ABSTRACT
BACKGROUND: The care environment significantly influences the experiences of patients with severe mental illness and the quality of their care. While a welcoming and stimulating environment enhances patient satisfaction and health outcomes, psychiatric facilities often prioritize staff workflow over patient needs. Addressing these challenges is crucial to improving patient experiences and outcomes in mental health care. OBJECTIVE: This study is part of the Patient-Reported Experience Measure for Improving Quality of Care in Mental Health (PREMIUM) project and aims to establish an item bank (PREMIUM-CE) and to develop computerized adaptive tests (CATs) to measure the experience of the care environment of adult patients with schizophrenia, bipolar disorder, or major depressive disorder. METHODS: We performed psychometric analyses including assessments of item response theory (IRT) model assumptions, IRT model fit, differential item functioning (DIF), item bank validity, and CAT simulations. RESULTS: In this multicenter cross-sectional study, 498 patients were recruited from outpatient and inpatient settings. The final PREMIUM-CE 13-item bank was sufficiently unidimensional (root mean square error of approximation=0.082, 95% CI 0.067-0.097; comparative fit index=0.974; Tucker-Lewis index=0.968) and showed an adequate fit to the IRT model (infit mean square statistic ranging between 0.7 and 1.0). DIF analysis revealed no item biases according to gender, health care settings, diagnosis, or mode of study participation. PREMIUM-CE scores correlated strongly with satisfaction measures (r=0.69-0.78; P<.001) and weakly with quality-of-life measures (r=0.11-0.21; P<.001). CAT simulations showed a strong correlation (r=0.98) between CAT scores and those of the full item bank, and around 79.5% (396/498) of the participants obtained a reliable score with the administration of an average of 7 items. CONCLUSIONS: The PREMIUM-CE item bank and its CAT version have shown excellent psychometric properties, making them reliable measures for evaluating the patient experience of the care environment among adults with severe mental illness in both outpatient and inpatient settings. These measures are a valuable addition to the existing landscape of patient experience assessment, capturing what truly matters to patients and enhancing the understanding of their care experiences. TRIAL REGISTRATION: ClinicalTrials.gov NCT02491866; https://clinicaltrials.gov/study/NCT02491866.
Subject(s)
Mental Disorders , Psychometrics , Humans , Male , Psychometrics/methods , Psychometrics/instrumentation , Female , Adult , Middle Aged , Cross-Sectional Studies , Mental Disorders/therapy , Mental Disorders/diagnosis , Patient Satisfaction , Patient Reported Outcome Measures , Reproducibility of Results , Surveys and QuestionnairesABSTRACT
The Clinical High Risk for psychosis (CHR) is a heterogeneous condition with multiple symptoms. CHR screening is challenging in routine care, as a wide variety of questionnaires exists. We propose to explore the extent to which these questionnaires differ or overlap in item content. We performed a systematic and quantitative analysis of item content in a set of widely-used CHR screening questionnaires. Items were extracted from questionnaires and reworded according to the Structured Interview for Psychosis-Risk Syndromes (SIPS). Then, symptoms were generated from individual items. The Jaccard Index was calculated to assess content overlap. The 14 analysed questionnaires were composed of 347 items, from which 198 symptoms were generated and, in turn, collapsed into 68 distinct symptoms. Positive symptoms were the most commonly represented. The overall overlap across questionnaires showed weak similarity (Jaccard = 0.19±0.50). CHR screening questionnaires might evaluate the same broad clinical construct, but have different scopes within that construct, and may be more or less comprehensive than one another. Clinicians and researchers should be mindful of the specific features of each instrument for optimal CHR screening.
