236 Clinical Trials for Various Conditions
This project will build on the investigators' work focused on early identification of ADHD, expanding to the development of a feasibility/pilot intervention involving early intervention for such infants. The investigators will evaluate the effectiveness of a telehealth-delivered, caregiver-implemented supportive intervention for infants/toddlers show early self-regulation difficulties.
Maternal sensitivity and contingent responsiveness to infant behavioral cues is an important contributor to infants' developing capacities to self-regulate. During early infancy, feeding interactions comprise a significant portion of mother-infant dyadic interactions and high-quality feeding interactions provide both nutritive and socioemotional benefits; recent data suggest that, for many dyads, mothers' sensitive responsiveness during feeding interactions is routinely impacted by the omnipresence of portable technology. The objective of the proposed research is to better understand the development and possible impacts of maternal technology use on infant feeding interactions, emotion and intake regulation, and sociobehavioral and growth outcomes.
The goal of this clinical trial is to test the feasibility and acceptability and compare outcomes of a trauma-informed prenatal intervention (TPI) in pregnant Black women with childhood adversity. TPI participants will receive four weekly individual virtual sessions of motivational interviewing to promote self-efficacy and mental wellness skills to enhance self-awareness and self-regulation. TPI is designed to foster behavior change and health coping by enhancing knowledge, beliefs, regulation skills and abilities. * With the assistance of a trained facilitator, participants will be guided to identify a specific goal related to the behavior they want to change. * Behavior change goals will be individualized to create a change plan that reinforces resilience-based coping, accountability, and self-care rewards. * Participants will learn to apply mental wellness skills to enhance regulation and to facilitate awareness of internal cues related to desire, motivation, and individual responses to stress. Researchers will compare usual prenatal care plus TPI versus usual prenatal care plus prenatal education to see if TPI reduces psychological (e.g., depression, anxiety, and perceived stress), and socio-emotional (e.g., mood, resilience, social support), and prenatal health behaviors.
Mood dysregulation and suicidal ideation are closely associated with disruption of sleep and circadian rhythms. Moreover, sleep problems and circadian disruption are commonplace features of military life. Critically, specifically timed light exposure plays a powerful role in regulating mood, circadian rhythms, and sleep-wake patterns. Therefore, we propose to conduct a large-scale clinical trial on the effectiveness of morning light exposure treatment for improving sleep-wake patterns, emotional and mental health, and suicidal thoughts in military personnel.
This study investigated the human-animal interaction (HAI) and bond (HAB) between a canine trained in therapy techniques or a canine plush toy and youth with autism spectrum disorder (ASD) during animal-assisted therapy (AAT) sessions. The purpose of this study is to explore identified gaps in knowledge pertaining to AAT in pediatric ASD care management by documenting human interaction between either a live canine or the plush toy canine during AAT sessions and evaluating prosocial behaviors observed during and after AAT sessions. This study addressed the following research questions: 1. How do children with autism ages 2 to 18 years interact with a live canine during AAT sessions? 2. How do children with autism ages 2 to 18 years interact with a toy plush dog during AAT sessions? 3. Is there a difference in HAI in the live canine group and the toy plush dog group? 4. Is there a difference in prosocial behavior observed during AAT sessions between the live canine group and the toy plush dog group? 5. Is there a difference in behavior after AAT sessions between the live canine group and the toy plush dog group? Participants were randomly assigned to either the live canine or toy plush dog group. Adaptive functioning and social responsiveness evaluations were obtained to compare baseline behavior between the two groups. Participants attended an AAT session once weekly for 6 to 8 weeks. Each group received the same therapy provided by the therapist; the only difference being the incorporation of a live canine during the therapy session. Caregivers completed a weekly assessment depicting participants' positive and negative affect at the beginning of each session. Caregivers also completed a monthly assessment noting strengths and difficulties in social functioning and behavior at the start of the first, middle, and final session. AAT sessions were recorded and behavior occurring during the sessions was coded to note HAI and HAB that occurred during the sessions.
Using the efficacious iTRAC intervention to enhance emotion regulation competencies as a foundation, this study will create and test iTRAC-HERO to teach emotion regulation skills in the context of sexual health education.
Concussions are incredibly common, and often result in severe and long lasting symptoms, including, but not limited to, sleep deprivation and emotion dysregulation. This study aims to demonstrate the therapeutic benefits of sleep extension (napping) on emotion regulation in individuals after they sustain a concussion. Thus, sleep extension may be a cost-effective, low risk, supplemental treatment for those with emotion dysregulation following a concussion. The main questions it aims to answer are: 1. Is a nap an effective way to improve emotion regulation in individuals with a concussion? 2. Does a nap reduce the required executive resources necessary to regulate emotions in individuals with a concussion?
