194 Clinical Trials for Various Conditions
The main purpose of this study is to examine differences in quality of life and psychological distress for both Multiple Myeloma patients receiving treatment and their caregivers and to assess patient and caregiver prognostic understanding (understanding of the likely course of a disease over time) of Multiple Myeloma to guide development of more personalized treatment plans. This study looks to further understand quality of life changes throughout multiple myeloma therapy for both patients and caregivers to help determine ways to improve patient and caregiver understanding of illness and in turn, tailor customized treatment that best aligns with patient preferences. The study will use a series of questionnaires to measure quality of life, mood, coping strategies, and prognostic understanding.
This research study is being done to monitor common symptoms and behavior, and to provide supportive care information and peer support, as well as research opportunities for young women ages of 18-39 years old who have been diagnosed with stage 0-IV stage breast cancer using a web-based portal (YES), built for smartphones, tablets, and computers.
The purpose of this study is to study the effects of attention training interventions on symptoms and brain function in major depressive disorder.
The researchers hope to find out effects of transcranial direct current stimulation (tDCS) sessions on the behavioral symptoms of Huntington's Disease. If participants are eligible to continue, they will be provided a device to administer the tDCS for 30 minutes each day and be asked to answer questions with the study staff . Participants will be asked to return to the study center more time for follow ups and to undergo additional thinking tests and questionnaires. Participants will also be asked to answer questionnaires over the phone or via a web conferencing platform (Zoom) 3 times during the course of the study. Caregivers of the participants will be asked to complete questionnaires to collect more information about the participants.
The purpose of this study is to assess acceptability, and safety of providing tDCS to ADRD patients with behavioral symptoms and to assess the efficacy of tDCS for ADRD-related symptoms, mainly behavioral symptoms.
This is an open label, eight week, clinical trial of a proprietary high CBD/low THC sublingual solution for the treatment of clinically significant anxiety and agitation in individuals with mild cognitive impairment (MCI) or mild to moderate Alzheimer's Disease (AD).
This study will investigate cortical stimulation to treat mood and behavioral symptoms in Parkinson's disease patients.
This randomized phase III trial studies how well mindfulness meditation or survivorship education work in improving behavioral symptoms in younger stage 0-III breast cancer survivors. Behavioral interventions, such as mindfulness meditation, use techniques to help patients change the way they react to environmental triggers that may cause a negative reaction. Survivorship education after treatment may reduce stress and improve the well-being and quality of life of patients with breast cancer. Mindfulness meditation or survivorship education may help improve the health behaviors of younger breast cancer survivors.
Frontotemporal dementia (FTD) is a progressive neurodegenerative illness that affects the frontal and anterior temporal lobes of the brain. Changes in behavior, including agitation, aggression, and repetitive behaviors, are common symptoms in FTD. The investigators currently do not have good medications to treat these symptoms in FTD, and the medications the investigators use often have side effects. In this project, the investigators will test the use of low-dose lithium, compared to a placebo pill, for the treatment of behavioral symptoms in FTD. Lithium greatly reduces the behavioral symptoms of bipolar disorder, and many have found low-dose lithium to be well-tolerated in patients with dementia. Lithium appears to inhibit the creation of a protein involved in many cases of FTD called tau.
Behavioral symptoms that commonly occur with dementia are associated with increased health care utilization and can lead to challenges for the person living with dementia and their caregivers. Caregivers need knowledge and skills to monitor these behaviors, to identify what triggers them, and to learn how to use proven, practical medication-free strategies to prevent and manage the behaviors. The purpose of this study is to develop and test the WeCareAdvisor, a customized, internet-based computer tool for family caregivers that helps them to assess, manage and track behavioral symptoms and their contributing factors (e.g., pain, sleep disturbance), and that provides tailored strategies for in-home, medication-free behavior management. This study is a collaboration between researchers at the University of Michigan and Johns Hopkins University.
The purpose of this study is to evaluate the safety and effectiveness of intranasal FE 992097 in children and adults with Prader-Willi Syndrome.