Subject(s)
Prodromal Symptoms , Psychotic Disorders , Humans , Psychotic Disorders/diagnosis , Surveys and QuestionnairesABSTRACT
Severe mental illness (SMI) patients often have complex health needs, which makes it difficult to access and coordinate their care. This study aimed to develop a computerized adaptive testing (CAT) tool, PREMIUM CAT-ACC, to measure SMI patients' experience with access and care coordination. This multicenter and cross-sectional study included 496 adult in- and out-patients with SMI (i.e., schizophrenia, bipolar disorder, or major depressive disorder). Psychometric analysis of the 13-item bank showed adequate properties, with preliminary evidence of external validity and no substantial differential item functioning for sex, age, care setting, and diagnosis, making it suitable for CAT administration. A post-hoc CAT simulation demonstrated that the tool was efficient and accurate, with an average of seven items, compared to the full item bank administration. Its use by clinicians can contribute to optimizing patient care pathways and transitioning towards more person-centered healthcare.
Subject(s)
Bipolar Disorder , Depressive Disorder, Major , Mental Disorders , Adult , Humans , Cross-Sectional Studies , Computerized Adaptive Testing , Mental Disorders/diagnosis , Mental Disorders/therapy , Bipolar Disorder/diagnosis , PsychometricsABSTRACT
OBJECTIVES: We aimed to assess the impact of the COVID-19 crisis on the occurrence of new hospital admissions for cases of psychosis in France. METHOD: We conducted a retrospective observational study from the French national PMSI database. We included patients hospitalized between 2018 and 2020 with a principal diagnosis of schizophrenia or delusional disorder with no history of psychosis in the previous 10 years. In total, we included 77,172 inpatients at crisis centers and/or in full-time hospitalization at 465 French hospitals. We assessed the number of inpatients during the year of the Covid crisis (2020) and the two years prior (2018, 2019). RESULTS: The number of inpatients in full-time hospitalization decreased gradually from 2018 to 2020 by 10.6%. This downward trend was observed in all age groups. In contrast, in crisis centers the number of inpatients increased by 13.4% between 2019 and 2020, while a 7.6% decrease was seen between 2018 and 2019. The greatest increase was observed in the 31-60-year age category, and particularly amongst 46-60-year-olds, i.e. 38.0%. CONCLUSION: The COVID-19 crisis was associated with an increase in the number of inpatients with a new episode of psychosis in crisis centers but not in full-time hospitalization. The profile of patients in crisis centers was different from that seen in preceding years and included more middle-to-late age adults. Particular attention should be given to this category of patients in the crisis environment to prevent the occurrence of new cases of psychosis in France.
ABSTRACT
Visual electrophysiological deficits have been reported in neurodegenerative disorders as well as in mental disorders. Such alterations have been mentioned in both the retina and the cortex, notably affecting the photoreceptors, retinal ganglion cells (RGCs) and the primary visual cortex. Interestingly, such impairments emphasize the functional role of the visual system. For this purpose, the present study reviews the existing literature with the aim of identifying key alterations in electroretinograms (ERGs) and visual evoked potentials electroencephalograms (VEP-EEGs) of subjects with neurodegenerative and psychiatric disorders. We focused on psychiatric and neurodegenerative diseases due to similarities in their neuropathophysiological mechanisms. Our research focuses on decoupled and coupled ERG/VEP-EEG results obtained with black-and-white checkerboards or low-level visual stimuli. A decoupled approach means recording first the ERG, then the VEP-EEG in the same subject with the same visual stimuli. The second method means recording both ERG and VEP-EEG simultaneously in the same participant with the same visual stimuli. Both coupled and decoupled results were found, indicating deficits mainly in the N95 ERG wave and the P100 VEP-EEG wave in Parkinson's, Alzheimer's, and major depressive disorder. Such results reinforce the link between the retina and the visual cortex for the diagnosis of psychiatric and neurodegenerative diseases. With that in mind, medical devices using coupled ERG/VEP-EEG measurements are being developed in order to further investigate the relationship between the retina and the visual cortex. These new techniques outline future challenges in mental health and the use of machine learning for the diagnosis of mental disorders, which would be a crucial step toward precision psychiatry.
