Efficacy of the my health too online cognitive behavioral therapy program for healthcare workers during the COVID-19 pandemic: A randomized controlled trial.

Background: Healthcare workers' mental health has been impacted by the COVID-19 pandemic, emphasizing the need for mental health interventions in this population. Online cognitive behavioral therapy (CBT) is efficient to reduce stress and may reach numerous professionals. We developed "MyHealthToo", an online CBT program to help reduce stress among healthcare workers during the COVID-19 pandemic. Objective: The aim of our study is to investigate the efficacy of an online CBT program on stress and mental health conditions among healthcare workers during a health crisis. Methods: We performed a multicentric randomized controlled trial among 155 participants allocated either to the experimental or active control group (bibliotherapy). The primary outcome was the decrease of perceived stress scores (PSS-10) post-treatment. Secondary outcomes included depression, insomnia and PTSD symptoms along with self-reported resilience and ruminations. Assessments were scheduled pretreatment, mid-treatment (4 weeks), post-treatment (8 weeks), and at 1-month and 4-months follow-up. Results: For both interventions, mean changes on the PSS-10 were significant post-therapy (W8), as at 1-month (W12) and 4-months (W24) follow-ups. The between-group comparison showed no difference at any time point (ps > 0.88). Work-related ruminations significantly decreased in the experimental group with a significant between-group difference at W8 (Δ = -1.83 [-3.57; -0.09], p = 0.04). Posttraumatic stress symptoms significantly decreased in the experimental group with a significant between-group difference at W12 (Δ = -1.41 [-2.68; -0.14], p = 0.03). The decrease in work-related ruminations at W8 mediated the decrease in posttraumatic stress symptoms at W12 (p = 0.048). Conclusion: The "MyHealthToo" online CBT intervention may help reduce ruminations about work and posttraumatic stress symptoms among healthcare workers during a major health crisis. Work-related ruminations may represent a relevant target of online interventions to improve mental health among healthcare workers.

Efficacy and Safety of Loxapine in Acute Agitation: A Systematic Review of Interventional Studies.

Objective: To assess the efficacy and safety of loxapine in acute agitation.Data Sources: PubMed, Cochrane database, EMBASE, PsycINFO, and ClinicalTrials.gov were searched to identify relevant articles published in English or French from inception to March 15, 2022. The term "Loxap*" was searched in titles and abstracts.Study Selection and Data Extraction: Interventional studies that compared the effectiveness of loxapine to any other intervention (including another administration route or dosage of loxapine, other drugs, and placebo) in acute agitation were included. From the 1,435 articles initially identified, and after the assessment of 73 full texts, 7 articles were selected, encompassing 1,276 participants. Two reviewers independently extracted data of interest using a predefined form.Results: Among included studies, 5 were double-blind, 2 were open-label, and all were randomized. The risk of bias was low for 2 studies, involving 658 participants. Four articles compared loxapine to placebo, and 3 compared it with haloperidol, aripiprazole, and droperidol. Loxapine was found to be more effective and faster regarding acute agitation control. Also, across included studies, loxapine was well-tolerated, with mildly or moderately severe adverse effects.Conclusions: Notwithstanding methodological limitations of the included studies, this systematic review provides reassuring results regarding the use of loxapine in acute agitation. However, further studies with methodological optimizations might be of interest.Prim Care Companion CNS Disord 2023;25(6):23r03552. Author affiliations are listed at the end of this article.

Epidemiology of insomnia disorder in older persons according to the Diagnostic and Statistical Manual of Mental Disorders: a systematic review and meta-analysis.

