Killeen

Researchers are evaluating a combined Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) against usual care vestibular rehabilitation in people aged 18 to 49 with mild traumatic brain injury (mTBI) related vestibular symptoms. The study focuses on military service members and civilians experiencing dizziness and other impairments after mTBI, aiming to improve recovery and reduce long-term psychological health issues. The trial involves 250 participants treated at two medical centers, exploring the added benefits of combining behavioral therapy with vestibular rehabilitation. The ACTIVE intervention integrates Acceptance and Commitment Therapy, which promotes mindfulness and psychological flexibility, with targeted vestibular therapy and behavioral strategies including physical activity, sleep, hydration, and nutrition. Usual care includes vestibular therapy exercises such as gaze stability, visual-vestibular habituation, and balance or gait training, without the ACT components. Both treatments are delivered weekly over four weeks, with the possibility of additional usual care at the providers' discretion. Participants will be assessed at the start of treatment, then at 4 weeks, 3 months, and 6 months after completing therapy. Researchers will measure dizziness-related impairment using the Dizziness Handicap Inventory and anxiety symptoms with the Generalized Anxiety Disorder scale. The study will monitor symptoms, functional improvements, and psychological health over six months to evaluate the effectiveness and lasting impact of the combined treatment compared to usual care.

Researchers are studying whether adding Crisis Response Planning (CRP), a brief personalized strategy to handle emotional crises, to massed Cognitive Processing Therapy (CPT) can better reduce suicidal thoughts and behaviors in military personnel and veterans with posttraumatic stress disorder (PTSD) or subthreshold PTSD. CPT is a proven psychotherapy for PTSD, and CRP has been shown to reduce suicidal ideation and attempts. The study aims to improve outcomes for those experiencing PTSD symptoms alongside recent suicidal thoughts or behaviors. Participants will receive 10 daily sessions of massed CPT over two consecutive weeks. They will be randomly assigned to either CPT combined with CRP or CPT combined with usual care suicide risk management, which includes standard safety planning. The suicide-risk intervention is introduced during the intake session and reviewed throughout CPT treatment. Optional booster sessions are also offered. Participants will complete baseline assessments, daily therapy sessions, and ecological momentary assessment surveys for four weeks. Follow-up assessments will occur at 1, 3, 6, 9, and 12 months. Researchers will monitor changes in suicidal thoughts and behaviors using standardized checklists and interviews, and study early treatment response indicators and use of CRP components. The study is conducted at the STRONG STAR clinical offices at Carl R. Darnall Army Medical Center, Fort Hood, with compensation offered for participation.

Researchers are evaluating a new approach to treat post-traumatic stress disorder (PTSD) in military service members and retirees aged 18 to 65. This Phase 2 clinical trial compares the effects of combining Massed Prolonged Exposure (PE), a behavioral therapy for PTSD, with a stellate ganglion block (SGB), an injection of a local anesthetic in the neck, against Massed PE combined with a sham injection. The study aims to determine if adding the SGB improves outcomes and whether changes in physiological arousal during exposure treatment explain these effects. Participants receive ten 90-minute sessions of Massed PE over two weeks, conducted by master- or doctoral-level therapists. Each treatment day involves about four to six hours of therapy Monday through Friday, including out-of-session assignments. Between the first and second PE sessions, half of the participants receive the SGB injection using 6.5cc of Ropivacaine hydrochloride 0.5%, while the other half receive a sham injection with normal saline. Medical staff closely monitor participants during and for an hour after the injection. After completing the two-week treatment, participants are offered three booster sessions at 1, 3, and 7 weeks post-treatment. Those initially receiving the sham SGB are later offered the actual SGB with ropivacaine. Participants undergo assessments before, during, and after treatment, as well as at 1-, 3-, and 6-month follow-ups. The study's main outcomes include changes in PTSD symptoms measured by the Clinician-Administered PTSD Scale-DSM 5 (CAPS-5) and the PTSD Checklist-DSM 5 (PCL-5). Researchers also track safety and recovery following the injection procedure. The total participation time covers treatment, booster sessions, and follow-up visits to monitor progress and treatment effects.

Researchers are evaluating an Acceptance and Commitment Training-based program designed to enhance resilience and optimize readiness among soldiers in the 3rd Security Force Assistance Brigades (SFAB) of the United States Army. These specialized military units carry out high-stress missions alongside allied and partner nations, making individual resilience vital to their operational success. This research addresses a gap in evidence-based interventions aimed at boosting resilience in military personnel through scientifically rigorous methods. Participants will undergo Psychological Flexibility Training (PFT), which consists of a 2-day workshop focusing on responding flexibly to challenging situations and practicing skills that encourage psychological adaptability. After the initial training, optional monthly booster sessions lasting one hour each will provide refreshers and opportunities to apply the concepts learned. The program aims to improve psychological flexibility, a key factor in resilience, by teaching mindfulness, acceptance, and committed action strategies. Soldiers will be assessed using resilience measures such as the Connor-Davidson Resilience Scale at the start of the study and every four months for 16 months. Evaluations will occur before and after training as well as before and after deployment. Researchers will monitor psychological resilience, readiness, and adaptation to stress over the study period to evaluate the impact of the training program on participants' ability to cope with operational challenges.

