109 Clinical Trials for Various Conditions
This study investigates whether the anxiolytic effects and anti-inflammatory properties of cannabis vary as a function of the ratio of CBD to THC, with the goal that these effects may shed light on the mixed data linking cannabis use and anxiety. Individuals with mild to moderate anxiety who elect to use cannabis (smoked flower or edible) will complete four weeks of observation. Participants complete cognitive tasks, a substance use history, health questionnaires concerning sleep and physical activity, and a blood draw at four different time points (Baseline, after 2 weeks of cannabis use, and immediately before and after self-administration after 4 weeks of use) with the use of a mobile pharmacology laboratory, which goes to a convenient location for each participant to self-administer their cannabis. Participants are then followed for five months to self-report on cannabis use, anxiety, subjective cognitive functioning, sleep quality, and other mental health symptoms.
A pre-post, single-group, quasi-experimental design will be used to determine the acceptability, feasibility, and appropriateness of a theory-based, 8-week/16-session virtual Tai Chi Easy (vTCE) intervention for adults with OUD, anxiety, and chronic pain. This dissertation has three Aims: 1) Determine the feasibility of an 8-week/16-session, vTCE intervention for adults with OUD, CP, and anxiety; 2) Determine the perceptions of the vTCE intervention participants by conducting a focus group interview post-vTCE; 3) Explore within-subject changes in generalized anxiety, chronic pain intensity, opioid use, opioid cravings, and basic psychological needs post-vTCE.
The purpose of this study is to evaluate, subjectively and objectively, whether playing music during procedures for treatment of chronic lower back pain has an effect on patients' anxiety and pain. The investigators hypothesize that playing music will result in reduced patient reported anxiety and pain scores and less variation from baseline of vital signs versus patients in the control group without music therapy. This is a pilot study.
This Nu-V3 clinical study is a randomized, phase II, open-label study evaluating the Nu-V3 cranial nerve stimulation treatment device in patients with chronic pain, anxiety, depression, and/or sleeplessness.
The Nu-V3 Clinical Study is a prospective, single-arm, open-label, multi-center study using the Nu-V3 cranial nerve stimulation treatment device in patients with chronic pain, anxiety, depression, and/or sleeplessness. For this Phase II study, a total of 100-200 patients at multiple centers will be registered for study participation. Study participants are those who have signed the informed consent form, met the inclusion and exclusion criteria, and are enrolled in the study at one of multiple sites. Enrolled participants are stratified based on their chronic pain, anxiety, depression, and/or sleeplessness symptom presentation at baseline and treated with the Nu-V3 device for 24 weeks. Interim analysis of reported data will be based on baseline stratifications and conducted at 6, 12, 18, and 24 weeks during this time. The participant will be evaluated after the initial 12-week treatment period to assess for further therapeutic need. Upon having three consecutive weeks of mean symptom reduction of ≥70% via patient reported numerical scales, the participant will continue as described in the study assessments table, but without device therapy. Then if the participant's primary symptom score increases at any time by ≥20%, they may again continue device therapy until week 24.
The purpose of this research is to test the feasibility of an intervention using biofeedback to treat stress and anxiety among individuals with tetraplegia. The expected duration of participation in this study is about 5 hours over the course of about 5 weeks. Participants will be randomly assigned to either a biofeedback training intervention or a control group. After completing questionnaires, participants will undergo physiological monitoring for the purpose of measuring heart rate and breathing. Those assigned to the biofeedback group will undergo 20 minutes of physiological monitoring while also participating in biofeedback training twice a week for 4 weeks (8 sessions) from home. Those assigned to the control group will undergo 20 minutes of physiological monitoring twice a week for 4 weeks (8 sessions) from home, but will not receive biofeedback training. Each session is expected to last 30 minutes to allow for completion of questionnaires over the the phone prior to and following each training session. It is hypothesized that the biofeedback intervention will demonstrate high feasibility and compared to those in the control group, participants who receive the biofeedback intervention will attain greater pre-post reductions in both physiological and self-reported stress.
