69 Clinical Trials for Various Conditions
The purpose of this research study is to develop a method to improve thinking difficulties in individuals who have experienced a traumatic brain injury and report experiencing difficulties in attention and concentration. This study aims to understand how cognitive rehabilitation of attention difficulties affects brain activity.
Participants will complete a pre and post training psychological assessment. Participants will be assigned to attention control training or the comparison stimuli computer task in a double-blind randomized control trial design. Both computerized dot probe tasks display two stimuli on a computer screen, one above the other, followed by a small right or left arrow appearing in the location vacated by one of the stimuli. Participants are required to respond as quickly as they can by pressing the indicated right or left arrow on their computer keyboard without compromising accuracy. Participants complete 6 training sessions.
Participants will complete a pre and post training psychological assessment. Participants will be assigned to attention control training or the comparison stimuli computer task in a double-blind randomized control trial design. Both computerized dot probe tasks display two faces on a computer screen, one above the other, followed by a small right or left arrow appearing in the location vacated by one of the faces. Participants are required to respond as quickly as they can by pressing the indicated right or left arrow on their computer keyboard without compromising accuracy. Participants complete 6 training sessions.
The purpose of this study is to test an innovative combination of direct-attention training and metacognitive training in the treatment of attention impairments in Veterans with moderate-to-severe traumatic brain injury (TBI) who report experiencing attentional problems. Enrolled participants will be randomized to receive either the direct-attention training or metacognitive training first and then will be crossed over to receive the opposite intervention. The study will consist of two treatment periods of 4 weeks and a post-treatment 4 weeks later. In addition to the rehabilitation treatments, participants will also perform measures of complex functional activities (e.g., independent activities of daily living or IADLs) and neurocognitive tests of attention-control functions. Participants will also perform an attentional task that probes the function of three different attentional systems while brain wave activity (i.e., electroencephalography or EEG) is being recorded in order to assess changes in brain function that may be improved by the rehabilitation approach. Planned enrollment will be 36 Veterans.
Cognitive impairments occur frequently after stroke, and are associated with significant long-term activities of daily living (ADL) disability and poor quality of life. This research study will undertake an innovative approach addressing cognitive impairments, by examining a new patient-centered functionally-relevant rehabilitation intervention that teaches individuals with cognitive impairments to manage their deficits to reduce ADL disability.
The decision to disclose one's serostatus to family members creates considerable emotional strain for people living with HIV (PLWH), regardless of gender and sexual orientation. While disclosure to family members has been linked to positive outcomes including increased social support, improved health outcomes (i.e., sexual, physical, mental), reduced loneliness and stress, and improved HIV disease management, the decision not to disclose can also lead to positive outcomes. To date, most research about serostatus disclosure has focused on the act of disclosing - the who, what, where, and when of disclosing - rather than the decision process involved. The investigator's long-range goal is to further refine and evaluate an intervention designed to enhance HIV disclosure decision-making among PLWH. To reach this goal, the investigators are proposing a course of study with the following specific aims: Specific Aim 1. Assess the effectiveness of the intervention relative to an attention-control condition on a variety of primary outcomes related to disclosure and health. Specific Aim 2: Examine the effects of the intervention over time. Specific Aim 3: Explore the potential mediating effects of disclosure decision making on the primary outcomes. Specific Aim 4: Explore potential moderating effects of participant demographics (e.g., gender, age), relationship characteristics (i.e., relationship satisfaction, proximity, importance of disclosure), and contextual variables related to family (e.g., adaptability, problem-solving) on intervention effectiveness. Specific Aim 5: Evaluate the effects of treatment engagement, retention and expectations on outcomes.
Individuals with cognitive impairments after stroke sustain significant disability in their daily tasks, and account for a significant proportion of stroke-related healthcare costs. The proposed study examines a novel intervention, strategy training, that shows promise for helping individuals with stroke-related cognitive impairments reduce disability in daily tasks, which may lead to reductions in healthcare costs. We predict that strategy training will result in significantly greater independence 6 months after stroke compared to an attention control intervention, and that strategy training may reduce cognitive impairments.
