Real-world Implementation of a Smartphone-Based Psychoeducation Program for Bipolar Disorder: Observational Ecological Study.

BACKGROUND: SIMPLe is an internet-delivered self-management mobile app for bipolar disorder (BD) designed to combine technology with evidence-based interventions and facilitate access to psychoeducational content. The SIMPLe app was launched to the real world to make it available worldwide within the context of BD treatment. OBJECTIVE: The main aims of this study are as follows: to describe app use, engagement, and retention rates based on server data; to identify patterns of user retention over the first 6-month follow-up of use; and to explore potential factors contributing to discontinuation of app use. METHODS: This was an observational ecological study in which we pooled available data from a real-world implementation of the SIMPLe app. Participation was open on the project website, and the data-collection sources were a web-based questionnaire on clinical data and treatment history administered at inclusion and at 6 months, subjective data gathered through continuous app use, and the use patterns captured by the app server. Characteristics and engagement of regular users, occasional users, and no users were compared using 2-tailed t tests or analysis of variance or their nonparametric equivalent. Survival analysis and risk functions were applied to regular users' data to examine and compare use and user retention. In addition, a user evaluation analysis was performed based on satisfaction, perceived usefulness, and reasons to discontinue app use. RESULTS: We included 503 participants with data collected between 2016 and 2018, of whom 77.5% (n=390) used the app. Among the app users, 44.4% (173/390) completed the follow-up assessment, and data from these participants were used in our analyses. Engagement declined gradually over the first 6 months of use. The probability of retention of the regular users after 1 month of app use was 67.4% (263/390; 95% CI 62.7%-72.4%). Age (P=.002), time passed since illness onset (P<.001), and years since diagnosis of BD (P=.048) correlate with retention duration. In addition, participants who had been diagnosed with BD for longer used the app on more days (mean 97.73, SD 69.15 days; P=.002) than those who had had a more recent onset (mean 66.49, SD 66.18 days; P=.002) or those who had been diagnosed more recently (mean 73.45, SD 66 days; P=.01). CONCLUSIONS: The user retention rate of the app decreased rapidly after each month until reaching only one-third of the users at 6 months. There exists a strong association between age and app engagement of individuals with BD. Other variables such as years lived with BD, diagnosis of an anxiety disorder, and taking antipsychotics seem relevant as well. Understanding these associations can help in the definition of the most suitable user profiles for predicting trends of engagement, optimization of app prescription, and management.

EMDR therapy vs. supportive therapy as adjunctive treatment in trauma-exposed bipolar patients: A randomised controlled trial.

INTRODUCTION: Patients with bipolar disorder (BD) are frequently exposed to traumatic events which worsen disease course, but this study is the first multicentre randomised controlled trial to test the efficacy of a trauma-focused adjunctive psychotherapy in reducing BD affective relapse rates. MATERIALS AND METHODS: This multicentre randomised controlled trial included 77 patients with BD and current trauma-related symptoms. Participants were randomised to either 20 sessions of trauma-focused Eye Movement Desensitization and Reprocessing (EMDR) therapy for BD, or 20 sessions of supportive therapy (ST). The primary outcome was relapse rates over 24-months, and secondary outcomes were improvements in affective and trauma symptoms, general functioning, and cognitive impairment, assessed at baseline, post-treatment, and at 12- and 24-month follow-up. The trial was registered prior to starting enrolment in clinical trials (NCT02634372) and carried out in accordance with CONSORT guidelines. RESULTS: There was no significant difference between treatment conditions in terms of relapse rates either with or without hospitalisation. EMDR was significantly superior to ST at the 12-month follow up in terms of reducing depressive symptoms (p=0.0006, d=0.969), manic symptoms (p=0.027, d=0.513), and improving functioning (p=0.038, d=0.486). There was no significant difference in dropout between treatment arms. CONCLUSIONS: Although the primary efficacy criterion was not met in the current study, trauma-focused EMDR was superior to ST in reducing of affective symptoms and improvement of functioning, with benefits maintained at six months following the end of treatment. Both EMDR and ST reduced trauma symptoms as compared to baseline, possibly due to a shared benefit of psychotherapy. Importantly, focusing on traumatic events did not increase relapses or dropouts, suggesting psychological trauma can safely be addressed in a BD population using this protocol.

Improving Depressive Symptoms through Personalised Exercise and Activation (IDEA): Study Protocol for a Randomised Controlled Trial.

