Anxiety clinical trials in Boston

Anxiety-, obsessive-compulsive and trauma- and stressor-related disorders reflect a significant public health problem. This study is designed to evaluate the predictive power of a novel biomarker based on a CO2 challenge, thus addressing the central question "can this easy-to-administer assay aid clinicians in deciding whether or not to initiate exposure-based therapy?"

A within-subjects design will be used for this preliminary investigation of four biomarkers across two contexts of use: prediction of treatment response (i.e., stratification) and quantification of response (i.e., change).

The primary goal of this Phase 2 clinical trial is to determine the effects of a novel V1a receptor antagonist (NTX-1472) in adults with Social Anxiety Disorder (SAD). The main questions this trial aims to answer are: * Is NTX-1472 safe and well tolerated in adults with SAD? * How effectively does NTX-1472 treat adults with SAD? Researchers will compare the effects of NTX-1472 with matching placebo (a look-alike capsule that contains no drug). Participants will: * Take NTX-1472 or matching placebo every day for 8 weeks * Visit the clinic 6 times over the course of 14 weeks for checkups and tests

This is a randomized, double-blind, placebo-controlled crossover pilot study of single-dose intranasal oxytocin (6 IU and 24 IU) vs. placebo in adult men and women (aged 18 years and above) with arginine-vasopressin deficiency to evaluate the effect of oxytocin on anxiety, depression, and socioemotional functioning (Part A), with an optional randomized, double-blind, placebo-controlled 2-week repeated dose substudy of intranasal oxytocin 6 IU or placebo (Part B). Following a screening visit to determine eligibility, participants will return for three main study visits in Part A. During the main study visits, study participants will receive either oxytocin or placebo, followed by assessments of emotional behavior. In Part A, thirty participants will be equally randomized to one of six possible groups: 1. 6 IU oxytocin - 24 IU oxytocin - placebo 2. 6 IU oxytocin - placebo - 24 IU oxytocin 3. 24 IU oxytocin - 6 IU oxytocin - placebo 4. 24 IU oxytocin - placebo - 6 IU oxytocin 5. placebo - 6 IU oxytocin - 24 IU oxytocin 6. placebo - 24 IU oxytocin - 6 IU oxytocin Following completion of the Part A crossover portion of the study, in Part B participants may also choose to continue participation in an optional, randomized, double-blind, placebo-controlled substudy of intranasal oxytocin 6 IU or placebo three times a day for two weeks, followed by assessments of emotional behavior.

The aim of this study is to test the effectiveness of a single-session, digital intervention teaching the principle of practicing the opposite, when administered to youths on the waitlist for psychotherapy, with usual waitlist procedures as a control condition.

TRIAGE-Psych is a survey study designed to assess potential participants' eligibility to screen for industry-sponsored psychiatry clinical trials.

This is a randomized, parallel-group, double-blind, placebo-controlled, monotherapy study to evaluate the efficacy, safety, and tolerability of SPT-300 (GlyphAllo) in adults with major depressive disorder (MDD), with or without anxious distress.

This study is being done to see if nitrous oxide during vasectomy decreases pain and anxiety, and also assess whether patients have better satisfaction when they control their own level of nitrous oxide during the procedure. If we find that patients experience less pain or anxiety with nitrous oxide, it could be suggested that self-adjusted nitrous oxide (SANO) may be a useful tool for improving experience of care during vasectomy.

Patients who undergo cardiothoracic surgery often experience pain and anxiety around the time of surgery. Currently, treatments for pain and anxiety around the time of surgery include opioids and benzodiazepines, which can have severe side effects and can be ineffective. Interventions combining virtual reality with olfactory stimuli are a promising alternative to opioids and benzodiazepines in the treatment of pain and anxiety around the time of surgery. The aim of this study is to evaluate the feasibility of a virtual reality and olfactory stimuli multimodal intervention in patients undergoing cardiothoracic surgery. In addition, the investigators will evaluate the preliminary effects of the VR/OS intervention on patient pain and anxiety before and after cardiothoracic surgery. Patients who meet study inclusion criteria and are undergoing cardiothoracic surgery may participate in this study. Patients have an equal being assigned to undergo the virtual reality and olfactory stimuli intervention or continue getting usual medical care with their doctor. If the patient is assigned to receive the virtual reality and olfactory stimuli intervention, the first therapy session will take place approximately two to four weeks before surgery. This will involve wearing a virtual reality headset and scented necklace for approximately 10 minutes. The second session will occur 90 minutes before the surgery. Additionally, for each day the patient recovers in the hospital after surgery, the patient will receive one session in the afternoon. During the patient's in-hospital recovery at night, they will receive lavender scented therapy.