Researchers are evaluating the Life Force training program, a group-based, skills training designed specifically for active-duty Soldiers to enhance mental toughness and reduce harmful and high-risk behaviors. The study compares participants who receive the 5-session training with a control group who do not participate in the training. Mental toughness is described as the ability to maintain peak performance under pressure, recover from setbacks, cope with challenges, and persevere toward goals. The Life Force program includes five group training sessions led by skilled trainers. The sessions focus on key skills such as building supportive relationships, pushing beyond quitting points, viewing failure as growth opportunities, taking accountability for setbacks, and managing emotions effectively. Eligible Soldiers are identified using an AI algorithm based on military and health records and then randomly assigned to either the Life Force training or control group. All participants complete a baseline survey and follow-up surveys at 6 and 12 months to assess risky or harmful behaviors, military performance indicators, self-reported mental toughness, job satisfaction, and overall functioning. The study measures the occurrence of high-risk behaviors within 12 months after baseline. Data from the training group will be compared with the control group to evaluate the program's impact.

Researchers are evaluating the Level Up program, a strengths-based, military-specific life skills training designed to reduce suicidal-related behaviors (SRBs), harmful behaviors, and early military separation among new U.S. Army Soldiers during their first duty assignment. This program aims to improve mental health, job performance, and resilience by building coping skills during a high-risk transition period. It is tested against a single session Army bystander intervention program called Engage. The study focuses on Soldiers arriving at their first duty location, especially those aged 17-24 who face high suicide risk and stress from life challenges like relationships and finances. The Level Up program includes a 90-minute live group session during Soldiers' in-processing week, access to a mobile app or online platform with interactive self-guided exercises on skills such as stress management and healthy relationships, personalized coaching messages during the first month, and virtual booster sessions over one year covering practical topics like finances and leadership. Participants are randomized to receive either Level Up or the Engage single session workshop focused on leadership and handling confrontations. Participants complete baseline and follow-up surveys at 1, 3, and 6 months post-baseline. Researchers will monitor occurrences of harmful and suicide-related behaviors within 12 months after randomization. The study also includes assessments of mental health, job performance, and military retention. The program's safety is monitored, with all participants able to opt out at any time and provided extra support as needed. Results will guide potential Army-wide implementation to enhance Soldier well-being and career success.

Researchers are conducting the REALITY study to collect both short- and long-term safety and effectiveness data on people implanted with Abbott's neurostimulation systems for chronic pain. This prospective, open-label, multi-center study includes a broad range of participants to reflect real-world use and aims to enroll up to 2,000 subjects across up to 100 centers. Enrollment is planned to be completed within 7 years, with an overall study duration of 13 years including follow-up and close out. Participants will receive market-approved Abbott neurostimulation devices, specifically spinal cord stimulation (SCS) or dorsal root ganglion stimulation (DRG) systems. Individuals scheduled to receive implantation within 60 days of the baseline visit can join the study. The study does not randomize or compare treatments but monitors the implanted devices over time to gather safety and performance information. During the study, participants will be followed for up to 5 years after implantation with regular assessments to track device- and procedure-related adverse events, deaths, and device deficiencies. These safety outcomes will be measured at multiple time points including baseline, the permanent implant procedure, and every six months up to five years. The study also involves collecting data on patient experience and device performance throughout this period.

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.

Posttraumatic headache (PTH) is a common and disabling condition among U.S. military service members and veterans who have experienced mild or moderate traumatic brain injury (TBI). This research aims to compare the effectiveness of Clinic-based Cognitive Behavioral Therapy (CCBT), Telemedicine-based Cognitive Behavioral Therapy (TCBT), and usual medical care (TAU) in reducing headache-related disability. The study will be conducted across seven treatment sites including VA medical centers and military facilities, assessing headache impact and psychiatric symptoms at multiple time points. Participants will be randomly assigned to one of three groups: CCBT involving eight weekly in-person sessions focused on headache awareness, relaxation, and problem-solving techniques; TCBT delivering the same eight cognitive behavioral therapy sessions via telemedicine; or TAU where participants continue their usual medical care for eight weeks. Sessions typically last 45 to 75 minutes depending on individual needs. Throughout the study, participants will complete headache diaries online and receive reminder calls. Researchers will monitor headache-related disability using the Headache Impact Test (HIT-6) from baseline to three months. The study also gathers participant feedback on treatment experiences and tracks safety by noting any changes in headache symptoms or psychiatric conditions. Total involvement spans the intervention period and follow-up assessments to evaluate therapy outcomes and participant perspectives.

Researchers are evaluating a specialized non-trauma treatment designed for military veterans and service members who have mild or moderate traumatic brain injuries (TBI) along with posttraumatic stress disorder (PTSD). This pilot study aims to test the treatment's acceptability and feasibility in a group of 20 participants seeking care at Fort Hood, Texas. The intervention focuses on managing PTSD symptoms in those with TBI through individual psychotherapy. The treatment being studied includes eight behavioral therapy sessions, each lasting about 60 minutes. These sessions cover relaxation training, identifying sources of stress, stress management techniques, and problem solving skills. The intervention is tailored specifically to address the unique needs of participants with both TBI and PTSD. Participants will be involved over approximately eight months, with assessments including the PTSD Checklist-DSM-5 (PCL-5) to measure symptom changes from baseline to six months after treatment. Researchers will also evaluate the treatment's feasibility and acceptability. Participants undergo interviews and clinical assessments to confirm eligibility and monitor progress throughout the study period.