The present study involves a randomized clinical trial of Digital Cognitive Behavioral Therapy (dCBT) targeting worry and anxiety symptoms in a population with chronic pain and clinical levels of generalized anxiety disorder (GAD) symptoms. The clinical trial calls for the recruitment and randomization of 80 individuals with chronic musculoskeletal pain and clinical levels of GAD symptoms to either a dCBT program or a waitlist (Control) condition. The current research represents the first-step investigation of a treatment strategy with the potential to enhance care for patients with chronic pain by introducing a scalable, affordable, and system-friendly digital intervention (dCBT) that targets a prominent source of distress and associated disability in these patients. The investigators propose that by targeting GAD in chronic pain in a way that does not tax engagement in ongoing medical care provision, there is the potential to improve the uptake of effective care and to address both GAD and associated distress and disability.
People with COPD have a greater risk for symptoms of depression, anxiety, and fear of breathlessness. Those emotions are independently associated with lower physical activity, poorer quality of life, and higher hospitalization and exacerbations; all independent predictors of survival and costs. There is a lack of treatment options to be routinely used in primary clinics for patients with COPD. Systematic reviews suggest that interventions that promote an accepting mode of response, such as mindfulness, might be more appropriate and effective for managing psychological distress in COPD patients, especially breathing-related anxiety. Hypothesis: A home-based 8-week Mindfulness-Based Stress Reduction (MBSR) for COPD targeted to individuals with symptoms of depression, anxiety, or fear of breathlessness delivered by a mindfulness coach using a combination of in-person sessions and remote video call sessions will be effective in improving emotional and overall quality of life, and measured physical activity.
There is a pressing public health need to develop novel interventions that aim to reduce alcohol consumption and concurrent alcohol among hazardous drinkers with comorbid chronic pain. The proposed study will draw upon NIH treatment development guidelines (Stage 1) to translate and innovate past work to address a major public health priority. Specifically, we propose to develop (Phase IA) and pilot test (Phase IB) a brief, integrated, single-session, computer-based personalized feedback intervention (PFI) designed to 1) enhance knowledge regarding adverse pain-related anxiety-alcohol interrelations; and (2) increase motivation and intention to reduce hazardous drinking.
The primary aim of this proposal is to refine the intervention under investigation (i.e., family-based CBT) and evaluate the feasibility and acceptability of the intervention and methods (e.g., recruitment, assessments). The secondary aim of this proposal is to compare the relative efficacy of an 8 session family-based cognitive-behavioral therapy (CBT) to Relaxation Training (RT) for reducing anxiety and chronic headaches in youth (N = 30) ages 7-17 years. It is hypothesized that CBT will result in greater reductions in both anxiety and headache frequency and severity compared to RT.
The objective of this study is to look at the effects of distractive auditory stimuli (DAS) on reducing dyspnea intensity and related anxiety and increasing exercise tolerance. Investigators hope that compared to a no-music control condition, that under a music condition participants with COPD will (a) demonstrate increased self-paced walk distance and enjoyment; (b) have less dyspnea intensity, (c) experience less dyspnea anxiety; (d) have less fatigue and state anxiety; and (e) higher maximum heart rate. The upbeat music with a tempo of 90 - 100 bpm (an average-to-moderate walking tempo) is expected to have distractive and performance enhancing effects in order to increase tolerance to dyspnea and exercise. The long-term goal of this study is to increase physical activity in adults with COPD and RLD by promoting dyspnea and fatigue management through use of distractive auditory stimuli in the form of music.
The purpose of this research study is to refine customized in-app notifications in order to optimize users' experience with a mobile app called Wysa for Chronic Pain. This app is designed to support people who have chronic pain and who also experience symptoms of depression and/or anxiety. This version of the app is not currently available to the public. Eligible participants will be asked to download and use the Wysa for Chronic Pain study app for several weeks, and to use it as they normally would if they were not part of a research study. At the beginning and end of the study period, participants will be asked to complete brief surveys about their mood, pain, physical function, and sleep. Additionally, a few participants will be asked to share their experience with the study app at the end of the research study in a casual interview using a secure audio/video recorded call. Participating in the interview portion is optional.
