View clinical trials related to Mental Disorders.
Filter by:Several studies agree on the increase in suicide attempts in children over the past 15 years. This trend has been aggravated by the COVID 19 pandemic. It is recognized that suicide attempts are mostly encountered in individuals with a psychiatric disorder. Serious suicide attempts, which probably better reflect the risk of completed suicide, are very poorly known and have been very little explored. They could be related to more specific and earlier psychiatric disorders or even concern children with developmental particularities that are insufficiently defined to fall under a categorical diagnosis, but which could be better understood with dimensional measurements. Better characterizing them would seem quite important given their high lethality. Indeed, a high lethality is found for half of the suicide attempts in children fewer than 12, contrasting with a moderate or low intentionality ; in children, the means used are often more violent and more lethal than in adolescents (over 12 years old): hanging, firearm, etc. The Necker-Enfants Malades hospital has a pediatric neurosurgery department as well as a specialized multidisciplinary team to care for polytraumatized children in a regional "Trauma Center" type structure. As a result, most children and adolescents in Ile-de-France who have made a violent suicide attempt are sent to the Necker hospital. Once medico-surgically stabilized, these children and adolescents are assessed by the hospital's child psychiatry team. This regional recruitment makes it possible to have an epidemiological representativeness. From this population, the investigative team proposes to better characterize the developmental profile and psychiatric disorders of children who have made a serious suicide attempt. The study also proposes to examine in detail the psycho-emotional development as well as the psychopathological characteristics of these children in order to shed light on these early and lethal acting out. The investigative team proposes in particular to use dimensional evaluations to analyze behavioral traits in more detail. To the knowledge of the child psychiatry department of the Necker Enfants Malades hospital, there is no such study to date. In addition to the question of neurodevelopmental disorders, an ancillary study will make it possible to question attachment disorders in children who have made a serious suicide attempt. In fact, a link between attachment disorders and suicidal ideation or attempted suicide has been shown in the literature. Attachment disorders correspond to an early imbalance in the bond between a child and the primary caregiver, particularly before the age of 3. Attachment relationships that do not allow a solid bond between the young child and the person occupying the maternal function may not be pathological in themselves but would be risk factors for pathologies in adolescence and adulthood, and in particular a category of so-called disorganized attachment disorders in the occurrence of dissociative symptoms.
Cognitive impairment is well established in people with psychosis and is associated with cannabis use. The current study will investigate the neurobiological basis of cognitive change associated with 28-days of cannabis abstinence in people with psychosis and non-psychiatric controls with cannabis use. Participants will be randomized to a cannabis abstinent group or a non-abstinent control group and will undergo magnetic resonance imaging at baseline and following 28-days of abstinence. This study will help characterize the neuropathophysiological processes underlying cognitive dysfunction associated with cannabis use and its recovery which may guide the development of novel interventions for problematic cannabis use.
People with psychotic disorders are excluded from most suicide-focused clinical trials despite incredibly high rates of completed suicide, and interventions that have been tested for this population have shown limited impact on suicide. Emotion dysregulation is a significant suicidogenic factor that is understudied in people with psychotic disorders. The investigators propose to implement and evaluate an intervention targeting emotion dysregulation in people with psychotic disorders while employing rigorous statistical modeling and measurement techniques including Ecological Momentary Assessment, which will support future advanced research on suicide and suicide prevention for this high-risk group.
Bipolar disorder is a severe and disabling disorder. The course of illness is often progressive but is highly heterogeneous between individuals and within the lifetime for an individual. The most common treatments are medications. However, for many individuals, combinations of medications are often required, and full recovery is infrequent. The novel brain stimulation treatment, transcranial direct current stimulation (tDCS), is a potential first-line treatment for bipolar depression. The present research question is whether tDCS can be provided as a home-based treatment for bipolar depression for adults with bipolar disorder.
