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460 active trials for Anxiety

Effect of rTMS on Anxiety

Given the overall lack of treatment adherence/efficacy, side effects of drugs, and the substantial burden of anxiety disorders on the individual and on the national healthcare system, there is a critical need for mechanistic research into the CNS mechanisms that underlie these disorders. Accordingly, the objective of this grant is to use noninvasive neuromodulation to causally identify the key neural mechanisms that mediate the cognitive symptoms of anxiety. This project is relevant to public health because it has the potential to lead to novel repetitive transcranial magnetic stimulation treatments for pathological anxiety.

Start: October 2019

Premedication With Melatonin in Lumbar Medial Branch Block Procedure

Lumbar medial branch blocks are commonly used as a diagnostic tool for facet-mediated chronic low back pain. This interventional pain procedure often occurs in the fluoroscopy suite. During this procedure, a physician inserts the needles to deliver local anesthetics such as lidocaine or bupivacaine to the nerves which innervate the lumbar facet joint. Many patients experience anxiety before and during the lumbar medial branch block procedure and require intravenous midazolam or fentanyl for sedation. Intravenous or conscious sedation requires one-to-one nursing care, monitoring, and recovery. In order to minimize the costs and time requirements of intravenous sedation, a suitable oral medication which is readily available and non-controlled would be ideal. Several randomized double-blinded, controlled trials have investigated the anxiolytic effects of melatonin before a surgery; however no studies to date have studied the anxiolytic effects of melatonin before less invasive interventional pain procedures. This study is designed to evaluate the efficacy of melatonin for reducing anxiety in patients undergoing a lumbar medial branch block procedure. The study is a randomized, double-blinded, placebo-controlled trial with 40 patients in each group: 2 mg melatonin, 10 mg melatonin and placebo. The primary outcome is anxiety reduction in patients before undergoing the procedure. The primary outcome is measured by visual numerical rating scale for anxiety and the Amsterdam Preoperative Anxiety and Information Scale. Based on the results of previous studies, the investigators hypothesize that melatonin may reduce anxiety in patients undergoing the procedure and be a suitable alternative to intravenous sedation in the pain clinic for patients undergoing lumbar medial branch blocks.

Start: July 2016

Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients

This is a prospective, randomized clinical trial to investigate the clinical impact of a preemptive pharmacogenomics strategy to guide antidepressant therapy in cancer patients. Those enrolled onto the clinical trial will be randomized to either DNA-guided choice of therapy or clinical management alone. Scores on self-reported measures of depressive and anxiety symptoms along with quality of life will be compared between cohorts.

Start: September 2018

Effects of Digital Stories Intervention on Psychosocial Well-being

Patients and caregivers undergoing hematopoietic stem cell transplantation often continue to experience anxiety, depression, isolation, and other psychosocial distress. A narrative-based digital stories intervention has shown promise in a pilot study with breast cancer patients in helping to alleviate emotional distress. This study is designed to test digital stories to be viewed and discussed by other HCT patients/caregivers as a psychosocial intervention in a randomized controlled trial and to test the effects of digital stories on how 110 patient and caregiver dyads (N=220) undergoing one of the most rigorous and aggressive treatments cope with treatment-related distress through supportive open dyadic communication and emotional expression.

Start: September 2017

Anxiety and Symptom Burden in Hemodialysis Patients

Anxiety has been identified as a prevalent and significant co-morbid condition in patients with End Stage Renal Disease (ESRD) being treated with hemodialysis. In particular, anxious sensitivity to symptoms commonly experienced by dialysis patients may lead patients to prematurely terminate their dialysis sessions and may have consequences on their dialysis adequacy and overall quality of life. The proposed study will examine the relationships between anxiety, depression, quality of life, symptom burden and dialysis prescription adherence. The primary regression analyses will be used to predict the influence of anxiety and depression (independently and together) on measures of adherence behaviors.

Start: August 2019

Clinical Study of TEAS Intervention in Relieving Anxiety Before Thoracoscopic Surgery

At present, effective clinical intervention methods for anxiety mainly include anti-anxiety drug treatment, psychotherapy and acupuncture-related treatment. Most of the anti-anxiety drugs are benzodiazepines, which have a very direct sedative effect, but frequent use is prone to drug dependence, excessive sedation and other shortcomings. Psychotherapy is expensive and not well accepted by the general public. Acupuncture-related treatments are adopted by more and more doctors and patients due to its advantages of small adverse reactions and low costs. Acupuncture has the effects of relieving anxiety and reducing pain, and can play a great role in the perioperative period. Systematic reviews have found that acupuncture has a significant effect on anxiety, and it is better than the drug control group. At the same time, the acupuncture effect can also relieve postoperative nausea and vomiting and prevent postoperative discomfort. However, although acupuncture is used to relieve anxiety in neurology and neurosurgery, onychomycosis, gynecology and other clinical departments and has drawn considerable conclusions, acupuncture intervention relieves anxiety during the perioperative period of thoracic surgery. There is still a lack of systematic research on the efficacy evaluation. Transcutaneous Electrical Acupoints Point Stimulation (TEAS) technology originated from traditional Chinese acupuncture and moxibustion. It is a type of peripheral stimulation that delivers low-frequency pulse currents to the human body through the skin to achieve a therapeutic effect. In contrast, TEAS has the advantages of being non-invasive, easy to repeat, safe, and low in cost, and is easy to be accepted by patients. Therefore, replacing the traditional acupuncture technology with TEAS technology has a more unique advantage in clinical application. As chest CT examinations become more common, the detection rate of early lung cancer has gradually increased in recent years. As the mainstream treatment of thoracic surgery, thoracoscopic surgery is widely used clinically. Therefore, how to make the majority of patients undergoing thoracoscopic surgery have a better diagnosis and treatment experience is an urgent clinical problem.