Over 5 million Americans have Alzheimer's disease or a related dementia, a progressive and irreversible neurodegenerative condition, affecting also close to 15 million family caregivers (CG). Sleep efficiency in AD patients is severely impaired and complicated by frequent night awakenings and nocturnal restlessness. Untreated sleep disruption in AD patients is associated with increased rates of neuropsychiatric symptoms, daytime napping, 'sundowning' behaviors, cognitive and functional decline, and morbidity and mortality. The added strain of sleep disruption is the primary reason family caregivers make the decision to institutionalize AD patients. The circadian abnormalities in the sleep-wake cycle commonly observed in AD patients occur more often in individuals with hypothalamic/ pituitary/adrenal (HPA) axis hyperactivity. HPA axis hyperactivity may influence diurnal sleep-wake activity by diminishing an AD patient's ability to respond to external zeitgebers which, in turn, can further propagate HPA axis dysfunction. Thus, interventions to normalize diurnal HPA axis patterns may be beneficial in treating sleep-wake disturbances. Nonpharmacologic treatments are the first line therapy in AD patients with sleep wake problems, given the ineffective and potentially harmful effects of pharmacologic agents. Current clinical sleep hygiene practices in institutional (e.g., nursing home) settings holds promise for reducing disruptive sleep by reestablishing circadian patterns in HPA functioning. These interventions include use of timed and planned activities during daylight hours and creating a relaxing environment in the evening. However little systematic work has been done to determine the efficacy of these interventions in the home setting (where most individuals with AD reside). We propose a pilot study to (a) characterize objective sleep parameters and behavioral symptoms of sleep-wake disturbance, and biological indicators of diurnal HPA axis activity in a sample of community residing older adults with AD: (b) examine the effects of timed and planned activities on subjective and objective characteristics of sleep, behavioral symptoms, and HPA status; and (c) evaluate measurement approaches in home-dwelling AD patients. Subjective (CG questionnaires) and objective (wrist actigraphy) characteristics of sleep and behavioral symptoms will be measured in fifty-four AD patients being cared for at home by a family. Patients and CG with then be randomized to receive an intervention of timed, planned activities (TPA) or attention control (AC) condition. We will also obtain diurnal measures of HPA activity including salivary cortisol and alpha amylase.
The optimal strategy for the treatment of behavioral complications in patients with probable Alzheimer's disease (AD) remains unclear. The objective of this study is to evaluate the risk of relapse following discontinuation of haloperidol in patients with Alzheimer's disease (AD) with psychosis or agitation who respond to it. In Phase A of this study, AD outpatients with behavioral complications receive 20 weeks of open haloperidol treatment with an oral dose of 1-5 mg daily, titrated individually to achieve the optimal trade-off between efficacy and side effects. Responders to Phase A participate in Phase B, a 24-week continuation trial in which patients are randomized to continuation haloperidol or placebo. The primary outcome is the time to relapse of psychosis or behavioral disturbance.
Mood disorders, such as depression and bipolar disorder, are difficult to treat. One reason is that there are no objective ways to measure how these disorders affect the body and respond to different treatments. In this study, researchers want to perform tests on people undergoing clinical care for mood disorders. The purpose is to understand the experience of receiving treatment for depression, bipolar disorder, and suicide risk. We also hope that this study will help us to predict which medications will improve thoughts of suicide. People 18 years or older who are receiving treatment for depression, bipolar disorder, or suicide risk may take part in this study. Participants must have also been enrolled in protocol 01-M-0254. This study will be conducted at the NIH Clinical Center in Bethesda, MD. The study typically lasts up to 12 weeks, but may last longer if a participant s treatment continues past that time. Participants will have weekly interviews and questionnaires while they are being treated for their mood disorder. Other tests are optional and include psychological testing, blood draws, sleep tests, and imaging scans. These will be done at the start and the end of research participation.
The goal of this community-engaged research is two-fold. The first goal is to gather stakeholder feedback to inform a school-based community health worker intervention with youth with poor school attendance and an enhanced usual care condition. The second goal is to evaluate the feasibility of implementing the school-based community health worker intervention and enhanced usual care approach within rural schools. The main question it aims to answer is whether it is feasibile to recruit children with poor school attendance and their families to the intervention, to complete the trauma-informed intervention, and to complete the associated study measures of meeting social determinants of health/mental health needs, school-based health center utilization, and behavioral helath symptoms. At least 38 rural students in grades 6-12 with poor school attendance and their parents/guardians will meet with the school-based community health worker for support around social determinants of health needs that may be barriers to attendance. Researchers will also assess the feasibility of recruiting at least 10 rural students and their parents/guardians to complete the study measures in an enhanced usual care condition in which the school-based health center without a school-based community health worker is reminded of the availability of an online social services directory.