Executive control processes involve initiate, coordinate, synchronize, and regulate elemental cognitive functions for the conduct of goal-directed behavior. The proposed research investigates whether exposure to a web-based training protocol designed to enhance executive control processes will improve cognitive performance in cognitively healthy older adults.
The primary aim is to identify the impacts of a behavioral intervention called "Mindfulness-Based Blood Pressure Reduction" (MB-BP) vs. enhanced usual care on the primary self-regulation target, specifically an assay of self-related processes (Multidimensional Assessment of Interoceptive Awareness) (MAIA) at 6 months, via a randomized controlled trial.
The purpose is to determine whether brief behavioral treatment is effective for insomnia in cancer survivors.
The primary aim is to evaluate impacts of a behavioral intervention called "Mindfulness-Based Blood Pressure Reduction" (MB-BP) vs. enhanced usual care control on systolic blood pressure at 6 months, via a randomized controlled trial.
Men who have sex with men (MSM) remain disproportionately represented in the national HIV/AIDS statistics. Little progress has been made in understanding the nuances of MSM sexual behavior or communication that may be perpetuating the spread of HIV. Non-disclosure of an HIV-positive status may be a key factor responsible for male-male HIV transmission. There are no known intervention programs whose primary focus is to help MSM develop requisite skills to disclose their status to casual sexual partners. The development of such interventions is essential because of the numerous repercussions for not disclosing when one is HIV-positive such as legal prosecution and the transmission of HIV. In a previous intervention development study (R21MH067494) the research team created and tested a 4 session intervention found to be promising for increasing disclosure to casual sexual partners. The purpose of the proposed research is to further refine and enhance our HIV disclosure intervention (DI) designed to increase disclosure to casual sexual partners and reduce sexual risk taking behaviors among HIV-positive MSM; assess the relative effectiveness of a disclosure intervention to an attention control case management group (ACCM) for HIV-positive MSM; examine the effects of the intervention over time; explore differential treatment responses to the disclosure intervention and ACCM on the basis of ethnicity, age, and education level as well as examine the mediating effect of baseline frequency of sexual activity, severity of substance abuse at baseline, and stigmatized fear on the relationship between intervention type and the outcome. Finally, the investigators will test how treatment engagement, retention and expectations predict subsequent disclosure and risky sexual outcomes.
The purpose of this study was to learn more about the brain circuits involved with effortful control in healthy adult participants. It was planned that the study would enroll 80 participants to a dual task paradigm pilot while undergoing a fMRI scan to assess brain mechanisms that cause the "depletion effect". This effect refers to the observation that people perform more poorly on effortful control tasks after they have already performed task requiring effortful control. Then subsequent study participants would be given either methylphenidate (also known as 'Ritalin') which is FDA approved and the most widely-used medication for Attention Deficit Hyperactivity Disorder (ADHD) or a placebo, which is a sugar pill. Each participant would also perform some computer tasks that have been shown in previous studies to require effortful control while undergoing an fMRI (functional Magnetic Resonance Imaging) which takes a special kind of picture of the brain. The study's goal was to learn more about the brain mechanisms by which methylphenidate improves effortful control. After enrolling the first 50 participants, the study assessed whether a depletion effect was observed in the dual task paradigm. It was found that there was not: there was no statistically significant difference in effortful control performance comparing subjects who did and did not perform a prior effortful control task. Because the behavioral manipulation failed, it was determined that the drug manipulation portion of the study was no longer justified. Thus, after enrolling 50 participants to the pilot part of the study, the decision was made to terminate the study without beginning the trial of methylphenidate.
The goal of this research is to understand the functioning of 'regulatory circuits' in the brain. We are also interested in how the medications methylphenidate and naltrexone affect these regulatory circuits. This research study will use a scanning technique known as functional magnetic resonance imaging (fMRI) which takes a special kind of picture of the brain that enables us to "see the brain at work". Adult participants will be given a one-time dose of either methylphenidate, naltrexone,or placebo before each fMRI scan session. The main purpose for this research is to better understand the functioning of regulatory circuits in healthy individuals and individuals with psychiatric disorders. This research may one day help us develop better treatments for these disorders.
