Treatment Trials

840 Clinical Trials for Various Conditions

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ENROLLING_BY_INVITATION
From Toddler to Early Adolescent Emotion Regulation Strategies
Description

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.

RECRUITING
Neuromodulation of Brain and Emotional Responses to Psychological Stress
Description

Investigators are conducting this study to test if temporarily and non-invasively stimulating the brain will affect the emotional response to stress in healthy participants. Participants will perform a series of tasks while completing an MRI scan. After this, participants will be randomized to undergo transcranial magnetic stimulation (TMS) at two visits, undergoing active stimulation at one visit and undergoing 'sham' stimulation at another visit. Immediately following both stimulation sessions, participants will repeat the tasks during MRI scanning.

Conditions
RECRUITING
Satisfaction With eMotion in a Diverse Group of Women
Description

The eMotion intervention, developed by the PI, provides training on multiple emotion regulation skills based on leading theories and evidence-based emotion regulation interventions. After initial pilot testing of eMotion, the investigators revised the intervention to make it more relevant to women from diverse backgrounds, as these women are disproportionately impacted by social determinants of health that complicate their recovery. It is important to revise the intervention to be acceptable to women from diverse backgrounds and to address their unique needs. The investigators want to explore if women from diverse backgrounds find the revised intervention relevant, meaningful, and easy to understand and apply to their lives. Their feedback will help investigators further revise the intervention to make it acceptable for this population.

COMPLETED
Emotion Regulation and Cancer Caregiving
Description

The purpose of the study is to determine how the behaviors of cancer caregivers can impact patients.

NOT_YET_RECRUITING
Emotion, Aging, and Decision Making
Description

Exercise is routinely recommended because of its benefits for physical, cognitive, and mental health. It is especially beneficial for older adults due to its potential buffering effects against Alzheimer's disease and related dementias (Luck et al., 2014). However, little is known about how to best encourage older adults to exercise. Based on behavior change theory, different intrapersonal and interpersonal motivational factors are likely to be relevant during the contemplation, action, and maintenance stages of behavior change. Generally, as a result of motivational shifts toward prioritizing positivity and socially meaningful goals with advancing age (Carstensen, 2006), socioemotional aspects of decision making may become more salient and influential for older adults (Mikels et al., 2015; Peter et al., 2011). Our previous work has demonstrated that positive affect (Mikels et al., 2020) and social goals (Steltenpohl et al., 2019) play a critical role in older adults' motivation to exercise, but these two lines of research have not been integrated to date. Recent work indicates that positive affect is particularly beneficial for health when shared in social connections (Fredrickson, 2016; Major et al., 2018), and the proposed work will, for the first time, examine how shared interpersonal positivity may impact exercise decision making and behavior, especially during the contemplation and action/maintenance stages of behavior change. But who are the older adults that benefit the most from exercise in terms of physical, cognitive, and mental health (and should be hence be targeted with messages)? Not all older adults reap the benefits of exercise (Sparks, 2014) and, conversely, sedentary older adults have the most to gain. Overall, the current proposed research program is innovative in its (a) translational application of insights from affective, cognitive, and aging theory and research to understand the antecedents and outcomes of exercise decision making in younger and older adults, (b) conceptualization of both the social and emotional aspects of decision making, (c) development of novel methods for health messaging that incorporate social influences, and (d) novel assessments of the exercise-health link.

ACTIVE_NOT_RECRUITING
Unified Protocol for Preventing Emotional and Academic Challenges in Education (U-PEACE)
Description

The purpose of the study is to evaluate the feasibility and effectiveness of a program for high school students with emotional and academic challenges U-PEACE and gaining feedback on that program.

Conditions
RECRUITING
Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons With Alzheimer's Disease
Description

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.

