Treatment Trials

121 Clinical Trials for Various Conditions

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Maladaptive Anger Treatment
Description

From a psychoevolutionary perspective, anger is a universal emotion that can serve the function of making us aware of wrongdoing and motivating us to undo/correct the wrongdoing. However, it is well recognized in clinical psychology that anger can be maladaptive, often causing distress and impairment in various areas of day-to-day life; untreated maladaptive anger has been found to raise the risk of certain physical health problems e.g., hypertension and coronary heart disease. At the very extreme, rage has been implicated in aggression and violence. Not surprisingly, there has been a widespread quest for anger treatments or what is popularly called "anger management". One treatment approach that has received increasing empirical support is Cognitive Behavioral Affective Therapy (CBAT), which has been applied to patients with chemical dependence and individuals with chronic pain. To extend this programmatic line of research, the proposed research aims to evaluate the efficacy of CBAT in reducing multiple (psychometric and self-monitored) measures of anger within a community sample.

Conditions

Anger, Intermittent Explosive Disorder, Emotional Distress, Aggression, Violence

Mobile Anger Reduction Intervention
Description

Difficulty controlling anger is the most commonly reported reintegration concern among combat Veterans, especially those with a diagnosis of posttraumatic stress disorder (PTSD). Problematic anger is associated with significant functional impairment. In the current project, the investigators will compare the Mobile Anger Reduction Intervention (MARI) with a health education mobile intervention (HED) among Veterans with PTSD and problematic anger. Participants will be randomized to the MARI or HED condition. The hypothesis is that participants in the MARI condition will experience greater anger reductions and functional improvements relative to the HED condition.

Conditions

Posttraumatic Stress Disorder, Anger

The Peace of Mind and Body Project: Treatment Development of Yoga for Anger Management in Incarcerated Adults
Description

The investigators will conduct a pilot randomized clinical trial (n = 40) of hatha yoga vs. a health education group (attention control) for prisoners high in self-reported anger dysregulation. The investigators will assess feasibility and acceptability of the yoga program, the health education control group, and research procedures.

Conditions

Anger, Aggression

Chronic Pain, Opioids, and Anger Treatment
Description

The current US opioid epidemic is a pressing public health concern. Links between opioid misuse and mortality are well-known; nearly 70% of all drug overdose deaths in 2017 were attributable to opioids. Given their pain-relieving properties, opioids have been widely used in the chronic pain population who are also susceptible to misuse of these analgesics.. In chronic pain patients with anger, the pain as well as opioid use may be aggravated. For example, suppression of anger has been linked with increased pain sensitivity in experiments, while anger-hostility scores and internalized anger predict pain severity variance and pain intensity, respectively. Anger is also linked with drug use/abuse, including opioids. The goal of this research is to implement a state-of-the-art program for anger regulation in chronic pain patients., Called Cognitive Behavioral Affective Therapy (CBAT), this program is evaluated on multiple measures of anger, sensory versus affective measures of pain, and measures of opioid misuse. CBAT is expected to reduce anger, and thereby produce reduction in pain as well as shift attitudes away from opioid misuse..

Conditions

Anger, Opioid Use, Chronic Pain

Men, Mood, and Attention Study: Examination of Alcohol, State Anger, and Emotion Regulation Sexual Aggression
Description

Given the public health and social relevance of sexual aggression and the gap in the extant literature regarding state anger, emotion regulation, alcohol, and sexual aggression, the present study will contribute to our understanding of emotion regulation's role in sexual aggression perpetration. The proposed 2-year research plan will examine the effects of alcohol intoxication, state anger, and emotion regulation on men's sexual aggression intentions. This study will recruit non-monogamous, men (individuals who identify their gender as male and whose biological sex is male) who have sex with women, ages 21-35. While more research on female perpetrators is needed, the proposed study will exclusively recruit males for the following reasons: 1) the scientific literature indicating the majority of sexually aggressive acts are perpetrated by men; and 2) the current sexual aggression analog has not been piloted with female participants and would require preliminary experiments to determine its appropriateness. The study will utilize a 2x2 design in which participants are randomized to beverage condition \[alcohol (target BAC= .08gm%) or control (no alcohol control)\] and an emotion induction (anger induction or control). The outcomes will be assessed using a sexual aggression analog which participants will complete on the descending limb of alcohol intoxication and indicate the likelihood that they would engage in various sexually aggressive acts. The study also includes self-report measurements of state anger and emotion regulation to explore emotion regulation as a moderator in the associations among alcohol intoxication, state anger, and sexual aggression intentions.