This study will examine the relation between behavioral emotion regulation (ER) strategies at toddler age 3 to cognitive ER strategies in early adolescence as part of an ongoing longitudinal study of children\'s typical development. Aim 1 is to test whether self-soothing/caregiver-focused and distraction behavioral ER strategies at child age 3 predict avoidant and engaging cognitive ER strategies, respectively, at a follow-up assessment to be completed when children are 10-14 years old. In a completed wave of data collection, children\'s ER behaviors were elicited in laboratory tasks characterized by threat (novelty and uncertainty) at age 3. Avoidant and engaged cognitive ER strategies will be assessed by youth self-report, parent-report, and interviews with youth after they engage in new laboratory tasks characterized by mild threat. Hypothesis 1a: Self-soothing/caregiver-focused toddler behavioral ER strategies will predict avoidant cognitive strategies in early adolescence. Hypothesis 1b: The toddler behavioral ER strategy of distraction will predict engaged cognitive ER strategies in early adolescence. To provide additional developmental information, Aim 2 is to test whether child age at the follow up assessment (ranging 10-14 years) moderates the relation between behavioral ER strategies at age 3 and cognitive emotion regulatory strategies in early adolescence. Hypothesis 2: Because older children will have undergone more development underlying cognitive ER strategies, relations specified in Hypotheses 1a and 1b will strengthen across older ages. Finally, the Exploratory Aim is to test theoretically-supported individual (i.e., inhibited/fearful temperament) and environmental (i.e., family emotional environment) variables as potential mediators or moderators of the relation between behavioral ER strategies at age 3 and cognitive ER strategies in early adolescence. The investigators expect inhibited/fearful temperament to be involved in the link between behavioral ER strategies and avoidant cognitive ER strategies. The investigators expect the emotional family environment to be involved in linking behavioral ER strategies to both avoidant and engaged ER strategies.
The goal of this study is to extend the efficacy evidence of sustained release methylphenidate compound (JornayPM) in adults with Attention-deficit/hyperactivity disorder (ADHD). JornayPM has recently been approved for treatment of patients 6 years and older with ADHD; the release mechanism is unique among ADHD products in that it is taken in the evening, with effects in the morning upon awakening and then throughout the subsequent day. Of note, to date, there is no clinical data as to the tolerability or clinical effects or dosing in adults with ADHD; therefore the primary aim of this trial is to gather the first set of these data.
The goal of this clinical trial is to learn if mindfulness and yoga can improve attention, problem-solving, memory, emotional awareness, and impulsivity in preschoolers. The main questions it aims to answer are: Can a 30-minute, once-a-week mindfulness and yoga program (Calm \& Alert) over seven weeks in preschool classrooms increase emotional regulation during the school day? Can a 30-minute, once-a-week mindfulness and yoga program decrease negative behavioral incidences during the school day? Can a 30-minute, once-a-week mindfulness and yoga program increase prosocial behaviors like caring, sharing, and perspective-taking during the school day? Researchers will compare the effects of students who participated in the mindfulness and yoga program to students in classrooms who did not receive the program. Student participants will be asked to complete a short self-regulation task test before and after the mindfulness program. Teachers will rate the students on their prosocial behavior before and after the mindfulness program and record negative behavioral incidents over the study period.
The goal of this project is to test whether regulating emotions with help from a friend is more effective and long-lasting in adolescents than regulating alone, and to characterize age-related differences in the neural mechanisms supporting social versus cognitive emotion regulation. Participants will complete a psychology experiment while undergoing fMRI scanning.
The goal of this clinical trial is to test ALDER (Anxiety Lowering and Deprescribing through Emotion Regulation), an online self-guided positive emotion intervention, in patients over the age of 65 who are candidates for benzodiazepine receptor agonist (BZRA, commonly called benzos, or z-drugs) deprescribing. The main questions it aims to answer are: * Is ALDER relevant to and satisfactory for older adult BZRA users? * Does ALDER help to increase positive emotions and decrease anxiety, trouble sleeping, and use of BZRA medications? Participants will complete the 5-week online self-guided ALDER intervention as well as two survey assessments, one before the intervention and one after.