PURPOSE: There is a scarcity of summarizing data on the epidemiology of insomnia in older persons, especially when diagnosed with international criteria. This study aimed to estimate the prevalence and correlates of insomnia disorder in older persons, according to the Diagnostic and Statistical Manual of Mental Disorders (DSM). METHODS: Through PubMed/MEDLINE, EMBASE, and Web of Science (WoS), we searched for relevant articles published before June 28, 2023. The risk of bias was weighed using the Joanna Briggs Institute's (JBI's) critical appraisal checklist for studies reporting prevalence data. For our analyses, we used a random-effect model, with subgroup analyses, meta-regression, and sensitivity analyses to explore potential sources of heterogeneity. We followed the Preferred Reporting Items for Systematic reviews and Meta-Analyses statement. RESULTS: We included 18,270 participants across 16 studies. The male/female ratio was 0.89 (12 studies), and the mean age varied from 65.9 to 83.1 years (8 studies). The pooled prevalence of insomnia was 19.6% (95% CI = [12.3%; 28.3%]), with substantial heterogeneity. This prevalence fluctuated according to the sample size, the minimal age for inclusion, and the study quality, considering that the risk of bias was moderate for most of studies. There was a publication bias, with a very low level of certainty. Insomnia disorder was associated with the female gender, depression, anxiety, and somatic illnesses notably cardiovascular, respiratory, and painful ones. CONCLUSION: Nearly one in every five old individuals was considered to have insomnia disorder, which was associated with the gender and the existence of mental health and/or somatic conditions. REGISTRATION: We registered the protocol in the International Prospective Register of Systematic Reviews (PROSPERO) with registration number: CRD42022344675.

Risk of hospitalization for self-harm among adults hospitalized with SARS-CoV-2 in France: A nationwide retrospective cohort study.

While much work has shown a link between the global SARS-CoV-2 pandemic and poor mental health, little is known about a possible association between hospitalization with SARS-CoV-2 infection and subsequent hospitalization for self-harm. Analyses performed on the French national hospital database between March 2020-March 2021 in 10,084,551 inpatients showed that hospitalization with SARS-CoV-2 infection was not associated with hospitalization for self-harm in the following year. However, hospitalization with SARS-Cov-2 was related to an increased risk of self-harm in patients with a suicidal episode at the inclusion (aHR=1.56[1.14-2.15]), suggesting an effect of SARS-CoV-2 in patients with a recent history of self-harm.

Association Between Depression Before Hematopoietic Stem Cell Transplantation and Posttransplant Survival: A Systematic Review and Meta-analysis.

BACKGROUND: Depressive symptoms are often found in patients undergoing hematopoietic stem cell transplantation (HSCT). However, the impact of depression on overall survival and other outcomes after HSCT has not been systematically reviewed. OBJECTIVE: The objective of this review was to determine if depression before HSCT is associated with poor posttransplant outcomes. METHODS: We performed a systematic research, following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISM) guidelines based on several databases (MEDLINE, EMBase, and PsycINFO) for cohort studies on adults undergoing HSCT, comparing overall survival or other outcomes (length of aplasia, infectious complications) between patients with depressive symptoms and controls. For studies reporting overall survival hazard ratios, we conducted a meta-analysis by calculating a 95% confidence interval hazard ratios, and we assessed heterogeneity with the I2 statistic. Study quality was assessed using the Newcastle-Ottawa Quality Assessment scale for cohort studies. RESULTS: A total of 18 studies were included in the systematic review (22,235 participants) and 8 in the meta-analysis. There were a variety of depression screening tools, the Hospital Anxiety and Depression Scale (HADS) being the most reported questionnaire. A significant association between depression and overall survival was found in 9 studies, whereas 8 studies shown no association. Depression tended to have an impact on length of aplasia and infectious complications. In the meta-analysis, depression was found to impact significantly overall survival after HSCT with a hazard ratio = 1.07 (95% confidence interval 1.03-1.11). A publication bias was found in the meta-analysis. CONCLUSION: Depression seems to have a significant impact on post-HSCT survival and on length of aplasia. A systematic screening of depression before HSCT should be considered, with validated tools such as HADS. Future research needs to be done to measure the impact of depression on HSCT response and understand its physiopathology.