RECRUITING
Acoustic Stimulation, Sleep, and Cognitive-Emotional Processes in Young Adults with Anxiety and Depression Symptoms
Description

In this study, the investigators will recruit young adults (ages 18-25 years) with elevated anxiety/depression symptoms and sleep disturbance. Participants will complete two overnights in a sleep lab. During one of the overnights, slow-wave activity will be enhanced by delivering sub-arousal auditory tones during slow-wave sleep using a headband device (Philips SmartSleep or Dreem 2). During the other overnight, tones will not be administered. Cognitive and emotional processes will be evaluated using behavioral task performance, self-report, and functional magnetic resonance imaging (fMRI). After the second overnight, participants will take the headband device home and wear it every night for approximately 2 weeks. For half of the participants, the headband will play tones every night and, for the other half, the headband will not play tones. Participants will then return for a final testing visit in which cognitive and emotional processes and anxiety/depression symptoms will be assessed using behavioral task performance and self-report.

COMPLETED
Using Neuroplasticity-Based Computerized Training to Improve Emotion Regulation in Bipolar Disorder (BRAINS)
Description

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).

RECRUITING
Dynamic Neural Systems Underlying Social-emotional Functions in Older Adults
Description

Assess the impact of a remote, app-delivered digital meditation intervention on emotional well-being of lonely older adults. Neuroimaging, electrophysiological (EEG), and autonomic physiology will be used to assess the neural correlates of the intervention. EEG and autonomic physiology will be collected while participants watch 30 min of an awe-inspiring movie. fMRI and autonomic physiology will be collected in the context of a social exploration/exploitation task.

RECRUITING
The Effect of Sleep Loss on Emotion Regulation
Description

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.

ENROLLING_BY_INVITATION
Spatiotemporal Dynamics of the Human Emotion Network
Description

The overall goal of this study is to elucidate how emotion network dynamics relate to the behavioral, autonomic, and experiential changes that accompany emotions and to investigate how emotion network dysfunction relates to affective symptoms. Affective symptoms are a common feature of neuropsychiatric disorders that reflect dysfunction in a distributed brain network that supports emotion. How aberrant functioning in a single emotion network underlies a wide range of affective symptoms, such as depression and anxiety, is not well understood. Anchored by the anterior cingulate cortex and ventral anterior insula, the emotion network responds to numerous affective stimuli. The recording of neural activity directly from the cortical surface from individuals is a promising approach since intracranial electroencephalography (iEEG) can provide direct estimates of neuronal populations to map the spatiotemporal dynamics of the emotion network at a millisecond level resolution. This study will exam how activity within emotion network hubs changes during emotions and how emotion network properties make some individuals more vulnerable to affective symptoms than others. A multidisciplinary approach is critical for understanding the dynamic brain network to advance neuroanatomical models of emotions and for guiding the development of novel treatments for affective symptoms.

COMPLETED
Neural Mechanisms of Enhancing Emotion Regulation in Bereaved Spouses
Description

This study investigates the underlying mechanisms of a novel emotion regulation intervention among recently bereaved spouses. More specifically, this study examines how thinking about an emotional stimulus in a more adaptive way can affect the relationship between psychological stress, psychophysiological biomarkers of adaptive cardiac response, and brain activity. The emotion regulation strategy targeted is reappraisal, specifically reappraisal-by-distancing (i.e., thinking about a negative situation in a more objective, impartial way) versus reappraisal-by-reinterpretation (i.e., thinking about a better outcome for a negative situation than what initially seemed apparent). The study seeks to determine if relatively brief, focused reappraisal training in bereaved spouses will result in reduction of self-reported negative affect, increases in respiratory sinus arrhythmia (RSA; a measure of heart rate variability reflecting adaptive cardiac vagal tone), reduction in blood-based inflammatory biomarkers, and changes in neural activity over time. Reappraisal-by-distancing is expected to lead to greater changes in these variables relative to reappraisal-by-reinterpretation. Additionally, it is expected that across time decreases in self-reported negative affect, increases in RSA, reductions in blood-based inflammatory biomarker levels, and changes in neural activity will in turn lead to reductions in depressive symptoms and grief rumination. Finally, it is expected that distancing training will lead to reductions in depressive symptoms and grief rumination that are mediated by changes in the targeted neurobiological and behavioral mechanisms.