This clinical trial aims to evaluate the safety and efficacy of PROSOMNIA Sleep Therapy (PSTx) for individuals suffering from chronic insomnia, sleep deprivation, and REM sleep disorders. Chronic insomnia, characterized by difficulty falling or staying asleep, significantly affects patients and quality of life, mood, and cognitive function. REM sleep disorders, in which the body struggles to enter or maintain restful REM sleep, can worsen these issues. The trial introduces a novel therapy using anesthesia-induced sleep, targeting sleep homeostasis and improving sleep architecture. Objectives: The primary goals of the trial are to determine: 1. Whether PROSOMNIA Sleep Therapy increases the quality of REM sleep. 2. Whether PSTx increases the duration of REM and/or NREM sleep. 3. Whether PSTx decreases the time it takes participants to fall asleep (sleep onset latency). Participants will receive ONE (1) PROSOMNIA Sleep Therapy session lasting between 60-120 minutes. Each session uses Diprivan/Propofol to induce sleep, and is monitored via an EEG to ensure proper sleep stages, particularly REM sleep. Participant Criteria: Inclusion: Adults aged 18-65 with diagnosed or undiagnosed chronic insomnia or sleep deprivation. Exclusion: Patients with severe obesity, significant cardiovascular, neurological, or psychiatric conditions, or those with an ASA status above II. Study Design: This trial is non-randomized, single-arm and open-label, with all participants receiving the PSTx. The trial does not include a comparison group, as the focus is on evaluating the immediate, direct effects of the therapy. Participants will undergo continuous EEG monitoring during therapy sessions, allowing researchers to track brain activity and sleep stages in real-time. This method ensures that sleep cycles, particularly REM sleep, are optimized for therapeutic benefit. Therapy Methodology: PROSOMNIA Sleep Therapy leverages anesthesia to mimic natural sleep patterns and enhance the efficiency of REM sleep. Diprivan/Propofol is used to induce REM sleep, while EEG monitoring tracks and maintains proper sleep architecture throughout the session. The therapy promotes the clearance of adenosine, a compound that builds up during wakefulness and drives the need for sleep. Adenosine is cleared during REM sleep, reducing sleep pressure and improving cognitive function. Outcome Measures: Primary Outcomes: Researchers will measure the increase in REM sleep duration, improvement in sleep quality (via self-reported questionnaires), and a reduction in sleep onset latency. Secondary Outcomes: These include changes in mood, cognitive function, and blood serum uric acid levels. Patient-reported outcomes will also be tracked through tools like the PROSOMNIA Sleep Quiz, which is specifically designed for PSTx. Significance: Chronic insomnia and REM sleep disorders affect millions globally, leading to cognitive impairment, mood disturbances, and poor overall health. Traditional treatments, including pharmacological approaches and Cognitive Behavioral Therapy for Insomnia (CBT-I), often provide suboptimal results for many individuals. PSTx offers a novel, therapeutic approach to restoring sleep balance and enhancing the overall quality of sleep, particularly for those who have not responded to conventional treatments. Study Process: Recruitment and Baseline Assessments: Participants undergo a comprehensive sleep assessment, including sleep questionnaires and polysomnography, to establish a baseline for sleep quality and duration. Blood serum uric acid levels will also be measured to track any biochemical changes due to therapy. Therapy Sessions: Only one (1) PROSOMNIA Sleep Therapy session will be administered, with the session lasting between 60-120 minutes. Diprivan/Propofol is used to induce sleep, and EEG will monitor brain activity to ensure the proper balance of sleep stages. Post-Therapy Follow-up: Follow-up assessments will occur at 24 hours, 7 days, and 30 days post-treatment. Researchers will analyze the therapy effects on REM sleep, mood, cognitive function, and other health indicators. Potential Implications: If successful, this trial could revolutionize how we treat sleep disorders by targeting the underlying mechanisms of sleep pressure and REM sleep disruption. PROSOMNIA Sleep Therapy may offer a safe, effective, and immediate alternative for patients who have exhausted other treatment options. Key Concepts: Homeostatic sleep drive, (Process S), caused by adenosine buildup during wakefulness, is disrupted by chronic insomnia. This impacts cognitive function health and recovery. Anesthesia-induced REM sleep via PSTx helps regulate this homeostatic sleep stage, offering deeper and more restorative sleep compared to other sleep therapies. The study uses statistical methods like ANOVA and Chi-square to measure outcomes.
The lack of postpartum primary care coordination is a missed opportunity to increase primary care engagement and manage chronic conditions early in life, especially for the \>30% of pregnant people who have or are at risk for these conditions. This study aims to increase postpartum primary care engagement, quality, and experience by strengthening postpartum transitions to primary care using a behavioral economics-informed, multi-component intervention integrated into usual inpatient postpartum care. Using a randomized controlled trial and repeated outcome assessments through administrative and survey data, this study will generate rigorous, actionable evidence to ensure primary care coordination becomes standard postpartum care practice, potentially catalyzing sustained primary care engagement throughout life.
