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BACKGROUND: Medical students are exposed to an emotionally exhausting training/work environment and to stressful academic demands. Consequently, psychopathologies, burnout and suicidal ideation are frequent in this population. These factors can also affect their empathy and quality of care. Therefore, the development and implementation of programs to promote resilience to stress specifically in medical students and the evaluation of their efficiency are a priority. Here, we describe the protocol of the first French study to assess the long-term effectiveness and acceptability of a mindfulness-based intervention (MBI) compared with relaxation training (RT) to reduce emotional exhaustion in medical students. METHODS: This multicenter randomized controlled trial ("Must prevent") plans to enroll 612 students in the fourth and fifth year of medical studies from nine French universities. After inclusion, they will be assigned randomly to the MBI or RT group. Both interventions are structured around an 8-week program that includes one group class per week and daily at-home exercises. The primary endpoint is the emotional exhaustion score assessed with the Maslach Burnout Inventory at month 12 of the follow-up. Secondary endpoints include anxiety-depressive symptomatology, suicidality, psychoactive substance use, depersonalization, psychological and physical pain, empathy, emotional regulation, self-compassion, mindfulness, quality of life, and program acceptability. Evaluations will be done before and immediately after the 8-week intervention, and at month 6 and 12 of the post-intervention follow-up. DISCUSSION: If the proposed interventions are well accepted and useful to decrease negative emotions and/or increase wellbeing among medical students, they should be disseminated among this population and even included as part of the training on emotional skills needed for the routine medical practice. TRIAL REGISTRATION: This trial is registered under the number NCT04026594 (July 18, 2019).
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Agotamiento Profesional/prevención & control , Agotamiento Profesional/terapia , Atención Plena , Estudiantes de Medicina/psicología , Francia , Humanos , Estudios Multicéntricos como Asunto , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Major Depressive Disorder (MDD) is highly prevalent and was associated with greater morbidity, mortality (including suicide), and healthcare costs. By 2030, MDD will become the leading cause of disability in high-income countries. Notably, among patients with a previous experience of a major depressive episode, it was indeed estimated that up to 85 % of those patients will suffer from relapse. Two main factors were associated with a significantly higher risk of relapse: poor medication adherence and low self-efficacy in disease management. Interestingly, these issues could become the targets of psychoeducational programs for chronic diseases. Indded psychoeducational program for depression are recommended in international guidelines, but have not yet been proposed in France. METHODS/DESIGN: We propose to evaluate the first French psychoeducational program for depression "ENVIE" in a multicenter randomized controlled trial. The group intervention will include 9 weekly sessions. Its aim is to educate patients on the latest knowledge on depression and effective treatments through didactic and interactive sessions. Patients will experiment the latest innovating psychological skills (from acceptance and commitment therapy) to cope with depressive symptoms and maintain motivation in behavioral activation. In total, 332 unipolar non-chronic (<2 years) outpatients with moderate to severe depression, without psychotic features, will be randomly allocated to the add-on ENVIE program (N = 166) or to a waiting list (N = 166). The follow-up will last 15 months and include 5 assessment visits. The primary endpoint will be the remission rate of the index episode at 15 months post-inclusion, defined by a Montgomery and Asberg Depression Rating Scale (MADRS) score ≤ 12 over an 8-week period, and without relapse during follow-up. We will also assess the response rate and relapse at 15 months post-inclusion, hospitalization rate and adherence to treatment during the follow-up period, quality of life and global functioning upon inclusion and at 9 and 15 months post inclusion. DISCUSSION: If the proposed trial shows the effectiveness of the intervention, but also an increased remission rate in depressed outpatients at 15-months post-inclusion, in addition to improved treatment adherence in patients, it will further promotes arguments in favor of a wide dissemination of psychoeducational programs for depression. TRIAL REGISTRATION: This trial is registered under number 2015-A00249-40 (PURE clinical trial: NCT02501226 ) (June 30th, 2015).
