Somatic Symptom Disorder involves persistent physical symptoms that can significantly affect daily life and well-being. Clinical trials in this area explore various treatment evaluations, including psychotherapy and pharmacological approaches, to add...
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Found 65 Actively Recruiting clinical trials
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Researchers are investigating how the medicine Filgotinib works to relieve pain in patients with moderate to severe active rheumatoid arthritis RA. This study focuses on understanding two main factors influencing pain relief brain pathways linked to central nervous system sensitization seen in fibromyalgia, and the inflammation surrounding joints and related immune signals. The study aims to clarify why Filgotinib may provide faster pain relief compared to other treatments by examining these mechanisms. Participants prescribed Filgotinib will be observed using advanced 7 Tesla MRI brain imaging to measure changes in brain connectivity and glutamate levels associated with pain processing. The study will assess Filgotinibs impact on both central nervous system pain pathways and peripheral inflammation over periods of up to 12 weeks. This observational test-retest design does not involve altering prescribed treatments but focuses on detailed imaging and biological assessments. During the study, participants will undergo brain MRIs and evaluations of joint inflammation through ultrasound and blood tests measuring cytokines and chemokines. They will also complete questionnaires on pain, fatigue, anxiety, sleep, and cognitive function. Researchers will monitor changes in these measures at intervals up to 12 weeks to understand how Filgotinib affects pain and related symptoms. Total participation time aligns with the 12-week observation period.
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Comparing Hand Function After Trigger Finger Surgery Using Transverse or Longitudinal Skin Incisions
Trigger finger is a common hand condition causing pain and difficulty with certain tasks. Treatment usually starts with conservative methods, but surgery may be needed if these fail. This study evaluates whether there are differences in hand function after surgery using either a transverse or longitudinal skin incision, measured by the Dash scale. The study compares two surgical techniques for trigger finger release one using a longitudinal skin incision and the other a transverse incision. Both procedures involve opening the A1 pulley to relieve symptoms. Participants are randomly assigned to one of the two incision methods, and functional outcomes are assessed immediately after surgery. Participants will be followed up to assess functional improvement using the Dash scale right after surgery, along with secondary measures such as surgeon comfort, symptom resolution, pain, infection, nerve injury, and return to work or activities at 1, 3, and 6 months after surgery. This careful monitoring helps evaluate recovery and potential complications over time.
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Suicide is the second leading cause of death among youth, and rates in the US are rising despite prevention efforts. Researchers are evaluating a digital platform called Vira to improve how care is delivered to adolescents at high risk for suicide. This platform aims to use smartphone data and secure communication tools to better understand and manage risk factors like psychological distress, anhedonia, behavioral withdrawal, and sleep problems in young people receiving intensive outpatient treatment. The study compares two groups of adolescent patients aged 13 to 18 years old who are in an intensive outpatient Dialectical Behavior Therapy DBT program. One group uses the Vira platform, which collects data passively from smartphone sensors about activity, sleep, mobility, and mood-related language. Vira also prompts daily check-ins and supports practitioners with reminders to encourage behavior changes. The other group receives the usual treatment with the addition of a passive monitoring app called EARS. Participants will use their assigned app during their intensive outpatient treatment. Researchers will assess outcomes using tools like the Columbia Suicide Severity Rating Scale and Scale for Suicidal Ideation over six months. Other measures include anxiety, risky behaviors, sleep quality, mood, and pleasure scales at three and six months. The study monitors clinical outcomes to determine if the digital platform enhances care for youth at risk of suicide.
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Researchers are evaluating the ViraSafe app, an enhanced version of the BRITE suicide safety planning app, to improve engagement with coping skills and safety planning among suicidal adolescents aged 13 to 24. This pragmatic randomized trial compares the new ViraSafe app integrated into the Vira behavior change platform with the original BRITE app, aiming to address rising youth suicide rates by using digital tools for intervention. The study focuses on youth who have experienced recent suicidal thoughts or attempts and are receiving care in clinical settings. Participants are randomly assigned to use either ViraSafe or BRITE. ViraSafe integrates safety planning and coping skills into a smartphone app with automated just-in-time reminders and daily distress ratings, supported by clinicians who can send additional nudges. The BRITE app offers self-monitoring, a safety plan, distress level ratings, and suggested coping activities based on distress. Both groups onboard the assigned app with a trained clinician or research staff. The trial lasts three months with assessments at baseline, one month, and three months. Participants complete virtual assessments including interviews and self-report measures at baseline, one month, and three months. Some participants using ViraSafe will take part in qualitative exit interviews for feedback. The study collects data on app engagement, technology acceptance, and suicide risk factors using standardized tools. Safety plans remain accessible throughout, and mental health indicators are monitored through self-reports and passive smartphone data. The total participation time is about three months, with ongoing support from clinical providers.
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Researchers are evaluating a cancer survivorship care intervention designed to help Chinese patients who have recently finished curative cancer treatment. This study uses a sequential multiple assessment randomized controlled trial SMART to assess how the intervention affects physical symptom distress, weight management, self-confidence in managing cancer, and overall health-related quality of life. The trial compares different approaches to survivorship care to find better ways to support patients after treatment. Participants are divided into groups receiving different types of support. One group attends a 120-minute survivorship clinic with a team including a nurse, dietitian, exercise physiologist, and psychologist, where they get personalized advice on symptom management, diet, exercise, and psychosocial issues. Another group receives skill-based pamphlets covering symptom management and lifestyle recommendations. Some participants who continue to struggle with symptoms or weight after initial care may receive a more personalized, step-up intervention focused on coaching to improve symptom relief and weight control. During the study, participants will be assessed at baseline and again at 4 and 12 months. Researchers will measure symptom distress, weight control, self-efficacy, fear of cancer recurrence, illness perception, and health-related quality of life. Participants will be monitored to see how their symptoms and quality of life change over time, helping to understand which care approaches work best. The total study period extends to the end of 2026, including follow-up assessments to track long-term effects.