Individuals who suffer from depressive symptoms experience a substantial impact on psychosocial functioning, physical health, mortality, and quality of life. In the search for therapeutic strategies, exercise has been found to play a relevant part in its treatment. However, the promotion of exercise entails adherence difficulties that arose out of the tendency towards sedentarism led by symptomatology. Personalised exercise plans on top of usual care have the potential to enhance behavioural changes and mental health. The present study aims at evaluating the changes in functioning deriving from a blended intervention merging a psychological intervention with a personalised exercise programme based on medical assessment. We will conduct a three-arm randomised controlled trial in which 172 participants suffering from mild-moderate depressive symptoms will be allocated to Intervention A (personalised exercise group programme + app with motivational messages), B (personalised exercise group programme + app with no motivational messages) or control group (app with no motivational messages). Data regarding global functioning, well-being, symptoms, physical activity, and exercise capacity will be collected at baseline, 4, 12, and 36 weeks. The results of this trial will provide information about whether this physical activity support programme may be efficient for improving mental and physical health outcomes. Trial registration: ClinicalTrials.gov NCT04857944 (accessed on 15 April 2021). Registered April 2021.

A prospective longitudinal study searching for predictors of response to group psychoeducation in bipolar disorder.

BACKGROUND: The efficacy of adjunctive group psychoeducation in bipolar disorder has been proven although treatment response differ among individuals. The aim of this study was to characterize responders and non-responders to group psychoeducation in order to identify baseline variables that could predict treatment response. METHODS: The sample was composed of 103 medicated euthymic patients with bipolar disorder referred to 21 sessions of group psychoeducation (6 months). Sociodemographic and clinical variables, temperament, circadian rhythms, BDNF, cognitive and psychosocial functioning were collected. At the 18-month endpoint, the patients were split in two groups on the basis of having suffered any recurrence. Significant group differences were included in a logistic regression analysis. RESULTS: Ninety patients out of 103 engaged in group psychoeducation, 47 of whom (52.2%) responded to psychoeducation and 43 (47.8%) did not. Recurrences occurred more often in the follow-up, the most common being depression. Responders and non-responders differed in gender, age at diagnosis, latency of diagnosis, temperament, attention composite score and BDNF. Lower age at diagnosis of bipolar disorder, lower cyclothimic temperament scores and being male -which was associated with bipolar type I and a trend to more previous manic episodes- were significantly related to a better response to psychoeducation in the regression analysis. LIMITATIONS: No control group. CONCLUSIONS: This study identifies age at diagnosis as a significant modifiable risk factor of treatment response, highlighting the need for early identification of bipolar disorder. Existing programs should be adjusted to the characteristics of specific subpopulations in the framework of a personalized approach.

[HIV-mother-to-child transmission in a tertiary hospital in the era of generalization of preventive interventions]. / Transmisión vertical global del virus de la inmunodeficiencia humana en la época de la generalización de las medidas preventivas.

BACKGROUND AND OBJECTIVE: Since 1994, when the PACTG 076 results were published, the rate of vertical transmission has decreased from 25% to 2%. Nowadays the prevalence of HIV infection in Catalan pregnant women is 0.17% yet it is 0.5% in our hospital. Our objectives were: to analyze the number of new cases of HIV infection by vertical transmission; to determine the importance of risk factors; to prove how important is to identify HIV-infected pregnant women; to determine the role of the rapid HIV-1 testing in labour room; and to detect mistakes in the prophylactic strategies. PATIENTS AND METHOD: One hundted and twenty four newborns from HIV-infected pregnant women born in Hospital del Mar were prospectively followed from 1996-2005. All them were separated in different groups in order to compare them. RESULTS: Eight children were infected, corresponding to 6.45%. In the group of newborns whose mothers were identified as infected during pregnancy, even with prophylactic measures well done, the transmission rate was 3.6% and it was 3.8% in the group born after 1999. When the prophylactic strategies were correct, 30% of pregnant women reached delivery with HIV RNA <1,000/ml copies. In the multivariate analysis, two variables were significant: amniorrhexis >4h and lack of identification of pregnant women as being HIV positive. CONCLUSIONS: The identification of HIV-pregnant women has been crucial to avoid HIV mother-to-child transmission. Rapid HIV-1 testing in labour room is key to set up preventive strategies in order to avoid the infection in the newborn. Adequate prophylaxis percentages are still low and improvement is needed.

Prospective cohort study of early biosignatures of response to lithium in bipolar-I-disorders: overview of the H2020-funded R-LiNK initiative.