ABSTRACT
BACKGROUND: Electrophysiological impairments in the magnocellular visual system have been reported among patients with schizophrenia, but previous theories proposed that these deficits may begin in the retina. We therefore sought to evaluate the potential contribution of the retina by comparing retinal and cortical visual electrophysiological impairments between patients with schizophrenia and healthy controls. METHODS: We recruited patients with schizophrenia and age- and sex-matched healthy controls. We recorded the P100 amplitude and latency using electroencephalography (EEG) while projecting low (0.5 cycles/degree) or high (15 cycles/degree) spatial frequency gratings at a temporal frequency of 0 Hz or 8 Hz. We compared the P100 results with previous results for retinal ganglion cell activity (N95) in these participants. We analyzed data using repeated-measures analysis of variance and correlation analyses. RESULTS: We recruited 21 patients with schizophrenia and 29 age- and sex-matched healthy controls. Results showed decreased P100 amplitude and increased P100 latency among patients with schizophrenia compared with healthy controls (p < 0.05). Analyses reported the main effects of spatial and temporal frequency but no interaction effects of spatial or temporal frequency by group. Moreover, correlation analysis indicated a positive association between P100 latency and previous retinal results for N95 latency in the schizophrenia group (p < 0.05). DISCUSSION: Alterations in the P100 wave among patients with schizophrenia are consistent with the deficits in early visual cortical processing shown in the literature. These deficits do not seem to correspond to an isolated magnocellular deficit but appear to be associated with previous retinal measurements. Such an association emphasizes the role of the retina in the occurrence of visual cortical abnormalities in schizophrenia. Studies with coupled electroretinography-EEG measurements are now required to further explore these findings. CLINICAL TRIALS REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT02864680.
Subject(s)
Schizophrenia , Humans , Evoked Potentials, Visual , Retina , ElectroencephalographyABSTRACT
BACKGROUND: Patients with psychiatric disorders are exposed to high risk of COVID-19 and increased mortality. In this study, we set out to assess the clinical features and outcomes of patients with current psychiatric disorders exposed to COVID-19. METHODS: This multi-center prospective study was conducted in 22 psychiatric wards dedicated to COVID-19 inpatients between 28 February and 30 May 2020. The main outcomes were the number of patients transferred to somatic care units, the number of deaths, and the number of patients developing a confusional state. The risk factors of confusional state and transfer to somatic care units were assessed by a multivariate logistic model. The risk of death was analyzed by a univariate analysis. RESULTS: In total, 350 patients were included in the study. Overall, 24 (7%) were transferred to medicine units, 7 (2%) died, and 51 (15%) patients presented a confusional state. Severe respiratory symptoms predicted the transfer to a medicine unit [odds ratio (OR) 17.1; confidence interval (CI) 4.9-59.3]. Older age, an organic mental disorder, a confusional state, and severe respiratory symptoms predicted mortality in univariate analysis. Age >55 (OR 4.9; CI 2.1-11.4), an affective disorder (OR 4.1; CI 1.6-10.9), and severe respiratory symptoms (OR 4.6; CI 2.2-9.7) predicted a higher risk, whereas smoking (OR 0.3; CI 0.1-0.9) predicted a lower risk of a confusional state. CONCLUSION: COVID-19 patients with severe psychiatric disorders have multiple somatic comorbidities and have a risk of developing a confusional state. These data underline the need for extreme caution given the risks of COVID-19 in patients hospitalized for psychiatric disorders.
Subject(s)
COVID-19 , Mental Disorders , Humans , Prospective Studies , Mental Disorders/epidemiology , Mental Disorders/diagnosis , Comorbidity , ConfusionABSTRACT
Perceptual disorders are not part of the diagnosis criteria for schizophrenia. Yet, a considerable amount of work has been conducted, especially on visual perception abnormalities, and there is little doubt that visual perception is altered in patients. There are several reasons why such perturbations are of interest in this pathology. They are observed during the prodromal phase of psychosis, they are related to the pathophysiology (clinical disorganization, disorders of the sense of self), and they are associated with neuronal connectivity disorders. Perturbations occur at different levels of processing and likely affect how patients interact and adapt to their surroundings. The literature has become very large, and here we try to summarize different models that have guided the exploration of perception in patients. We also illustrate several lines of research by showing how perception has been investigated and by discussing the interpretation of the results. In addition to discussing domains such as contrast sensitivity, masking, and visual grouping, we develop more recent fields like processing at the level of the retina, and the timing of perception.