Conditions

Alcohol Intoxication, Anger

Mobile Intervention for Veterans With PTSD and Anger
Description

Anger is the mostly commonly reported reintegration concern among combat Veterans, especially those with PTSD. Problematic anger is associated with significant functional impairment. In the current project, the investigators will pilot-test a newly developed mobile app, entitled Mobile Intervention for Reducing Anger (MIRA), among Veterans with PTSD and problematic anger. The project will compare the MIRA app to a contact control condition. The investigators hypothesize that Veterans with PTSD and problematic anger will find the MIRA app acceptable and will be willing to use it to reduce their anger difficulties and improve psychosocial and occupational functioning.

Conditions

Posttraumatic Stress Disorder, Anger

Mindfulness Treatment for Anger in Veterans With PTSD
Description

Research has consistently shown that Veterans with PTSD are more likely to experience higher levels of anger and commit aggressive acts compared to Veterans without PTSD. Given the significant negative impact that anger and aggression can have on the lives of Veterans, their families, and society at large, there is a great need to examine novel interventions that could decrease anger and aggression risk with this population. Mindfulness may be one such technique, given its effectiveness in assisting individuals in regulating difficult emotions and in decreasing physiological reactivity, which have both been implicated in PTSD and aggression perpetration. Findings showing that a mindfulness intervention is effective in reducing anger and aggressive behavior would be relevant for Veterans with PTSD experiencing such difficulties and would help prevent the detrimental consequences that can come from anger and aggression among these individuals.

Conditions

Anger, Aggression

SAD and MAD Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of TD-1473 in Healthy Subjects
Description

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses and multiple ascending doses of the investigational drug TD-1473 compared to placebo in healthy subjects.

Conditions

Healthy

Computerized Anger-Reduction Treatment for Smoking Cessation
Description

Problematic anger is a strong predictor of failed attempts at smoking cessation. The investigators proposed study seeks to evaluate whether a novel 8-session computerized anger-reduction treatment improves quit rates among smokers. Smokers with elevated trait anger will be administered transdermal nicotine patch therapy and either anger-reduction treatment or a control intervention. They will be assessed throughout treatment and up until three months after a scheduled mid- treatment quit date. The investigators propose to test whether, compared to the control condition, the anger-reduction treatment will lead to: 1) greater reductions in anger and 2) greater abstinence rates at post-cessation and at follow-up assessments. The investigators will also test whether changes in anger-related symptoms account for group differences in abstinence rates.

Conditions

Anger, Smoking Cessation

Treatment of Trauma-Related Anger in OEF/OIF/OND Veterans
Description

Excessive and poorly controlled anger is one of the most common problems experienced by war Veterans. The consequences can be severe, including increased risk for divorce, domestic violence, job loss and instability, and other serious impairments in family, social, and occupational functioning. Availability of effective treatments is critical to reducing the adverse effects of anger in Veterans. The investigators propose to conduct a controlled study to determine whether a cognitive behavior treatment that has been adapted for treating anger problems in Veterans of Iraq and Afghanistan results in improved outcomes compared to a supportive therapy. Results will be examined for improvement in anger, functioning, and quality of life at end of 12 weekly sessions, and at 3 and 6 months following treatment.

Conditions

Anger Problems

Remote Exercise for Learning Anger and Excitation Management
Description

The immediate objective of this project was to demonstrate the feasibility of Remote Exercises for Learning Anger and Excitation Management (RELAX). The application is a remote, technology- enabled, anger treatment and management system based on current evidence-based CBT interventions. The project's objective was to show that RELAX (1) enables the practice of anger management strategies remotely through mobile phone interfaces; (2) integrates with evidence-based treatments through the implementation of an existing CBT anger management course; (3) provides information, direction, and feedback through physiological sensors and signal analysis; and (4) supports communication and direction by the therapist through a web-based therapist interface.

Conditions

Anger, Stress Disorders, Post-Traumatic

Two Anger Management Programs for Teens.
Description

The general aim of the proposed pilot study is to evaluate the the efficacy of mind-body bridging (MBB) for anger management compared with the Real Deal anger management program, in helping adolescents control or reduce their anger.