This study fills a notable gap in the transdiagnostic literature by evaluating whether an evidence-based transdiagnostic treatment for emotional disorders such as the Unified Protocol for Children (UP-C) is effective for treating childhood behavior problems.
This study will compare the effectiveness (how well the drug works) of aripiprazole with placebo (fixed dose) in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).
Background: Major depressive disorder (MDD) is a serious mental illness that can put people at risk of self-harm and death. Many drugs are used to treat MDD, but it can take a long time for them to be effective. Researchers want to know if a faster-acting drug, (2R,6R)-hydroxynorketamine (HNK), can better treat the symptoms of MDD. Objective: To test a study drug (HNK) in people with MDD. Eligibility: People aged 18 to 70 years with MDD. They must have had a screening assessment under protocol 01-M-0254. Design: Participants will be tapered off their current MDD drugs over 2 to 5 weeks. They will stay off of the drugs for up to 2 weeks prior to starting the study medication and procedures. They will have a physical exam with blood tests. They will have tests of their heart function, mood, and thinking. They will answer questions about their symptoms. They may choose to have imaging scans and scans of their brain activity. HNK is given through a tube attached to a needle inserted into a vein. Participants will receive infusions on this schedule: They will receive 4 infusions over 2 weeks. They will stay in the clinical center overnight after each infusion or for the duration of the study. They will receive no drugs for 2 to 3 weeks. They will have 4 more infusions over 2 weeks, with overnight stays after each or for the duration of the study. One set of 4 infusions will be the HNK. The other set of 4 infusions will be a placebo. A placebo looks just like the real drug but contains no medicine. Participants will not know when they are getting the HNK or placebo. ...
The purpose of this study is to use a program called Regulating Together (RT), a remote, non-pharmacologic intervention to treat symptoms of emotion dysregulation in children and adolescents with Tuberous Sclerosis Complex (TSC) and TSC-Associated Neuropsychiatric Disorder (TAND).
This is a placebo-controlled clinical trial to assess whether Guanfacine Extended Release (GXR) reduces aggression and self injurious behavior in individuals with Prader Willi Syndrome (PWS). In addition, the study will establish the safety of GXR with a specific focus on metabolic effects.
The goal of this clinical trial is to study the effects of dronabinol in US Veterans with agitation related to moderate to severe dementia. The main goals of the study are: * To evaluate the efficacy of dronabinol for the treatment of agitation in moderate to severe dementia compared to placebo * To evaluate the safety of dronabinol in the treatment of agitation in moderate to severe dementia compared to placebo Fifty (50) subjects will be given either dronabinol or placebo for 8 weeks. All subjects will then undergo a "washout" phase for 3 weeks, followed by the crossover intervention (i.e. subjects who received placebo during the first phase will receive dronabinol during the second phase, and vice versa). Thus, all participants will be taking dronabinol at some point during the study. During the study, subjects will undergo evaluations for: * Agitation * Cognitive changes * Physical changes (i.e. labs, ekg, physical exam)
The goal of this pilot study is to improve the STAR-Caregivers Virtual Training \& Follow-up (STAR-VTF) intervention for Latino caregivers of people living with dementia. The main objectives are to: (1) culturally adapt STAR-VTF online training modules, (2) pilot test Latino caregivers' responses to the adapted online training modules, and (3) develop an online survey to collect caregiver outcomes in a future study. Participants will receive the STAR-VTF intervention and asked to complete online surveys and participate in an exit interview to provide feedback on their experience.
This randomized pilot trial uses a waitlist control parallel design of a novel internet-based cognitive behavioral therapy program for older adults with elevated depressive symptoms. This study will enroll approximately 35 older adults per group throughout Michigan. The intervention will take approximately ten weeks to complete. Participants will have lower levels of depression after completing the intervention than before enrollment. Participants will be able to use the internet-based platform with minimal support.
