392 Clinical Trials for Various Conditions
This study will be conducted to determine the effect of daily Tetrasol consumption in supporting gut health using assessments of gastrointestinal symptoms (GSRS) and bowel habits (BSS) as primary outcome measures. The investigators also intend to explore fecal and blood biomarkers of intestinal permeability/function, determination of anxiety and stress levels through both validated assessments and saliva and blood biomarkers, establishment of intervention safety and tolerability through comprehensive metabolic panels and overall compliance, explore the effects of the intervention on inflammation and acute stress (Cold Presser Test), blood lipid profiles, and gut microbiota composition as secondary outcomes.
This study is a randomized controlled pilot trial using a hybrid type 1 effectiveness-implementation design to evaluate the feasibility, acceptability, and preliminary effectiveness of a brief cognitive-behavioral intervention delivered by medical assistants in a primary care setting. The trial compares clinical outcomes of participants assigned to the intervention condition to those of participants assigned to a usual care condition. The clinical outcome is change on a self-report measure of health anxiety. Assessments occur at baseline, four weeks, and 12 weeks post-treatment. The study will also measure engagement with the intervention and assess feasibility and acceptability of the intervention in terms of fidelity of trained study therapists and ratings of the intervention by participants. The usual care condition consists of a referral to a mental health provider. The intervention is comprised of four sessions of individually administered cognitive-behavioral therapy addressing health anxiety. Treatment focuses on building motivation for change, psychoeducation about health anxiety, cognitive restructuring, and situational and interoceptive exposure. The study will recruit from three primary care clinics within the Dartmouth-Hitchcock Health system. The study will also assess facilitators and barriers to implementation using qualitative analyses of interview responses provided by the medical assistants delivering the intervention, primary care providers, and clinic administrators at the study sites.
This randomized clinical on-line study examines whether whether a daily practice of meditation or Kundalini Yoga with anxiety reduction training leads to a greater reduction in anxiety than anxiety reduction training alone.
This prospective Medical College of Wisconsin Cancer Center study will evaluate stress levels in breast cancer patients undergoing genetic testing. It aims to establish baseline stress levels, evaluate pre- and post-test stress levels at multiple time points, focus on the changes in stress levels for the different resulting subgroups. This will help the clinical staff to provide better care for patients both medically and psychologically through potential interventions to decrease stress.
The investigators are interested in studying the effect of an animated video depicting a nail biopsy procedure on the anxiety, health literacy, and satisfaction of participants recommended to undergo a nail biopsy procedure. The investigators hypothesize that the animated video will reduce preoperative anxiety, increase health literacy, and increase patient satisfaction in relation to nail biopsy procedures.
This is a prevention intervention study that will examine the efficacy of a smartphone-based intervention in decreasing cancer risk by targeting mental health risk factors of anxiety and depression.
A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on feelings of anxiety and related health outcomes
The goal of this clinical trial is to evaluate whether digital cognitive behavioral therapy (dCBT) can be used to address clinical anxiety in marginalized and low-income pregnant people in California. The main question it aims to answer is: What is the efficacy of digital cognitive behavioral therapy (dCBTI) for reducing clinical anxiety among marginalized and low-income pregnant people? Participants will receive digital cognitive behavioral therapy immediately, or 10 weeks after enrollment (i.e., waitlist control). Participants will complete surveys and interviews until 6-8 weeks postpartum.
A randomized, double-blinded, placebo-controlled study assessing the impact of health and wellness products on feeling of anxiety, stress, and other health outcomes
The treatment of generalized anxiety disorder (GAD) in an accessible manner represents an unmet need for those with cardiovascular disease (CVD), given that patients with CVD experience numerous barriers for in-person treatment engagement. The research plan for the proposed pilot project will entail: (1) open study of the acceptability of the digital intervention (N=5), followed by (2) recruitment and randomization of 90 individuals with a history of acute CVD events and clinical levels of GAD symptoms to dCBT or a waitlist (Control) condition, using a 1.5:1 allocation (dCBT:Control).
This is a randomized control trial to test the effect of an anxiety sensitivity intervention on health behaviors among 18-35 year-olds.
This study will examine the efficacy of a computerized cognitive behavioral therapy (CCBT) program for children with anxiety disorders in community health centers. The first phase of the study will offer insight into the feasibility of providing this intervention in community health centers, while the second phase will compare CCBT to treatment as usual.
This interventional study will investigate the effect of daily use of a mindfulness app on measures of participant anxiety, well-being, and future outlook during the Covid-19 pandemic, by comparing pre-intervention survey responses to post-intervention survey responses.
