct validity was evaluated through correlations with other measures of self-reported quality of life (QoL), functioning, and symptoms. Factorial structure was examined through an exploratory factor analysis. Results: Internal reliability and test–retest reliability standards were met. Correlations in expected directions with other QoL, functioning, and depressive symptom scales supported convergent validity. The item loadings structure of the French QoL.BD largely replicated the original English version, with some modifications. Conclusion: The French version of the QoL.BD (full and brief) is comparable in its psychometric properties to the English version. It is a valid and sound measure for the evaluation of the QoL of French-speaking patients with BD.

Downloading a mobile health (m-health) app on your smartphone does not mean you will ever use it. Telling another person about an app does not mean you like it. Using an online intervention does not mean it has had an impact on your well-being. Yet we consistently rely on downloads, clicks, ‘likes’ and other usage and popularity metrics to measure m-health app engagement. Doing so misses the complexity of how people perceive and use m-health apps in everyday life to manage mental health conditions. This article questions commonly used behavioural metrics of engagement in mental health research and care, and proposes a more comprehensive approach to measuring in-app engagement.

Objective: Bright light therapy is increasingly recommended (alone or in combination with antidepressant medication) to treat symptoms of nonseasonal major depressive disorder (MDD). However, little is known about its impacts on quality of life (QoL), a holistic, patient-valued outcome. Methods: This study utilizes secondary outcome data from an 8-week randomized, controlled, double blind trial comparing light monotherapy ( n = 32), fluoxetine monotherapy ( n = 30), and the combination of these ( n = 27) to placebo ( n = 30). QoL was assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF). Treatment-related differences in QoL improvements were assessed using a repeated measures analysis of variance. The influence of potential predictors of QoL (demographic variables and change in depressive symptoms) were investigated via hierarchical linear regression. Results: Q-LES-Q-SF scores significantly improved across all treatment conditions; however, no significant differences were observed between treatment arms. QoL remained poor relative to community norms by the end of the trial period: Across conditions, 70.6% of participants had significantly impaired QoL at the 8-week assessment. Reduction in depressive scores was a significant predictor of improved QoL, with the final model accounting for 54% of variance in QoL change scores. Conclusion: The findings of this study emphasize that improvement in QoL and reduction in depressive symptoms in MDD, while related, cannot be taken to be synonymous. Adjunctive therapies may be required to address unmet QoL needs in patients with MDD receiving antidepressant or light therapies. Further research is required to explore additional predictors of QoL in order to better refine treatments for MDD.

Background: Recruitment processes for clinical trials of digital interventions for psychosis are seldom described in detail within the literature. While trial staff have expertise in describing barriers and facilitators to recruitment a specific focus on understanding recruitment from the point of view of trial staff is rare.Methods: We applied pluralistic ethnographic methods including analysis of trial documents, observation and focus groups explored the recruitment processes of the EMPOWER feasibility trial (ISRCTN: 99559262).Results: Recruitment barriers fell into two main themes; service characteristics (lack of time available to mental health staff to support recruitment, staff turnover, patient turnover (within Australia only), management styles of community mental health teams, physical environment) and clinician expectations (filtering effects and resistance to research participation). Trial staff negotiated these barriers through strategies such as emotional labour (trial staff managing feelings and expressions in order to successfully recruit participants) and trying to build relationships with clinical staff working within community mental health teams.Conclusions: Researchers in clinical trials for digital psychosis interventions face numerous recruitment barriers and do their best to work flexibly negotiate these barriers and meet recruitment targets. The recruitment process appeared to be enhanced by trial staff supporting each other throughout the recruitment stage of the trial.Trial Registration: (ISRCTN: 99559262 registered 21/12/2015)

