Clinical Research Directory

Integrating the Youth Nominated Support Team (YST) With CBT for Black Youth With Acute Suicide Risk: Aim 2b

This is a second pilot study being completed based on lessons learned from the Aim 2a feasibility pilot study (NCT06941311). Following modifications, the investigators are testing the acceptability, feasibility, and preliminary effectiveness of the combination of two psychosocial interventions, Cognitive Behavioral Therapy for Suicide Prevention (CBT-SP) and the computer-assisted version of the Youth-Nominated Support Team (eYST). In this phase of the study, CBT-SP + eYST will be tested in an open trial (number of youth = 15). Investigators will recruit Black adolescents (ages 12-17) that come to an urban acute care setting for suicidal thoughts and/or self-injurious behaviors to receive the intervention in an outpatient community mental health agency. Participants will receive 12-14 sessions of CBT-SP in addition to YST. Participants will nominate up to 5 caring adults in their lives to serve as support persons. These support persons will attend an education/orientation session to learn more about their role and how to support the youth. Support persons will have weekly contact with the youth and weekly follow up contacts from the youth's clinician/YST intervention specialist. Youth will be assessed at baseline, 6 weeks, and 14 weeks. Parents will be assessed at baseline and 14 weeks. Support persons will be assessed at baseline and 14 weeks. Fidelity assessments will be completed by clinicians after each session, after the YST psycho-ed session, and weekly to document contact with the support team.

A Chatbot to Reduce Chemsex and HIV-related Risk Behaviors Among Men Who Have Sex With Men

The goal of this clinical trial is to investigate whether receiving chatbot-delivered stage-of-change-tailored online interventions is effective in reducing chemsex among men who have sex with men in Hong Kong. The main question it aims to answer is: Does chatbot-delivered stage-of-changed online interventions reduce chemsex among men who have sex with men Eligible participants will be randomly assigned to either the intervention or the control group. The control group will watch one online video introducing chemsex-related knowledge and harm reduction skills per week for 12 weeks. On top of the interventions received by the control group, participants in the intervention group will have access to a chatbot during the 12-week intervention period. The chatbot will deliver 12 weekly episodes of interventions tailored to once's current stage-of-change related to chemsex. The chatbot will also address questions related to chemsex during the intervention period.

PA Moves Trial - PCP Participants

The purpose of this voluntary research study is to determine the impact of an ECHO intervention on the likelihood that rural primary care providers (PCP) will refer their physically inactive patients to be more active.

Mobile Health Technology-Enabled AFib Management

The overall objective of this proposal is to evaluate the effect on quality of life of a comprehensive digital atrial fibrillation (AFib) management tool that will empower patients to a) take an active role in learning about AFib management options, starting and adhering to evidence-based therapies and lifestyle changes and b) to guide the patients during AFib episodes which are associated with anxiety and impairment in quality of life. Researchers plan to evaluate the effectiveness of this novel digital toolkit in improving quality of life and decreasing AFib burden in a randomized clinical trial (RCT). A pilot study assessing feasibility and retention of the intervention was previously conducted (NCT05400837)

The Effect of Virtual Reality Distraction on Pain and Discomfort Associated With Bitewing Radiographs in Pediatric Patients

