Clinical Research Directory

Clinician Supported Mobile App to Reduce Mental Health Symptoms Among World Trade Center Responders in Florida

This study examines mental health challenges among World Trade Center (WTC) General Responders, who continue to experience significant psychological trauma from the WTC collapse. PTSD and depression remain common, and nearly six percent of the WTC Health Program (WTCHP) cohort now resides in Florida. Many identify as Hispanic, underscoring the need for linguistically appropriate services. Research shows that remotely delivered, clinician-supported mobile applications can reduce mental health symptoms. PTSD Coach, developed by the Veterans Administration, is a free self-managed mobile app designed to help users manage PTSD symptoms through tools such as relaxation exercises, calming self-talk, and sleep hygiene practices. Reviews of the app have found it feasible, acceptable, and effective in reducing PTSD symptoms. Clinician-Supported PTSD Coach was designed for individuals unlikely to use the app independently. This model pairs the PTSD Coach app with four remote 20-30-minute clinician sessions over eight weeks. Studies with Veterans demonstrate reductions in PTSD and depression, higher satisfaction, and increased treatment engagement compared with usual care. However, these interventions have not yet been tested with WTC General Responders or Hispanic populations. This study will evaluate the feasibility, acceptability, and effectiveness of Clinician-Supported PTSD Coach in reducing PTSD, depression, anxiety, and sleep disturbances among English- and Spanish-speaking WTC General Responders in Florida. Participants will be randomly assigned to one of three conditions: (1) Clinician-Supported PTSD Coach, (2) Self-Managed PTSD Coach, or (3) Waitlist Control. Assessments at 8 and 12 weeks will measure symptom reductions and examine engagement, satisfaction, and barriers within the app-based conditions. It is expected that both interventions will reduce symptoms, with greater improvements in the clinician-supported condition. This project addresses a critical gap in evidence-based mental health treatments for dispersed WTC Responders and responds to the WTCHP Scientific/Technical Advisory Committee's call for more research on mental health interventions. By focusing on Hispanic and Spanish-speaking Responders-an understudied group-this study may support the development of scalable, app-based interventions that can be deployed nationally to meet the mental health needs of WTC responders and survivors.

Sleep Promotion Program Primary Care

Investigators developed a brief, scalable, behavioral Sleep Promotion Program (SPP) for adolescents with short sleep duration and sleep-wake irregularity, which relies on two individual sessions and smart phone technology to deliver evidence-based strategies. This R34 will test the feasibility and initial effectiveness of the SPP program and provider training via pilot randomized controlled trial (RCT, n=50) comparing SPP to Sleep Psychoeducation, a brief session on healthy sleep habits. Participants will be adolescents (12-18 years) with short sleep duration, sleep-wake irregularity, and depression.

iACT & iTBS for Sleep Quality in Depressed Adolescents

This study evaluated whether combining an internet-delivered Acceptance and Commitment Therapy program with intermittent theta burst stimulation improves subjective sleep quality in adolescents with depressive disorders and sleep disturbances. Acceptance and Commitment Therapy is a psychological treatment that teaches skills for accepting difficult thoughts and feelings, reducing unhelpful struggle with them, and taking actions consistent with personal values. Intermittent theta burst stimulation is a brief, noninvasive form of brain stimulation delivered over the left dorsolateral prefrontal cortex. A total of 152 adolescents aged 11 to 19 years were randomly assigned to one of four groups: combined internet-delivered Acceptance and Commitment Therapy plus intermittent theta burst stimulation, internet-delivered Acceptance and Commitment Therapy alone, intermittent theta burst stimulation alone, or a waitlist control group. Treatment was provided over 12 consecutive days. Participants completed assessments before treatment, immediately after treatment, and 30 days later. The study was registered retrospectively after participant recruitment and data collection had begun. The primary outcome was subjective sleep quality, measured with the Pittsburgh Sleep Quality Index. Secondary outcomes were depressive symptom severity and psychological flexibility. The study also assessed treatment exposure and adverse events, including headache or scalp discomfort associated with brain stimulation.

Radicle RestTM VGI: A Study Assessing the Impact of Health and Wellness Products on Sleep and Related Health Outcomes

Radicle RestTM VGI: A randomized, double-blind, placebo- controlled study assessing the impact of health and wellness products on sleep and related health outcomes.