Introduction: Oxytocin (OT) is a nine-amino acid neuropeptide, known to have a fundamental role in social communication. In a recent randomized, double-blind, placebo-controlled study carried out in Shalvata Mental Health Center, OT was administrated to patients suffering from severe mental health illness. The results indicated that OT has a clear beneficial effect on therapeutic outcomes. However, to our knowledge, the effect of OT administration to both patients and therapists on the therapeutic process was never tested. Substance administration to caregivers is therefore possible, and could, in some cases, provide further knowledge about the caregiving dynamics. Since we know the therapist's characteristics effect the therapeutic alliance and that OT is associated with the therapeutic alliance, patient-therapist bond, and therapy outcome, we are led to ask if OT administration to patients and therapists could allow for a deeper understanding of OT's effects on the therapeutic process. Another variable found to be associated with the therapeutic process is Physiological Synchronization. Physiological Synchronization (PS) is a primarily interpersonal phenomenon which includes coordination of physiological signals between two or more interacting individuals. Despite the rising number of studies examining PS, its physiological and psychological mechanisms are yet to be fully understood. Based on literature indicating associations between OT and PS, and associations each of them has with the therapeutic process and its facilitators, in this study we wish to examine the influence of OT on PS through intranasal OT administration to patients alone and to patients and therapists together. Research Hypotheses: 1. Patients receiving OT will demonstrate higher levels of PS during the measured session compared to patients receiving placebo. 2. Patients receiving OT will report higher levels of perceived therapist empathy as compared to patients receiving placebo. 3. These associations will be stronger when both patient and therapist receive OT in comparison to patient alone. 4. Changed in PS and empathy will be associated with OT even after controlling for patient rated alliance and session impact. 5. These findings will sustain after controlling for severity of symptoms and attachment patterns. Method: Participants. Sixty patients and their therapists will be recruited for the pilot study. Patients will be recruited from the inpatient adult psychiatric wards at Shalvata Mental Health Center. Therapists in this study will be comprised of psychologists, psychiatrists, and social workers, in different stages of seniority and training. Instruments. Attachment patterns, symptom severity, side effects and therapeutic process measurements - working alliance, perceived empathy and session impact - will be assessed using self-report questionnaires. PS will be measured by recordings of the electrodermal activity (EDA) measured by skin conductance signals, using a galvanic skin response (GSR) device. Oxytocin Administration will be performed intranasally using a spray containing 24U. Procedure. Sixty patients meeting inclusion criteria and their therapists will be recruited for the pilot study. Dyads will be randomized and double-blindly allocated to receive intra-nasal oxytocin or placebo. Dyads will be followed for two consecutive sessions, approximately at their fourth and fifth sessions. After signing informed consent forms, patients and therapists will complete therapeutic process measurements, and patients will be assessed for the severity of their symptoms and attachment patterns. Prior to the first session, patients will be administrated with either IN-OT or PLC and will wait for 30 minutes before the beginning of the session. Skin conductance synchrony will be measured during the session. At the end of the session, therapeutic process measurements will be assessed in both patients and therapists, and patients will complete a side-effect questionnaire. Prior to the second session, both patients and therapists will receive either IN-OT or PLC (each dyad will receive the same substance) and will wait for 30 minutes before the beginning of the session. Skin conductance synchrony will then be measured during the session. At the end of the session, therapeutic process measurements will be assessed in both patients and therapists alongside with a side-effect questionnaire. The uniqueness of the proposed study is rooted in the view of the psychotherapy dyad as undetached, by focusing on the dyad and not on the patient alone. Focusing on patient-therapist synchronization lies on the understanding of the patient-therapist bond as co-dependent and co-affected. Such research could increase our understanding of PS between patient and therapist and its meaning in psychotherapy research and practice.
This is a naturalistic treatment and follow-up study of youth with bipolar spectrum disorders (BSDs) across four US sites of The Childhood Bipolar Network (CBN). CBN sites have expertise in diagnosing, assessing, and treating BSDs in youth. The primary aims of this study are to (1) identify and reliably diagnose youth (ages 9 to 19 yrs) with full bipolar disorder (BD) and BSDs, and (2) examine predictors (e.g., mood instability, inflammatory marker C-reactive protein) of clinical outcome over a 12 month period. Participating youth will initially complete a screening that includes a structured diagnostic interview and a baseline blood draw to measure inflammatory processes. Youth with BSD and parents (80 families) will be asked to participate in multiple follow up research visits with interviews, rating instruments, and questionnaires. Per established CBN guidelines, study psychiatrists will provide and track medication management and sites will also track psychosocial treatments. This study ultimately aims to further understanding of best practice pediatric BSD psychiatric and psychosocial treatments and development of a standardized and validated set of clinical tools for patient assessment, diagnosis, and tracking.