Background Quality of life (QoL) is considered a key treatment outcome in bipolar disorder (BD) across research, clinical, and self-management contexts. Web-based assessment of patient-reported outcomes offer numerous pragmatic benefits but require validation to ensure measurement equivalency. A web-based version of the Quality of Life in Bipolar Disorder (QoL.BD) questionnaire was developed (QoL Tool). Objective This study aimed to evaluate the psychometric properties of a web-based QoL self-report questionnaire for BD (QoL Tool). Key aims were to (1) characterize the QoL of the sample using the QoL Tool, (2) evaluate the internal consistency of the web-based measure, and (3) determine whether the factor structure of the original version of the QoL.BD instrument was replicated in the web-based instrument. Methods Community-based participatory research methods were used to inform the development of a web-based adaptation of the QoL.BD instrument. Individuals with BD who registered for an account with the QoL Tool were able to opt in to sharing their data for research purposes. The distribution of scores and internal consistency estimates, as indicated by Cronbach alpha, were inspected. An exploratory factor analysis using maximum likelihood and oblique rotation was conducted. Inspection of the scree plot, eigenvalues, and minimum average partial correlation were used to determine the optimal factor structure to extract. Results A total of 498 people with BD (349/498, 70.1% female; mean age 39.64, SD 12.54 years; 181/498, 36.3% BD type I; 195/498, 39.2% BD type II) consented to sharing their QoL Tool data for the present study. Mean scores across the 14 QoL Tool domains were, in general, significantly lower than that of the original QoL.BD validation sample. Reliability estimates for QoL Tool domains were comparable with that observed for the QoL.BD instrument (Cronbach alpha=.70-.93). Exploratory factor analysis supported the extraction of an 11-factor model, with item loadings consistent with the factor structure suggested by the original study. Findings for the sleep and physical domains differed from the original study, with this analysis suggesting one shared latent construct. Conclusions The psychometric properties of the web-based QoL Tool are largely concordant with the original pen-and-paper QoL.BD, although some minor differences in the structure of the sleep and physical domains were observed. Despite this small variation from the factor structure identified in the QoL.BD instrument, the latent factor structure of the QoL Tool largely reproduced the original findings and theoretical structure of QoL areas relevant to people with BD. These findings underscore the research and clinical utility of this instrument, but further comparison of the psychometric properties of the QoL Tool relative to the QoL.BD instrument is warranted. Future adaptations of the QoL Tool, including the production of an app-based version of the QoL Tool, are also discussed.

To investigate the anxiolytic properties of a standardized extract of Sceletium tortuosum (trademarked-ZembrinTwo studies utilized a placebo-controlled, double-blind, between-subject experimental design to investigate the effects of a single dose of Sceletium tortuosum (25 mg, ZembrinA series of analysis of covariances (baseline entered as the covariate) revealed no treatment effect in study 1; however, study 2 revealed subjective anxiety levels to be significantly lower in the ZembrinWe provide the first tentative behavioral evidence to support the anxiolytic properties of Sceletium tortuosum (25 mg Zembrin

BackgroundRelapse in schizophrenia is a major cause of distress and disability and is predicted by changes in symptoms such as anxiety, depression, and suspiciousness (early warning signs [EWSs]). These can be used as the basis for timely interventions to prevent relapse. However, there is considerable uncertainty regarding the implementation of EWS interventions.ObjectiveThis study was designed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) against treatment as usual (TAU). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, safety, and outcome signals of a digital health intervention as an adjunct to usual care that is deliverable in the UK National Health Service and Australian community mental health service (CMHS) settings. We will assess the feasibility of candidate primary outcomes, candidate secondary outcomes, and candidate mechanisms for a definitive trial.MethodsWe will randomize CMHSs to EMPOWER or TAU. We aim to recruit up to 120 service user participants from 8 CMHSs and follow them for 12 months. Eligible service users will (1) be aged 16 years and above, (2) be in contact with local CMHSs, (3) have either been admitted to a psychiatric inpatient service or received crisis intervention at least once in the previous 2 years for a relapse, and (4) have an International Classification of Diseases-10 diagnosis of a schizophrenia-related disorder. Service users will also be invited to nominate a carer to participate. We will identify the feasibility of the main trial in terms of recruitment and retention to the study and the acceptability, usability, safety, and outcome signals of the EMPOWER intervention. EMPOWER is a mobile phone app that enables the monitoring of well-being and possible EWSs of relapse on a daily basis. An algorithm calculates changes in well-being based on participants’ own baseline to enable tailoring of well-being messaging and clinical triage of possible EWSs. Use of the app is blended with ongoing peer support.ResultsRecruitment to the trial began September 2018, and follow-up of participants was completed in July 2019. Data collection is continuing. The database was locked in July 2019, followed by analysis and disclosing of group allocation.ConclusionsThe knowledge gained from the study will inform the design of a definitive trial including finalizing the delivery of our digital health intervention, sample size estimation, methods to ensure successful identification, consent, randomization, and follow-up of participants, and the primary and secondary outcomes. The trial will also inform the final health economic model to be applied in the main trial.Trial RegistrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 99559262; http://isrctn.com/ISRCTN99559262International Registered Report Identifier (IRRID)DERR1-10.2196/15058