Conditions

Anger, Hostility, Aggression

Controlled Evaluation of a Computerized Anger-reduction Treatment for Suicide Prevention
Description

The purpose of this study is to determine whether a computerized intervention designed to reduce anger-provoking interpretation biases will reduce suicide risk among individuals with elevated levels of trait anger.

Conditions

Anger, Suicidal Ideation

Anger Self-Management in Traumatic Brain Injury
Description

The present study addresses problematic anger and irritability in community dwelling persons with traumatic brain injury (TBI). It is designed to test the worth of a novel treatment approach called Anger Self-Management Training (ASMT), compared to a treatment offering supportive therapy focused on personal readjustment and education, the PRE (Personal Readjustment and Education). The project is a 3-center randomized controlled trial employing equivalent therapist time and therapeutic structure in the delivery of treatment options. The overall aim is to evaluate the relative response rate and correlates of treatment response for the ASMT as compared to the PRE.

Conditions

Traumatic Brain Injury

Anger Control Therapy (ACT) With RAGE-Control: An Outpatient Videogame-assisted Therapy for the Treatment of Anger
Description

The purpose of this study is to determine whether adding an interactive biofeedback video game to anger control cognitive behavioral therapy is an effective and feasible treatment.

Conditions

Anger, Aggression

Efficiency and Outcomes of Stress-Only Anger and D-SPECT Stress-Only SPECT MPI
Description

The purpose of this study is to compare clinical efficiency and patient outcomes using ultra low-dose stress only Tc-99m and solid-state SPECT versus traditional Anger SPECT.

Conditions

Coronary Artery Disease

Effectiveness of Anger Management Treatment in Reducing Anger-Related Behaviors in Female Juvenile Offenders
Description

This study will evaluate the effectiveness of an anger management treatment program, Juvenile Justice Anger Management for Girls, in reducing anger-related behaviors displayed by girls in the juvenile justice system.

Conditions

Anger

Anger Control Training for Youth With Tourette Syndrome
Description

This is a clinical study of a cognitive-behavioral therapy known as anger control training in adolescents with Tourette Syndrome and explosive, disruptive behavior. ACT is compared to treatment as usual (TAU) in a randomized clinical trial.

Conditions

Tourette Syndrome, Chronic Tic Disorder, Oppositional Defiant Disorder, ADHD

Treatment of Aggression, Anger and Emotional Dysregulation in Borderline Personality Disorder
Description

This study examines the effects of 12 months of dialectical behavior therapy (DBT) for subjects with borderline personality disorder on aggression, anger and emotional dysregulation. Treatment effects will be measured by changes in interview, self-report, psychophysiology testing and fMRI neuroimaging.

Conditions

Borderline Personality Disorder

A Pilot Study Comparing the Efficacy of Group Versus Individual Anger Management in Subjects With IED
Description

The purpose of this study is to see how different forms of "Anger Management" compare in reducing anger and impulsive aggressive symptoms in people. "Anger Management" is a common form of "talk therapy" used to help people with anger problems. There are different types of "talk therapy" used to help people for anger problems and this study will compare two types of talk therapy in people with Intermittent Explosive Disorder (IED). IED is a disorder in which there are frequent and sudden outbursts of anger (yelling, throwing and breaking things, hitting people) that lead to problems with other people socially or at work.

Conditions

Anger, Intermittent Explosive Disorder

SAD and MAD Study of FTX-101 in Healthy Male Subjects
Description

This is a Phase 1, first-in-human (FIH), single-center, randomized, double-blind, placebo-controlled study in healthy male subjects. The study will include the following 2 parts: * Part A: Single Ascending Dose (SAD) in healthy male subjects * Part B: Multiple Ascending Dose (MAD) in healthy male subjects

Conditions

Healthy Volunteers

Treatment of Chronic Anger and Aggression Following Military-Related Betrayal
Description

The goal of this clinical trial is to learn if a treatment designed to deal with anger and aggression from a past betrayal will work. The study will be done on active duty military service members and veterans aged 18 or older. The main questions it aims to answer are: * Will participants be satisfied with the treatment, and is the treatment feasible to do in a military outpatient setting * Will the treatment help with anger and aggression issues. Researchers will compare differences in groups that have different wait times (2-, 3-, or 4-weeks). Participants will complete surveys before, during and after the treatment. The treatment will be 14 modules given twice a week. About 1 month after treatment ends, surveys will be taken again.