Hospitalizations for Anorexia Nervosa during the COVID-19 Pandemic in France: A Nationwide Population-Based Study.

The COVID-19 pandemic has had a detrimental impact on mental health, including on food-related behaviors. However, little is known about the effect of the pandemic on anorexia nervosa (AN). We sought to assess an association between the COVID-19 pandemic and a potential increase in hospitalizations for AN in France. We compared the number of hospitalizations with a diagnosis of AN during the 21-month period following the onset of the pandemic with the 21-month period before the pandemic using Poisson regression models. We identified a significant increase in hospitalizations for girls aged 10 to 19 years (+45.9%, RR = 1.46[1.43−1.49]; p < 0.0001), and for young women aged 20 to 29 (+7.0%; RR = 1.07[1.04−1.11]; p < 0.0001). Regarding markers of severity, there was an increase in hospitalizations for AN associated with a self-harm diagnosis between the two periods. Multivariate analysis revealed that the risk of being admitted for self-harm with AN increased significantly during the pandemic period among patients aged 20−29 years (aOR = 1.39[1.06−1.81]; p < 0.05 vs. aOR = 1.15[0.87−1.53]; NS), whereas it remained high in patients aged 10 to 19 years (aOR = 2.40[1.89−3.05]; p < 0.0001 vs. aOR = 3.12[2.48−3.98]; p < 0.0001). Furthermore, our results suggest that the pandemic may have had a particular effect on the mental health of young women with AN, with both a sharp increase in hospitalizations and a high risk of self-harming behaviors.

Hospitalization for self-harm during the early months of the COVID-19 pandemic in France: A nationwide retrospective observational cohort study.

BACKGROUND: Little is known to date about the impact of COVID-19 pandemic on self-harm. METHODS: The number of hospitalizations for self-harm (ICD-10 codes X60-X84) in France from 1st January to 31st August 2020 (including a two-month confinement) was compared to the same periods in 2017-2019. Statistical methods comprised Poisson regression, Cox regression and Student's t-test, plus Spearman's correlation test relating to spatial analysis of hospitalizations. OUTCOMES: There were 53,583 self-harm hospitalizations in France during January to August 2020. Compared to the same period in 2019, this represents an overall 8·5% decrease (Relative Risk [95% Confidence Interval] = 0·91 [0·90-0·93]).This decrease started in the first week of confinement and persisted until the end of August. Similarly, decrease was found in both women (RR=0·90 [0·88-0·92]) and men (RR=0·94 [0·91-0·95]), and in all age groups, except 65 years and older. Regarding self-harm hospitalizations by means category, increases were found for firearm (RR=1·20 [1·03-1·40]) and for jumping from heights (RR=1·10 [1·01-1·21]). There was a trend for more hospitalizations in intensive care (RR=1·03 [0·99-1·07]). The number of deaths at discharge from hospital also increased (Hazard Ratio = 1·19 [1·09-1·31]). Self-harm hospitalizations were weakly correlated with the rates of hospitalization for COVID-19 across administrative departments (Spearman's rho =-0·21; p = 0·03), but not with overall hospitalizations. INTERPRETATION: The COVID-19 pandemic had varied effects on self-harm hospitalizations during the early months in France. Active suicide prevention strategies should be maintained. FUNDING: French National Research Agency.

Fewer Type A personality traits in type 2 diabetes patients with diabetic foot ulcer.