Community-Engaged Sleep Intervention for School-Aged Children With Autism Spectrum Disorder

As many as 78% of children with autism spectrum disorder (ASD) have significant sleep disturbance compared to 20% of children without ASD. In children with ASD, shorter sleep duration and lower sleep efficiency, are associated with disruptive behavior, anxiety, and increased parental stress. Therefore, multiple sleep dimensions (B-SATED: behaviors, satisfaction, alertness, timing, efficiency, duration) are appropriate therapeutic targets to improve daytime behavioral functioning and other psychosocial outcomes. The primary objective is to evaluate the implementation of a modification of a behavioral sleep and circadian intervention to improve multiple sleep dimension in school-age children with ASD. To accomplish this objective, a 12-week, randomized pilot study will be conducted to assess the feasibility, acceptability, and preliminary efficacy of a modified behavioral sleep and circadian intervention with up to 50 school-age children with ASD, to determine whether the intervention improves multiple dimensions of sleep (B-SATED: behaviors, satisfaction, alertness, timing, efficiency, duration), daytime behavior, quality of life, parental stress, and parental self-efficacy. This modified intervention is guided by the Pediatric Sleep Health Framework that encourages improvement in six pediatric sleep dimensions (B-SATED): sleep behaviors; parents' satisfaction with child sleep; daytime alertness/sleepiness; appropriate timing of sleep within the 24-hour day; sleep efficiency, i.e., ease of falling and staying asleep; and sleep duration. The Sadeh and Anders Sleep-Wake Regulation Model was used to propose linkages between outcomes. The investigators hypothesize that parents implementing the modified intervention will improve the primary outcome (clinician- and parent-ratings of child sleep) and secondary child (sleep dimensions, daytime behavior, quality of life) and parent outcomes (stress and self-efficacy).

Mindfulness-Based Intervention for Pain and Sleep in Adolescents and Young Adults With Sickle Cell Disease

This study examines the feasibility and acceptability of a mindfulness-based mobile intervention designed to support pain and sleep management among adolescents and young adults with sickle cell disease. Chronic pain and sleep problems are common in this population and can negatively affect daily functioning and quality of life. Participants will use a smartphone-based mindfulness program that includes structured modules and guided mindfulness exercises over an approximately 8-week period. The study aims to evaluate whether the intervention is feasible and acceptable for adolescents and young adults with sickle cell disease.

RCT of a Weighted Blanket to Reduce Pain in Veterans With Chronic Pain

Chronic pain is a major health concern for returning Veterans and is associated with decreases in quality of life. In addition, chronic pain is often accompanied by significant disturbance in sleep. Sensory interventions may offer effective, low-cost complementary tools for chronic pain and sleep disturbance in Veterans. Weighted Blankets (WB)- blankets sewn with weighted material inside to provide widespread pressure to the body- are a low-cost wellness product used for anxiety and sleep. WBs have demonstrated large reductions in insomnia, and the investigators have also shown that they can reduce the severity of chronic pain. However, effects and mechanisms of longer WB use have not been examined in individuals with pain and sleep disturbance. The investigators therefore propose a randomized controlled trial examining the effects of WBs on pain and sleep quality in Veterans. the investigators will recruit Veterans with chronic pain and sleep disturbance from the VA San Diego Healthcare System (VASDHS) and VA San Francisco Healthcare System (VASFHS) and randomize 160 Veterans to receive either a light (3-lb; N = 80) or heavy (15-lb; N = 80) blanket. The investigators will remotely collect measures of pain (primary), pain catastrophizing, and pain medication use, as well as sleep disturbance (primary) and sleep efficiency and total sleep time over 6 weeks of overnight home use of the assigned blanket. The investigators will also explore physiological effects of WBs on sleep quality using actigraphy (exploratory) in VASDHS participants. Ecological momentary assessment (EMA) methods will be deployed via smartphone to capture study adherence.

NeuroFinance Human Stress Trial During Financial and Informational Volatility

The NeuroFinance Human Stress Trial (NFHST-2026-001) is a decentralized observational clinical study designed to evaluate how financial market volatility, economic uncertainty, digital media exposure, and information-driven stress environments affect human physiologic and behavioral health. Participants will undergo remote monitoring using wearable biosensors, cardiovascular telemetry devices, sleep tracking systems, heart rate variability monitoring, and behavioral analytics platforms. The study will use artificial intelligence and machine learning systems to analyze relationships between external financial and informational events and biologic stress responses, including autonomic nervous system activity, sleep disruption, cardiovascular strain, emotional resilience, and inflammatory signaling. The goal of the study is to develop predictive digital biomarkers and AI-assisted forecasting systems capable of identifying stress-related physiologic deterioration before clinical manifestation.