This study will be conducted at King Abdulaziz University Dental Hospital (KAUDH). Ethical approval was obtained from the Research Ethics Committee of the Faculty of Dentistry at King Abdulaziz University (32-03-25). Inclusion criteria will include healthy and cooperative children aged 4 to 12 years who are referred to the radiology department for two-bitewing radiographs. Children with a history of epilepsy or anxiety disorder will be excluded. The study's purpose, risks, benefits, and limitations will be explained to the parents or guardians of eligible children by trained dental interns. Those who agree to participate will be asked to sign an Arabic consent form before their involvement. Additionally, an assent form will be obtained from children aged seven and older. Subjects' age, gender, previous dental experience, and behavior during previous dental visits, as assessed by Frankl's behavior rating scale , will be recorded, along with whether they own or have prior exposure to a virtual reality device. Only children with cooperative and definitely cooperative behavior will be included. A randomization sequence with an allocation ratio of 1:1 will be generated using computer software and kept with a radiology assistant who is not involved in the study to ensure allocation concealment. Due to the nature of the study, neither the subject nor the radiologist will be blinded to the group allocation. However, the statistician will be blinded to which group each subject will be allocated. Before taking the radiographs, subjects will be asked to select a video from a list of popular cartoon shows or a video of their preference. In the test group, the subjects will wear virtual reality device goggles (LG 360 virtual reality \[VR\] headset, LG Electronics) connected to a mobile phone, and the chosen video will be played. In the control group, radiographs will be taken without the use of any distraction device. The sounds of the videos will be played on headphones. All bitewing radiographs will be taken by the same radiologist, following the As Low As Reasonably Achievable (ALARA) protocol and hospital guidelines. The procedure uses either size one or size two bitewing Photostimulable Phosphor digital sensors, along with a film holder and a rectangular collimator. While taking the radiographs, the Tell-Show-Do behavior management technique will be used with all participating children, and they will be recorded with a high-resolution camera. The camera will aim toward the face and the body. Later, two trained and calibrated evaluators will independently assess the participating children's behavioral pain using the face, legs, activity, cry, and consolability (FLACC) behavioral pain assessment scale. The FLACC scale ranges from 0 to 10, with 0 indicating no pain and 10 the worst possible pain. Additionally, the behavior during the BWS will also be recorded using Frankl's behavior rating scale classification. Training and calibration for the evaluators will involve watching videos of 20 randomly selected children during their dental treatment. A stopwatch will be used to measure the chair time required to take the radiographs. In the test group, the time needed to place the VR device will be included. Immediately after taking the BWS, the subjects will be shown the Arabic version of the Wong-Baker FACES pain rating scale. They will be asked to select the face that best describes their feelings during the procedure. Finally, the satisfaction with the use of VR during BWS taking will be assessed using a five-point Likert scale, where zero indicates 'not satisfied at all' and 10 means' very satisfied'. Subjects who require repeating any of the BWS will be excluded from the study

Physical Activity Trends in Cancer Survivors Treated at the 'MOvement and REhabilitation' Clinic

An active lifestyle after a cancer diagnosis can reduce the side effects of treatment and improve quality of life, mental health, and survival. Recent evidence in the literature confirms its benefits across various types and stages of cancer. However, the majority of cancer patients do not reach the recommended levels of physical activity due to physical, psychological, and logistical barriers. It is essential that healthcare professionals provide motivational support and address individual barriers to physical activity through the active involvement of patients, thus promoting the adoption and maintenance of an active lifestyle. To achieve this, personalization of physical activity programs is crucial. For this reason, the MOvement \& REhabilitation clinic was established in 2022, where a dedicated physiotherapist provides personalized consultations and educational support to promote physical activity among cancer patients. This study aims to evaluate the trend over time in the amount of physical activity among cancer patients attending the "MOvement and REhabilitation" (MO.RE) clinic. The study also seeks to assess patient engagement, the amount of resources used to help patients maintain an active lifestyle, and any barriers to physical activity.

Effects of Virtual Reality With Multisensory Stimulation on Emotional and Behavioral Disorders in Individuals With Acquired Brain Injury and Disability Requiring Institutional Care: a Single Case Experimental Design (SCED) Study.

Acquired brain injuries (ABIs) frequently cause emotional and behavioral disorders that impair independence and quality of life, particularly in institutions. Virtual reality (VR), already used in various mental and neurological disorders, offers therapeutic potential that remains largely unexplored in this context. Multisensory devices offer enhanced immersion that can potentially increase the relaxation and calming effect. Their use in specialized care home (SCH) could provide additional support for care. The main objective of the study is to measure the effect of an 8-week multisensory VR relaxation program on the most significant emotional and behavioral disorders in adults with acquired brain injury living in SCH. The SCED method with multiple baselines across subjects (ABA) is used with three adult residents with ABCI and behavioral disorders living in SCH. The study consists of three phases (baseline, intervention, follow-up), during which the three main emotional and behavioral disorders of each resident are assessed weekly based on observations made throughout the week. Additional measures include the assessment of the socio-emotional profile by the care team (ECCSEG) and the emotional distress experienced by residents (QOLIBRI), collected twice per phase. The intervention consists of eight weeks of VR relaxation (VirtySens®), with two 15-minute sessions per week. All measurements taken during the experiment will be anonymized and used only by the investigators, who are fully aware of the European GDPR (General Data Protection Regulation) concerning the protection of personal data.