The goal of this clinical trial is to determine if a peer-delivered emotion regulation training (Brief-Unified Protocol) workshop is effective for preventing posttraumatic stress and other psychological health symptoms in firefighter trainees. The main questions it aims to answer are: * Do firefighter recruits who receive peer-delivered Brief-Unified Protocol report lower PTSD symptom severity over time compared to those who receive psychoeducation? * Do firefighter recruits who receive peer-delivered Brief-Unified Protocol report lower AUD, depression, anxiety, and functional impairment symptom severity over time compared to those who receive psychoeducation? * Do changes in neuroticism or emotion regulation mediate the effect of receiving the Brief-Unified Protocol on the treatment outcomes? Participants will: * Participate in a Brief-Unified Protocol workshop or psychoeducation workshop during fire academy training. * Complete a questionnaire prior to the workshop. * Complete a questionnaire immediately following the workshop and follow up questionnaires at 6, 12, 18, and 24 months after completing the fire academy. Researchers will compare firefighters who receive a peer-delivered Brief-Unified Protocol workshop to firefighters who receive peer-delivered psychoeducation to see if the Brief-Unified Protocol is effective for preventing posttraumatic stress and other psychological health symptoms.
The objective of this study protocol is to test whether intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to the inferior parietal lobule (IPL) can strengthen functional connectivity with a key region in emotion regulation (ER) neurocircuitry (anterior insula, AI) and improve performance on ER-related tasks in patients with bipolar disorder. Individual IPL sites for stimulation will be identified through baseline, pre-TMS functional magnetic resonance imaging (fMRI) scans. Patient-specific IPL subregions showing positive functional connectivity with the anterior insula and falling within the patient-specific frontoparietal control network will be used as individualized target sites for TMS stimulation. Patients will be randomized to receive 24 sessions of active versus sham iTBS to patient-specific IPL targets (6 sessions/day, 4 days, 43,200 pulses total). Post-iTBS resting-state and task-based fMRI scans will be acquired 3 days after the final day of iTBS administration (Day 4) following identical procedures as baseline. Effects of iTBS-TMS on ER will be evaluated by comparing pre-TMS versus post-TMS functional connectivity and behavior during performance on ER tasks.
The purpose of the study is to determine how the behaviors of cancer caregivers can impact patients.
Alzheimer's Disease (AD) and Alzheimer's Disease-Related Dementias (ADRD) not only exact a heavy toll on patients, they also impose an enormous emotional, physical, and financial burden on unpaid, often family, caregivers. The strain of providing care for a loved one diagnosed with AD, often across several years, is associated with elevated depression risk and poorer overall health. Emotion regulation skills represent an ideal target for psychological intervention to promote healthy coping in ADRD caregivers. The project seeks to use an experimental medicine approach to test the efficacy and biobehavioral mechanisms of a novel, relatively brief, targeted, scalable, smartphone-based cognitive emotion regulation intervention aimed at improving psychological outcomes (i.e., reducing perceived stress, caregiver burden, and depressive symptoms) in ADRD unpaid primary caregivers as well as examine potential benefits of the caregiver intervention on quality of life in care recipients. Cognitive reappraisal is the ability to modify the trajectory of an emotional response by thinking about and appraising emotional information in an alternative, more adaptive way. Reappraisal can be operationalized via two primary tactics: psychological distancing (i.e. appraising an emotional stimulus as an objective, impartial observer) and reinterpretation (i.e., imagining a better outcome than what initially seemed apparent). The project will investigate the efficacy and underlying biobehavioral mechanisms of a novel, one-week cognitive reappraisal intervention in this population, with follow-up assessments at 2 weeks, 4 weeks, and 3 months. ADRD unpaid primary caregivers will be randomly assigned to receive training in either distancing, reinterpretation, or a no regulation natural history control condition, with ecological momentary assessments of self-reported positive and negative affect, remotely- collected psychophysiological health-related biomarkers (i.e., heart rate variability data) using pre-mailed Polar H10 chest bands, and health-related questionnaire reports. Distancing training is expected to result in longitudinal reductions in self-reported negative affect, longitudinal increases in positive affect, and longitudinal increases in HRV that are larger than those attributable to reinterpretation training and no-regulation control training.
FOREST is a positive emotion skills program designed to target mental health and coping needs for frontline violence prevention workers at UCAN. Ten skills are taught over a period of nine months during existing meetings and wellness activities, as well as in online modules in UCAN's Learning Management System (LMS). Through infusing the FOREST skills throughout UCAN, we hope to inspire organizational culture change that will emphasize the importance of wellbeing and enhance resilience, therefore reducing burnout and turnover.