Racial Differences in Circadian and Sleep Mechanisms for Nicotine Dependence, Craving, and Withdrawal

The number one preventable cause of death in the world is tobacco use. Cigarette smoking in particular, costs an estimated $300 billion due to expenses related to medical care and lost productivity. Despite similar smoking prevalence rates, blacks suffer disproportionately from smoking-related harms compared to whites.Sleep disparities such as shortened sleep duration, shorter circadian periodicity, earlier chronotype, and increased variability of sleep timing have been reported more frequently in blacks compared to whites. Given that poor sleep quality predicts relapse from smoking cessation programs, particularly among socioeconomically disadvantaged adults, sleep deficiencies and irregular timing of sleep may impact smoking craving and withdrawal symptoms over the course of the 24-hour day. Surprisingly, few studies have examined these temporal patterns of smoking and craving, and none with regard to sleep disruption, chronotype or racial disparities. A better understanding of these factors may explain heterogeneity within the smoking population, especially in minorities. Thus, the purpose of this proposal is to test the central hypothesis that the impact of chronotype and impaired sleep on cigarette usage as well as smoking dependence, urge/craving, and withdrawal depends on race.

Examining the Role of the Orexin System in Sleep and Stress in Persons With Opioid Use Disorder

This study is designed to elucidate the role of the orexin neurotransmitter system in sleep disturbance and circadian rhythms of stress that might in turn influence relapse behaviors in persons on medication-assisted treatments (MAT) who are in early recovery from opioid use disorder (OUD). Briefly, the study will enroll recently abstinent OUD patients (N=200) maintained on either extended-release naltrexone (XR-NTX), buprenorphine, or methadone. Within each MAT group, participants will be randomized to either suvorexant or placebo. The study is expected to have a 20% treatment attrition rate which will result in N=160 completers in the entire study. Patients will be recruited from and treated at Ashley Addiction Treatment, Addiction Treatment Services at Johns Hopkins Bayview Medical Center, Man Alive, or community providers.

Self-Acupressure and Social Jet Lag in Female Health Sciences Students

This randomized, sham-controlled trial aims to evaluate the effects of self-administered acupressure on social jet lag, sleep patterns, and sleep quality in female health sciences students. Participants will be randomly assigned to either a self-acupressure intervention group or a sham self-acupressure control group. The intervention will be performed daily for 12 weeks. Outcomes will be assessed at baseline and at the end of the intervention period, with the primary outcome being the change in social jet lag. Secondary outcomes include changes in sleep quality, daytime sleepiness, and participant blinding assessment.

Tension-type Headache and Its Association

To estimate the prevalence of tension-type headache among adults attending the outpatient clinics at Assiut University Hospitals, and to assess its association with smartphone use, sleep quality, and quality of life.

The Effect of Foot Massage After Open Heart Surgery on Postoperative Pain, Sleep Quality and Mood of Patients

The randomized controlled experimental study was conducted in the cardiovascular surgery clinic of Atatürk University Health Practice and Research Center between April 2021 and September 2021.The research sample consisted of 91 patients who met the research criteria. Since exclusion criteria were met in 15 patients during the research process, the study was completed with 76 patients. Descriptive Information Form, Visual Analog Scale, State-Trait Anxiety Scale, Visual Analog Sleep Scale and Hospital Anxiety and Depression Scale were used as data collection tools. All scales were applied to the patients preoperatively. According to the Postoperative Visual Analog Scale, the patients in the experimental group who stated that they had more than 4 pains were given foot massage for a total of 20 minutes, 10 minutes on each foot. After the surgery, classical foot massage was applied to the patients for 3 consecutive days, including the day they came to the service from the intensive care unit. One day after each application, the patients' pain, sleep quality and mood levels were examined. Data were collected by applying the same procedure steps without foot massage to the patients in the control group.

A Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Effects of Various Cannabinoids on Sleep Quality

This double-blind, randomized, placebo-controlled study will assess the safety and effects of different combinations of CBN, CBG, and THC, with and without CBD and melatonin, for enhancing sleep quality, other factors related to sleep, daytime fatigue, and mood symptoms related to sleep (i.e., depression, anxiety, irritability, and perceived stress).