Effortful control refers to the mental processes that help a person to regulate his or her own attention, thoughts, and emotions. This study will examine behavioral differences in healthy individuals when performing a task that induces fatigue. The purpose of this study is to examine the effects of methylphenidate on the cognitive functions in healthy individuals when performing fatiguing cognitive tasks.
The purpose of this trial is to evaluate the efficacy of combined behavioral and pharmacological treatment on chronic daily headache in children ages 10 to 17.
This study will compare the effectiveness of cognitive-behavior therapy (CBT) to a minimal attention control (AC) condition for treatment of pediatric trichotillomania (TTM).
The purpose of this study is to better understand the neural correlates of higher-order cognition, both in the healthy brain and in schizophrenia, and to determine how these mechanisms are modulated by transcranial direct current stimulation (tDCS) at frontal and occipital scalp sites. Testing the effects of tDCS at these scalp sites on cognitive task performance will help us understand the roles of the brain regions corresponding to these sites during higher-order cognitive processing (language comprehension, cognitive control, and related attention and memory processes). Behavioral and electrophysiological (EEG) measures will be used to assess cognitive performance. Our overarching hypothesis is that stimulating prefrontal circuits with tDCS can improve cognitive control performance, and ultimately performance on a range of cognitive tasks, as compared to stimulating a different cortical region (occipital cortex) or using sham stimulation. This study is solely intended as basic research in order to understand brain function in healthy individuals and individuals with schizophrenia. This study is not intended to diagnose, cure or treat schizophrenia or any other disease.
The purpose of this research study with a randomized controlled design is to examine the effects of prism adaptation treatment on two visual-spatial recovery components. After a stroke, an "internal GPS", locating where objects or people lie in a particular area of space, may be impaired. Alternately, a stroke may impair precise visual-spatial hand and body aiming movements. The research team wishes to discover whether prism adaptation treatment (two weeks of daily 20-min sessions of goal-directed movement with prism goggles) affects visual-spatial where or aiming errors selectively after stroke. This research represents one of the first attempts to apply what we know about the brain from neuroscience research, to modern clinical rehabilitation practices.
The goal of this clinical trial is to test the effectiveness of sport-based physical education (PE) curriculum on activity behaviors (moderate to vigorous physical activity and sedentary behavior), executive functions, and academic performance in elementary school-aged children, particularly among low-income ethnic minorities. The main questions it aims to answer are: * Whether a school-based sport program can improve child engagement in school-time moderate-to-vigorous physical activity (MVPA) and total daily MVPA, compared to a control group (standard PE class)? * Whether a school-based sport program can improve child executive functions and academic performance, compared to a control group (standard PE class)? Participants randomized to receive the ACtive Children Enhance LEaRning and AttenTION (ACCELERATION) intervention (treatment) received * 45-minute weekly for 10 weeks soccer (ball mastery exercises) curriculum led by trained PE teachers during the school PE lesson time. * Homework required practicing learned ball mastery skills daily for 15-20 minutes at home. A required ball was provided to them. * Virtual parent workshops, which required the attendance of parents of study participants to improve their understanding of all about the program Researchers will compare the control group, who received a regular PE class curriculum, to see if there are any differences in child activity behaviors, executive functions, and academic performance.
This study is being done to find out if a new series of evaluations called the SAE (Sensory-Attention-Executive) Battery can help researchers learn more about how cancer treatment does or does not change the way the brain processes/filters information, emotions, attention span, and behavior by comparing the results of the SAE Battery with traditional evaluations like questionnaires.
The purpose of this study will be to assess the attentional ability of patients with mild to moderate traumatic brain injury (TBI) using the functional Magnetic Resonance Imaging (fMRI) technique. Methodology for specific aim 1: sagittal pilot scan, 3-D anatomical MRI, Whole brain echo-planar imaging (EPI), and functional MRI techniques with traumatic brain injured subjects doing a Continuous Performance Test (CPT) attention task and compare the pattern of activation with those of normal controls to see if there is a failure to activate frontal lobes in the traumatic brain injured subjects.