AIM: Type A personality-characterized by time urgency, strong drive, and a need for achievement and competitiveness-has been shown to be associated with reduced mortality in patients with diabetes. However, it is not known whether a Type A personality might protect against diabetic foot ulcer (DFU). This prompted our present analysis of the association between Type A personality and DFU. METHODS: The Bortner Scale questionnaire was used to assess Type A personality in 386 patients with type 2 diabetes (T2D), including 104 patients also presenting with, and 282 presenting without, DFU. Additional questionnaires were used to assess perceived stress and depression. RESULTS: Type A Bortner scores were significantly lower in T2D patients with vs without DFU (166.64 ± 38.76 vs 178.79 ± 36.61, respectively; P = 0.005). In patients with DFU, the prevalence of Type A personality traits was significantly lower than in those without DFU (48% vs 64.5%, respectively; P = 0.005) whereas, in contrast, Type B personality traits (the opposite of Type A) were more prevalent (52% vs 35.5%, respectively; P = 0.005). On multivariate analysis, Type A Bortner scores were negatively associated with DFU (P = 0.008) independently of age, gender, BMI, depression scores or perceived stress. CONCLUSION: The Type A personality, characterized by competitiveness and a need for achievement, is significantly less frequently seen in T2D patients with DFU. On the other hand, the Type B personality is much more prevalent in such patients. It may be that the Type B personality, which is characterized by fewer problem-focused coping strategies and a decreased adherence to care, might favour the development of DFU.

Association between hospital admission for ketoacidosis and subsequent suicide attempt in young adults with type 1 diabetes.

AIMS/HYPOTHESIS: The aim of this study was to examine the associations between hospitalisation for diabetic ketoacidosis and subsequent hospitalisation for suicide attempt in young adults with type 1 diabetes. METHODS: This nationwide historical cohort study included hospital data on all young people hospitalised in France for type 1 diabetes in 2008. Epidemiological follow-up focused on hospitalisations (medical and psychiatric hospital data) from the index hospitalisation to 2017. Survival analyses were done using a Cox proportional hazards regression model to explore the association between hospitalisation for ketoacidosis and subsequent hospitalisation for a suicide attempt. RESULTS: In 2008, 16,431 people aged 18-35 years had a hospitalisation mentioning type 1 diabetes. Among them, 1539 (9.4%) had at least one hospitalisation for ketoacidosis between 2008 and 2010. At 9 years, 7.2% of the group hospitalised for ketoacidosis had been hospitalised for a suicide attempt vs only 2.5% in the group not hospitalised for ketoacidosis. The association between hospitalisation for ketoacidosis and suicide attempt decreased over time and was no longer significant after 5 years. CONCLUSIONS/INTERPRETATION: We found that young adults admitted to hospital for diabetic ketoacidosis have an increased risk of being admitted to hospital for a subsequent suicide attempt. The risk of a suicide attempt was the highest in the 12 months following the ketoacidosis episode. Our findings support the recommendation that screening for depression and suicide risk should be part of the routine clinical assessment of individuals with type 1 diabetes and ketoacidosis.

Personality types in individuals with type 1 and type 2 diabetes.

OBJECTIVE: The Type A personality, characterized by impatience, strong career ambition and competitiveness, is associated with greater sensitivity to external stress. Type 1 diabetes (T1D) is an auto-immune disease, which is potentially influenced by stress, unlike type 2 diabetes (T2D). The aim of this study was to assess whether individuals with T1D and T2D exhibited significant differences on the Type A personality scale. We also assessed the personality in patients with thyroid auto-immune diseases to validate potential links between auto-immune disease and Type A. DESIGN AND METHODS: The Bortner questionnaire was used to assess Type A personality in 188 patients with T1D, 430 patients with T2D and 85 patients with auto-immune thyroid disease (Graves' disease or Hashimoto thyroiditis). RESULTS: Type A Bortner scores were significantly higher in T1D patients than in T2D patients (188±34 vs 177±36, p<0.0001). Patients with auto-immune thyroid diseases and T1D patients had similar Type A Bortner scores (189±33 vs 188±34, p=0.860). CONCLUSION: Patients with auto-immune T1D have higher Type A scores than T2D patients. Furthermore, patients with auto-immune thyroid disease also have elevated Type A scores similar to those observed in type 1 diabetes, suggesting that an elevated Type A score in T1D is potentially related to its autoimmune origin. This suggests a possible link between Type A personality and auto-immune diseases via stress-triggering psychobiological pathways. The different personality score between T1D and T2D is an important factor to consider that could influence the diabetes self-care coping strategies and long-term prognosis.