Subject(s)
Perceptual Disorders , Psychotic Disorders , Schizophrenia , Humans , Visual Perception , Schizophrenia/complications , Psychotic Disorders/complicationsABSTRACT
The impact of regular cannabis use on retinal function has already been studied using flash (fERG) and pattern (PERG) electroretinogram. Delayed ganglion and bipolar cells responses were observed as showed by increased peak time of PERG N95 and fERG b-wave recorded in photopic condition. Hypoactivity of amacrine cells was also showed by decreased amplitudes of oscillatory potentials (OPs). However, it is unknown how these retinal anomalies evolve according to the level of cannabis use in cannabis users. The aim of this study was to longitudinally assess the retinal function during a treatment aiming to reduce cannabis use. We recorded PERG and fERG in 40 regular cannabis users receiving either an 8 weeks mindfulness-based relapse prevention program or an 8 weeks treatment-as-usual therapy. ERGs were recorded before treatment, at the end of it, and 4 weeks afterward. We found reduced peak times in PERG N95 and fERG b-wave (p = 0.032 and p = 0.024: Dunn's post-hoc test) recorded at week 8 and increased amplitudes in OP2 and OP3 (p = 0.012 and p = 0.030: Dunn's post-hoc test) recorded at week 12 in users with decreased cannabis use. These results support variations of retinal anomalies with the level of cannabis use, implying that reduction of cannabis use could restore retinal function in regular users.
ABSTRACT
BACKGROUND: One goal of research into major depressive disorder (MDD) is to develop markers to predict and monitor the response to psychotropic treatments. The retina is endowed with a complex neurotransmission system, composed of the main neurotransmitters involved in the pathophysiology of MDD. The retina is therefore a relevant site of investigation for the identification of reliable and robust markers. However, the effects of antidepressants on the human retina are poorly studied. Here, we seek to study the potential specific effects of various antidepressants on retinal function in MDD patients. METHODS: We assessed retinal function using flash (fERG), pattern (PERG) and multifocal (mfERG) electroretinogram in 19 MDD patients treated using antidepressants at baseline and at weeks 4, 8 and 12. RESULTS: We observed reduced b-wave amplitude of photopic fERG 3.0 in patients treated with Selective Serotonin Reuptake Inhibitor (SSRI) in comparison with patients treated with Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) or Tricyclic Antidepressant (TCAD). We also showed that SNRIs were associated both with a decrease in PERG P50 implicit time and an increase in fERG 3.0 b-wave amplitude. TCADs were associated with an increase in fERG flicker 3.0 a- and b-wave amplitude. CONCLUSIONS: This is the first study in real-life conditions to show a specific effect of various antidepressants on retinal function evaluated by electroretinogram. Further investigations should be led to specify the effects of antidepressants on ERG in order to isolate reliable and reproducible markers for predicting and monitoring the response to antidepressants.
Subject(s)
Depressive Disorder, Major , Serotonin and Noradrenaline Reuptake Inhibitors , Antidepressive Agents/pharmacology , Antidepressive Agents/therapeutic use , Antidepressive Agents, Tricyclic/therapeutic use , Depressive Disorder, Major/drug therapy , Humans , Norepinephrine , Retina , Serotonin , Selective Serotonin Reuptake Inhibitors/therapeutic useABSTRACT
Bipolar disorder is a lifelong condition. Today, there is a urgent need to find indicators of the disease. Specifically, they could be useful to improve the diagnosis and the early detection, the prognosis, to estimate the treatment response and to create homogeneous subgroups of patients based on similar pathophysiological mechanisms. Here, we assume that visual electrophysiology in combination with a neuropsychological assessment can give additional data to routine practice, especially to precise specific damages and pathophysiological characteristics of these patients. Visual electrophysiology is characterized by an electroretinogram and the delivery of visual evoked potentials, which measure retinal and visual cortical neuronal functioning in response to visual stimulations. This review highlights the interest of visual electrophysiology and neuropsychology performed in isolation and to present the benefits of combining these measures. We will review the results based on these measures in patients with bipolar disorders. Finally, we argue for the use of innovative techniques such as signal processing and artificial intelligence techniques for routine care and precision medicine in bipolar disorders.