Start: June 2021

Clinical Trial Using Pupillometry to Measure Nociception in Healthy Volunteers.

Pupillometry has been used in healthy volunteers to investigate the usefulness of the pupil light reflex as an indicator of pain intensity on pressure as a nociceptive stimulus. In this sense, it is necessary to check if the pupillometry is sensitive to different types or sources of pain. One of these devices is the Algiscan® portable pupillometer (IdMed, Marseille, France), which we propose to use in the present study. This pupillometer has previously been used in healthy volunteers, and in patients admitted to the intensive care unit, subjected to mechanical ventilation and sedation / analgesia. This study in healthy volunteers aims to evaluate whether the PDR can be a reliable and discriminatory measure of the intensity of nociception, applying various types of nociceptive stimuli. If so, this study could lead to the use of pupillometry as an objective measure of nociception in settings where patients cannot communicate, such as intensive care areas or perioperative settings.

Start: April 2021

Effects of Hypnosis Therapy on Outcomes in Shoulder Replacement Therapy

The purpose of this study is to collect information to evaluate the role of the psychogenic component of pain induced by anxiety on postoperative outcomes in major orthopaedic surgery and to determine whether hypnosis therapy provided during the perioperative period will lead to decreased use of opioid therapy. Patients are randomly assigned to one of two treatment groups: (I) usual care, or; (II) hypnotherapy treatment. Patients have an equal chance of being assigned to one of the two groups.

Start: December 2020

Improving Access to Child Anxiety Treatment

There is strong evidence that cognitive behavioral therapy (CBT) with exposure is the preferred treatment for youth with anxiety disorders, but outpatient services that provide this type of treatment are limited. Even for those who do have access to anxiety-specific treatment, a traditional outpatient model of treatment delivery may not be suitable. Among the numerous logistical barriers to treatment access and response is the inability to generalize treatment tools to settings outside of the office. Patient-centered (home-based or telehealth; patient-centered telehealth closed as of 5/1/21) treatment models that target symptoms in the context in which they occur could be more effective, efficient, and accessible for families. The present study aims to compare the efficacy, efficiency, and feasibility of patient centered home-based CBT and patient centered telehealth CBT with a traditional office-based model of care. The question proposed, including proposed outcomes, have been generated and developed by a group of hospital, payer, patient and family stakeholders who will also contribute to the iterative process of protocol revision. The investigators anticipate 379 anxious youth to be randomized to receive outpatient treatment using telehealth (patient-centered telehealth closed as of 5/1/21), home-based services, or treatment as usual using a traditional outpatient model. Results of this study are expected to provide evidence for the efficacy and efficiency of patient-centered treatment, as well as increase treatment access and family engagement in the treatment process.

Start: July 2018

Online Wellness Intervention for College Students

We are evaluating the effects of an online single-session mental health intervention (the Common Elements Toolbox; COMET). To evaluate COMET, we are conducting a randomized controlled trial with college students attending American universities. Students will be randomized to the COMET condition or to a wait-list control condition.

Start: March 2021

Evaluating Implementation Strategies to Scale-up Transdiagnostic Evidence-based Mental Health Care in Zambia

This study utilizes a Hybrid Type 1 multi-arm parallel group randomized control design to compare the effectiveness of an evidence-based treatment (CETA) delivered either in-person or via telephone, compared with a treatment as usual (TAU) control group, on improving adolescent and young adult (AYA) mental and behavioral health outcomes. The study will also gather information on counselor treatment knowledge, fidelity and competency following a technology-delivered training. Lastly, the cost associated with these strategies will be explored to inform future scale-up of training and services. This study will be conducted in Lusaka, Zambia and participants will be enrolled at four different levels: prospective CETA trainers, prospective CETA counselors, AYA clients, and research/organizational staff. AYA clients are the primary participant type.

Start: February 2020

The Moving 2 Mindful (M2M) Study: Mindfulness Group + Ecological Momentary Intervention

This study will evaluate the feasibility and acceptability of Learning to BREATHE (a mindfulness intervention for adolescents) plus an ecological momentary intervention (Learning to Breathe Plus), and will examine the extent to which mindfulness reduces dysregulated stress physiology, perceived stress, and anxiety in adolescents from high conflict homes.