Conditions

Anger Problems, Aggression

VH3739937 Phase 1 Multiple Ascending Dose (MAD) Study in Healthy Volunteers Including Relative Bioavailability (RBA), Optional Food Effect (FE), and Drug-drug Interaction (DDI)
Description

This study will assess safety, tolerability and pharmacokinetic (PK) of VH3739937 in healthy participants.

Conditions

HIV Infections

MAD of IVT VP-001 in PRPF31 Mutation-Associated Retinal Dystrophy Subjects (Wallaby)
Description

A Phase 1 Open-Label, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of Intravitreally Administered VP-001 in Participants with Confirmed PRPF31 Mutation-Associated Retinal Dystrophy

Conditions

Retinitis Pigmentosa 11, Retinal Degeneration, Eye Diseases, Retinal Disease, Retinal Dystrophies

A SAD and MAD Study of the Safety, Tolerability, and Pharmacokinetics of ATH-1105
Description

The goal of this Phase 1 interventional study is to assess the safety, tolerability and pharmacokinetics of ATH-1105 in healthy male and female participants.

Conditions

Healthy Volunteers

MAD Study to Assess the Safety, Tolerability, PKs and Efficacy of YJ001 for Spray Use in Patients With DPNP
Description

This Phase I, randomized, double-blind and placebo controlled study is to evaluate the safety, tolerability, and PK, and to preliminarily assess the efficacy of topically administered YJ001 in a multiple-ascending dose (MAD) fashion in the patients with DPNP. The study will be conducted at a single study center. In this study, 2 cohorts (N=24, 12 subjects for each cohort), each cohort will consist of 10 active and 2 placebo, with approximately equal numbers of male and female subjects. Each subject will be administered a single dose of YJ001 as multiple sprays topically on both feet and below the ankle in the morning on Day 1 and Day 2, and will be administered as twice daily doses once in the morning and the other in the evening (with an interval of 11 to 13 h) from Day 3 through Day 11.

Conditions

Diabetic Peripheral Neuropathic Pain

Mandibular Advancement Device (MAD) in Pregnant Women With Obstructive Sleep Apnea (OSA)
Description

We propose a single-arm trial to test the patient uptake and preliminary efficacy of MAD in a sample of 10 pregnant women with mild-to-moderate OSA. Study outcomes include patient-reported symptoms and objectively assessed sleep parameters assessed before treatment, during and after 10 weeks of MAD intervention (during pregnancy) and postpartum.

Conditions

Obstructive Sleep Apnea of Adult, Pregnancy Related

A Sequential Single and Multiple Ascending Dose (SAD/MAD) Study of SK10 Powders in Healthy Adult Subjects
Description

The purpose of this study is to assess the safety and tolerability of orally administered SK10 powders in healthy adult subjects at three dose levels, following single and multiple doses.

Conditions

Chemotherapy-induced Diarrhea

A 2-part Study Consisting of Multiple Ascending Dose (MAD) Safety Study, and a Dose-finding Masked Study to Assess the Safety and Efficacy of Intravitreal (IVT) EYE103 in Patients With Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD)
Description

EYE103-101 is a 2-part study assessing safety and preliminary efficacy of EYE103 in patients with diabetic macular edema (DME) given as monotherapy or neovascular macular degeneration (NVAMD) given in combination with anti-VEGF. In the first part, termed the multiple ascending dose (MAD) portion of study, the safety of EYE103 will be assessed at escalating doses. Approximately 12 participants will be entered in this part of the study. In the second part of the study, called the dose finding part two doses of EYE103 will be selected and their effectiveness will be compared. Approximately 80 participants will be entered in this part of the study.

Conditions

Neovascular Age-related Macular Degeneration (NVAMD), Diabetic Macular Edema (DME)

A First-In-Human SAD and MAD Study to Evaluate the Safety, Tolerability, PK and PD of SC Administered ALTB-268 in Healthy Volunteers
Description

This study with ALTB-268 will determine the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of ALTB-268 in healthy volunteers.

Conditions

Healthy Volunteers