BACKGROUND: Lithium is recommended as a first line treatment for bipolar disorders. However, only 30% of patients show an optimal outcome and variability in lithium response and tolerability is poorly understood. It remains difficult for clinicians to reliably predict which patients will benefit without recourse to a lengthy treatment trial. Greater precision in the early identification of individuals who are likely to respond to lithium is a significant unmet clinical need. STRUCTURE: The H2020-funded Response to Lithium Network (R-LiNK; http://www.r-link.eu.com/ ) will undertake a prospective cohort study of over 300 individuals with bipolar-I-disorder who have agreed to commence a trial of lithium treatment following a recommendation by their treating clinician. The study aims to examine the early prediction of lithium response, non-response and tolerability by combining systematic clinical syndrome subtyping with examination of multi-modal biomarkers (or biosignatures), including omics, neuroimaging, and actigraphy, etc. Individuals will be followed up for 24 months and an independent panel will assess and classify each participants' response to lithium according to predefined criteria that consider evidence of relapse, recurrence, remission, changes in illness activity or treatment failure (e.g. stopping lithium; new prescriptions of other mood stabilizers) and exposure to lithium. Novel elements of this study include the recruitment of a large, multinational, clinically representative sample specifically for the purpose of studying candidate biomarkers and biosignatures; the application of lithium-7 magnetic resonance imaging to explore the distribution of lithium in the brain; development of a digital phenotype (using actigraphy and ecological momentary assessment) to monitor daily variability in symptoms; and economic modelling of the cost-effectiveness of introducing biomarker tests for the customisation of lithium treatment into clinical practice. Also, study participants with sub-optimal medication adherence will be offered brief interventions (which can be delivered via a clinician or smartphone app) to enhance treatment engagement and to minimize confounding of lithium non-response with non-adherence. CONCLUSIONS: The paper outlines the rationale, design and methodology of the first study being undertaken by the newly established R-LiNK collaboration and describes how the project may help to refine the clinical response phenotype and could translate into the personalization of lithium treatment.

Transmisión vertical global del virus de la inmunodeficiencia humana en la época de la generalización de las medidas preventivas / HIV-mother-to-child transmission in a tertiary hospital in the era of generalization of preventive interventions

Fundamento y objetivo: Desde que en 1994 se publicaron los resultados del estudio PACTG 076, la tasa de transmisión vertical del virus de la inmunodeficiencia humana (VIH) ha ido disminuyendo. La prevalencia de la infección entre las gestantes catalanas es del 0,17%, y en nuestro hospital del 0,5%, en 2005. Los objetivos del trabajo han sido: analizar el número de nuevos casos de infección por el VIH por transmisión vertical; detectar la importancia de los diferentes factores de riesgo; demostrar la importancia de identificar a las gestantes infectadas; objetivar el papel de la prueba rápida en sala de partos, y detectar los fallos en la prevención de la transmisión vertical. Pacientes y método: Se han incluido, de manera prospectiva, los 124 recién nacidos hijos de madre infectada por el VIH positiva nacidos en el Hospital del Mar, Barcelona entre 1996 y 2005, divididos en diferentes grupos para compararlos entre ellos. Resultados: Han resultado infectados 8, lo que supone un 6,45%. En el grupo de madres identificadas con profilaxis correcta, la tasa de transmisión fue del 3,6% y en el grupo posterior a 1999 del 3,8%. Cuando la profilaxis es correcta, hay un 30% más de gestantes con carga viral <1.000copias/ml. El modelo multivariado de regresión logística mostró como significativas dos variables: amniorrexis >4h y la no identificación de la gestante como infectada por el VIH. Conclusiones: La identificación de la gestante es un factor primordial para evitar la transmisión vertical. La prueba diagnóstica rápida del VIH en la sala de partos es fundamental para establecer medidas preventivas y evitar la transmisión vertical. Los porcentajes de profilaxis correcta son bajos y susceptibles de una gran mejoría (AU)

Background and objective: Since 1994, when the PACTG 076 results were published, the rate of vertical transmission has decreased from 25% to 2%. Nowadays the prevalence of HIV infection in Catalan pregnant women is 0.17% yet it is 0.5% in our hospital. Our objectives were: to analyze the number of new cases of HIV infection by vertical transmission; to determine the importance of risk factors; to prove how important is to identify HIV-infected pregnant women; to determine the role of the rapid HIV-1 testing in labour room; and to detect mistakes in the prophylactic strategies. Patients and method: One hundted and twenty four newborns from HIV-infected pregnant women born in Hospital del Mar were prospectively followed from 1996–2005. All them were separated in different groups in order to compare them. Results: Eight children were infected, corresponding to 6.45%. In the group of newborns whose mothers were identified as infected during pregnancy, even with prophylactic measures well done, the transmission rate was 3.6% and it was 3.8% in the group born after 1999. When the prophylactic strategies were correct, 30% of pregnant women reached delivery with HIV RNA <1,000/ml copies. In the multivariate analysis, two variables were significant: amniorrhexis >4h and lack of identification of pregnant women as being HIV positive. Conclusions: The identification of HIV-pregnant women has been crucial to avoid HIV mother-to-child transmission. Rapid HIV-1 testing in labour room is key to set up preventive strategies in order to avoid the infection in the newborn. Adequate prophylaxis percentages are still low and improvement is needed (AU)