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Researchers are evaluating the use of an accelerated, intermittent theta burst stimulation a-iTBS-rTMS protocol targeting the left dorsolateral prefrontal cortex for people with Psychogenic Non-Epileptic Seizures PNES or Seizure-Type Functional Neurologic Disorder FND-seiz. This early-phase study aims to assess the feasibility, tolerability, and preliminary effects of this brain-network based treatment, which may help address the challenges and poor outcomes seen with current treatments. The study is open-label and focuses on improving seizure frequency and quality of life measures in this population. Participants will receive 6 to 10 sessions of theta burst TMS per day, each session consisting of 600 pulses, over 3 to 5 days, targeting a total of 30 sessions 18,000 pulses. Treatment is delivered using a MagVenture MagPro TMS System aimed at a specific brain region called Beam F3 to align with previous research and clinical practice. The sessions are spaced with 15-minute intervals, and the study includes a safety protocol developed with experts to monitor risks, including seizure induction. During the study, participants will be assessed through self-report measures before treatment and again four weeks after completing sessions. Researchers will track seizure frequency, stigma, quality of life, depression, PTSD, somatic symptoms, psychosocial functioning, and overall improvement. Safety is monitored daily during treatment and at follow-up. The total participation duration covers screening, treatment days, and a 4-week follow-up to evaluate the interventions effects and tolerability.
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This research aims to adapt a fatigue management program called the FACETS program, which combines cognitive-behavioral therapy and energy conservation techniques, specifically for adult patients living with sickle cell disease. The study focuses on evaluating the feasibility of this adapted program, named Drpa-FACETS, for managing fatigue symptoms in this population. Participants will take part in the Drpa-FACETS program designed for sickle cell disease. The program includes sessions and home exercises tailored to help manage fatigue. The study will monitor participants from enrollment through the end of the protocol visits over a 10-week period. During the study, participants will complete assessments and questionnaires to measure fatigue and their ability to follow the program. The research team will evaluate how well the program works for adults with sickle cell disease by tracking adherence and outcomes related to fatigue management over the course of the study.
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Researchers are evaluating the effectiveness of a mobile app-based adaptive coping skills training called Blueprint for adults who have survived serious cardiorespiratory illnesses such as acute respiratory distress syndrome ARDS, congestive heart failure, COVID pneumonia, and sepsis. These conditions often lead to persistent psychological distress including depression, anxiety, and PTSD, which negatively impact quality of life. The study focuses especially on racially and ethnically minoritized populations who have been underrepresented in past research. Participants will be randomly assigned to one of two groups one using the Blueprint app which delivers adaptive coping skills over four weeks, and the other using a specially developed Education Program app with condition-specific informational videos. Both interventions include weekly safety monitoring surveys and complementary printed or PDF workbooks. The study will follow participants for six months after enrollment to compare the effects of these two programs. During the study, participants will use the assigned mobile app and complete surveys at baseline, 1 month, 3 months, and 6 months post-randomization to measure symptoms of depression, anxiety, PTSD, stress, and quality of life. The researchers will monitor safety through weekly surveys within the apps and collect data to understand who benefits most from the programs. The total participation duration includes the initial 4-week intervention and six months of follow-up assessments.
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This observational study evaluates the accuracy of the Okaya AI platform in detecting fatigue and depression among cardiology patients. It compares the platforms assessments to standard screening tools like the PHQ-9 and Fatigue Assessment Scale FAS. The study aims to address underdiagnosis of these symptoms by using advanced technology to analyze facial and vocal biomarkers during conversations. Participants will complete a single baseline check-in using the Okaya platform, which collects facial expressions, eye contact, speech pitch, volume, and patterns. These features are processed by computer vision and natural language processing to create an AI-based score that reflects fatigue and depression levels. Participants also complete the PHQ-9 and FAS questionnaires for comparison. No treatments or interventions are provided. During the study visit, participants undergo the Okaya assessment and complete the PHQ-9 and FAS questionnaires. Researchers will measure how well the AI-based score correlates with the traditional assessments and evaluate the usability and patient satisfaction with the platform. The study involves a one-time visit and concludes with analysis of baseline data. The total duration of participation is limited to this single assessment.
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Researchers are investigating how emotional awareness, attachment style, and the ability to think abstractly and symbolize IQ may influence the development of somatic symptoms in children and adolescents. These symptoms, such as pain, weakness, and chronic fatigue, often lead patients to seek medical advice but may lack an identifiable organic cause. The study also aims to better understand psychological and family factors tied to chronic somatic symptoms and to measure health costs incurred during the diagnostic process before a formal diagnosis is made. The study involves pediatric patients aged 11 to 17 years who have somatic symptom disorders, along with their caregivers. Participants complete psychological assessments during their first consultation, including questionnaires evaluating emotional awareness, attachment style, and cognitive abilities. Parents also provide information through questionnaires about demographic, medical, psychological, and lifestyle factors. A control group of similar age and language proficiency without somatic symptoms is also included. Participants fill out various questionnaires during their enrollment visit to assess emotional, behavioral, and psychological factors, as well as pain perception and coping strategies. These assessments help researchers measure the primary outcomes related to emotional awareness, attachment, and IQ, along with several secondary outcomes such as stress, behavioral issues, and parental reflective functioning. The study helps identify markers for early diagnosis and guides more comprehensive care for affected youths.
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