Quality of life (QoL) is increasingly a target of interventions for bipolar disorders (BD). While the subjective experience of consumers is often elevated as central to the construct of QoL in BD, limited investigation in this area means subjective QoL remains poorly understood. The present qualitative study seeks to address this by investigating how people with BD appraise the quality of their lives in the context of a QoL self-management intervention. Semi-structured interviews were conducted with 43 individuals who had participated in a self-management intervention for improving QoL in BD. Individuals were questioned about experiences of the intervention and perceptions of their QoL. Thematic analysis was used to explore participants’ appraisal of their QoL. An overarching theme concerned the intrinsic relativity of subjective QoL: individuals located QoL as relative to self, others and possible futures. Incorporating illness-related reference points for QoL (‘given my circumstances…’) was associated with perceptions of improved QoL. Deliberately modifying reference points for QoL was perceived as self-compassionate. The present study generates novel hypotheses about how individuals with BD make sense of their QoL. Data suggest that individuals located their QoL relative to a variety of reference points, use of which was flexible. In accord with gap theories of QoL, individuals experienced acceptance of illness impacts as improving subjective sense of QoL. Rather than ‘settling for’ a lower standard of QoL, individuals experienced these changes as adaptive and positive. Findings are discussed in relation to the measurement and amelioration of QoL in BD.

BackgroundAlthough quality of life (QoL) is receiving increasing attention in bipolar disorder (BD) research and practice, little is known about its naturalistic trajectory. The dual aims of this study were to prospectively investigate: (a) the trajectory of QoL under guideline-driven treatment and (b) the dynamic relationship between mood symptoms and QoL.MethodsIn total, 362 patients with BD receiving guideline-driven treatment were prospectively followed at 3-month intervals for up to 5 years. Mental (Mental Component Score – MCS) and physical (Physical Component Score – PCS) QoL were measured using the self-report SF-36. Clinician-rated symptom data were recorded for mania and depression. Multilevel modelling was used to analyse MCS and PCS over time, QoL trajectories predicted by time-lagged symptoms, and symptom trajectories predicted by time-lagged QoL.ResultsMCS exhibited a positive trajectory, while PCS worsened over time. Investigation of temporal relationships between QoL and symptoms suggested bidirectional effects: earlier depressive symptoms were negatively associated with mental QoL, and earlier manic symptoms were negatively associated with physical QoL. Importantly, earlier MCS and PCS were both negatively associated with downstream symptoms of mania and depression.ConclusionsThe present investigation illustrates real-world outcomes for QoL under guideline-driven BD treatment: improvements in mental QoL and decrements in physical QoL were observed. The data permitted investigation of dynamic interactions between QoL and symptoms, generating novel evidence for bidirectional effects and encouraging further research into this important interplay. Investigation of relevant time-varying covariates (e.g. medications) was beyond scope. Future research should investigate possible determinants of QoL and the interplay between symptoms and wellbeing/satisfaction-centric measures of QoL.