A double-blind, placebo controlled study of solriamfetol for adults age 18 to 65 with diagnosis of Attention Deficit Hyperactivity Disorder.
The purpose of this study is to determine whether a controlled release formulation of mazindol is more effective than a placebo in the treatment of Attention Hyperactivity Disorder (ADHD) in adults.
Computer-based attention bias modification treatment (ABMT), which is brief, cost-effective, and easy to administer, targets a key mechanism in pathological anxiety - the threat bias, or exaggerated attention feared or threatening stimuli. It remains unclear how and for whom ABMT is effective, limiting clinical translation. The proposed research involves an RCT using a highly sensitive measure of neurocognitive functioning, scalp-recorded event-related potentials (ERPs), to delineate key mechanisms of an emerging treatment for anxiety. Researchers will recruit 90 anxious participants to engage in the study and pursue the following three specific aims: Aim 1 will examine relations between neural and behavioral responses to threat prior to ABMT. Aim 2 will examine the effects of ABMT on ERPs to threat, threat bias, and anxiety. Aim 3 will examine relations between ERP responses to threat and reductions in threat bias and anxiety. Researchers will test whether post-training neural changes, specified in Aim 2, are associated with reductions in behavioral threat bias and anxiety severity. Researchers will also explore whether ERP measures of greater attention capture and/or reduced control of attention to threat at baseline predict treatment response, helping identify which patients will benefit most from ABMT. Through the innovative combination of a highly sensitive neurocognitive measure and an RCT design, this study aims to delineate core neurocognitive responses to threat as mechanisms in the remediation of anxiety. Confirmation of study hypotheses would, ultimately, accelerate the pace of development of more biologically-informed, accessible, and targeted interventions for anxiety.
This project aims to develop an adaptation of the Collaborative Life Skills Program (CLS) that will be supported by mHealth technology. CLS is an evidence-based intervention for 2nd-5th grade children with ADHD that is delivered in schools through coordinated efforts among school mental health providers, teachers, and parents. School mental health providers are trained to coordinate evidence-based teacher- (i.e., Daily Behavioral Report Card) and parent-mediated (i.e., Behavioral Parent Training) behavioral interventions, and lead child social and organizational skills training groups. The adapted intervention, which integrates mHealth technology (CLS-M), will improve the usability, feasibility, and acceptability of CLS in schools with limited resources serving children from low-socioeconomic status (SES) and ethnic/racial minority (ERM) backgrounds, reducing disparities in access to evidence-based ADHD interventions in these populations. Barriers to service use in schools where low-SES and ERM families are most likely to receive services include logistical constraints (e.g., time, transportation, childcare, work schedules), perceptual barriers (e.g., cultural mistrust, stigma, perceived efficacy), and insufficient resources (e.g., staff, time, consultation support). Building on prior research, the investigators will develop and test a fully functional web-based mHealth application to support CLS-M that includes an integrated user portal for school mental health providers, teachers, and parents. The application will also include separate interfaces that support key features to facilitate each person's role in CLS implementation at school or at home, such as access to shared information about child assessments, goals, and automatically generated graphs of child Daily Behavioral Report Card performance. Messaging features will facilitate communication among school mental health providers, parents, and teachers, and calendar features that integrate with third- party calendar applications (e.g., Google Calendar) will facilitate scheduling, meeting tracking, and sharing links to third-party videoconferencing applications (e.g., Zoom). Based on stakeholder feedback from school administrators, school mental health providers, teachers, and parents, the investigators will work with mobile application developers to design a fully functional web-based mHealth application prototype to support the CLS-M protocol. the investigators will then test and refine the prototype through a series of individual usability tests and an open feasibility trial. the investigators will also collect formative data from stakeholders in rural schools in Imperial County to inform future research on adapting CLS-M for low-SES and ERM families served in this setting. Finally, the investigators will conduct a Hybrid Type I cluster randomized trial in 24 schools in a large urban school district, to evaluate whether CLS-M results in acceptable implementation outcomes and improved child outcomes in comparison to usual school services. The specific aims are to 1) Develop CLS-M and test its usability, feasibility, and acceptability among key stakeholders; 2) Collect formative data to inform future CLS-M adaptations for families living in rural settings; and 3) Evaluate CLS-M implementation and impact on child outcomes relative to typical school services.
