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NCT07282158
This clinical trial tests an adapted version of the Helping Ovarian Cancer Patients Cope (HOPE) intervention to address burnout among gynecologic oncology clinicians. Stress and burnout among gynecologic oncology clinicians can have far-reaching impacts not only on physicians at the individual level (e.g., distress, mental illness) but also at the professional (e.g., worse patient outcomes, increased errors) and societal levels (fewer physicians in this specialty, more system strain). The original Helping Ovarian Cancer Patients Cope (HOPE) is a workshop to promote hope among patients with ovarian cancer through creating positive narratives using the hope theory and social-cognitive theory. The adapted intervention for clinicals (HOPE-C) will use the same concepts but tailored to clinician experiences by fostering peer support and retelling their challenging stories and may address burnout for gynecologic oncology clinicians.
NCT06843187
The goal of this clinical trial is to learn if Lemborexant works to treat residual insomnia in adults with depression that is being treated. It will also learn about how practical, tolerable, and effective Lemborexant is. The main questions it aims to answer are: * Does Lemborexant help participants improve sleep and reduce insomnia symptoms? * How practical is it to use Lemborexant (how many participants join, drop out, and follow the study rules)? How do participants feel about using it (based on surveys and interviews)? Researchers will compare Lemborexant to a placebo (a look-alike substance that contains no drug) to see if Lemborexant works to treat residual insomnia in adequately treated major depressive disorder. Participants will: * Take Lemborexant or a placebo every day for 6 weeks (2 weeks at 5 mg then 4 weeks at 10 mg) * Complete clinical assessments and in-person study visits * Maintain a digital sleep diary and complete daily and weekly self-report ecological momentary assessments (EMAs) * Use a wearable device which will be used to collect and monitor physiological data
NCT04725409
This ClincialTrials.gov record originally corresponded to the protocol approved under IRB # 202370. The study was expanded to include stimulation and recordings approved under new IRB #211037, as well as IRB #251231. The participant data originally acquired from IRB# 202370 will be included in this new record: This study seeks to better understand the neural activity underlying neuro cognitive disorders. Resting state local field potential recordings will be collected from medically refractory epilepsy patients implanted with depth electrodes for seizure localization, and metrics of neural activity will be correlated with psychiatric symptoms as measured from questionnaires. Subjects will also participate in neuro cognitive tasks while neural recordings are performed, and/or receive neural stimulation through implanted depth electrodes. A better understanding of disordered neural activity underlying neuropsychiatric disorders may additionally contribute to novel methods for diagnosing, treating, and preventing these diseases.
NCT07497763
The goal of this randomized control trial is to assess the effectiveness of a Brief Case Management (BCM) intervention aimed at promoting personal recovery and reducing the negative effects of coercion among people involuntarily admitted to a psychiatric hospital. The main questions it aims to answer are : * Does the Brief Case Management intervention reduce the incidence of involuntary readmission18 months after the initial involuntary hospitalisation? * What impact does the Brief Case Management intervention have on patients' involuntary readmission 6 months after the initial involuntary hospitalisation, as well as on their personal recovery, perceived coercion, satisfaction with treatment, and on their exposure to other forms of formal and informal coercion? Participants will be randomly assigned to either the control or the intervention group, accordingly they will be asked to take part in: Control Group: * Three evaluation sessions (baseline, 6 and 18 months follow-up); Intervention Group : * Three evaluation sessions (baseline, 6 and 18 months follow-up); * The 5 sessions of the brief case management intervention (6th session optional).
NCT01778504
Background: \- Many psychiatric, behavioral, and developmental disorders are genetic. This means that they tend to run in families. Some begin in childhood, while others do not appear until adulthood. Researchers want to look at people of all ages who have these disorders that started in childhood. They will also look at relatives of people with these disorders. This information will allow doctors to learn more about childhood behavioral problems and how they are inherited. It may also help doctors treat those disorders. Objectives: \- To study the onset and treatment of childhood behavioral, psychiatric, and developmental disorders. Eligibility: * Individuals of any age who have a psychiatric, autism spectrum, or developmental disorder, or other behavioral problems. * Family members of individuals with the above disorders. This group may include parents, grandparents, siblings, aunts/uncles, cousins, and children. Design: \- Participants will be screened with a medical history and physical exam. They may have a psychiatric history with tests of thinking, judgment, and behavior. Brain imaging scans may be performed to look at brain function....
