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Found 5 Actively Recruiting clinical trials

C

Actively Recruiting

Researchers are studying the best behavioral treatment for insomnia in active duty service members who have both insomnia and prolonged postconcussive symptoms lasting at least three months after a mild traumatic brain injury mTBI. This study compares Cognitive Behavioral Therapy for Insomnia CBT-I with Brief Behavioral Therapy for Insomnia BBT-I to see how each affects insomnia severity and related postconcussive symptoms. The research also investigates the impact on blood-based biomarkers to better understand treatment effects. Participants will receive either six weekly 50-minute sessions of CBT-I or four weekly 30-minute sessions of BBT-I, both delivered individually by trained behavioral health providers. Treatments can be given in person or through telehealth to fit participants schedules. Completion requires attending at least four CBT-I sessions or three BBT-I sessions, along with baseline, 7-week, and 12-week follow-up assessments. During the study, participants will undergo evaluations that include the Insomnia Severity Index, Neurobehavioral Symptom Inventory, and NIH Toolbox assessments at baseline and follow-ups. Additional questionnaires will assess sleep beliefs, nightmares, sleepiness, mood, fatigue, headache impact, anxiety, and suicidality. The study lasts about 12 weeks, with monitoring to track changes in symptoms and treatment effects.

Age: 18Years - 45YearsAll GendersPhase Not Applicable
1 location
S

Actively Recruiting

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Age: 18Years +All Genders
2368 locations
S

Actively Recruiting

Researchers are studying rehabilitation programs for individuals with Achilles tendon pain, aiming to find effective treatments that improve pain and reduce disability. This trial focuses on expanding access to care for military personnel, especially those in battlefield settings or busy military facilities, by comparing different approaches to physical therapy. The study also seeks to identify early signs that predict how well someone will respond to rehabilitation. Participants will be randomly assigned to one of two rehabilitation programs a single-visit, physical therapist-initiated program delivered via telehealth with self-paced online modules, or a multi-visit, physical therapist-guided program with six telehealth sessions. Both programs include education about Achilles tendinopathy and a progressive exercise plan, with participants completing home exercise logs and quizzes. The study lasts 8 weeks, but outcomes will be assessed up to one year. During the trial, participants will complete online modules or telehealth visits that include exercise instruction and education. Researchers will evaluate tendon pain and disability at 4 weeks as primary outcomes, with additional assessments at 8 weeks, 26 weeks, and 1 year. The study also collects baseline data and early responses at 2 weeks to help predict treatment success. This helps monitor progress and safety throughout the study period.

Age: 18Years - 60YearsAll GendersPhase Not Applicable
2 locations
E

Actively Recruiting

This research focuses on active duty military personnel with posttraumatic stress disorder PTSD, aiming to understand how Shared Decision Making SDM affects treatment engagement, retention, and outcomes. The study evaluates how patient characteristics and preferences relate to starting and completing PTSD treatments and examines the impact of SDM on symptom reduction compared to prior trials. The research is designed as a partially randomized preference trial to match patients to evidence-based therapies using SDM. Participants receive one of three cognitive behavioral therapy types for PTSD Prolonged Exposure PE Therapy, Cognitive Processing Therapy CPT, or Written Exposure Therapy WET. Each therapy is delivered either in a massed daily or spaced weekly format, with up to 24 sessions for PE and CPT, and up to 7 sessions for WET. The study includes a pre-treatment SDM session to determine patient preferences for therapy type, session frequency, and treatment delivery. During the study, participants undergo assessments including the Posttraumatic Stress Disorder Checklist PCL-5 and other measures of psychosocial functioning, depression, anxiety, suicidality, and trauma-related cognitions from baseline through treatment and follow-up up to seven months. Researchers monitor treatment initiation, session completion, and symptom changes to evaluate the effectiveness of SDM in improving PTSD care. The total participation duration varies depending on treatment progress and selected therapy.

Age: 18Years +All GendersPhase Not Applicable
2 locations
P

Actively Recruiting

Healthy Volunteer

Researchers are evaluating a new treatment designed to address anger and aggression stemming from military-related betrayal among active duty military service members and veterans aged 18 and older. This study aims to determine whether participants find the treatment satisfactory and if it is practical to deliver in a military outpatient setting. The study will compare groups with different wait times before treatment to explore how timing affects outcomes. Participants will be randomly assigned to one of three groups with wait times of 2, 3, or 4 weeks before starting the treatment. The treatment, called Countering Chronic Anger and Aggression Related to Trauma and Transgressions CART, involves 14 therapy modules delivered twice a week. Sessions are conducted face-to-face at the STRONG STAR offices or through secure telebehavioral health methods when necessary. During the wait period, participants complete brief assessments twice weekly and have weekly check-in calls with their therapist. During treatment, participants continue regular assessments before each session to measure anger, aggression, and social interactions. After treatment, they complete follow-up surveys and interviews about a month later. The study measures outcomes including satisfaction with the treatment, levels of anger and aggression, interpersonal problems, and psychosocial functioning. Participation may last from the initial wait period through about 18 weeks after starting the study.

Age: 18Years +All GendersPhase Not Applicable
1 location