Subject(s)
Bipolar Disorder , Artificial Intelligence , Electrophysiology , Evoked Potentials, Visual , Humans , NeuropsychologyABSTRACT
BACKGROUND: Major depressive disorder (MDD) is a major public health problem. The retina is a relevant site to indirectly study brain functioning. Alterations in retinal processing were demonstrated in MDD with the pattern electroretinogram (PERG). Here, the relevance of signal processing and machine learning tools applied on PERG was studied. METHODS: PERG - whose stimulation is reversible checkerboards - was performed according to the International Society for Clinical Electrophysiology of Vision (ISCEV) standards in 24 MDD patients and 29 controls at the inclusion. PERG was recorded every 4 weeks for 3 months in patients. Amplitude and implicit time of P50 and N95 were evaluated. Then, time/frequency features were extracted from the PERG time series based on wavelet analysis. A statistical model has been learned in this feature space and a metric aiming at quantifying the state of the MDD patient has been derived, based on minimum covariance determinant (MCD) mahalanobis distance. RESULTS: MDD patients showed significant increase in P50 and N95 implicit time (p = 0,006 and p = 0,0004, respectively, Mann-Whitney U test) at the inclusion. The proposed metric extracted from the raw PERG provided discrimination between patients and controls at the inclusion (p = 0,0001). At the end of the follow-up at week 12, the difference between the metrics extracted on controls and patients was not significant (p = 0,07), reflecting the efficacy of the treatment. CONCLUSIONS: Signal processing and machine learning tools applied on PERG could help clinical decision in the diagnosis and the follow-up of MDD in measuring treatment response.
Subject(s)
Depressive Disorder, Major , Adult , Depression , Depressive Disorder, Major/diagnosis , Depressive Disorder, Major/therapy , Electroretinography , Humans , Machine Learning , Retina/diagnostic imaging , Retinal Ganglion Cells/physiologyABSTRACT
Precision medicine in psychiatry is based on the identification of homogeneous subgroups of patients with the help of biosignatures-sets of biomarkers-in order to enhance diagnosis, stratification of patients, prognosis, evaluation, and prediction of treatment response. Within the broad domain of biomarker discovery, we propose retinal electrophysiology as a tool for identification of biosignatures. The retina is a window to the brain and provides an indirect access to brain functioning in psychiatric disorders. The retina is organized in layers of specialized neurons which share similar functional properties with brain neurons. The functioning of these neurons can be evaluated by electrophysiological techniques named electroretinogram (ERG). Since the study of retinal functioning gives a unique opportunity to have an indirect access to brain neurons, retinal dysfunctions observed in psychiatric disorders inform on brain abnormalities. Up to now, retinal dysfunctions observed in psychiatric disorders provide indicators for diagnosis, identification of subgroups of patients, prognosis, evaluation, and prediction of treatment response. The use of signal processing and machine learning applied on ERG data enhances retinal markers extraction, thus providing robust, reproducible, and reliable retinal electrophysiological markers to identify biosignatures in precision psychiatry. We propose that retinal electrophysiology may be considered as a new approach in the domain of electrophysiology and could now be added to the routine evaluations in psychiatric disorders. Retinal electrophysiology may provide, in combination with other approaches and techniques, sets of biomarkers to produce biosignatures in mental health.