Bao Yuan Tang Extract and Galactooligosaccharides for Sleep Regulation

Certain classical formulas in traditional Chinese medicine and dietary prebiotics have demonstrated beneficial effects on various aspects of suboptimal health status in previous studies. This research aims to evaluate the effects of Bao Yuan Tang full-component extract combined with galactooligosaccharides on improving health-related outcomes in female registered nurse with suboptimal health status, including sleep disturbances, fatigue, endocrine dysregulation, and glucose and lipid metabolic abnormalities.

Comparing Effect of Intradialytic Aerobic Exercise Versus Incentive Spirometer on Fatigue and Sleep Quality Among Hemodialysis Patients.

In order to accomplish the objectives of this investigation, a single-blind experimental comparative design was implemented to evaluate the impact of intradialytic aerobic exercise and Incentive Spirometer on sleep quality and fatigue. Three experimental groups (aerobic exercise and Incentive Spirometer) and one control group were subjected to pre- and post-tests. Is there a difference in the levels of fatigue and sleep quality between hemodialysis patients who receive aerobic exercise and incentive spirometer therapy and those who do not receive it? Researcher will compare the levels of fatigue and sleep quality between hemodialysis patients who receive interventional therapy and those who do not receive it to see if interventional therapy works to relieve the fatigue and improve sleep quality. Participants will take aerobic exercise therapy group applied on the leg muscles for 20 minutes per session, and incentive spirometer group on respiratory muscles * Ask the patient to hold the breath as long as possible (at least five seconds) then exhale slowly. * Session was in the form of 30 times in sets, each set consist of 5-6 repetitions with rest 1 minute between sets , 3 times per week for total three month, during the first hour of each hemodialysis. sessions.

Effect of a Nurse-Led Environmental Stressor Reduction Package on Perceived Stress and Sleep Quality in Intensive Care Unit Patients

This study aims to evaluate the effect of a nurse-led Environmental Stressor Reduction Package on perceived environmental stress and sleep quality among adult patients in the intensive care unit (ICU). The Environmental Stressor Reduction Package is a structured, multicomponent nursing intervention designed to reduce potentially disturbing environmental stimuli during nighttime care. The package focuses on reducing unnecessary noise, optimizing nighttime lighting, supporting thermal comfort, limiting nighttime visitor activity, and organizing nursing care to minimize avoidable sleep interruptions while maintaining patient safety and essential clinical care. Participants in the intervention group will receive the Environmental Stressor Reduction Package during their ICU stay, while participants in the control group will receive standard ICU care. The study will assess whether the nurse-led intervention reduces perceived environmental stress and improves self-reported sleep quality compared with standard care. Perceived environmental stress will be assessed using the Intensive Care Unit Environmental Stressor Scale (ICUESS), and sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ).

Effect of Isometric Neck Exercises on Cervicogenic Headache Symptoms, Cortisol and BDNF Levels Among Smart Phone Users

Cervicogenic headache (CGH) is a secondary headache type caused due to refereed pain arising from the cervical spine in the forehead, sometimes in temporal region. Which may have great impact on our daily life activities; decreased range of motion at cervical spine, decreased sleep quality, increased stress, disturbed mood and altered physiologic chemicals. It is found to be more prevalent in females and is experimentally diagnosed by the Cervical Flexion-Rotation Test (CFRT) which is performed by a therapist. Also, the upper trapezius midpoint (2 cm lateral to C2) mostly acts as a pressure point. Other pressure points in cervical region may also develop. The pain is mostly on one side and remains on one side. It can be dull aching or pressure like pain. No photophobia, phonophobia, nausea, or tearing of eyes is associated with it. In the modern age, smartphone addiction (SPA) contributes significantly to CGH by promoting forward head posture, rounded shoulders, and impaired proprioception. (4)Despite this, there is a clear gap in the literature regarding body awareness, ergonomics, and targeted prevention strategies for smartphone-related postural problems. There is an urgent need for structured training programs and therapeutic interventions to address these concerns, combined with long-term follow-up studies. In this study, investigators focus on brain-derived neurotrophic factor (BDNF) as a key biomarker of pain sensitization. Chronic stress and pain reduce neuronal BDNF uptake, decreasing the serum BDNF levels, while effective interventions are expected to elevate BDNF levels, improving motor performance and reducing nociceptive signaling. Literature shows that there is a significant increase in BDNF levels in moderate intensity aerobic exercise groups as compared to the control group. This study aims to improve BDNF levels through isometric targeted exercise and ultimately improve the synaptic plasticity, mitochondrial activity, increased beta-endorphins. An increase in body temperature through exercise will also reduce pain sensitization and improve function. In this study, we also target stress levels by focusing on cortisol as a biomarker. As the physiological and psychological stress is increased due to prolonged flexion and increased screen tim,e sleep quality is also disturbed. We aim to evaluate whether targeted isometric neck exercises can enhance BDNF levels, regulate cortisol as a stress marker, and ultimately improve CGH symptoms. As we know that high stress elevates cortisol and disrupts the HPA axis, This study was having hypothesis that exercise-induced adaptations will downregulate the HPA axis, decrease cortisol, restore neuronal health, and enhance cognitive and motor functions and we also address how poor sleep, exacerbated by excessive screen time, contributes to cognitive, memory, and metabolic issues. By investigating the effects of exercise on sleep quality, our study fills a crucial research gap linking SPA, stress, BDNF, cortisol, and CGH offering a novel therapeutic approach that combines patient education, circadian rhythm alignment, and structured isometric exercise to improve health outcomes in adolescents.

