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BACKGROUND: Evidence for the effectiveness of treatments in early-onset psychosis is sparse. Current guidance for the treatment of early-onset psychosis is mostly extrapolated from trials in adult populations. The UK National Institute for Health and Care Excellence has recommended evaluation of the clinical effectiveness and cost-effectiveness of antipsychotic drugs versus psychological intervention (cognitive behavioural therapy [CBT] and family intervention) versus the combination of these treatments for early-onset psychosis. The aim of this study was to establish the feasibility of a randomised controlled trial of antipsychotic monotherapy, psychological intervention monotherapy, and antipsychotics plus psychological intervention in adolescents with first-episode psychosis. METHODS: We did a multicentre pilot and feasibility trial according to a randomised, single-blind, three-arm, controlled design. We recruited participants from seven UK National Health Service Trust sites. Participants were aged 14-18 years; help-seeking; had presented with first-episode psychosis in the past year; were under the care of a psychiatrist; were showing current psychotic symptoms; and met ICD-10 criteria for schizophrenia, schizoaffective disorder, or delusional disorder, or met the entry criteria for an early intervention for psychosis service. Participants were assigned (1:1:1) to antipsychotics, psychological intervention (CBT with optional family intervention), or antipsychotics plus psychological intervention. Randomisation was via a web-based randomisation system, with permuted blocks of random size, stratified by centre and family contact. CBT incorporated up to 26 sessions over 6 months plus up to four booster sessions, and family intervention incorporated up to six sessions over 6 months. Choice and dose of antipsychotic were at the discretion of the treating consultant psychiatrist. Participants were followed up for a maximum of 12 months. The primary outcome was feasibility (ie, data on trial referral and recruitment, session attendance or medication adherence, retention, and treatment acceptability) and the proposed primary efficacy outcome was total score on the Positive and Negative Syndrome Scale (PANSS) at 6 months. Primary outcomes were analysed by intention to treat. Safety outcomes were reported according to as-treated status, for all patients who had received at least one session of CBT or family intervention, or at least one dose of antipsychotics. The study was prospectively registered with ISRCTN, ISRCTN80567433. FINDINGS: Of 101 patients referred to the study, 61 patients (mean age 16\u00b73 years [SD 1\u00b73]) were recruited from April 10, 2017, to Oct 31, 2018, 18 of whom were randomly assigned to psychological intervention, 22 to antipsychotics, and 21 to antipsychotics plus psychological intervention. The trial recruitment rate was 68% of our target sample size of 90 participants. The study had a low referral to recruitment ratio (around 2:1), a high rate of retention (51 [84%] participants retained at the 6-month primary endpoint), a high rate of adherence to psychological intervention (defined as six or more sessions of CBT; in 32 [82%] of 39 participants in the monotherapy and combined groups), and a moderate rate of adherence to antipsychotic medication (defined as at least 6 consecutive weeks of exposure to antipsychotics; in 28 [65%] of 43 participants in the monotherapy and combined groups). Mean scores for PANSS total at the 6-month primary endpoint were 68\u00b76 (SD 17\u00b73) for antipsychotic monotherapy (6\u00b72 points lower than at randomisation), 59\u00b78 (13\u00b77) for psychological intervention (13\u00b71 points lower than at randomisation), and 62\u00b70 (15\u00b79) for antipsychotics plus psychological intervention (13\u00b79 points lower than at randomisation). A good clinical response at 6 months (defined as \u226550% improvement in PANSS total score) was achieved in four (22%) of 18 patients receiving antipsychotic monotherapy, five (31%) of 16 receiving psychological intervention, and five (29%) of 17 receiving antipsychotics plus psychological intervention. In as-treated groups, serious adverse events occurred in eight [35%] of 23 patients in the combined group, two [13%] of 15 in the antipsychotics group, four [24%] of 17 in the psychological intervention group, and four [80%] of five who did not receive any treatment. No serious adverse events were considered to be related to participation in the trial. INTERPRETATION: This trial is the first to show that a head-to-head clinical trial comparing psychological intervention, antipsychotics, and their combination is safe in young people with first-episode psychosis. However, the feasibility of a larger trial is unclear because of site-specific recruitment challenges, and amendments to trial design would be needed for an adequately powered clinical and cost-effectiveness trial that provides robust evidence. FUNDING: National Institute for Health Research.
\n \n\n \n \n\u00a9 2020 Elsevier Ltd Paranoia is theorised to build upon feelings of inferior social rank. Power posing has been shown to increase feelings of power, and hence could reduce paranoia. One hundred participants with current paranoia and 50 individuals without paranoia were recruited. Using a double-blind randomised controlled experimental design, participants twice held powerful or neutral postures before entering neutral virtual reality social environments. In the paranoid sample, those who held a powerful pose did not significantly increase in feelings of power by the end of testing in comparison to controls (group difference = 0.67, C.I. = \u22121.12; 1.46; p = 0.098), or decrease in paranoia (group difference = \u22120.23, C.I. = \u22121.17; 0.72; p = 0.634). In the non-paranoid sample, there was a small significant increase in powerful feelings by the end of testing in the powerful group (group difference = 1.13, C.I. = 0.23; 2.02; p = 0.013), but no significant decrease in paranoia (group difference = \u22120.71, C.I. = \u22122.16; 0.74; p = 0.338). Paranoia status was not a modifier on the relationship between condition and feelings of power. We conclude that power posing results in only very small changes in self-reported feelings of power and has no subsequent effect on paranoia.