Depression and obesity, data from a national administrative database study: Geographic evidence for an epidemiological overlap.

BACKGROUND: Depression and obesity are two major conditions with both psychological and somatic burdens. Some data suggest strong connections between depression and obesity and more particularly associated prevalence of both disorders. However, little is known about the geographical distribution of these two diseases. This study aimed to determine if there is spatial overlap between obesity and depression using data from the entire French territory. METHODS: Data for 5,627 geographic codes for metropolitan France were collected from the two national hospital databases (PMSI-MCO and RIM-P) for the year 2016. We identified people who were depressed, obese or both registered in the two public medico-administrative databases, and we assessed their location. In addition, a multivariable analysis was performed in order to determine geographic interactions between obesity and depression after controlling for age, sex, environmental and socio-economic factors (social/material deprivation, urbanicity/rurality). RESULTS: 1,045,682 people aged 18 years and older were identified. The mapping analysis showed several cold and hot regional clusters of coinciding obesity and depression. The multivariable analysis demonstrated significant geographic interactions, with an increasing probability of finding a high prevalence of obesity in regions with major depression (OR 1.29 95% CI 1.13-1.49, p = 0.0002) and an increased probability of finding a high prevalence of depression in regions with a high ration of obesity (OR 1.32, 95% CI 1.15-1.52, p<0.0001). CONCLUSION: Our study confirms the significant bidirectional relationships between obesity and depression at a group level. French geographic patterns reveal a partial overlap between obesity and depression, suggesting these two diseases can be included in a common approach. Further studies should be done to increase the understanding of this complex comorbidity.

Distinct Expression Pattern of Epigenetic Machinery Genes in Blood Leucocytes and Brain Cortex of Depressive Patients.

In major depressive disorder (MDD), altered gene expression in brain cortex and blood leucocytes may be due to aberrant expression of epigenetic machinery coding genes. Here, we explore the expression of these genes both at the central and peripheral levels. Using real-time quantitative PCR technique, we first measured expression levels of genes encoding DNA and histone modifying enzymes in the dorsolateral prefrontal cortex (DLPFC) and cingulate cortex (CC) of MDD patients (n = 24) and healthy controls (n = 12). For each brain structure, transcripts levels were compared between subject groups. In an exploratory analysis, we then compared the candidate gene expressions between a subgroup of MDD patients with psychotic characteristics (n = 13) and the group of healthy subjects (n = 12). Finally, we compared transcript levels of the candidate genes in blood leucocytes between separate samples of MDD patients (n = 17) and healthy controls (n = 16). In brain and blood leucocytes of MDD patients, we identified an overexpression of genes encoding enzymes which transfer repressive transcriptional marks: HDAC4-5-6-8 and DNMT3B in the DLPFC, HDAC2 in the CC and blood leucocytes. In the DLPFC of patients with psychotic characteristics, two genes (KAT2A and UBE2A) were additionally overexpressed suggesting a shift to a more transcriptionally permissive conformation of chromatin. Aberrant activation of epigenetic repressive systems may be involved in MDD pathogenesis both in brain tissue and blood leucocytes.

Increased Risk of Rehospitalization for Acute Diabetes Complications and Suicide Attempts in Patients With Type 1 Diabetes and Comorbid Schizophrenia.