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Trastorno Depresivo Mayor/terapia , Educación del Paciente como Asunto/métodos , Psicoterapia/métodos , Adolescente , Adulto , Anciano , Enfermedad Crónica , Femenino , Francia , Costos de la Atención en Salud , Humanos , Masculino , Cumplimiento de la Medicación , Persona de Mediana Edad , Pacientes Ambulatorios , Calidad de Vida , Recurrencia , Resultado del Tratamiento , Adulto Joven , Prevención del SuicidioRESUMEN
Background: As mHealth may contribute to suicide prevention, we developed emma, an application using Ecological Momentary Assessment and Intervention (EMA/EMI). Objective: This study evaluated emma usage rate and acceptability during the first month and satisfaction after 1 and 6 months of use. Methods: Ninety-nine patients at high risk of suicide used emma for 6 months. The acceptability and usage rate of the EMA and EMI modules were monitored during the first month. Satisfaction was assessed by questions in the monthly EMA (Likert scale from 0 to 10) and the Mobile App Rating Scale (MARS; score: 0-5) completed at month 6. After inclusion, three follow-up visits (months 1, 3, and 6) took place. Results: Seventy-five patients completed at least one of the proposed EMAs. Completion rates were lower for the daily than weekly EMAs (60 and 82%, respectively). The daily completion rates varied according to the question position in the questionnaire (lower for the last questions, LRT = 604.26, df = 1, p-value < 0.0001). Completion rates for the daily EMA were higher in patients with suicidal ideation and/or depression than in those without. The most used EMI was the emergency call module (n = 12). Many users said that they would recommend this application (mean satisfaction score of 6.92 ± 2.78) and the MARS score at month 6 was relatively high (overall rating: 3.3 ± 0.87). Conclusion: Emma can target and involve patients at high risk of suicide. Given the promising users' satisfaction level, emma could rapidly evolve into a complementary tool for suicide prevention.
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Mental health issues, including major depressive disorder, which can lead to suicidal behavior, are considered by the World Health Organization as a major threat to global health. Alterations in neurotransmitter signaling, e.g., serotonin and glutamate, or inflammatory response have been linked to both MDD and suicide. Phosphodiesterase 8A (PDE8A) gene expression is significantly decreased in the temporal cortex of major depressive disorder (MDD) patients. PDE8A specifically hydrolyzes adenosine 3',5'-cyclic monophosphate (cAMP), which is a key second messenger involved in inflammation, cognition, and chronic antidepressant treatment. Moreover, alterations of RNA editing in PDE8A mRNA has been described in the brain of depressed suicide decedents. Here, we investigated PDE8A A-to-I RNA editing-related modifications in whole blood of depressed patients and suicide attempters compared to age-matched and sex-matched healthy controls. We report significant alterations of RNA editing of PDE8A in the blood of depressed patients and suicide attempters with major depression, for which the suicide attempt took place during the last month before sample collection. The reported RNA editing modifications in whole blood were similar to the changes observed in the brain of suicide decedents. Furthermore, analysis and combinations of different edited isoforms allowed us to discriminate between suicide attempters and control groups. Altogether, our results identify PDE8A as an immune response-related marker whose RNA editing modifications translate from brain to blood, suggesting that monitoring RNA editing in PDE8A in blood samples could help to evaluate depressive state and suicide risk.
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Trastorno Depresivo Mayor , Intento de Suicidio , 3',5'-AMP Cíclico Fosfodiesterasas/genética , Trastorno Depresivo Mayor/genética , Humanos , Hidrolasas Diéster Fosfóricas , Edición de ARN , Ideación SuicidaRESUMEN
Background: The ability to differentiate emotions in social contexts is important for dealing with challenging social situations. Suicide attempters show some difficulties in emotion recognition that may result in hypersensitivity to social stress. However, other studies on the recognition of social complex emotions found that suicide attempters have similar performances as depressed non-attempters. Objectives: To investigate differences in social emotion recognition in patients with current Major Depressive Episode (MDE) with and without history of suicide attempt. Methods: Two hundred and ten patients with MDE were recruited among whom 115 had lifetime history of suicide attempt (suicide attempters, SA) and 95 did not (affective controls, AC). Recognition of complex social emotions was assessed using the Reading the Mind in the Eyes Test (RMET). Emotions were separated in three valence categories: positive, negative, and neutral. Verbal intelligence quotient (IQ) and attention were measured with the National Adult Reading Task (NART) and the d2 test, respectively. Results: Mixed logistic regression models adjusted for sex, lifetime bipolar disorder, verbal IQ and attention showed that the RMET performance for neutral emotions was worse in the SA than AC group (OR = 0.87 [0.75, 0.99]). Furthermore, when violent/serious SA were compared to non-violent/non-serious SA and AC, the RMET neutral valence category showed a trend for group factor (p < 0.059) and RMET scores were lower in the violent/serious SA than AC group (OR = 0.79 [0.64, 0.96]). Conclusion: Recognition of neutral emotions is poor in SA and this may complicate their daily life. Interventions to improve the understanding of complex emotions may be helpful to prevent suicidal risk in patients with depression.