NCT06165445
In this project, the efficacy of different tDCS protocols in major depression will be investigated. The tDCS protocols have already been investigated in humans, and results showed that stimulation intensity has a different effect on tDCS long-term aftereffects based on the human motor cortex model. The project has three major goals: first, we want to see if the differential outcome of tDCS dosage, as present in healthy populations, can be translated to patients with major depression. Second, we want to compare the efficacy of a multi-channel novel protocol with conventional tDCS modules. Lastly, we are interested in the safety and tolerability of optimized multi-channel. The project output will be an optimized tDCS protocol for major depression treatment.
NCT07453108
Our studies on MRI (Magnetic resonance imaging) biomarkers in neuropsychiatric disorders rely on reference data from control subjects which are dependent from our scanner. Due to the upcoming replacement of our MR scanner, the investigators need to 'recalibrate' our current database by acquiring the same data on both the old and the new device from a small group of controls (n = 36 to 40). This will be combined with measures of cortical excitability using robotized TMS (transcranial magnetic stimulation) that will be combined to MRI biomarkers in forthcoming studies. Therefore, the primary objective of this biomedical trial is to collect MRI and physiological measurements in normal subjects whose characteristics match to our study populations.
NCT07417813
This study aims to evaluate the effectiveness and safety of lemborexant (a new dual orexin receptor antagonist) in the treatment of patients with mental disorders complicated with insomnia. The subjects are patients aged 18 years and above, who meet the DSM-5 diagnostic criteria for mental disorders and have an Insomnia Severity Index (ISI) score ≥11. They will receive lemborexant treatment for 8 weeks, with follow-up to observe the improvement of insomnia symptoms and adverse events, so as to provide real-world evidence for the clinical optimization of treatment regimens for insomnia comorbid with psychiatric disorders.
NCT07406113
Cancer is among the leading causes of morbidity and mortality worldwide, profoundly affecting patients' lives at every level, and its psychological and psychiatric impacts remain a major concern. Psychiatric disorders are frequently observed in cancer patients. Nevertheless, they were also underdiagnosed, with a consequent undermining possible interventions. Still, psychiatric disorders in cancer patients are not merely secondary complications but may actively contribute to poor oncological outcomes. The pathophysiology of cancer-related psychiatric disorders is multifactorial and is related to several neuropsychological and neurobiological factors. Specifically, the production of cytokines associated with cancer appears to play a role in the development of depression. Tumours trigger an inflammatory response that leads to the release of pro-inflammatory cytokines. These cytokines influence central nervous system function and disrupt the regulation of the HPA axis, contributing to psychological symptoms such as depression, fatigue, sleep disturbances, and appetite loss. Moreover, psychiatric symptoms in cancer patients are often accompanied by neuropsychological alterations including deficits in memory, executive function, and attention. Compared to other individuals with psychiatric disorders, cancer patients may experience more severe cognitive impairments which can be exacerbated by cancer treatments, including surgery, chemotherapy, and radiotherapy. These treatments stimulate cytokine production by nearby non-cancerous cells and immune cells activated in response to treatment-induced cell death, thereby driving systemic inflammation. Cancer profoundly affects not only patients but also their families, who often bear the emotional and caregiving burden. Being close to a loved one with cancer can lead to significant psychological distress, including anxiety and depression, among family members and caregivers. The ripple effects of this burden underscore the need for a holistic approach to mental health in oncology. Given the background presented so far, identifying and managing psychiatric comorbidities in oncological patients and their families is crucial. This multifaceted interplay between cancer and psychiatric disorders necessitates a comprehensive, interdisciplinary approach to understanding, diagnosing, and treating these conditions effectively.
NCT04806620
The unhide® Project is a non-interventional, longitudinal research study designed to establish a secure data repository of demographic, health, and lifestyle information from individuals with brain inflammation and related neuroinflammatory conditions. Participants in the United States aged 2 years and older will provide self-reported health data, biometrics, and symptom diaries through the MyDataHelps™ app (branded as unhide® for this study). The goal is to create comprehensive longitudinal profiles to facilitate research into disease subtypes, causes, diagnostics, and potential treatments, as well as to identify potential participants for future optional studies. "Healthy" individuals without brain inflammation are also eligible to participate. The digital health research platform used in this study was originally developed and designed by Solve M.E and was called SolveTogether. The Brain Inflammation Collaborative (BIC) expanded upon Solve M.E.'s work to include related diagnoses, pediatric participants, enhance symptom tracking, and more. BIC and Solve M.E. combined Solve Together and unhide®, to create The unhide® Solve Together Unified Platform in 2025.