A randomized, blinded, placebo-controlled, direct-to-consumer study assessing the impact of health and wellness products on feelings of anxiety, stress and other health outcomes
Brief Summary: Background: There is a growing demand for mental health services on college campuses. At the same time there has been a dramatic surge in development of mobile mental health apps. Given the widespread popularity and utilization of mobile apps in the college-age population, there is an opportunity to leverage these tools to improve services. The study aims to evaluate the effects of a mobile app on reducing symptoms of depression and anxiety for students awaiting their first visit at Harvard Counseling and Mental Health Services (CAMHS), and on enhancing recovery after beginning treatment. Methods: Students seeking an appointment at Harvard CAMHS who meet eligibility criteria will be randomized to receive one of two apps: a direct online social support (7cups) or an app that provides information about community, health, wellness, academic, and support resources on campus (Bliss). Participants will complete a baseline assessment using the PHQ-9 and GAD-7 and a measure of perceived social support. They will be asked to use their assigned app while awaiting their intake appointment and during treatment. The primary endpoint will be at 2 weeks after enrollment and the secondary endpoints at 4, 8- and 12 weeks after enrollment. At all endpoints participants will complete a PHQ-9, GAD-7 and a survey assessing their experience with the app. At the 8-week endpoint they will also be asked about their overall satisfaction with their care and their perceived social support. Results: Feasibility and acceptability of the app will be evaluated by analyzing usage metrics of the 7cups app, self-report satisfaction questionnaire as well as trial adherence. Changes in PHQ-9 and GAD-7 scores between the two groups at baseline, primary and secondary endpoints will be analyzed as well as associations between PHQ-9, GAD-7 scores and patient socio-demographic and social support variables. Mediators of change in symptoms including frequency of use, activities used on app and perceived social support will also be analyzed.
Dental and health anxiety are common and potentially distressing problems, for both patients and health care providers. Anxiety has been identified as a barrier to regular dental visits and as an important target for enhancement of oral health-related quality of life. possible groups, (1) high dental anxiety and (2) low dental anxiety. The study aimed to develop and evaluate a computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT) that could be easily implemented in dental healthcare settings. A cognitive-behavioral protocol based on psychoeducation, exposure to feared dental procedures, and cognitive restructuring was developed. A randomized controlled trial was conducted (N=151) to test its efficacy. Consenting adult dental patients who met inclusion (e.g., high dental anxiety) and exclusion criteria were randomized to one of two groups, (1) immediate treatment (IT) (n=74) or (2) a waitlist control (WL) (n=77).
Although mobile applications ("apps") for mental health are popular and widely available, little is known about how well they actually help people with common mental health symptoms of depression, anxiety, and stress. We are partnering with a commercially available app to test how well this app helps people's mental health over 8 weeks. Participants will be randomly assigned (like flipping a coin) to two groups: (a) using the app, (b) no app until after 8 weeks. We will ask participants to complete online surveys about their mood and well-being so we can better understand the effects of these different treatments.
The purpose of this research is to measure alterations in anxiety and brain activity associated with the use of an approved health device called Transauricular Vagal Nerve Stimulation (TaVNS) in distressed persons who work in a health care and distressed healthcare workers in the the Philadelphia, PA region. The Investigators will be using functional magnetic resonance imaging (or fMRI) to measure changes in each subject's brain function during the use of VNS. This study is designed to allow researchers to understand the changes in cerebral (brain) activity that occur when a subject uses VNS. Thus, the primary goal of the proposed study is to evaluate the ability of the TaVNS system to reduce distress and change neurophysiology among health care providers. The Investigators, hypothesize that using the TaVNS device will help reduce distress in individuals. In order to understand the mechanisms of change that occur while using the VNS study, the Investigators have added a substudy of participants who do not experience high levels of distress to evaluate the effects of the functional changes that may occur in the brain while using the TaVNS device. In addition to the primary aims of the overalll study to assess distress in workers while enrolled in a TaVNS program, a subgroup of 50 subjects will undergo functional magnetic resonance imaging (fMRI) while using the VNS device to assess the changes in the brain including neurophysiological effects of TaVNS. The goal of this substudy is to observe the changes in the brain while using the TaVNS earbuds in the MRI to increase our understanding of the mechanisms and processing involved while using TaVNS. In this substudy, which is amendment version 3.0, the investigators have increased the number of persons to include 50 subjects who will use the device in the MRI to evaluate the neural processes and cerebral blood flow while using TaVNS.
This is a pilot feasibility study of a mobile health tool (smartphone app) for primary care patients receiving treatment for depression or anxiety delivered in an integrated primary care-based behavioral health program.
The objectives of this study are to determine if the 'Teams Engaged in Accessible Mental Health Interventions for Lupus Erythematosus and Dermatomyositis Stress' (TEAM-LEADS) intervention is feasible and acceptable to adolescents and young adults with lupus and dermatomyositis and whether it can help reduce stress and promote cardiovascular health behaviors in these individuals.