OBJECTIVE: The aim of this large retrospective cohort study was to estimate the supplementary morbidity and mortality risks conferred by the co-occurrence of schizophrenia among young people with type 1 diabetes. RESEARCH DESIGN AND METHODS: This nationwide population-based study included individuals aged 15-35 years hospitalized in France for type 1 diabetes from 2009 to 2012 with or without schizophrenia. For assessment of the occurrence of rehospitalization for acute diabetes complications, suicide attempts, and hospital mortality, multivariate logistic regressions and survival analysis adjusted for age, sex, and Charlson comorbidity index scores were performed. The association between hospitalization for suicide attempts and acute diabetes complications was further explored in a survival analysis, with the exposure of acute diabetes complications as a time-dependent covariate. RESULTS: Among 45,655 individuals aged 15-35 years who were hospitalized for type 1 diabetes, 341 (0.75%) had a previous or contemporary hospitalization for schizophrenia. Within 3 years of follow-up, schizophrenia was associated with increased risks of rehospitalization for hypoglycemia (adjusted odds ratio 3.21 [95% CI 1.99-5.20]), hyperglycemia (7.01 [3.53-13.90]), ketoacidosis (2.01 [1.49-2.70]), and coma (3.17 [1.90-5.27]); hospitalization for suicide attempts (12.15 [8.49-17.38]); and hospital mortality (2.83 [1.50-5.36]). Hospitalization for a suicide attempt was associated with an increased risk of hospitalization for acute diabetes complications independently from schizophrenia (hazard ratio 3.46 [95% CI 2.74-4.38]). CONCLUSIONS: Patients suffering from the combination of type 1 diabetes and schizophrenia are at increased risk of hospitalization for acute diabetes complications as well as suicide and hospital mortality. These individuals may require specific care programs and close monitoring of mental, somatic, and social health.

[Biopsychosocial approach to caregiving burden: Why should we care about caregivers' health?] / Impact biopsychosocial de la charge des aidants : pourquoi faut-il porter une attention spécifique envers la santé des aidants ?

There are 11 million family caregivers in France and some estimates indicate that there will be 17 million in 2020. Caregiving is a source of chronic stress that requires adaptation and coping strategies. Caregiving may benefit the health of a caregiver with a positive coping style and altruistic goals. However, the caregiver's burden is frequently associated with negative effects in terms of biopsychosocial imbalance and medical conditions, with frequent anxiety and depression. The management of the caregiving burden starts with the recognition of health professionals - caregivers may benefit from consultation-liaison psychiatry and multidisciplinary medico-social strategies, in addition to constant support from their GPs.

Personality and breast cancer screening in women of the GAZEL cohort study.

The potential benefit of breast cancer screening is mitigated by the risk of false positives and overdiagnosis, thus advocating for a more personalized approach, based on the individual benefit-harm balance. Since personality might influence the women's appraisal of this balance, this prospective observational cohort study examined whether it could influence mammography use. A total of 2691 postmenopausal women of the GAZEL Cohort Study completed the Bortner Type A Rating Scale and the Buss and Durkee Hostility Inventory in 1993. Associations between personality scores and subsequent mammography use, self-reported through up to five triennial follow-up questionnaires, were estimated with Odds Ratio (OR) and 95% confidence interval (CI) with logistic mixed model regressions, adjusting for age, occupational grade, marital status, family history of breast cancer, age at menarche, age at first delivery, gynecological follow-up, hormone therapy use, and depressive symptoms. Individual propensity scores were used to weight the analyses to control for potential selection biases. More than 90% of the participants completed at least two follow-up questionnaires. Type A personality, but not hostility, was associated with mammography use in both univariate (crude OR [95% CI]: 1.62 [1.24-2.11], P < 0.001) and multivariate analyses (OR [95% CI]: 1.46 [1.13-1.90], P < 0.01). Type A personality traits (i.e., sense of time urgency, high job involvement, competitiveness) independently predicted mammography use among postmenopausal women. While paying more attention to the adherence of women with low levels of these traits, clinicians may help those with higher levels to better consider the risks of false positives and overdiagnosis.

Outcome of Non-Invasive Brain Stimulation in Substance Use Disorders: A Review of Randomized Sham-Controlled Clinical Trials.