COMPLETED
Dairy Based Probiotic Intervention and Cognitive, Emotional, and Inflammatory Outcomes
Description

The purpose of this study was to determine the effect of dairy-based probiotics on cognitive function, emotional wellbeing, and inflammation. Subjects were assigned to either consume 6 oz of yogurt/day or abstain from consuming yogurt and other probiotic-containing foods for 12 weeks. Subjects completed baseline testing and 12-week follow-up testing consisting of a laboratory blood draw to assess inflammatory biomarkers, and a computerized assessment to evaluate cognitive and emotional wellbeing measures.

COMPLETED
Experiential Training in Eliciting Disclosure & Emotions for Mental Health Trainees
Description

Many people seek psychotherapy to alleviate symptoms related to trauma and stressful conflicts, and many psychotherapy approaches aim to help people process trauma and conflicts through eliciting client disclosure of these experiences and activating related emotions. However, many therapists avoid implementing such approaches because they are emotionally challenging for both the client and the therapist, and because therapists lack direct training in specific skills related to eliciting client disclosure and working with emotions. This suggests that providing therapists with a training experience that is experiential, includes direct supervision and feedback, and addresses therapists' reservations and anxieties may be an important approach to increase therapist skills in disclosure elicitation and emotional activation. This is a randomized trial that will test two methods of training (experiential vs. standard) of master's level psychotherapy students in specific therapeutic skills aimed at increasing trainees' emotional awareness and self-regulation and reducing trainee anxiety and avoidance of eliciting disclosure and working with emotions in psychotherapy. In the standard training condition, the trainee will receive a lecture about the skills including rationale and research background, examples, and opportunities to ask questions. In the experiential training condition, the trainees will receive information about the skills with examples and will have opportunity to practice using short video clips of actors portraying clients. The trainees will be asked to respond to the short clips using the skills they learned, and a trainer will process the trainees' reactions after they respond to each practice video clip and will provide feedback to the trainees about their performance on the practice. Findings from this study will provide information about the feasibility of training in specific disclosure elicitation and emotional activation therapy skills, and will provide information about whether or not live supervision will lead to greater improvement in the targeted skills compared to entirely standard training.

COMPLETED
Emotion Regulation Intervention to Sustain Physical Activity in Rural-dwelling Women and Men After Myocardial Infarction
Description

The purpose of this study is to evaluate early preliminary efficacy of the eMotion intervention in US adults who have experienced a first cardiac event and participating in phase II cardiac rehabilitation. This study will evaluate early efficacy and evaluate the cognitive processes as intervention response variables. Investigators will also examine the relationships between emotion regulation and other cognitive processes and symptoms (threat and stress, cognition and motivation), symptoms \[depression, anxiety, pain, sleep, and fatigue\]), and health related quality of life among adults enrolled in cardiac rehabilitation after a first cardiac event.

COMPLETED
Effect of Emotion Mindsets on Emotion Processing
Description

The guiding scientific premise for this research is that a growth emotion mindset will promote more adaptive emotion processing than a fixed emotion mindset. Because emotional sensitivity is particularly salient in adolescent girls, we will focus on this group. Using an experimental design, adolescent girls will be randomly assigned to either a mindset manipulation or a control group (brain education). Each group will complete a 25-minute computer-based lesson followed by a social stressor and a functional magnetic resonance imaging session. Two specific aims will be addressed: (1) to determine whether a growth mindset induction, relative to a control condition, predicts more adaptive emotion processing at the neural, behavioral, and psychological levels of processing; and (2) to determine whether neural processing of emotion accounts for the effect of a growth emotion mindset manipulation on behavioral and psychological processing of emotion. This study builds on a strong empirical database establishing the effect of mindsets on multiple domains of functioning but will be the first to examine the implications of a growth vs. fixed mindset about emotion for emotion processing in adolescent girls, thereby elucidating one specific youth attribute that can support or disrupt emotional development.