NCT07317388
This study evaluates the effectiveness of group psychoeducation for users and carers to help people with severe psychiatric disorders achieve autonomy at home.
NCT07294443
Objective: This study was conducted to examine the effect of Qigong relaxation exercises applied in a psychiatric clinic on the anxiety and depression levels of patients diagnosed with depression. Design: This study was designed as a single-blind, randomized controlled trial. Research Hypotheses H1: State anxiety levels are lower in patients who perform Qigong exercises than in those who do not. H2: Depression levels are lower in patients who perform Qigong exercises than in those who do not. The study population consisted of 140 individuals aged 18 years and older diagnosed with depression who were hospitalized at a private psychiatric hospital in Turkey between March 1 and September 1, 2025. In the sample selection, the STAI-I and Beck Depression Scale were administered to the patients by the researchers. Since differences in anxiety and depression levels would affect group homogeneity, patients who scored below 35 on the STAI-I (mild and moderate levels) and between 17 and 30 on the Beck Depression Scale constituted the study sample. The study sample consisted of 70 patients.
NCT06534047
Tobacco smoking is the leading preventable cause of morbidity and mortality worldwide. However, currently available treatments, including standard pharmacotherapy and behavioural support, are limited in their efficacy, tolerability, and acceptability by patients. Additionally, tobacco use is substantially higher in individuals with comorbid mental illness, constituting a particularly vulnerable population. As such, the development of multiple evidence-based treatments for smoking cessation is of upmost importance. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain-based approach in which alternating magnetic fields are applied to the scalp to induce electrical currents in cortical tissue. As it can modulate neural circuits implicated in neuropsychiatric disorders, it is a promising brain-based approach in the treatment of substance use disorders. Recently, a deep TMS coil has been cleared by the Food and Drug Administration (FDA) as efficacious for tobacco use disorder, representing the first rTMS indication for addictions. Before adoption of this intervention into smoking cessation clinics, it is important to investigate whether implementation of rTMS into clinical care is feasible, acceptable, and appropriate for patients receiving care for nicotine dependence. The objective of this study is to compare the effectiveness of rTMS versus treatment as usual for patients with psychiatric disorders seeking treatment for smoking cessation. Also, barriers to the implementation of rTMS in routine clinical care will be examined by speaking with patients and health care providers on their experience with rTMS.
NCT04191811
Many psychiatric patients are not sufficiently improved by current interventions. Functional magnetic imaging brain imaging (fMRI) has proven to be a promising method for predicting treatment outcomes in psychiatric treatment. Individuals moment-to-moment variability have not yet been evaluated as a predictor of treatment of three common forms of mental illness: depression, insomnia and health anxiety. The goal is to investigate whether objective measurements of brain function contribute to a better prediction of a patient's success in treatment than experiences and self-reports, e.g., treatment credibility and patients expectations about the treatment. The prediction model will be tested on internet-delivered CBT (iCBT) for depression, insomnia and social anxiety. Patients in each diagnostic group are asked for participation before treatment. The total number of participants in this study will amount to 225 participants. The goal is that 35% consists of healthy controls and that the remaining part is equally distributed between the three diagnostic patient groups. Being able to better predict how well a psychiatric treatment will work for an individual has great value from both an economic and a treatment perspective. The findings from this study may contribute to increased knowledge about neurobiological complications in mental illness. In the longer term, it can lead to improved routines and help in clinical decision-making when patients should be recommended treatment.