The purpose of this study is to integrate digital health (dHealth) technology into the Collaborative Life Skills Program (CLS), an established, school-based behavioral intervention for students with ADHD, to make the program accessible to schools that serve students from low-socioeconomic (SES) backgrounds. Existing evidence-based interventions for students with ADHD are often inaccessible in schools with limited resources to support implementation. By adapting CLS to include a dHealth tool-CLS-D-investigators aim to improve the feasibility of intervention implementation in schools with limited resources and mitigate disparities in access to evidence-based interventions among students with ADHD who are from low-SES backgrounds.
The investigators propose addressing and evaluating the efficacy of a behavioral, contingency management app by conducting a randomized controlled trial (RCT) that will evaluate the app compared to a placebo app control group. Participants will be randomly assigned to immediate intervention using the treatment condition or to a placebo app condition. Participants will not know which condition they are assigned to until after the study completion; they will also not know that they are using the treatment app until after the study completion. The sample will consist of 100 families of school-age children (ages 6-12) who display significant behavioral problems. The treatment app is a task management platform containing a self-directed rewards system through which caregivers can assign token rewards to their children for completing routine tasks (e.g., cleaning their room, completing homework). Participants in the placebo app condition will have a similar user experience, however, tokens are assigned non-contingently (dispensed daily, rather than based on task completion). While participants will not be required to complete any tasks or behaviors in the app as part of their participation in the study, they will be asked to use the app at least once per day for 8 weeks. Given the self-directed nature of the treatment app (parents decide how frequently they access the app-based rewards system and how many tasks they assign to their child), parent involvement in the intervention will vary slightly in duration. However, based on the literature and routine practice, we anticipate parents will log in at least once a day to assign tasks to their child and follow up on completed rewards. Assessments (see details below) will occur at baseline, weekly during the intervention, and at the end of the study. The study will take about 8 weeks in total to complete once participants have been enrolled in the app.
This study uses different types of functional magnetic resonance imagining (fMRI) to generate individual transcranial magnetic stimulation (TMS) targets. During the TMS/fMRI imagining sessions, the investigators stimulate a target of either high or low regional controllability during a working memory task to investigate network responses and the impact of TMS on behavior.
Background: Children with attention deficit hyperactivity disorder (ADHD) often have cognitive problems. It may be hard for them to control their behaviors, concentrate for long periods, or make decisions. This can affect their education, friendships, and daily life. Virtual reality-based games may help improve cognitive skills in children with ADHD. It may also help change how the brain functions. Objective: To see if virtual reality-based games help improve thinking skills and brain function in children with ADHD. Eligibility: Children aged 8 to 16 years with ADHD. Design: We will first do a pilot study, meaning that everyone will receive the games. If this is successful, we will then conduct a randomized controlled trial, meaning that some participants will be randomly assigned to the full version of the games and some will be randomly assigned to a limited version. Participants will be screened. Their physical and mental health, medical and family history, and intellectual and emotional development will be evaluated. They will have tests of their mood, memory, attention, thinking, and behavior. Blood or saliva may be collected. Participants may have an MRI scan of the brain. Participants will receive a set of virtual reality games. The set includes 4 different games all played using a virtual reality headset. The participant will play the games for 20 minutes 5 days a week for 4 weeks. The parent or caregiver will start each game using an iPad. Each of the games is designed to help the participant practice specific cognitive skills. These include inhibition control, processing speed, temporal information processing, and working memory. Participants will have interviews each week. They will answer questions about motion sickness, eye strain, headache, and any other side effects, as well as number of game sessions played. Blood or saliva tests and the MRI may be repeated after the last game session. For the pilot, participants will have a final interview at the study end. For the full trial, a 1-month follow-up visit will be done by telehealth.