Non-invasive brain stimulation (NIBS) might be a new approach to treat substance use disorders (SUD). A systematic review and critical analysis was performed to identify potential therapeutic effects of NIBS on addictions. A search of the Medline database was conducted for randomized sham-controlled trials using NIBS in the field of addiction and published until August 2016. Twenty-six studies in various SUD met the inclusion criteria. Converging evidence indicates that NIBS might be a promising mean to treat patients with alcohol and tobacco use disorders, by acting on craving reduction and other mechanisms such as improvement in cognitive dysfunctions.

Stress, anxiety and depression in heart disease patients: A major challenge for cardiac rehabilitation.

Cardiovascular events and emotional disorders share a common epidemiology, thus suggesting fundamental pathways linking these different diseases. Growing evidence in the literature highlights the influence of psychological determinants in somatic diseases. A patient's socio-economic aspects, personality traits, health behavior and even biological pathways may contribute to the course of cardiovascular disease. Cardiac events often occur suddenly and the episode can be traumatic for people not prepared for such an event. In this review of the literature, the authors tackle the question of psychobiological mechanisms of stress, in a pathophysiological approach to fundamental pathways linking the brain to the heart. Various psychological, biological and genetic arguments are presented in support of the hypothesis that various etiological mechanisms may be involved. The authors finally deal with biological and psychological strategies in a context of cardiovascular disease. Indeed, in this context, cardiac rehabilitation, with its global approach, seems to be a good time to diagnose emotional disorders like anxiety and depression, and to help people to cope with stressful events. In this field, cardiac rehabilitation seems to be a crucial step in order to improve patients' outcomes, by helping them to understand the influence of psychobiological risk factors, and to build strategies in order to manage daily stress.

Efficacy of transcranial direct current stimulation (tDCS) in reducing consumption in patients with alcohol use disorders: study protocol for a randomized controlled trial.

BACKGROUND: Approximately 15 million persons in the European Union and 10 million persons in the USA are alcohol-dependent. The global burden of disease and injury attributable to alcohol is considerable: worldwide, approximately one in 25 deaths in 2004 was caused by alcohol. At the same time, alcohol use disorders remain seriously undertreated. In this context, alternative or adjunctive therapies such as brain stimulation may play a prominent role. The early results of studies using transcranial direct current stimulation found that stimulations delivered to the dorsolateral prefrontal cortex result in a significant reduction of craving and an improvement of the decision-making processes in various additive disorders. We, therefore, hypothesize that transcranial direct current stimulation can lead to a decrease in alcohol consumption in patients suffering from alcohol use disorders. METHODS/DESIGN: We report the protocol of a randomized, double-blind, placebo-controlled, parallel-group trial, to evaluate the efficacy of transcranial direct current stimulation on alcohol reduction in patients with an alcohol use disorder. The study will be conducted in 14 centers in France and Monaco. Altogether, 340 subjects over 18 years of age and diagnosed with an alcohol use disorder will be randomized to receive five consecutive twice-daily sessions of either active or placebo transcranial direct current stimulation. One session consists in delivering a current flow continuously (anode F4; cathode F3) twice for 13 minutes, with treatments separated by a rest interval of 20 min. Efficacy will be evaluated using the change from baseline (alcohol consumption during the 4 weeks before randomization) to 24 weeks in the total alcohol consumption and number of heavy drinking days. Secondary outcome measures will include alcohol craving, clinical and biological improvements, and the effects on mood and quality of life, as well as cognitive and safety assessments, and, for smokers, an assessment of the effects of transcranial direct current stimulation on tobacco consumption. DISCUSSION: Several studies have reported a beneficial effect of transcranial direct current stimulation on substance use disorders by reducing craving, impulsivity, and risk-taking behavior, and suggest that transcranial direct current stimulation may be a promising treatment in addiction. However, to date, no studies have included sufficiently large samples and sufficient follow-up to confirm the hypothesis. Results from this large randomized controlled trial will give a better overview of the therapeutic potential of transcranial direct current stimulation in alcohol use disorders. TRIAL REGISTRATION: Clinical Trials Gov, NCT02505126 (registration date: July 15 2015).