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Found 5 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating two types of behavioral therapies to treat insomnia in active duty service members who have ongoing postconcussive symptoms following a mild traumatic brain injury (mTBI). The study compares six sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) with four sessions of Brief Behavioral Therapy for Insomnia (BBT-I). The goal is to find the best insomnia treatment and see how it affects both sleep problems and prolonged postconcussive symptoms, along with blood-based biomarkers. This trial is conducted at a single site and includes adults aged 18 to 45 years old who have had persistent symptoms for at least three months after mTBI. Participants receive either CBT-I, which involves six weekly 50-minute individual sessions, or BBT-I, which consists of four weekly 30-minute individual sessions. Both treatments are delivered by trained behavioral health providers and can be done in person or through telehealth to accommodate service members' schedules. To complete the study, participants must attend a minimum of four CBT-I sessions or three BBT-I sessions, along with baseline and follow-up assessments. During the study, participants are evaluated using tools such as the Insomnia Severity Index, Neurobehavioral Symptom Inventory, and NIH Toolbox at baseline, during treatment, and at 7- and 12-week follow-ups. Researchers will monitor sleep symptoms, cognitive and neurobehavioral symptoms, and other health outcomes. The study takes place at the Intrepid Spirit Center and STRONG STAR offices, both part of the Carl R. Darnall Army Medical Center at Fort Cavazos, and includes safety and progress checks throughout the trial period.
Actively Recruiting
Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.
Actively Recruiting
Researchers are evaluating rehabilitation programs for individuals with Achilles tendon pain, focusing on military personnel who may face challenges accessing timely care. This study aims to find an effective treatment that improves pain and disability while expanding access to care. It is a randomized controlled trial that compares different approaches to rehabilitation and seeks to identify early factors that predict treatment success within four weeks. Participants will be randomly assigned to one of two groups: a single-visit physical therapist (PT)-initiated program delivered via telehealth with self-guided exercise modules, or a standard multi-visit PT-guided program consisting of six one-on-one telehealth sessions. All participants will receive education about Achilles tendinopathy, including symptoms, diagnosis, recovery expectations, self-management strategies, and additional treatment options. The exercise program involves progressive loading of the Achilles tendon. Throughout the study, participants will be assessed at baseline, 2 weeks, 4 weeks (primary outcome), 8 weeks, 26 weeks, and 1 year. Researchers will monitor tendon pain and disability, using patient-reported outcomes to measure improvements. The study involves telehealth visits, educational materials, and exercise adherence, with the goal of identifying efficient rehabilitation pathways that enable a quick and pain-free return to duty.
Actively Recruiting
Researchers are studying how Shared Decision Making affects treatment engagement, completion, and outcomes for active duty military members seeking treatment for posttraumatic stress disorder (PTSD). The study aims to understand patient characteristics, treatment preferences, and how these relate to starting and finishing therapy, as well as reducing PTSD symptoms. It also evaluates the impact of Shared Decision Making on matching patients to cognitive behavioral treatments for PTSD. Participants will engage in Shared Decision Making to choose among three therapies: Prolonged Exposure (PE), Cognitive Processing Therapy (CPT), or Written Exposure Therapy (WET). These therapies vary in length and session frequency, with PE and CPT allowing up to 24 sessions and WET up to 7 sessions. Shared Decision Making involves a five-step approach to help patients participate in treatment planning, explore options, assess preferences, reach decisions, and evaluate outcomes. During the study, participants will be assessed at baseline, during treatment, and at follow-ups up to seven months depending on therapy length and progress. Measures include treatment initiation and completion rates, patient treatment preferences, and PTSD symptom levels using the Posttraumatic Stress Disorder Checklist (PCL-5). Researchers will monitor treatment engagement, symptom changes, and safety throughout the study.
Actively Recruiting
Healthy Volunteer
This research aims to evaluate a treatment designed to address anger and aggression resulting from military-related betrayal. The study involves active duty military service members and veterans aged 18 years or older. It seeks to determine whether participants are satisfied with the treatment and if it is feasible to deliver in a military outpatient setting. Researchers will compare groups assigned to different wait times of 2, 3, or 4 weeks before starting treatment. Participants will receive Countering Chronic Anger and Aggression Related to Trauma and Transgressions (CART), a behavioral intervention consisting of 14 treatment modules provided twice a week. Treatment sessions typically last one hour and are delivered either face-to-face at the STRONG STAR offices or through telebehavioral health via phone or secure video calls, depending on individual circumstances. During the wait time, participants complete brief assessments twice weekly and receive weekly therapist check-ins by phone. Throughout the study, participants complete surveys before, during, and after treatment to assess anger, aggression, interpersonal interactions, and mental and physical health. Follow-up assessments occur 1 month after treatment ends, including questionnaires, an exit interview, and a satisfaction survey. The study's primary outcomes include recruitment success, participant satisfaction with the treatment, and changes in anger and aggression levels over approximately 11 to 18 weeks.