Settling Down for Sleep in ADHD: The Impact of Sensory and Arousal Systems on Sleep in ADHD

The goal of this study is test the hypothesis that sleep problems for children with ADHD are linked to sensory over-responsivity, a type of sensory processing difference that causes a person to interpret daily sensory input as stressful. This study examines the impact of sensory over-responsivity on bedtime arousal levels in 30 children with ADHD (ages 6-13). We will also test a bedtime intervention targeting sensory over-responsivity at bedtime and examine how it impacts bedtime arousal levels and sleep difficulties.

The Power Down Pilot Study: A Novel Bedtime Manipulation Protocol

The goal of this pilot intervention study is to examine the feasibility and acceptability of a novel bedtime manipulation protocol called "The Power Down" for autistic youth, ages 6-10. The main questions it aims to answer are: 1. Is the Power Down feasible for caregivers to do each night? 2. Do the families find the Power Down an acceptable intervention to address their child's difficulties settling down to fall asleep?

Weighted Blankets for Sleep Disturbance Among Children With ADHD

Many children with ADHD suffer from sleep disorders and dysfunction, which may affect development and well-being. According to the clinicians, some children find relief from restlessness and difficulty sleeping by using weighted blankets which have been proposed to reduce restlessness and stress via sensory integration and to calm the child by stimulating the sense of touch, muscles and joints. However, evidence for an effect on sleep is scarce, and only one RCT has investigated the effect of weighted blankets among children with ADHD. Using a RCT design, the aim is to investigate the effect on sleep disorders and dysfunction in children with ADHD aged 5-12 years by (1) using a weighted blanket during night and daytime in addition to usual treatment, compared to (2) usual treatment and a non-weighted sham blanket, with the primary outcome being differences in total sleep time. Results will support health- and social professionals who are involved in the treatment of children with ADHD.

Dream2Heal: An Adaptive Stepped-care Intervention for Chinese Cancer Survivors With Mild-to-moderate Insomnia

The primary objective of this feasibility study is to assess the feasibility and acceptability, and potential clinical significance of an adaptive stepped-care intervention for improving sleep quality among Chinese cancer patients with mild-to-moderate sleep disturbance, using a sequential multiple assessment randomized controlled trial (SMART) design.

Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment

Opioid use disorder (OUD) is a treatable medical illness with three medications FDA approved for treatment. However, persons with OUD report significant sleep disturbance, even when treated with medications for opioid use disorder, leading to high rates of relapse. In this project, we will investigate a special set of photosensitive neurons in the retina as an underlying mechanism for circadian rhythm and sleep disturbance from opioid use and medications for OUD that could lead to novel intervention and improve treatment outcomes.

GUT-FEELINGS: Using Citizen Science for Large-Scale Prebiotic Clinical Trials for Mental Health in Adults

The goal of this study is to evaluate the effects of different products in participants experiencing feelings of anxiety. The main question it aims to answer is: \- Do these products affect feelings of anxiety and related wellness outcomes compared with a placebo? Researchers will compare participants taking active products to those taking a placebo to see whether the active products influence feelings of anxiety and related outcomes, and to monitor safety. Participants will: * Be randomly assigned to receive either an active product or a placebo (an inactive look-alike). * Take their assigned product or placebo without knowing which group they are in until the study is completed. * Complete evaluations and tasks to track safety, feelings of anxiety, and related health outcomes.