Crisis Response Planning is an efficacious, one-session intervention that increases positive affect, decreases negative affect and psychiatric hospitalizations, and reduces suicide attempts by 76% among Servicemembers. Crisis Response Planning is hypothesized to reduce suicidality by identifying a variety of personalized strategies that are designed to strengthen and/or promote emotion regulation processes.Research in nonmilitary samples suggests the effectiveness of emotion regulation strategies varies across situations. The applicability of these findings to suicidality among Servicemembers is unknown. Improved understanding of what strategies work under which circumstances and for whom will significantly advance our ability to prevent suicide among Servicemembers. Hypotheses include: 1. Use of self-management strategies, thinking about reasons for living, and seeking social support at time t will be associated with significant reductions in suicidal ideation at time t+1. 2. Use of distraction, reappraisal, and interpersonal emotion regulation strategies at time t will be associated with significant reductions in suicidal ideation at time t+1. 3. Affect intensity and social context will significantly moderate the time-lagged effects of Crisis Response Planning and emotion regulation strategy use on suicidal ideation. 4. Distinct profiles of demographic (e.g., gender, age), historical (e.g., prior suicide attempts), and psychological characteristics (e.g., emotion dysregulation, symptom severity) will predict who experiences a decrease in suicidal ideation following the use of Crisis Response Planning and emotion regulation strategies. 5. (Exploratory): Individuals who utilize their Crisis Response Planning more frequently and perceive Crisis Response Planning as more effective will be more likely to engage in mental health treatment at follow-up.
The goal of this study is to evaluate the feasibility and potential benefit of a behavioral intervention designed to improve emotion regulation in individuals with bipolar disorder. The intervention consists of game-like exercises that involve the 'Cognitive Control of Emotion (CCE) - i.e. the ability to control the influence of emotional information on behavior. Deficits in the cognitive control of emotion are a central feature of Bipolar Disorder that contributes to emotion dysregulation, maladaptive mood episodes, and, ultimately, the overall chronicity and severity of illness. Neuroimaging studies of bipolar patients demonstrate neural abnormalities in brain systems involved in cognitive control and emotion processing. Furthermore, these abnormalities predict mood and behavior problems associated with cognitive control of emotion, such as emotion lability, disinhibited behavior, and extreme mood states. The aim of this study is to determine feasibility and examine whether a computer-based program of progressively difficult cognitive control emotion exercises will improve cognitive control of emotion skills and, thereby, result in better emotion regulation and daily functioning in young adults with bipolar disorder. To test the intervention, a single group of young adults (18-30 years old) with Bipolar I Disorder will complete behavioral assessments before and after 20 hours (4 weeks) of CCE training. In order to identify baseline deficits associated with bipolar disorder, a comparison group of healthy young adults will complete behavioral assessments at a single time-point (without CCE training).
The proposed study is designed to first test whether teaching people personalized or standardized emotion regulation skills leads to greater decreases in daily negative emotion intensity. Second, using data from an initial sample, the investigators will prospectively assign an independent sample of participants to receive their predicted optimal or non-optimal skills to determine if it is feasible and efficacious to match participants to the most appropriate training condition. Results of these studies may identify the mechanisms by which emotion regulation interventions impact emotional functioning and allow for the development of personalized, evidence-based, and scalable emotion regulation interventions.
The goal of this study is to investigate the effects of a single bout of aerobic exercise on neurophysiological indices of emotion regulation and cognitive control in individuals with clinically significant PTSD symptoms. In this proposed study, 50 adult females with clinically significant PTSD symptoms will be randomized into two groups: a 20-minute moderate-to-vigorous intensity aerobic exercise group, or a 20-minute silent sitting control group. Prior to and following the exercise/sitting session, participants will complete a letter flanker task and an emotion regulation picture viewing task while their electrical brain activity is continuously recorded via electroencephalogram (EEG). Utilizing a multimodal assessment approach, cognitive control will be measured using behavioral (i.e., accuracy, reaction time) and neurophysiology (i.e., error-related negativity; ERN). Emotion regulation will be measured using self-reported and neurophysiological indices of emotional reactivity (i.e., late positive potential; LPP).
This study is an open trial designed to examine individual changes that occur before, during, and after 12 sessions of Emotion Regulation Therapy (ERT) delivered via telehealth for individuals in New York State who are experiencing elevated worry, rumination, or self-criticism.
The goal of the proposed study, is to adapt a positive emotion intervention for Alzheimer's Disease (AD) caregivers into a self-guided online format that incorporates social connection components and adaptive system feedback mechanisms to promote intervention adherence. Previous tests of the facilitated version of the program, called SAGE-LEAF (Social Augmentation to self-Guided Electronic delivery of the Life Enhancing Activities for Family caregivers), have shown efficacy for improving well-being in dementia caregivers. If effective, the SAGE-LEAF program can be disseminated to Alzheimer's caregivers nationwide through AD treatment and research centers.