The study involves multiple retrospective analyses to understand the utilization of mental health treatments provided at Greenbrook and their effectiveness
The goal of this study is to test the effectiveness of a stress self-management mobile health system (smartphone app + wearable sensor) alongside an intense physical cycling intervention to reduce symptoms of stress in a veteran population. The main questions this study aims to answer are: Does a mobile stress self-management system alongside intensive physical activity reduce the amount of physiologically detected, via machine-learning algorithm, stressful moments or PTSD hyperarousals? Can a mobile stress self-management system alongside intensive physical activity reduce symptoms of stress, anxiety, and depression on self-assessments like PCL-5, GAD-7, and PHQ-8? Participants will: Use a stress self-management system called First Watch Device (FWD) and confirm/deny detected stress moments on the app for a 2 month period. Use FWD self-management features as coping stragies for mental health and stressors for a 2 month period. Participate in the Project Hero 1-week Ride 2 Recovery Challenge events in the middle of the study.
Sub-clinical behavioral health services in the military are performed by BH technicians, who receive minimal training. Due to this, embedding more technicians in military units is unlikely to benefit service members. Giving technicians training in, and access to, evidence-based interventions (EBI) could make their work more effective. The proposed study is a training trial examining the efficacy of the full integrated operational support (IOS) toolkit (evidence-based interventions for behavioral health), relative to routine care using standard resources, as a prevention resource for active-duty airmen.
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.
We want to explore if emphasizing certain instructions (i.e. "bothered by") will affect the way participants respond to a questionnaire.
The goal of this clinical trial is to learn if Therabot-CALM (Cannabis, Anxiety, Low Mood) has acceptability among users and could work to improve the symptoms of persons with cannabis use disorder and anxiety and/or depression. The main question it aims to answer is: What is the usability, feasibility, and acceptability of Therabot-CALM in persons with Cannabis Use Disorder and Anxiety and/or Depression? Participants will * Take a screening questionnaire * Participate in two virtual 1-hour interviews to provide feedback on app design and suggest features. * Engage with Therabot-CALM in a 4-week clinical trial and provide feedback on their app experience in a third virtual interview
This project will examine changes in depression and anxiety following a 10-week intervention promoting nature-based physical activity in mental health settings. We will recruit ten licensed therapists whose caseload includes adults with depression and anxiety. Following a training by our team, each participating therapist will recruit six clients, who will be randomly assigned to the intervention or control condition. Clients in the intervention condition will engage in walk-and-talk therapy outdoors during weekly sessions and discuss strategies for being active outdoors on their own. We will assess changes in depression, anxiety, and nature-based physical activity in both groups.
* Statement of the Research Study. Participants are being invited to volunteer to take part in our research study. It is up to participants whether to choose to take part or not. There will be no penalty or loss of benefits to choosing not to take part or decide later not to take part. * Purpose. The reason that the researchers are doing this research is to evaluate the effectiveness and feasibility of administering a computerized anxiety intervention in a setting of five or more individuals. This intervention has already been tested and shown promise with individuals, and researchers want to see if it will function in a group setting as well. * Duration. Researchers think that taking part in our study will last approximately two hours, with an additional follow-up survey one month later to be completed at home via computer or smartphone. * Research Activities. Participants will first be asked to complete several questionnaires dealing with your thoughts and feelings. Once these questionnaires are completed, participants will be assigned to one of two groups, with each group viewing one of two computerized presentations and completing some group exercises afterward. Once participants have completed the designated intervention, participants will then be asked to fill out surveys once again, which will complete the study appointment. One month following the appointment, participants will be sent surveys once again and will be asked to complete them at home. Risks: The risks or discomforts to participants while taking part in this research include temporary distress or anxiety pr potentially feeling mild discomfort answering questions about your thoughts and feelings. Benefits: As a result of taking part in this research, participants may experience improvements in mental health.
This U.S. multicenter, double-blind, placebo-controlled Phase 2 clinical trial is designed to evaluate the efficacy, safety, and tolerability of a repeat intranasal (i.n.) dose of Fasedienol Nasal Spray (fasedienol) (3.2 µg) to relieve symptoms of acute anxiety in adult subjects ages 18 through 65 with Social Anxiety Disorder induced by a public speaking challenge (PSC) in a clinical setting. In addition, safety and tolerability of i.n. administration of 3.2 µg of fasedienol, as-needed, up to 6 times per day for up to 12 months, will be assessed in those subjects who complete PH94B-CL036 and choose to enter the distinct open-label extension phase of the study.
This study will explore how exercise affects brain chemicals called endocannabinoids, which may improve thinking skills and reduce feelings of stress, anxiety, and low mood in children and teens aged 9 to 17. Participants will take part in a single 30-minute activity session, where they will be randomly assigned to one of three groups: 1. Moderate-intensity exercise (walking or running on a treadmill at 50-70% of their maximum heart rate). 2. Light stretching (gentle movements at less than 40% of their maximum heart rate). 3. Seated meditation (relaxing without movement at less than 30% of their maximum heart rate). The investigators will measure endocannabinoid levels, thinking skills, and mood before and after the activity to see how these activities affect the brain and emotions.