This study is a randomized effectiveness trial that tests the online delivery of a video-based intervention (One Talk at a Time (OTAAT)) relative to a control group over a one-year span. Hypotheses include: 1.) The OTAAT intervention will increase parental motivation to engage in racial-ethnic socialization (RES) conversations, their skills and confidence in having these conversations, and the frequency and quality of these conservations; 2.) The OTAAT intervention will increase youth reports of their coping with discrimination, perceived efficacy in coping with discrimination in the future, ethnic-racial identity, and youth mental and academic outcomes; 3.) Greater parental discrimination and youth discrimination will moderate links between OTAAT intervention and parental ethnic-racial motivation + competency as well as youth ethnic-racial identity, coping, and psychosocial outcomes.
This is a single group study of a novel internet-based cognitive behavioral therapy program for older adults with elevated depressive symptoms. This study will enroll approximately 300 older adults throughout the state of Michigan to test the effectiveness of Empower@Home with older adults. The intervention will take approximately 10 weeks to complete. Participants will have lower levels of depression after completing the intervention than before enrollment. Participants will be able to use the internet-based platform with minimal support.
Anhedonia is characterized by loss of interest or pleasure. The proposed pilot study would be the first to test an innovative, neuroscience-informed intervention in mothers reporting depressive symptoms and stress to enhance positive emotionality with the goal of preventing anhedonia and associated emotional disturbances in their children. This study will recruit dyads (mothers and their children) for the intervention.
The investigators will conduct a Randomized Controlled Trial (RCT) comparing the Remote Motivational Enhancement (RME) coaching sessions + MindWell screenings arm to an Information-only + MindWell screenings arm on early engagement in treatment support services, as measured by overall action plan initiation.
This research will test the WeCareAdvisor tool for family caregivers of military veterans with dementia to help caregivers assess, manage and track behavioral symptoms and their contributing factors (e.g., pain, sleep disturbance), and that provides tailored strategies for in-home, medication-free behavior management. 60 caregiver-person with dementia dyads will be recruited (30 Treatment Group, 30 Wait-List Control Group).
This study will investigate the effects of an organizational implementation strategy called Leadership and Organizational Change for Implementation (LOCI), relative to training and technical assistance only, on fidelity to, and youth service outcomes of, a well-established digital measurement-based care intervention called the Outcomes Questionnaire-Analyst in outpatient community mental health clinics.
Major depression (MD) in youth is a serious psychiatric illness with extensive morbidity and mortality. The American Academy of Pediatrics recently released practice guidelines promoting primary care (PC)-based youth MD screening; however, even when diagnosed by PC providers, \<50% of youth with MD access treatment. Thus, a need exists for interventions that are feasible for youths and parents to access and complete-and that may strengthen parents' likelihood of pursuing longer-term services. Single-session interventions (SSIs) may help forward these goals. SSIs include elements of comprehensive treatments, but their brevity makes them easier to disseminate at scale. Meta-analytic evidence suggests SSIs can reduce youth psychopathology, including self-administered (e.g., online) SSIs. One computer-based SSI, teaching growth mindset (GM; viewing personal traits as malleable), has reduced adolescent depressive symptoms in multiple RCTs. A second computer-based SSI was recently developed to reduce youth depressive symptoms via targeting reductions in self-hate-a symptom identified as important for the maintenance of other depressive symptoms in teenagers. This study will test whether either the growth mindset SSI (GM-SSI), the self-kindness SSI (SK-SSI), or both SSIs reduce symptoms of depression in adolescents, relative to an active "supportive therapy" SSI, which teaches adolescents to share their emotions with trusted others. Youths participating in existing research through the Healthy Brain Network (N=501) will receive either the growth mindset SSI (GM-SSI), the self-kindness SSI (SK-SSI), or the supportive therapy SSI (ST-SSI). The investigators will examine whether the GM-SSI and/or the SK-SSI, versus the ST-SSI will reduce youth depressive symptoms across three months. Results may identify two novel, potent, and brief interventions for adolescent depressive symptoms.