This study will examine the effect of a real-time functional magnetic resonance imaging (fMRI) dyadic neurofeedback protocol with mothers and their adolescent daughters. Mothers in the experimental condition will view a moving bar showing their daughters' brain activity on a computer screen while talking to their daughters.
The proposed study will investigate the utility of a single-session emotion regulation training to reduce CVD risk among young adults diagnosed with MDD living in Southern MS. Using an single-arm, non-randomized design, young adults aged 18-29 will undergo a single-session emotion regulation skills training. Before and immediately after the skills training session, participants will supply several biological metrics tied to CVD risk: resting HRV, inflammation (measured via c-reactive protein \[CRP\]), and blood pressure. Participants will provide the same biological metrics at a one-week follow-up visit to assess short-term sustained gains following the single-session intervention and complete a 7-day ecological momentary assessment (EMA) of their daily emotion regulation skills use and depressive symptoms between these two visits.
This study will examine the relation between behavioral emotion regulation (ER) strategies at toddler age 3 to cognitive ER strategies in middle childhood/pre-adolescence as part of an ongoing longitudinal study of children's typical development. Aim 1 is to test whether self-soothing/caregiver-focused and distraction behavioral ER strategies at child age 3 predict avoidant and engaging cognitive ER strategies, respectively, at a follow-up assessment to be completed when children are 8-14 years old. In a completed wave of data collection, children's ER behaviors were elicited in laboratory tasks characterized by novelty and uncertainty at age 3. Avoidant and engaged cognitive ER strategies will be assessed by children's self-report, parent-report, and interviews with children after they engage in new laboratory tasks characterized by uncertainty. Hypothesis 1a: Self-soothing/caregiver-focused toddler behavioral ER strategies will predict avoidant cognitive strategies in middle childhood/pre-adolescence. Hypothesis 1b: The toddler behavioral ER strategy of distraction will predict engaged cognitive ER strategies in middle childhood/pre-adolescence. To provide additional developmental information, Aim 2 is to test whether child age at the follow up assessment (ranging 8-14 years) moderates the relation between behavioral ER strategies at age 3 and cognitive emotion regulatory strategies in middle childhood/pre-adolescence. Hypothesis 2: Because older children will have undergone more development underlying cognitive ER strategies, relations specified in Hypotheses 1a and 1b will strengthen across older ages. Finally, the Exploratory Aim is to test theoretically-supported individual (i.e., temperament) and environmental (i.e., family emotional environment) variables as potential mediators or moderators of the relation between behavioral ER strategies at age 3 and cognitive ER strategies in middle childhood-preadolescence. The investigators expect inhibited temperament to be involved in the link between behavioral ER strategies and avoidant cognitive ER strategies, effortful control to be involved in the link between behavioral ER strategies and engaged cognitive ER strategies, and the emotional family environment to be involved in linking behavioral ER strategies to both avoidant and engaged ER strategies.
Having a family member or loved one in the ICU can be a very stressful experience. The investigators have created a tablet-based tool (FAMCOPE-ICU) that is designed to help people in this position cope with this experience.
The study is designed to investigate the impact of three nights of sleep restricted to 4 hours per night, on the processing and regulation of emotional information compared to Insomnia Disorder and control. The investigators will address and attempt to answer two questions. (i) How do three nights of reduced sleep or a diagnosis of Insomnia Disorder affect the processing and regulation of emotional information compared to typical, undisturbed sleep? (ii) What overlapping and distinct neural mechanisms are engaged and associated with behavioral effects when attempting to process and regulate emotions in a sleep restricted state or with a clinical diagnosis of Insomnia Disorder? This study will investigate sleep's role in emotion processing and regulation. The findings will help further understanding of the role of sleep in healthy emotional functioning.
The research team recruited physicians (medical oncologists and specialty palliative care providers) trained in a communication tool called the serious illness conversation guide. Physicians conducted a simulated, telehealth serious illness conversation with an actor playing the role of a patient with advanced cancer. Physicians completed psychologic inventories before and after the encounter, documented the encounter using a template in the electronic medical record, and then participated in a structured interview afterwards discussing what they were feeling during the encounter and how it impacted the encounter. Physicians also wore three heart rate variability sensors during the simulated encounter.
This pilot study is designed to investigate the clinical outcomes and neural mechanisms of emotion regulation behavioral treatment , in a small sample of young adults diagnosed with autism spectrum disorder.