Subject(s)
Mental Disorders , Psychiatry , Electrophysiology , Electroretinography , Humans , Mental Disorders/diagnosis , RetinaABSTRACT
BACKGROUND: Retinal dysfunction is widely documented in schizophrenia using flash (fERG) and pattern electroretinograms (PERG), but the role of dopamine transmission has seldom been explored. METHODS: We explored the role of dopamine transmission by evaluating the spatial location of retinal anomalies using multifocal ERG (mfERG) in photopic condition and the oscillatory potentials (OPs) extracted from fERG measured in scotopic condition in 29 patients with schizophrenia and 29 healthy controls. RESULTS: With the mfERG, our main results revealed reduced amplitudes in the center of the retina: P1 (p < .005) and N2 amplitudes (p < .01) in the <2° region, N1 (p < .0005) and P1 amplitudes (p < .001) in the 2-5° region and P1 amplitude (p < .05) in the 5-10° region. For OPs, our results showed a decrease in the O1 (p < .005), O2 (p < .005), O3 (p < .05) and overall O1, O2, O3 index amplitudes (p < .005) in patients with schizophrenia. CONCLUSIONS: Both the central location of retinal dysfunctions of the mfERG and OPs results could reflect a hypodopaminergic effect in patients with schizophrenia. In future studies, OPs should be considered as a measure to evaluate the hypodopaminergy in patients.
Subject(s)
Amacrine Cells , Schizophrenia , Electroretinography/methods , Humans , Retina , Schizophrenia/complications , Schizophrenia/drug therapyABSTRACT
Regular cannabis using causes vision impairment by affecting human retinal neurotransmission. However, studies less considered its impact on the subsequent visual cortical processing, key feature for the integration of the visual signal in brain. We aimed at investigating this purpose in regular cannabis users using spatial frequencies and temporal frequencies filtered visual stimuli. We recruited 45 regular cannabis users and 25 age-matched controls. We recorded visual evoked potentials during the projection of low spatial frequency (0.5 cycles/degree) or high spatial frequency gratings (15 cycles/degree), which were presented statically (0 Hz) or dynamically (8 Hz). We analyzed the amplitude, latency, and area under the curve of both P100 and N170, best EEG markers for early visual processing. Data were compared between groups by repeated measures ANCOVA. Results showed a significant decrease in P100 amplitude among regular cannabis users in low spatial frequency (F(1,67) = 4.43; p = 0.04) and in dynamic condition (F(1,67) = 4.35; p = 0.04). Analysis also reported a decrease in P100 area under the curve in regular cannabis users to low spatial frequency (F(1,67) = 4.31; p = 0.04) and in dynamic condition (F(1,67) = 7.65; p < 0.01). No effect was found on P100 latency, N170 amplitude, latency, or area under the curve. We found alteration of P100 responses to low spatial frequency and dynamic stimuli in regular cannabis users. This result could be interpreted as a preferential magnocellular impairment where such deficit could be linked to glutamatergic dysfunction. As mentioned in the literature, visual and electrophysiological anomalies in schizophrenia are related to a magnocellular dysfunction. Further studies are needed to clarify electrophysiological deficits in both populations. CLINICAL TRIALS REGISTRATION: Electrophysiological Study of the Functioning of Magnocellular Visual Pathway in Regular Cannabis Users (CAUSA MAP). [NCT02864680; ID 2013-A00097-38]. https://clinicaltrials.gov/ct2/show/NCT02864680?cond=Cannabis&cntry=FR&draw=2&rank=1.
Subject(s)
Brain/drug effects , Cannabis/adverse effects , Evoked Potentials, Visual/drug effects , Visual Perception/drug effects , Adult , Female , Humans , Male , Retina/drug effects , Substance-Related Disorders , Synaptic Transmission/drug effects , Visual Pathways/physiopathologyABSTRACT
BACKGROUND: Developing easy-to-access biomarkers is crucial in Major Depressive Disorder. The retina has already been suggested as relevant. However, there is a need for a global and local assessment of whole retinal function using a reproducible, standardized protocol allowing for comparison across studies. Our aim is to assess whole retinal function in patients with actual unipolar Major Depressive Episode (MDE) using pattern, flash and multifocal electroretinogram (ERG) according to the International Society for Clinical Electrophysiology of Vision standardized protocols. METHODS: We assessed retinal function in 14 males and females with MDE, diagnosed based on the Diagnostic and Statistical Manual of Mental Disorders, and in age- and sex-matched healthy controls. RESULTS: Comparing the patients with the controls, we observed the following using multifocal ERG: a significant increase in N1 peak time in ring 3 and a decrease in P1 amplitude in ring 2; using pattern ERG: a significant increase in P50 peak time; using flash ERG: a decrease in a- and b-wave peak time and an increase in the b-wave amplitude in dark-adapted 3.0, a decrease in a- and b-wave peak time and an increase in both wave amplitudes in light-adapted 3.0, and a decrease in the b-wave peak time in light-adapted flicker. LIMITATIONS: Sample size. Contribution of pharmacological treatments to the outcomes cannot be formally excluded. CONCLUSIONS: Patients with MDE exhibit delayed signaling in the central retina and hyperreactivity to light in the periphery. Central retinal function may be a marker of psychomotor retardation and cognitive impairment in MDE.