\n \n\n \n \n<jats:sec>\n <jats:title>Background</jats:title>\n <jats:p>Real-world implementation of psychological interventions for psychosis is poor. Barriers include therapy being insufficiently usable and useful for a diverse range of people. User-centered, inclusive design approaches could improve the usability of therapy, which may increase uptake, adherence, and effectiveness.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Objective</jats:title>\n <jats:p>This study aimed to optimize the usability of an existing psychological intervention, Thinking Well, which targets reasoning processes in paranoia using a basic digital interface.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Methods</jats:title>\n <jats:p>We conducted inclusive, user-centered design research characterized by purposive sampling of extreme users from the margins of groups, ethnographic investigation of the problem context, and iterative prototyping of solutions. The UK Design Council\u2019s double diamond method was used. This consisted of 4 phases: discover, including a case series of Thinking Well, stakeholder interviews, desk research, user profiling, system mapping, and a mood board; define, consisting of workshops to synthesize findings and generate the design brief; develop, involving concept workshops and prototype testing; and deliver, in which the final minimal viable product was storyboarded and iteratively coded.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Results</jats:title>\n <jats:p>Consistent with our previous work, the Thinking Well case series showed medium to large effects on paranoia and well-being and small effects on reasoning. These were maintained at follow-up despite some participants reporting difficulties with the therapy interface. Insights from the discover phase confirmed that usability was challenged by information complexity and poor accessibility. Participants were generally positive about the potential of technology to be enjoyable, help manage paranoia, and provide tailored interpersonal support from therapists and peers, although they reported privacy and security concerns. The define phase highlighted that the therapy redesign should support monitoring, simplify information processing, enhance enjoyment and trust, promote personalization and normalization, and offer flexible interpersonal support. During the develop phase over 60 concepts were created, with 2 key concepts of thoughts visualized as bubbles and therapy as a journey selected for storyboarding. The output of the deliver phase was a minimal viable product of an innovative digital therapy, SlowMo. SlowMo works by helping people to notice their worries and fast thinking habits, and encourages them to slow down for a moment to find ways of feeling safer. A Web app supports the delivery of 8 face-to-face sessions, which are synchronized to a native mobile app.</jats:p>\n </jats:sec>\n <jats:sec>\n <jats:title>Conclusions</jats:title>\n <jats:p>SlowMo makes use of personalization, ambient information, and visual metaphors to tailor the appeal, engagement, and memorability of therapy to a diversity of needs. Feasibility testing has been promising, and the efficacy of SlowMo therapy is now being tested in a multicentered randomized controlled trial. The study demonstrates that developments in psychological theory and techniques can be enhanced by improving the usability of the therapy interface to optimize its impact in daily life.</jats:p>\n </jats:sec>
\n \n\n \n \nBACKGROUND: Psoriasis is associated with significant morbidity, which negatively impacts upon quality of life. Sleep disturbance is reported to be common in patients with psoriasis and is associated with physical and psychological variables, although there is little published work in this area. Understanding sleep and the factors involved in its disturbance in psoriasis is a potentially important clinical area given the role of sleep in health and disease processes. OBJECTIVES: To explore the experience of sleep and sleep disturbance in psoriasis using the Common-Sense Model of Self-Regulation (CS-SRM). METHODS: Semistructured interviews were conducted with adults diagnosed with psoriasis. Interview questions were informed by the CS-SRM and previous research. Framework analysis was applied, including coding data into the CS-SRM dimensions and allowing additional inductive themes to emerge. RESULTS: Seventeen people with psoriasis (nine women, eight men; aged 19-86\u00a0years) were interviewed about sleep and sleep disturbance. Seven themes emerged, with six accounted for by the CS-SRM: characteristics of sleep disturbance, change in sleep patterns, thoughts about and symptoms of disease disturbing sleep, impact of poor sleep on daily life, attempts to improve sleep, a daily battle for control and a seventh relating to metacognitive processes. A reciprocal relationship between sleep and psoriasis was evident across themes with interactions between key sleep-related thoughts, emotions and behaviours. CONCLUSIONS: This study showed that sleep disturbance is a persistent concern for people with psoriasis; it has a 24-h impact, and interacts with the psychological and physical aspects of psoriasis. The distress and frustration felt when managing sleep disturbance perpetuated problematic sleep. Addressing this with currently available sleep treatments may therefore confer sleep and psoriasis-related benefits for people living with this condition.
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