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BACKGROUND: Many suicide risk factors have been identified, but traditional clinical methods do not allow for the accurate prediction of suicide behaviors. To face this challenge, emma, an app for ecological momentary assessment (EMA), ecological momentary intervention (EMI), and prediction of suicide risk in high-risk patients, was developed. OBJECTIVE: The aim of this case report study was to describe how subjects at high risk of suicide use the emma app in real-world conditions. METHODS: The Ecological Mental Momentary Assessment (EMMA) study is an ongoing, longitudinal, interventional, multicenter trial in which patients at high risk for suicide are recruited to test emma, an app designed to be used as a self-help tool for suicidal crisis management. Participants undergo clinical assessment at months 0, 1, 3, and 6 after inclusion, mainly to assess and characterize the presence of mental disorders and suicidal thoughts and behaviors. Patient recruitment is still ongoing. Some data from the first 14 participants who already completed the 6-month follow-up were selected for this case report study, which evaluated the following: (1) data collected by emma (ie, responses to EMAs), (2) metadata on emma use, (3) clinical data, and (4) qualitative assessment of the participants' experiences. RESULTS: EMA completion rates were extremely heterogeneous with a sharp decrease over time. The completion rates of the weekly EMAs (25%-87%) were higher than those of the daily EMAs (0%-53%). Most patients (10/14, 71%) answered the EMA questionnaires spontaneously. Similarly, the use of the Safety Plan Modules was very heterogeneous (2-75 times). Specifically, 11 patients out of 14 (79%) used the Call Module (1-29 times), which was designed by our team to help them get in touch with health care professionals and/or relatives during a crisis. The diversity of patient profiles and use of the EMA and EMI modules proposed by emma were highlighted by three case reports. CONCLUSIONS: These preliminary results indicate that patients have different clinical and digital profiles and needs that require a highly scalable, interactive, and customizable app. They also suggest that it is possible and acceptable to collect longitudinal, fine-grained, contextualized data (ie, EMA) and to offer personalized intervention (ie, EMI) in real time to people at high risk of suicide. To become a complementary tool for suicide prevention, emma should be integrated into existing emergency procedures. TRIAL REGISTRATION: ClinicalTrials.gov NCT03410381; https://clinicaltrials.gov/ct2/show/NCT03410381.
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Trastornos Mentales , Aplicaciones Móviles , Prevención del Suicidio , Evaluación Ecológica Momentánea , Humanos , Encuestas y CuestionariosRESUMEN
BACKGROUND: Although psychoeducation programmes are the gold-standard intervention in bipolar disorder (BD), more innovative tools are needed to broaden and consolidate their effects, especially on treatment adherence. Serious games could be an option. METHODS: We carried out a two-arm open randomized controlled trial to compare the add-on use of the serious game BIPOLIFE® for one month (n = 20) vs. treatment as usual (TAU; nâ¯=â¯21) following the completion of a psychoeducation programme in euthymic adults with BD. The primary outcome was the percentage of adherent patients (i.e., patients with a Medication Adherence Rating Scale, MARS, total score >7) at 4 months after the end of the psychoeducation programme. We also measured the changes in therapeutic adherence and beliefs on pharmacological treatments (Drug Attitude Inventory, DAI) between study inclusion and the 1-month (end of BIPOLIFE® use) and 4-month visits, healthcare use during the study period, and BIPOLIFE® acceptability. RESULTS: The percentage of adherent patients was lower in the BIPOLIFE® group than in the TAU group at inclusion (p = 0.02). Conversely, the absolute variation of the MARS and DAI scores was higher in the BIPOLIFE® than in the TAU group at the 1-month visit (pâ¯=â¯0.03 and pâ¯=â¯0.002, respectively) but not at the 4-month visit (pâ¯=â¯0.22 and pâ¯=â¯0.07, respectively). LIMITATIONS: Small sample size, and low frequency of connexion to BIPOLIFE® declared by the patients. CONCLUSION: BIPOLIFE® may help patients with BD to increase their confidence in medications, if used regularly.