The purpose of this study is to pilot two resilience interventions for cardiac arrest survivors and their informal caregivers, Recovering Together after Cardiac Arrest 1 and Recovering Together after Cardiac Arrest 2 . The data the investigators gather in this study will be used to further refine the interventions.

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).

The goal of this study is to find the best way to help participants and families manage the stress of facing a serious illness and be better able to "bounce back" or be resilient after a difficult situation. Participants will take part in the "Promoting Resilience in Stress Management" PRISM program, which is designed to provide skills to change or improve the impact of stress in everyday life. The name of the intervention used in this research study is: -PRISM (a mobile app program comprised of 6 sessions of skills-based, manualized resilience education)

This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo as adjunctive therapy to GAD treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD who have an inadequate response to ongoing GAD treatment.

Aerobic exercise has emerged as an effective treatment to reduce sport-related concussion symptom severity, yet existing work lacks rigor regarding the precise exercise volume and intensity required to elicit therapeutic effects, how exercise can alter concussion-related pathophysiology, and whether exercise can prevent the development of secondary sequelae. Our objective is to examine if a high dose exercise program (higher volume than currently prescribed at an individualized, safe intensity level) initiated within 14 days of concussion results in faster symptom resolution, altered physiological function, or reduced secondary sequalae. Findings from this research will lead to more rigorous and precise rehabilitation guidelines and improved understanding about how exercise affects neurophysiological function among adolescents with concussion.

This study will determine the effects of pregnenolone on brain function, inflammation and depressive symptoms in people with HIV who have depression. Participants in this study will receive a pill of either pregnenolone or placebo, and can stay on their current antidepression medications. Brain imaging and behavioral assessments will be performed during the study.

The aim of this research study is to test the feasibility of a physical and mental health intervention (Positive Minds, Strong Joints or PMSJ) for Black adults with knee osteoarthritis (OA).

This project will evaluate a telemedicine-delivered, Unified Protocol for Cognitive-Behavioral Therapy (UP-CBT) enhanced with continuous glucose monitor (CGM) review to target anxiety and depressive symptoms and glycemic control in adults with type 1 diabetes.

The goal of this clinical trial is to learn whether a journaling intervention can reduce stress and anxiety in parents of children with urogenital conditions (such as differences of sex development and hypospadias). The main questions it aims to answer are: * Does guided journaling help to reduce anxiety levels in parents of children with urogenital conditions? * What are parents' perspectives on group-based writing interventions for future support programs? Participants will: * Complete a short anxiety questionnaire (the General Anxiety Disorder-7 scale) at the beginning of the study * Receive a physical journal with 5 writing prompts designed to help process emotions related to their child's condition * Complete 5 journal entries over several weeks, writing about their experiences and feelings * Complete the same anxiety questionnaire again after finishing the journal entries * Participate in a 45-minute interview to discuss how the journaling affected their stress levels and gather feedback on potential group-based writing programs

The investigators are doing this research to test whether parents of children ages 2-7 can better manage their child's anxiety by completing a brief, online, self-guided parent education program. One way to provide anxiety management skills to more children, and to potentially prevent worsening outcomes, is to offer online and self-guided educational programs that parents can complete without a clinician. This randomized trial will evaluate the effects of two brief, online, self-guided parent education programs designed to improve parents' understanding of anxiety and teach parents way to help their children cope with anxiety. Parents will be randomly assigned to one of the three programs. The main aim of the study is to examine whether the parent programs, compared to an educational control reduce parental accommodation of anxiety across a 1-, 4-, and 8-month follow-up period. As a secondary aim, the investigators will explore whether the parent programs reduce children's anxiety symptoms over the 8-month follow-up period. Results will inform the development of a scalable, low-cost model for promoting access to evidence-based treatment to young children.

There are few treatment options available for patients once they have failed standard psychopharmacological therapy for generalized anxiety disorder. Existing brain stimulation methods such as rTMS fail to target deep brain structures associated with anxiety disorders; structures such as the amygdala. In this double-blind sham-controlled clinical trial, the investigators propose to establish baseline severity of anxiety in 48 patients, then deliver eight treatments over four sessions of focused ultrasound stimulation to the amygdala. Anxiety severity will be assessed using standard psychometric scales after each session, and at follow-ups.