Introduction 16.8% of the Danish adult population are obese (Body Mass Index> 30 kg / m2). Obesity increases the risk of lifestyle diseases such as type-2 diabetes and non-alcoholic fatty liver. People with mental illness have an increased risk of developing obesity. Both obesity and certain mental disorders (bipolar disorder and schizophrenia) are associated with circadian rhythm disorders. Clinically, this may manifest as reduced sleep quality, depressive symptoms and increased fatigue, but also deregulation of a wide range of bodily processes subject to the circadian rhythm. In circadian rhythm disorders, the pattern of how mRNA of specific 'clock genes' is expressed in the cell may be affected. These clock genes are associated with obesity, bipolar disorder and schizophrenia. Despite the clear indications of an interplay between mental illness, obesity and circadian rhythm disorders, the relationship between these illnesses are largely unexplored. Aim The aim of this study is to investigate circadian disturbances in people with and without obesity, as well as people with obesity and a comorbid diagnosis of either schizophrenia or bipolar disorder. Methods The study population will consist of: 1. People with obesity and schizophrenia (N=22) 2. People with obesity and bipolar disorder (N=22) 3. People with obesity without psychiatric disease (N=22) 4. People with BMI 18.5 - 25kg/m2 and no psychiatric disease (N=20) Study Procedure Participants will visit the clinic 2 times. At each visit participants fill in questionnaires and perform physical tests. Between visit 1 and 2, participants will over a 2-day period (at-home), collect biological samples (Four hair- and six saliva samples per day). In addition, participants will wear accelerometers and continuous glucose monitors (CGMs) for a total of 8 days, including the 2-day sampling period. Sampled hair follicles are analyzed for relative expression of clock gene mRNA. Saliva is analyzed for cortisol- and melatonin content. The four participants groups are analyzed and compared on daytime variation in mRNA expression, cortisol- and melatonin concentration, and body temperature. Perspectives A comparison of patient groups presenting with mental disease, obesity and circadian disturbances may provide new insight into the association between these diseases.
Comorbid insomnia represents a frequent health problem in patients with severe mental disorders, and cognitive behavioral therapy for insomnia (CBT-I) has been identified as the first line treatment. However, CBT-I has not sufficiently been implemented in acute psychiatry settings. Rather, patients are often overtreated with benzodiazepines or benzodiazepine receptor agonists, related to adverse effects and the risk of tolerance and dependency. This work aims to empower patients with severe mental disorders to take care of their own sleep health based on a pragmatic behavioral treatment program ("Become your own SLEEPexpert"). Implementation research strategies in collaboration with patients and health care providers were used to adaptat CBT-I components to the needs of psychiatric inpatients. Evidence for feasibility in an acute hospital setting and preliminary evidence for efficacy has been shown. ln the proposed project, the investigators aim to compare treatment as usual (TAU) + SLEEPexpert to TAU + sleep monitoring in a pilot randomized controlled trial. The objective is to target sleep to improve mental health and to investigate the efficacy of the SLEEPexpert programme for the improvement of sleep and mental health. Given the high burden of comorbid insomnia in psychiatry, the investigators believe that the presented work is of interest to basic scientists and clinicians and, potentially, of heightened public health relevance.
The primary aim of the proposed project is to investigate the prevalence of insomnia in patients with psychiatric disorders treated as inpatients in psychiatric hospitals in two study sites in Switzerland and nine study sites in Germany. The secondary aim is to investigate whether there are demographic or disorder specific parameters that influence the prevalence of insomnia in patients with psychiatric disorders.
The aim of this study is to examine the effect of a non-pharmacological transdiagnostic sleep intervention as add on to standard treatment for bipolar disorder, depression and attention deficit disorder. Our hypothesis is that the intervention will reduce the severity of the sleep problem and increase sleep quality compared to a control group receiving sleep hygiene education.