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Trastorno Bipolar/terapia , Trastorno Ciclotímico/terapia , Cumplimiento de la Medicación/psicología , Educación del Paciente como Asunto , Juegos de Video/psicología , Adulto , Trastorno Bipolar/psicología , Trastorno Ciclotímico/psicología , Femenino , Conocimientos, Actitudes y Práctica en Salud , Humanos , Masculino , Persona de Mediana EdadRESUMEN
The aims of the study are to examine the predictive role of fluctuations in daily life mood, social contexts, and behavior on subsequent suicidal ideation (SI); and to identify clinical and psychological factors associated with the general frequency of SI in a high-risk sample. The sample comprised 42 adults (73.8% female) hospitalized for a suicide attempt. Immediately following hospital discharge, they used Ecological Momentary Assessment for seven consecutive days, providing repeated measures of SI, environmental, contextual, and behavioral factors. Controlling for prior SI, a number of contextual variables were associated with subsequent SI. Being at home or at work were both associated with an increased probability of SI, while being in the home of close others, or in a festive or leisure environment decreased SI probability. Working, passive leisure and inactivity all increased the likelihood of SI. Being alone increased SI while being with close others significantly reduced this risk. Finally, no overall effect for stressful events was found but negative family events specifically were associated with increased likelihood of SI (γ = 0.448, t = 2.255, df = 29, p < 0.05). The findings provide preliminary results regarding proximal environmental and behavioral factors associated with the occurrence of suicidal ideation in a high-risk sample.
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Alta del Paciente/tendencias , Ideación Suicida , Intento de Suicidio/psicología , Intento de Suicidio/tendencias , Adulto , Afecto/fisiología , Femenino , Humanos , Acontecimientos que Cambian la Vida , Masculino , Persona de Mediana Edad , Proyectos Piloto , Valor Predictivo de las Pruebas , Factores de Riesgo , Adulto JovenRESUMEN
BACKGROUND: The influence of life events on suicidal behavior remains inconclusive, while reasons for living (RFL) may be protective. OBJECTIVES: To analyze the association between positive and negative life events and suicidal ideation (SI) and the interaction between life events and RFL on SI. METHOD: Patients with history of suicide attempts (n = 338) underwent a comprehensive clinical evaluation, including SI (Beck's Suicidal Ideation scale), RFL (Reasons for Living Inventory, RFLI) and life events (family, school, student or professional, social, health and religion-related and other life events) during the last twelve months. RESULTS: The only negative life events associated with SI were health-related events (OR = 2.01 95%CI[1.04;3.92]). Family-related positive life events and RFL were negatively associated with SI (OR = 0.73 95%CI[0.58;0.91] and OR = 0.98 95%CI[0.97;0.98], respectively). No significant interaction between the number of positive life events and RFLI total score with current SI (p = 0.57) was detected. Family-related positive life events and RFL did not have any additive effect on SI. Positive life events did not moderate the association between health-related negative life events and SI. LIMITATIONS: This was a retrospective study, the presence of axis II disorders was not investigated and results cannot be generalized due to the sample choice (only suicide attempters). CONCLUSIONS: Patients with history of suicide attempts could be less sensitive to negative life events, except for those related to health. Clinicians should pay more attention to somatic problems in patients at risk of suicide. Family support, positive psychology and therapies that strengthen RFL should be developed to prevent suicide.