This study will determine the relationship of one's self-reported awareness of their body and their ankle motor control for people with chronic ankle instability. This study will further identify the correlates between certain psychological characteristics (i.e., fear and anxiety) and autonomic nervous system arousal (i.e., heart rate variability). Furthermore, this study will elucidate the potential impact of a brief hypnosis practice on balance performance.
The purpose of this study is to determine if the use of musical intervention reduces patient anxiety and provides a less painful experience during office-based procedures in a pain management clinic setting.
The goal of this study is to investigate a new treatment for chronic symptoms after concussion or mild traumatic brain injury in people aged 18-65 years old. Chronic symptoms could include dizziness, headache, fatigue, brain fog, memory difficulty, sleep disruption, irritability, or anxiety that occurred or worsened after the injury. These symptoms can interfere with daily functioning, causing difficulty returning to physical activity, work, or school. Previous concussion therapies have not been personalized nor involved direct treatments to the brain itself. The treatment being tested in the present study is a noninvasive, personalized form of brain stimulation, called transcranial magnetic stimulation (TMS). The investigators intend to answer the questions: 1. Does personalized TMS improve brain connectivity after concussion? 2. Does personalized TMS improve avoidance behaviors and chronic concussive symptoms? 3. Do the improvements last up to 2 months post-treatment? 4. Are there predictors of treatment response, or who might respond the best? Participants will undergo 14 total visits to University of California Los Angeles (UCLA): 1. One for the baseline symptom assessments and magnetic resonance imaging (MRI) 2. Ten for TMS administration 3. Three for post-treatment symptom assessments and MRIs Participants will have a 66% chance of being assigned to an active TMS group and 33% chance of being assigned to a sham, or inactive, TMS group. The difference is that the active TMS is more likely to cause functional changes in the brain than the inactive TMS.
Developed nations worldwide are currently enduring a health crisis, as chronic diseases continue to decrease quality of life and promote additional disease states or even death for much of the population. Rural populations are at a particular disadvantage, as they lack access to health clubs, wellness programs and similar resources that are more available in urban areas. Although pharmaceutical therapies have continued to show therapeutic advancements, the rates of disease onset and death from chronic disease has not seen similar improvements, and in fact continue to worsen. Excitingly, significant evidence has been published demonstrating an affordable, effective treatment to directly treat and prevent these chronic diseases, but few have demonstrated successful implementation of this therapy, which is improved lifestyle. Specifically, physical activity and healthy body composition are powerful therapeutics that have been demonstrated to effectively combat and prevent chronic diseases. Additionally, improving these lifestyle factors are often more effective than pharmaceutical interventions without the wide range of side effects. Unfortunately, barriers exist on multiple tiers in the practice of family medicine that demote the implementation of lifestyle medicine. To better serve patients at risk of, or suffering from chronic disease, the investigators are seeking to establish a lifestyle medicine prescription program for rural West Virginia. This program will provide patient education on the benefits of physical activity, body composition, and help patients identify strategies to implement healthy lifestyle choices that can be sustainable for the long-term. Patients will be advised on local opportunities to increase physical activity (yoga studio, martial arts, fitness facilities, aquatic center, etc.) and provided access to the facilities they are most likely to adhere to regularly. They will also be provided training on exercise techniques, equipment, and facilities to increase familiarity and comfort in these settings.
A study aimed to assess the efficacy of the various approaches to prescribing Ketamine currently in use off-label. The focus will be to include ketamine within the study plan of those with chronic conditions who are receiving ketamine.
Social psychological research has demonstrated that internalized stereotypes affect people's attitudes and behaviors. Music-based interventions that rely on stereotypes might have promise for keeping participants engaged in health interventions, reducing stress, and improving wellbeing.
The purpose of this study is to assess the therapeutic response to VR Solace in patients with chronic pain and anxiety using real-time clinical and survey data. Regression analysis of demographic characteristics, lab and survey data will be conducted to better understand the efficacy of VR Solace in treating chronic pain and anxiety. The investigator also aims to explore the possible association between the patient-reported changes in pain or anxiety levels with real-time physiological changes observed during VR Solace use.