Conditions
COMPLETED
Men's Sexual Risk Behaviors: Alcohol, Sexual Aggression, and Emotional Factors
Description

Although correct, consistent condom use can greatly reduce sexually transmitted infections and unplanned pregnancies, resistance of condom use is common among young adults. Young men's alcohol intoxication and sexual aggression history are predictive of greater condom use resistance and other sexual risk behaviors (e.g., unprotected sex). Moreover, emotional factors may play a role in these associations, suggesting a promising avenue for continued research. This project builds upon our prior research through investigation of the emotional mechanisms involved in young men's alcohol-related sexual risk behavior. This research addresses a critical knowledge gap and advances the field through the use of multiple methods designed to evaluate distal and proximal emotional factors implicated in alcohol-related sexual risk. Male drinkers aged 21-30 who use condoms inconsistently (N = 420) will first complete a screening procedure followed by a baseline survey that will assess relevant constructs, including emotional traits, emotion dysregulation tendencies, and alcohol expectancies. They will then complete a 30-day daily diary assessment of their daily emotional states, daily coping motives pertaining to drinking and sex, and daily drinking and sexual risk behaviors to evaluate daily relationships among these factors. The same participants will complete an in-lab experiment assessing in-the-moment effects of alcohol intoxication and provocation on emotional states and sexual risk intentions. Statistical analyses will be used to examine the daily influence of emotional states and coping motives on alcohol consumption and sexual risk behaviors and the experimental effects of alcohol intoxication and provocation on emotional states and other mediators, as well as sexual risk intentions. Moderating effects of emotion dysregulation tendencies will also be examined, and the linkages between event-level and experimental relationships will be investigated. This research is both significant and innovative in that it will address the public health concern of men's sexual risk behaviors, including condom use resistance; will evaluate the role of emotional processes in men's alcohol-related sexual risk; and will use multiple methods to gather complementary types of data that will elucidate the mechanisms underlying alcohol-related sexual risk behaviors and provide an empirical evidence base from which to develop and inform prevention and intervention programs.

COMPLETED
Emotion Study/Substudy: Flexible Brain Study
Description

The proposed research applies the highly innovative technology of real-time functional Magnetic Resonance Imaging (rtfMRI) to examine plasticity of brain-regulatory mechanisms related to cognitive and affective processing and to determine benefits for cognition and affect in young and older adults and in Parkinson Disease (PD) patients.

COMPLETED
Emotion Regulation and Emotion Perception
Description

The purpose of this study is to assess the impact of a brief, emotion regulation intervention on the ability to perceive other people's emotions.

Conditions
RECRUITING
The Effect of Sleep Deprivation and Recovery Sleep on Emotional Memory and Affective Reactivity
Description

To further understand the impact of acute sleep deprivation and recovery sleep on the processing of emotional information the investigators will address and attempt to answer three questions, (i) how both undisturbed sleep and sleep deprivation affect the processing and retrieval of emotional information, (ii) what neural and psychophysiological mechanisms are associated with these behavioral effects, and (iii) to explore the ability of recovery sleep to reverse the effects of sleep deprivation. Together, these studies will provide a greater breadth and depth of knowledge concerning sleep's role in emotion processing and regulation. Given the growing societal tendency to view sleep as unproductive-foregoing it to lengthen work days and increase social opportunities- such knowledge would be of practical importance for understanding the role of sleep in healthy emotional functioning, particular for individuals experiencing periods of increased stress and emotional distress (e.g., new parents, hospital staff, or combat troops).

COMPLETED
Emotions Immunology and Breast Cancer
Description

Pilot study representing a proof of concept regarding the potential for immune system enhancement with psychotherapy, resulting in improved immunological response at lumpectomy or mastectomy in patients undergoing neoadjuvant chemotherapy.

COMPLETED
Neural Predictors of Social Emotion Regulation Training
Description

The purpose of this study is to investigate the basic psychological and neural mechanisms underlying the social regulation of emotion - that is, how one person's actions can impact, or regulate - the emotions of another person - and how this ability changes with practice. As such, this study is not designed to directly address clinical health outcomes and provide no treatment or intervention.