BACKGROUND Self-monitoring of symptoms is a cornerstone of psychological interventions in bipolar disorder (BD), but individuals with lived experience also value tracking holistic outcomes, such as quality of life (QoL). Importantly, self-monitoring is not always experienced positively by people with BD and may have lower than expected rates of engagement. Therefore, before progressing into QoL tracking tools, it is important to explore user perspectives to identify possible risks and benefits, optimal methods to support engagement, and possible avenues to integrate QoL self-monitoring practices into clinical work. OBJECTIVE This study aimed to conduct a qualitative exploration of how individuals with BD engaged with a Web-based version of a BD-specific QoL self-monitoring instrument, the QoL tool. METHODS A total of 43 individuals with BD engaged with a self-management intervention with an optional Web-based QoL self-assessment tool as part of an overarching mixed method study. Individuals were later interviewed about personal experiences of engagement with the intervention, including experiences of gauging their own QoL. A thematic analysis was used to identify salient aspects of the experience of QoL self-monitoring in BD. RESULTS In total, 4 categories describing people’s experiences of QoL self-monitoring were identified: (1) breadth of QoL monitoring, (2) highlighting the positive, (3) connecting self-monitoring to action, and (4) self-directed patterns of use. CONCLUSIONS The findings of this research generate novel insights into ways in which individuals with BD experience the Web-based QoL self-assessment tool. The value of tracking the breadth of domains was an overarching aspect, facilitating the identification of both areas of strength and life domains in need of intervention. Importantly, monitoring QoL appeared to have an inherently therapeutic quality, through validating flourishing areas and reinforcing self-management efforts. This contrasts the evidence suggesting that symptom tracking may be distressing because of its focus on negative experiences and positions QoL as a valuable adjunctive target of observation in BD. Flexibility and personalization of use of the QoL tool were key to engagement, informing considerations for health care providers wishing to support self-monitoring and future research into Web- or mobile phone–based apps.

Background Self-monitoring of symptoms is a cornerstone of psychological interventions in bipolar disorder (BD), but individuals with lived experience also value tracking holistic outcomes, such as quality of life (QoL). Importantly, self-monitoring is not always experienced positively by people with BD and may have lower than expected rates of engagement. Therefore, before progressing into QoL tracking tools, it is important to explore user perspectives to identify possible risks and benefits, optimal methods to support engagement, and possible avenues to integrate QoL self-monitoring practices into clinical work. Objective This study aimed to conduct a qualitative exploration of how individuals with BD engaged with a Web-based version of a BD-specific QoL self-monitoring instrument, the QoL tool. Methods A total of 43 individuals with BD engaged with a self-management intervention with an optional Web-based QoL self-assessment tool as part of an overarching mixed method study. Individuals were later interviewed about personal experiences of engagement with the intervention, including experiences of gauging their own QoL. A thematic analysis was used to identify salient aspects of the experience of QoL self-monitoring in BD. Results In total, 4 categories describing people’s experiences of QoL self-monitoring were identified: (1) breadth of QoL monitoring, (2) highlighting the positive, (3) connecting self-monitoring to action, and (4) self-directed patterns of use. Conclusions The findings of this research generate novel insights into ways in which individuals with BD experience the Web-based QoL self-assessment tool. The value of tracking the breadth of domains was an overarching aspect, facilitating the identification of both areas of strength and life domains in need of intervention. Importantly, monitoring QoL appeared to have an inherently therapeutic quality, through validating flourishing areas and reinforcing self-management efforts. This contrasts the evidence suggesting that symptom tracking may be distressing because of its focus on negative experiences and positions QoL as a valuable adjunctive target of observation in BD. Flexibility and personalization of use of the QoL tool were key to engagement, informing considerations for health care providers wishing to support self-monitoring and future research into Web- or mobile phone–based apps.