Clinical Research Directory

The Implementation of a Trans-tailored Harm Reduction Service for Transgender Persons in Relation to chemsEX and Substance Use (iT-REX)

This study evaluates a comprehensive transgender-tailored harm reduction service for transgender women, transgender men, and non-binary individuals engaging in chemsex or substance use in Thailand, focusing on PrEP uptake, HIV/STI outcomes, mental health, and socio-legal impacts.

Effectiveness of the SoundHeal Multi-Sensory Integrative Therapy Among Justice-Involved Youth

Emotional dysregulation in justice-involved youth (JIY) is a condition that significantly impacts young people, their families, and juvenile justice and public health systems. Affecting an estimated 60-70% of detained Attention deficit hyperactivity disorderadolescents, it is a major driver of aggression, substance use, school failure, and later recidivism. Despite available treatments, managing emotional dysregulation in custody remains challenging, with youth often enduring high arousal, anger, and anxiety that persist into adulthood. Current popular therapies, including Cognitive Behavioral Therapy (CBT) and Dialectic Behavioral Therapy (DBT), often fall short in detention because they rely on verbal processing, require multiple scheduled sessions, and/or need highly trained staff. Other technologies, like biofeedback and neurostimulation techniques, are still under scrutiny for adolescents, given their higher-than-usual Adverse Events (AEs). This SoundHeal study aims to evaluate a sensory intervention using the Healpod, a distraction-free physical space where a participant sits, delivering sound, music, gentle vibrations, and ambient light. Following this is a brief expressive journaling exercise to compare any before, during and after experience changes from the sensory immersion. This prospective, single-center cohort study hypothesizes that these sessions will improve juveniles' ability to emotionally regulate, improve therapeutic alliance, mental health outcomes and build coping skills that can potentially help in long-term mental health and substance abuse treatment in JIY and beyond.

Evaluating the Acceptability, Feasibility and Usability of Various Conversational Data Collection Software

This research study is being conducted to evaluate digital software tools that collect health information through conversations. The study will test how acceptable, feasible, and usable these conversational software programs are for patients with chronic pain. Purpose of the Study: The goal is to understand whether digital conversational tools can effectively gather biopsychosocial information (biological, psychological, and social factors related to health) from patients experiencing chronic pain. Biopsychosocial information includes details about your physical symptoms, emotional well-being, social circumstances, and how these factors interact to affect your health. These digital tools are designed to have conversation-like interactions with patients to collect this comprehensive health data in a more natural and engaging way. What Participation Involves: If you join this study, you will interact with digital conversational software that will ask you questions about your health, pain experience, and related factors. The software is designed to communicate with you in a conversational manner, similar to talking with a healthcare provider, to gather information about your condition. You will be asked about various aspects of your chronic pain experience, including how it affects your daily life, your emotional state, and your social interactions. Who Can Participate: This study is looking for participants who have chronic pain conditions. Medical providers who treat patients with chronic pain are encouraged to refer eligible patients to this study. Healthcare providers interested in referring patients or learning more about the study can contact the study sponsor, AugMend Health Inc. Why This Research Matters: Chronic pain affects millions of people and understanding the full scope of how it impacts patients requires collecting detailed information about physical, psychological, and social factors. Traditional methods of collecting this information can be time-consuming and may not capture the complete picture. Digital conversational tools offer a potential new approach to gathering comprehensive health information in a more efficient and patient-friendly manner. This research will evaluate whether patients find these tools acceptable to use, whether they work practically in real-world clinical settings, and whether they are user-friendly and accessible for people with chronic pain. Study Location: The study is being conducted at AugMend Health in Cambridge, Massachusetts. Study Sponsor: This study is sponsored by AugMend Health Inc. Healthcare providers or potential participants who would like more information about the study or wish to make a referral can contact AugMend Health Inc. Participation in this study is voluntary, and you can choose to stop participating at any time without affecting your regular medical care.

DECIDE to Improve Maternal Mental Health Care Delivery

Appropriate training for perinatal mental health care is an important public health concern as mental health disorders are common pregnancy complications. Perinatal and mental health care providers report the difficulty of treating perinatal individuals due to insufficient information available regarding mental health treatment decisions, differences in beliefs and attitudes, and concerns about adverse effects on patients, such as self-harm and suicide. Effective shared decision-making skills can improve perinatal and mental health care providers' competencies to meet the unique decision needs of perinatal individuals, particularly those with mental health disorders. The proposed project titled "DECIDE to Improve Maternal Mental Health Care Delivery" aims to adapt the DECIDE Provider Training developed by Dr. Alegria and her team,1 to improve the rapid and wide dissemination and implementation of DECIDE in meeting the mental health needs of perinatal individuals. DECIDE stands for Decide the problem; Explore the questions; Closed or open-ended questions; Identify the who, why, or how of the problem; Direct questions to your health care professional; Enjoy a shared solution. The DECIDE provider training was developed based on theories of intergroup contact in social psychology and a patient-centered framework.28-30 DECIDE teaches mental health providers how to improve perspective-taking, reduce attributional errors, and increase receptivity to the client population.1,15-17 The proposed project will (1) make content adaptation (i.e., adding topical training content to fit perinatal mental health care) and process adaption (i.e., creating asynchronous training modules to reduce the burden for care providers) to the DECIDE Provider Training and (2) assess the acceptability, appropriateness, and usability of adapted DECIDE provider training for rapid and wide dissemination and implementation of DECIDE in maternal mental health care delivery.

Non-interventional Pre-screening Protocol Aims to Evaluate Participants for Potential Trial Eligibility in Future Clinical Trials/Studies Focusing on Metabolic and Psychiatric Health.

DOVE-MET-COME-100 is a single site prescreening survey study designed to identify adults who may be eligible for future industry-sponsored clinical trials. A physician will oversee the informed consent process, after which participants will be surveyed on demographics, medical history, current health conditions and symptoms. The study team may also collect basic health information, including vital signs, urine drug tests, blood samples and pregnancy tests (if applicable). A physician will review each participant's medical history in a one-on-one interview to assess potential fit for upcoming trials. If needed, the doctor may contact the participant's current doctors or pharmacies to gather more information for eligibility review.

Supporting Treatment Access and Recovery Through Linkage and Support

This 3-year Hybrid Type 1 study will randomize 208 people with co-occurring substance use and mental health disorders (COD) referred from the Worcester Hub. This study seeks to evaluate the effectiveness of MISSION, a multi-component team approach, versus linkage with a Peer Specialist on improving outcomes among individuals with CODs. We expect that individuals receiving MISSION versus linkage only will show greater improvement in treatment engagement, substance use, and mental health outcomes. This study will also concurrently conduct a process evaluation to inform sustainability and future implementation of such interventions.