Start: February 2021

Effects of Multi-day Interruptions in Sitting on Type 2 Diabetes-relevant Outcomes in Children

The overall objective of this in-lab randomized controlled trial is to test the efficacy of multi-day interruptions in sedentary behavior vs. single bouts of sustained exercise on metabolic, cognitive, and affective responses in children with overweight and obesity who are at risk for type 2 diabetes. The use of continuous glucose monitoring will provide insight into the daily and cumulative metabolic effects of each condition that have thus far not been studied. In-lab studies demonstrating sustained efficacy of this approach in ameliorating negative effects of sedentary behaviors in children are necessary for the optimization of field-based interventions. Given the lack of success of interventions to prevent obesity-related diseases and increasing rates of type 2 diabetes in children and its related healthcare costs, this study addresses a critical public health need by testing of novel intervention strategies to reduce obesity-related diseases in children with overweight and obesity.

Start: October 2021

Impact of Virtual Reality Distraction on Pain and Anxiety for Bedside Abdominal VAC Dressing Change

We aim to study the use of a virtual reality device (VRD) in addition to our standardized analgesic care protocol for abdominal bedside VAC dressing change and we hypothesize to decrease pain and anxiety and to increase patients' comfort by this intervention.

Start: April 2021

Green Light Effects on Anxiety

The main goal of this study is to determine whether exposure to a narrow band of green light (NBGL) improves outcome of psychotherapy sessions for the treatment of anxiety. This is a within-subject study design that examines NBGL effects (as compared to white light) on anxiety level and treatment success, as evaluated by the treating psychotherapist and the patient. For each participant, the study will consist of 8 therapy sessions, each lasting 60 minutes, in which light conditions will be presented in the following order Session 1: White light, Session 2: white light, Session 3: NBGL (i.e., green light), Session 4: NBGL, Session 5: NBGL, Session 6: NBGL, Session 7: White light, Session 8: White light Effects of lights (white vs.NBGL) on anxiety level will be evaluated at the beginning and end of each therapy session by the patient, using a validated questionnaire. At the end of each session, the treating psychotherapist will fill another evaluation form that summarizes her/his impression of the treatment success or lack of.

Start: May 2021

Development of a Patient Centered Mental Health Intervention for Recent Veterans

Recent Veterans of the OIF/OEF/OND conflicts are presenting in VA care with high rates of: PTSD, depression, anxiety, and alcohol abuse, reporting significant difficulties with community reintegration, and dropping out of mental health care at high rates. Surveys of recent Veterans show that Veterans want the VA to provide mental health care tailored to their concerns and reintegration priorities. The VA is committed to providing personalized, proactive, patient centered care (PCC); but little research or intervention development has been done on PCC in mental health care settings and preliminary research indicates Veterans may lack the skills and knowledge to be active partners in PCC. This study aims to examine PCC behaviors in VA mental health care and, informed by this data, develop a brief patient centered mental health intervention that will help recent Veterans take the lead in their care personalization and support their functional recovery. Results from this study will demonstrate the acceptability, feasibility, and preliminary efficacy of this intervention.

Start: July 2017

Associations Between Analgesia Nociception Index and Preoperative Anxiety

The management and prediction of pain is one of the most crucial jobs for anesthetists. It has been shown that a patient's ability to remain calm during stressful situations is related to their post-surgical pain scores. The MetroDoloris Analgesia Nociception Index (ANI) monitor is a heart-rate monitor that provides us with a number which reflects a patient's state of relaxation (or parasympathetic tone). For this reason, the investigators are testing whether ANI can be used as a metric for perioperative anxiety, and a predictive tool for pain after c-sections.

Start: February 2021

Computerized Substance Use and Depression Screening and Behavioral Treatment in HIV Primary Care

Substance use disorders (SUDs), depression and anxiety in HIV-infected patients result in poor HIV outcomes, yet are often unrecognized and untreated. To address these problems, this study examines the implementation and effectiveness of a clinical intervention consisting of self-administered tablet-based SUD and depression screening at routine HIV primary care clinic visits, followed by evidence-based treatments for SUD, anxiety and depression delivered by a behavioral health specialist. If successful, this study has potential to reduce SUD-, anxiety- and depression-related problems and reduce HIV treatment disparities for patients with these comorbidities.

Start: August 2017

Pharmacogenetically-guided Escitalopram Treatment for Pediatric Anxiety: Aiming to Improve Safety and Efficacy (PrEcISE)

This double-blind, 12-week study will consist include132 anxious youth who are randomized (1:1) to standard or pharmacogenetically-guided escitalopram dosing. Block randomization (1:1) will be stratified by sex and metabolizer status.

Start: December 2020

Improving Quality of Life for Veterans With Stroke and Psychological Distress

The study will create a treatment to improves mobility, physical activity, engagement in activities with family and friends and overall satisfaction with life for Veterans who have depression and anxiety after having a stroke. The treatment will then be tested to ensure it makes the desired improvements in the Veterans.

Start: November 2019