Effectiveness of Digital Intervention (HM4MH-app) on Perinatal Psychological Wellbeing

As many as 25% of pregnant women report mental health problems such as depressiveness and anxiety. This is a major concern as mental illness during pregnancy can have severe and long-lasting consequences for the pregnant woman, the baby, as well as the partner. Digital interventions (e.g., apps) have shown to be promising in promoting mental wellbeing, at scale, however, the majority of tools have been developed and evaluated in a general population rather than tailored for pregnancy. The objective of this trial is to investigate the effectiveness of a new digital tool (HealthyMoms4MentalHealth-app) on mental health outcomes during the perinatal period.

Impact of Therapy Dogs on Child Anxiety and Behavior During Local Anesthesia for Dental Procedures

Therapy dogs in dental offices might help anxious children during dental care. Therapy dogs might help children during injection of local anesthetic, when we inject numbing medication before working on the teeth. The goal of this study is to learn if having a therapy dog with a child during the injection of numbing medication helps children to be more comfortable at the dentist's office. This study is of children who need dental care using local anesthesia. Study participant's behavioral reactions and heart rate during injection of local anesthetic with and without having a therapy dog present will be recorded and children and their guardians will be asked a few short questions about the injection and therapy dog after injection.

Modulating Reward Learning Using Transcranial Magnetic Stimulation

Our specific aim is to examine the effects of TMS on reward processing during goal-directed behavior. In these experiments the investigators will utilize a scalp-recorded brain oscillation called frontal midline theta that is believed to index the sensitivity of the cingulate cortex to reward feedback. Here the investigators will asked whether this electrophysiological signal can be modulated up or down using TMS while participants engage in decision making tasks, and if so, whether it would affect the encoding of rewards and subsequent choices during task performance.

Cold Water and Decision-Making

The behavioral within-subject cross-over design study "CoVa" aims to investigate the effect of a short-term full-body cold-water immersion vs. warm-water immersion control on value-based choice, psychological well-being, and peripheral physiology.

Decision-making and Food Intake

The study will investigate how the expectation of food availability impacts the response to food cues, mood, interoceptive awareness, and consumption of food intake in healthy, naturally cycling women.

Interventions in Mathematics and Cognitive Skills

The purpose of this study is to investigate neurocognitive mechanisms underlying response to intervention aimed at enhancing, and remediating weaknesses in, numerical skills in children, including those with mathematical learning disabilities (MLD).

DIAMOND-Lewy Guidelines for Antipsychotic Use in Older Patients

The goal of this observational study is to learn about current practices for the acute neuropsychiatric management of older adults during emergency department (ED) visits. Researchers will compare current standard of care practices with implemented guideline practice to see if standardized medication guidelines help reduce the usage of antipsychotics and/or benzodiazepines during acute presentations. The main questions this study aims to answer are: * How many older adults are receiving antipsychotics or benzodiazepines during emergency department visits? * Why are older adults receiving antipsychotics or benzodiazepines during emergency department visits? * How many older adults who receive antipsychotics or benzodiazepines during emergency department visits have an underlying cognitive or movement disorder? * What effects does administration of antipsychotics or benzodiazepines during emergency department visits have on patient outcomes in older adults and adults with neurocognitive disorders? * Does implementation of standardized medication guidelines help reduce the usage of antipsychotics and/or benzodiazepines during acute presentations?

Studies of Human Inference Using On-line Testing

The investigators will record behavioral responses from human participants on crowdsourcing platform Prolific to identify the decision strategies humans apply short-term, long-term, and multi timescale (across both timescales) inference tasks. Participants will perform a Jar Switching Task (described in Research Strategy Aim 1- "Jar Switching Task") in which balls are drawn with replacement from one of two known jars. The current jar in use switches based on an underlying change rate across trials. Subjects must perform three task blocks: 1) report the current jar in use (short-term inference), 2) predict the subsequent jar (long-term inference), and 3) both report and predict the jars (multi-timescale inference). The investigators will record these responses, the number (and sequence) of balls drawn, and the response time (time from the end of trial until the response) for each trial. Subjects will perform all blocks (parameters and number of blocks to be determined by inference model development and testing prior to task development) so that we can compare responses at each timescale. Since participants participate voluntarily for small sums of money (around $10/ hour based on duration of task) and the investigators' previous studies have collected over 200 subjects in a matter of days, they will aim to record behavioral data from 1000 subjects. This number allows them to address the broad range of subject variability expected using Bayesian statistical methods such as Bayes factors.