NCT06818656
The Economic Impact Study of IVIG treatment for PANS is a part of the Unhide™ Project, which is a research initiative developed by the Brain Inflammation Collaborative. Specifically, the Unhide™ project is a collection of investigations with the overall goal of better understanding the problems with thinking and mood that can sometimes be symptoms of conditions like autoimmune disease, infection-associated chronic conditions like Long COVID, ME/CFS, PANDAS, PANS, and other illnesses. Your contribution to this research will allow us to better describe these symptoms and understand what causes them, how they develop, and how they can best be treated and prevented. This study seeks to assess how PANDAS/PANS affects the financial well-being of families who pursue IVIG treatment, as well as the overall health and quality of life of children with the condition. By gathering data through this survey, we aim to gain important insights into the economic consequences of treating - or not treating - PANS with IVIG, including how it impacts parents' ability to work and children's ability to attend school. Key Eligibility Criteria * Aged 2-89, U.S. resident, fluent in English, and have access to computer and/or smartphone * Suspected or confirmed diagnosis of PANS/PANDAS * Have received IVIG OR have sought and/or been prescribed IVIG but have not received it
NCT07158359
Psychiatric disorders often require specific treatments, usually involving medications called psychotropic drugs. While effective, these medications can cause significant side effects. One of the most common is hypersalivation (excess saliva), which can make swallowing difficult and be very uncomfortable in daily life. Current medication-based solutions are often not very effective and may cause additional side effects. For this reason, we are exploring a different approach: using chewing gum as a form of rehabilitation. The goal of this study is to determine whether chewing gum can help reduce excessive saliva. To do this, we will compare two groups: one that will follow a swallowing rehabilitation program including chewing gum, and another that will not. We hope this simple, non-drug-based approach will improve the management of hypersalivation. More broadly, this research aims to highlight innovative and accessible solutions in psychiatry, showing that alternative strategies-sometimes very simple ones-can also be effective.
NCT05316948
According to the World Health Organization (WHO), "Sexual health is a state of physical, emotional, mental and social well-being in relation to sexuality, not merely the absence of disease, dysfunction or of infirmity. Sexual health requires a positive and respectful approach to sexuality and sexual relationships \[...\]". The main objective is to show that a training intervention intended for psychiatric care teams and targeted on the question of the impact of psychiatric disorders and psychotropic drugs on the sexuality of young people, increases the proportion of young people with whom the question of sexual health is discussed (in connection with psychiatric disorders and, if applicable, with the taking of psychotropic treatment, while they are hospitalized for a psychiatric disorder in the clinics of the FSEF and receive, or not, psychotropic treatment ).
NCT05840900
Dispositional optimism (the general assumption that more good things than bad will occur across various life domains) has been tied to improved somatic and mental health outcomes. Dispositional optimism is malleable, although prior interventions have been time and resource intensive and thus are not well-tailored to the peripartum period. The purpose of this pilot study is to evaluate the feasibility and acceptability of a pregnancy-oriented mindfulness phone application (Expectful) versus standard care among first-time mothers with low dispositional optimism in early pregnancy. Other aims include evaluating the impact of Expectful use on dispositional optimism, adverse pregnancy outcomes (cesarean delivery, hypertensive disorders of pregnancy, and gestational diabetes) and postpartum post-traumatic stress symptoms.
NCT07023419
In complex detoxification hospital units, patients receive a common care system (interviews, therapeutic workshops, support for discharges, etc.). In the event of a relapse during hospitalization, i.e., a relapse into addiction, hospital care is called into question, and discharge is generally considered. A key care issue is therefore to prevent these relapses by identifying risk profiles to strengthen their management. According to studies, psychiatric diagnoses increase the risk of relapse, but the investigators do not fully understand which ones or to what extent. The objective of this study is to analyze the influence of psychiatric diagnoses on the risk of relapse. This would allow for adapting the care of these patients to reduce this risk. The investigators are also seeking to study the value of screening questionnaires in improving the reliability of psychiatric diagnoses.
NCT06320457
The goal of this clinical trial is to assess whether a brief case management intervention aimed at promoting personal recovery and reducing the negative effects of coercion among people involuntarily admitted to a psychiatric hospital would be well accepted by them, practically feasible and useful. The main questions it aims to answer are: * Is the case management intervention acceptable and feasible? * What are the preliminary effects of the case management intervention on patients' personal recovery and its sub-dimensions, as well as on their level of perceived coercion and their global satisfaction with hospital care? Participants will be asked to take part in: * the five sessions of the case management intervention; * two evaluation sessions (pre and post-intervention); * a final in-depth semi-structured interview (optional).