This will be a prospective randomized controlled trial with sixty adults, 20 to 40 years of age. There will be three groups as follows: the normal group, control group, and intervention group where subjects will receive instructions for home use of TENS for pain reduction. The aim is for an equal distribution of males and females in each group.
Chronic pelvic pain (CPP) is a debilitating condition that disproportionately affects women Veterans (25% vs. 16% of civilian women). Predisposing factors include higher rates of strenuous physical activity during military service, duty-related injuries, psychiatric distress, and sexual trauma. CPP is associated with a high burden of illness, disability, and economic costs (estimated at $5.8 billion in annual health care expenditures). Multimodal, interdisciplinary approaches are emphasized in the treatment of CPP. Psychological interventions are essential for optimizing pain self-management for CPP. Psychosocial factors are known to affect pain intensity and recovery. Women Veterans report higher rates of depression and anxiety with CPP, that leads to greater disability and poorer quality of life. Cognitive and behavioral therapies, such as Acceptance and Commitment Therapy (ACT), are effective options for pain self-management. Barriers to effective pain treatment are high attrition and non-adherence. Additionally, women Veterans prefer treatments that address their gender-specific needs. Gender-specific services remain limited in the Veterans Health Administration (VHA). In line with VHA's priorities to expand women's health care, this study implements ACT in a brief intervention format to address a highly prevalent reproductive health issue among women Veterans. ACT is transdiagnostic and thus provides a unified approach to the treatment of co-occurring disorders, such as chronic pain, depression, and anxiety. Brief workshop formats increase treatment completion and patient engagement. This study seeks to adapt an existing 1-day ACT workshop for use in VHA integrated primary care (PCMHI) and specialty medical settings with women veterans experiencing CPP. Primary outcomes are feasibility and acceptability of the adapted intervention.
The aim of this randomized controlled trial (RCT) is to assess outcomes for virtual reality therapy (including pain intensity, pain interference, anxiety, depression, physical function, sleep, behavioral skills development, health outcomes and satisfaction) along with healthcare utilization and costs in participants with Chronic Low Back Pain.
This study will explore the use of Cereset Research for symptoms associated with refractory chronic nausea in patients with gastroparesis (GP) in a randomized, clinical trial.
The investigators are looking to conduct a study looking at the effects of cannabidiol (CBD) from Hemp Oil in patients with Chronic pain, anxiety and insomnia. It is believed that CBD will improve pain anxiety and sleep quality and reduce opioid use. The study will last a total of 4 weeks and involve onsite visits in addition to weekly pain assessments.
Adults and children undergoing medical care (inpatient or outpatient) often experience pain and anxiety either as a result of their medical condition or a side effect of medical procedures. The purpose of this study is to create a registry of patients using virtual reality (VR) mindfulness therapy through different aspects of their medical care to determine if VR mindfulness therapy is more effective than the standard of care (i.e., no technology based distraction) for treating or preventing anxiety and pain in adults and children suffering from chronic pain, GI conditions where pain is a common symptom, or undergoing any painful medical procedure (i.e. IV access, blood draws, endoscopy, surgery). The anticipated primary outcome will be reduction of pain and anxiety for both acute and chronic pain.
Prior literature demonstrates that human stress can be reduced with exposure to animals. This study challenges current dogma by introducing a widely available, low cost method of dog therapy to reduce patient and provider stress. The objectives of this study are to determine if interaction with a certified therapy dog and handler can; * decrease reported anxiety levels in emergency department (ED) patients, * decrease salivary cortisol in ED patients, * decrease total morphine equivalent dosing in the emergency department or at discharge and/or, * decrease reported stress levels in emergency department providers caring for participating patients when compared to usual care.
The overall goal of this study is to use the National Health and Aging Trends Study (NHATS) data to gain an understanding of how multiple chronic conditions impact the health outcomes of older adults with back pain.
As a potential solution to address high rates of depression and anxiety seen in epilepsy patients and poor mental health care access, this trial aims to carry out treatment for depression and anxiety directly in the epilepsy clinic. Patients that meet eligibility criteria, including significant symptoms of depression and/or anxiety, will be enrolled in the intervention. The intervention will consist of an initial prescription for an FDA-approved medication to treat depression/anxiety and telephone-based chronic care management plan for repeated symptom measurement and side effect surveillance. The purpose of this pre-piloting limited study is to streamline recruitment, intervention and outcome assessment process in preparation for a randomized, controlled pilot of the intervention.