A Savings Intervention to Reduce Men's Engagement in HIV Risk Behaviors

This randomized control trial will test an economic intervention to reduce Kenyan men's engagement in behaviors that increase the risk of HIV/STIs. Participants randomized to the intervention group will be able to open accounts with a partner bank and will be incentivized to save with lottery-based rewards.

The VESPA Pilot Study

Physical activity has been described by the US federal government as a 'best buy' for public health. Unfortunately, most adults in the United States are not sufficiently active, and this worsens with age. Low levels of participation are driven by many challenging barriers, including lack of access, few opportunities for enjoyable activity, and few supportive social relationships, which is especially important given the central role of social connection for lasting behavior change. A half-century of research in behavioral sciences has generated effective group-based physical activity programs, but these are inaccessible to most as they are often delivered in a few select research centers. Recent advances in telehealth have offered media for extending these interventions more broadly, but the experience of such programs is often hampered by technology that does not allow for a sense of physical and social presence. Fortunately, uptake of virtual reality (VR) is increasing rapidly, and the medium has a high level of potential for advancing the delivery of immersive evidence-based group interventions to those that most need it. Thus our specific aims are: Specific aim 1: To test the feasibility and acceptability of a group-mediated physical activity intervention delivered fully via modern VR to older adults. Specific aim 2: To examine the impact of this program on overall physical activity among older adults compared to the current standard-of-care for telehealth: the video conference meeting platform.

Omaha System-Based Health Application on Improving Knowledge, Attitude, and Behaviors Regarding Infectious Disease Prevention in the Community

Background: Infectious diseases remain significant public health concerns due to several factors such as climate and environmental changes and natural disasters. Mobile health applications (mHealth apps) can be an appropriate way for fostering community participation, disseminating knowledge, and promoting behavior change toward infectious disease prevention. This study aims to describe a protocol for a pilot randomized controlled study to evaluate the impact of the Omaha System-Based mHealth app (BUHOS) on improving knowledge, attitude, and behaviors (KAB) regarding infectious disease prevention in an earthquake-affected region of Türkiye. Methods: This study is a two-armed, parallel-group, randomized controlled trial design. A total of 112 eligible participants will be recruited from two separate container cities of an earthquake-affected region. These participants will be randomly allocated to either an intervention group or a control group. BUHOS will be designed based on the Omaha System, a widely recognized standardized taxonomy for the assessment, planning, and evaluation of healthcare services. BUHOS will be a two-week nursing intervention that includes monitoring KAB, employing Education, Guidance and Counseling (education videos), and Surveillance (reminder messages), and assessing the outcomes. Outcome variables will include the Problem Rating Scale for Outcomes, Community Communicable Diseases Knowledge Survey, Communicable Diseases Risk Awareness and Protection Scale and System Usability Scale. Outcome variables will be assessed on the 15th and 30th day after intervention. Hypotheses: H1: Among the Omaha System Problems, the Communicable/ Infectious Condition Problem Knowledge score will be higher on the 15th and 30th days compared to the control group. H2: Infectious diseases risk awareness and prevention score will be higher on the 15th and 30th days compared to the control group. H3: Communicable/ Infectious Condition Status Behaviour Parameter score will be higher on the 15th and 30th days compared to the control group H4: The knowledge and behaviour of the communicable/ infectious status and the awareness and prevention of the risk of infectious diseases of the experimental group will be higher than before the intervention on the 15th and 30th days.