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Acontecimientos que Cambian la Vida , Resiliencia Psicológica , Ideación Suicida , Intento de Suicidio/psicología , Pensamiento , Adolescente , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Escalas de Valoración Psiquiátrica , Psicometría , Encuestas y Cuestionarios , Adulto JovenRESUMEN
Ecological Momentary Assessment has been used to investigate a wide range of behaviors and psychiatric conditions. Previous investigations have consistently obtained promising results with high acceptance and compliance rates, and with only minor reactive effects for specific variables. Despite the promise of this methodology for the study of severe psychiatric populations, little is known about its feasibility in samples at risk for suicide. In the present study, four samples at varying risk for suicide completed an Ecological Momentary Assessment study by responding to five electronic assessments per day over a one-week period. Samples included healthy controls (n=13), affective controls (n=21), past suicide attempters (n=20), and recent suicide attempters (n=42). The results demonstrate satisfactory participation rates and high compliance with daily life repeated assessments across all groups. Importantly, negative thoughts or suicidal ideation were not reactive to the duration of the study, indicating that the repeated assessment of such cognitions in daily life have little or no effect on their frequency. The findings provide support for the use of Ecological Momentary Assessment in the study of suicidal ideation and suggest that mobile technologies represent new opportunities for the assessment of high-risk cognitive states experienced by patients in daily life.
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Trastornos Mentales/psicología , Ideación Suicida , Intento de Suicidio/psicología , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Medición de RiesgoRESUMEN
OBJECTIVE: To date, most researchers rely on suicidal items of scales primarily designed to measure depression severity to capture suicidal ideation (SI). This study aims at investigating how well the suicide item of the clinician rated Hamilton Scale for Depression (HAM-D) and principal factors derived from this scale correlate with SI scores derived from a well validated measure of SI: the Beck's scale for SI (SSI). METHOD: 281 suicide attempters consecutively hospitalized between 2007 and 2009 were assessed by using the SSI, the HAM-D and the self-report Beck Depression Inventory (BDI). Principal Component Analysis (PCA) was computed to extract main factors. Correlations between these factors, BDI's and HAM-D's suicide items and the SSI scores were then computed. RESULTS: Three components were derived from the PCA. Factor 2 showed a major loading for the HAM-D suicide item. Both the HAM-D suicide item and Factor 2 positively correlated with the SSI total score (both p<0.00001). Moreover, the BDI suicide item highly correlated with the Factor 2 (p<0.001) and the SSI total score (p<0.00001). Finally, the HAM-D suicide item correlated significantly with the number of suicide attempts (p=0.0001) and the age at the first attempt (p=0.002). LIMITATIONS: Our sample was heterogeneous and future studies should refine the taxonomy of the suicidal behavior in specific sub-populations. The study design was cross-sectional and replication in a prospective study is needed. CONCLUSION: These findings suggest that the use of a single suicide item or a dimensional factor derived from a depression scale might be a valid approach to assess the suicidal ideations. Moreover, the results suggest that clinician rated scales as well as self-report questionnaires are equally valid to do so.
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Depresión/diagnóstico , Ideación Suicida , Intento de Suicidio/estadística & datos numéricos , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Escalas de Valoración Psiquiátrica , Adulto JovenRESUMEN
OBJECTIVE: Compared to other eating disorders, anorexia nervosa (AN) has the highest rates of completed suicide whereas suicide attempt rates are similar or lower than in bulimia nervosa (BN). Attempted suicide is a key predictor of suicide, thus this mismatch is intriguing. We sought to explore whether the clinical characteristics of suicidal acts differ between suicide attempters with AN, BN or without an eating disorders (ED). METHOD: Case-control study in a cohort of suicide attempters (nâ=â1563). Forty-four patients with AN and 71 with BN were compared with 235 non-ED attempters matched for sex, age and education, using interview measures of suicidal intent and severity. RESULTS: AN patients were more likely to have made a serious attempt (ORâ=â3.4, 95% CI 1.4-7.9), with a higher expectation of dying (ORâ=â3.7,95% CI 1.1-13.5), and an increased risk of severity (ORâ=â3.4,95% CI 1.2-9.6). BN patients did not differ from the control group. Clinical markers of the severity of ED were associated with the seriousness of the attempt. CONCLUSION: There are distinct features of suicide attempts in AN. This may explain the higher suicide rates in AN. Higher completed suicide rates in AN may be partially explained by AN patients' higher desire to die and their more severe and lethal attempts.