Subject(s)
Depressive Disorder, Major , Electroretinography , Female , Humans , Male , Photic Stimulation , RetinaABSTRACT
INTRODUCTION: Major depressive disorder (MDD) affects more than 264 million people worldwide and is associated with an impaired quality of life as well as a higher risk of mortality. Current routine treatments demonstrate limited effectiveness. Light therapy (LT) on its own or in combination with antidepressant treatments could be an effective treatment, but the use of conventional LT devices use is restrictive. Portable LT devices allow patients to continue with their day-to-day activities and therefore encourage better treatment compliance. They have not been evaluated in MDD. METHODS AND ANALYSIS: The study is a single-centre, double-blind, randomised controlled trial assessing the efficacy of LT delivered via a portable device in addition to usual care (medical care and drug treatment) for inpatients and outpatients with unipolar non-seasonal MDD. Over the course of 8 weeks, patients use the device daily for 30 min at medium intensity as soon as possible after waking up and preferably between 07:00 and 09:00. All patients continue their usual care with their referring physician. N=50 patients with MDD are included. The primary outcome measure is depressive symptom severity assessed using the Montgomery-Åsberg Depression Rating Scale between baseline and the eighth week. Secondary outcome measures are sleep quality assessed using the Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale and anxiety level assessed on the Hamilton Anxiety Rating Scale, between baseline and week 8. Further parameters relating to cognitive function are measured at baseline and after the intervention. An ancillary study aims to evaluate the impact of MDD on the retina and to follow its progression. Main limitations include risk of discontinuation or non-adherence and bias in patient selection. ETHICS AND DISSEMINATION: The study protocol was approved by Ile de France X's Ethics Committee (protocol number 34-2018). Findings will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03685942.
Subject(s)
Depressive Disorder, Major , Antidepressive Agents/therapeutic use , Depressive Disorder, Major/drug therapy , France , Humans , Phototherapy , Quality of Life , Randomized Controlled Trials as Topic , Treatment OutcomeABSTRACT
INTRODUCTION: Several questionnaires have been developed for screening cannabis use disorder in clinical populations, but very few studies have compared the screening abilities of the different instruments. Here, we aimed to confirm the psychometric properties of a French version of the Cannabis Use Disorder Identification Test-Revised (CUDIT-R), and to compare its screening abilities with those of the Cannabis Abuse Screening Test (CAST), in subjects consulting in mental health settings. METHODS: Two hundred and thirteen cannabis smokers who sought treatment for any type of mental disorder, recruited in four French centres, completed the French CUDIT-R (CUDIT-R-Fr) and the full version of the CAST, and were assessed for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria of cannabis use disorder by an addiction specialist. They were retested with the CUDIT-R-Fr after approximately a week. The factorial construct validity, internal consistency and test-retest reliability of the CUDIT-R-Fr were assessed. The compared sensitivity and specificity of the CAST and CUDIT-R-Fr were explored, using the clinician assessment as the reference. RESULTS: The French CUDIT-R showed a good internal consistency (Cronbach's alpha = 0.89) and an excellent test-retest reliability (ρ = 0.97). The sensitivity and specificity for screening cannabis use disorder were 0.81 and 0.77 for the CUDIT-R, and 0.92 and 0.63 for the CAST, respectively. CONCLUSIONS: Based on the recommended cut-offs, the CAST appeared more sensitive, while the CUDIT-R was more specific, for screening cannabis use disorder in a population of cannabis users with heterogeneous types of mental health disorders.