Development and Feasibility of a Nurse-led Person-centered Education Program

Background Psoriasis is a chronic inflammatory skin disease causing reduced quality of life. Psoriasis patients are often insufficiently informed about their disease with its treatment possibilities leading to non-adherence of treatment resulting in unsatisfactory patient outcomes. We therefore propose to develop an educational intervention for psoriasis patients; evaluate the feasibility of implementing it in a nurse-led psoriasis-outpatient clinic and compare the psoriasis percentage reduction, quality of life, health literacy and patient benefit, between patients receiving this educational intervention and those receiving standard care. Method/Design We first will develop an evidence-based educational intervention in collaboration with an expert panel and second will conduct a quasi experimental feasibility study in a psoriasis outpatient clinic in Western Switzerland. Twenty four eligible patients with psoriasis will receive a multidisciplinary education, for 6 weeks. Data will be analyzed using R conducting linear models allowing us to assess the impact of the intervention on psoriasis reduction and other secondary outcomes of interest, once controlled for reliable socio-economic cofounding factors. Discussion This trial will investigate the feasibility of the elaborated nurse-led education and the planed randomized controlled trial. In this study, we will elaborate and provide an informational brochure with information concerning psoriasis in addition to a nurse-led oral educational program in addition to medical standard care. We expect that this nurse-led person-centered intervention will contribute to enhanced education with a higher functioning, better self-efficacy and improved quality of life, better disease knowledge with a better adherence to the medication protocol. The results will further inform the final design of a subsequent large-scale randomized controlled trial, which will examine the effectiveness of this educational intervention. Additionally, through this study the role of the nursing profession and its research will be strengthened in assuring that the voice of individuals, families and communities are incorporated into design and operations of clinical health systems by eliminating gaps and disparities in health care.

Validity and Reliability Study of the Pain Indicator Behavior Scale-Brain Damage (ESCID-DC)

A multicentre observational study to validate the adaptation of the Pain Indicator Behavior Scale (ESCID) for patients with acquired Brain Damage (ESCID-DC), as a measuring instrument.

Influence of the 3D-sonographic Representation of the Fetal Face on the Health-conscious Behavior of Pregnant Women

Studies have shown that ultrasound examinations during pregnancy have a short-term anxiety and stress-reducing effect, without having any influence on the mother-child bond or health-conscious behavior. It has not yet been investigated to what extent the representation of the child's face alone achieves a lasting positive effect if the representation in 3D form were permanently available.

Adaptation and Implementation of a Patient Navigation Program for Cervical Cancer Screening Across Contexts in Senegal

The goal of this project is to prevent unnecessary deaths due to cervical cancer in Senegal. This mixed methods research responds to identified intrapersonal- and community-level barriers to early cervical cancer screening uptake, follow-up, and treatment among women there. Investigators will apply the Dynamic Adaptation Process (DAP) as integrated into the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to study the adaptation of an evidence-based cervical cancer patient navigation program in urban and rural contexts in Senegal, measure the intervention effectiveness, and evaluate programmatic implementation outcomes. By studying the process of adaptation of a patient navigation program in a low- and middle-income country (LMIC), investigators will build new knowledge while addressing an important public health issue. The project demonstrates innovation by advancing both adaptation and implementation process knowledge of an evidence-based patient navigation intervention in various contexts within a LMIC with a particular focus on how the adaptation responds to cancer-related stigma, misinformation, and women's autonomy in healthcare decision-making. Investigators will build knowledge through local learning which will further the long-term goal to inform the national cervical cancer prevention and control programs in two areas of Senegal and other similar LMICs.

Impact of Bright Light Therapy on Prader-Willi Syndrome

This is a placebo controlled clinical trial to assess the utility of light therapy as a sufficient treatment for excessive daytime sleepiness in patients with Prader-Willi Syndrome

The ENERGYCO Study

The aims of this school-based cycling intervention called "ENERGY Commuting to school" (ENERGYCO) will be divided into two phases: Phase I will aim: 1) to design, test, and validate predictive equations for the objective quantification of the energy expenditure related to different modes of commuting to school (i.e., walking, cycling, motorized-vehicle); and 2) to quantify the energy expenditure of each mode of commuting to school using indirect calorimetry in adolescents; and Phase II will aim to evaluate the effect of a school-based cycling intervention on different health-related outcomes, such as energy expenditure, resting metabolic rate, basal metabolism, physical activity levels, body composition, muscle strength, cardiorespiratory fitness, blood pressure, physical literacy, motor competence, and psychosocial outcomes on Spanish adolescents.