COMPLETED
The Effects of Emotional Exposure on State Anxiety
Description

A randomized repeated-measures crossover clinical trial was performed. Forty healthy, female college students completed a 30 min session of YogaFit and a time-matched seated rest condition on separate days. After each condition, participants viewed 30 min of emotional picture stimuli. State anxiety, heart rate and time-domain and frequency-domain measures of HRV were assessed baseline, post- condition, and post-exposure to emotional stimuli. Data were analysed using a condition x time (2 × 3) repeated-measures ANOVA.

COMPLETED
Researching Emotions And Cardiac Health: Phase III
Description

The focus of this study is to examine the feasibility, acceptability, and preliminary impact of a 12-week, telephone-delivered, positive psychology (PP)-based health behavior intervention in a group of patients with mild to moderate heart failure (HF), compared to a motivational interviewing- (MI-) based education condition and treatment as usual (TAU).

COMPLETED
Emotional Response in Psychiatric and Control Participants
Description

The purpose of this research is to understand how the emotions of people with different mental health concerns (e.g., people with schizophrenia, people with major depressive disorder) differ from individuals without mental health concerns. A large body of literature suggests that people with mental illnesses have emotional abnormalities compared to healthy individuals, but a number of these abnormalities are not well understood. For example, often people with schizophrenia report on questionnaires that they experience fewer pleasant emotions when talking with other people, but some evidence suggests these individuals report a similar amount of pleasant emotion when they are actually engaged in a pleasant activity. Thus, it is unclear the extent to which reports of emotional abnormalities extend to a more real-world setting. In the tasks in the current proposal, participants will engage in a series of tasks designed to assess their emotional functioning. These tasks involve viewing emotional stimuli on the computer, engaging in social interactions, and consuming small amounts of food. In all tasks, participants will make ratings of their experiences of pleasure (and displeasure). We will then compare the experiences of patient groups to those of healthy individuals to test how emotional ratings might differ across these tasks.

COMPLETED
Boosting Emotions & Happiness in Outpatients Living With Diabetes: Phase I
Description

The focus of this study is to examine the feasibility, acceptability, and preliminary impact of a customized, combined positive psychology and motivational interviewing (PP-MI) health behavior intervention in a group of patients with type 2 diabetes (T2D).

COMPLETED
Researching Emotions And Cardiac Health (REACH): Phase II
Description

The focus of this study is to examine the feasibility, acceptability, and preliminary impact of our customized positive psychology (PP)-based health behavior intervention in a group of patients with mild to moderate heart failure (HF).

COMPLETED
Differential Influences of Integral and Incidental Emotion on Cancer-related Judgments and Decision Making
Description

Background: Researchers are testing new methods for research projects. They want to see how people respond to different types of communication, including videos. They also want to learn how people respond to life events and how they pay attention to computer tasks. They want to learn about how various risks and threats affect the way people make decisions. Objectives: To learn how different stimuli and events affect the way people make decisions. Eligibility: Adults ages 18 and older with a U.S. computer address Design: Participants will be recruited online. Participants will take one of three studies online. Each study will take about a half hour. Participants in Study 1 will watch a short video from a popular movie then answer questions. They will also complete 2 questionnaires. One will be about how likely they think it is that they will experience different risks and threats. The other will be about goals for behavior change. Participants in Study 2 will write in detail about a life event. Then they will answer questions. They will also complete the same 2 questionnaires as Study 1. Participants in Study 3 will pay close attention to words and images on a computer. They will answer questions about attitudes toward different behaviors, products, and experiences. ...

COMPLETED
Researching Emotions And Cardiac Health
Description

The purpose of the study is to understand how positive emotions (e.g., optimism, happiness) are associated with health behavior adherence in patients with heart failure (HF), as well as whether performing exercises to improve positive emotions may help to improve health behavior adherence as well.