+1 877 705 191424 / 7
HIPAA Compliant
ISO 27001 Certified

Search Bar & Filters

Found 13 Actively Recruiting clinical trials

C

Actively Recruiting

Researchers are investigating treatments for symptoms related to mild traumatic brain injury mTBI, particularly in military service members who experience lasting symptoms such as dizziness, headache, and cognitive issues. This clinical trial compares Acceptance and Commitment Therapy Integrated Rehabilitation ACT, a therapy combining mindfulness and behavioral techniques, with usual care rehabilitation. The goal is to see if the combined ACT and rehabilitation approach improves symptom relief and functional recovery more effectively than usual care alone. Participants will be randomly assigned to one of two groups. One group receives the ACT intervention, which includes weekly in-person therapy sessions over four weeks plus daily at-home activities focusing on psychological flexibility and goal setting alongside targeted vestibular therapy and behavioral management strategies. The other group receives usual care rehabilitation tailored to individual needs, including therapies such as vestibular rehabilitation, neuropsychology, physical therapy, and general mental health support, but without ACT components. During the study, participants will be evaluated at baseline, after the 4-week treatment, and then at 3 and 6 months post-treatment. Assessments include questionnaires measuring anxiety, neurobehavioral symptoms, dizziness, mood, PTSD symptoms, disability, and activity levels, as well as objective measures like eye movement tracking and physical activity monitoring using Fitbit devices. This allows researchers to monitor symptom changes, functional improvements, and overall health throughout and after the treatment period.

Age: 18Years - 49YearsAll GendersPhase Not Applicable
2 locations
C

Actively Recruiting

This research aims to find out if adding Crisis Response Planning CRP, a brief strategy to help manage emotional crises, to massed Cognitive Processing Therapy CPT, a talk therapy for posttraumatic stress disorder PTSD, can better reduce suicidal thoughts and behaviors. The study focuses on military personnel and veterans with PTSD or subthreshold PTSD who have experienced recent suicidal ideation or attempts. It builds on earlier findings suggesting that combining CRP with CPT may improve outcomes for those facing both PTSD symptoms and suicide risk. Participants will be randomly assigned to one of two groups one receiving massed CPT plus CRP, and the other receiving massed CPT plus usual care suicide risk management, which involves a standard safety planning procedure. All participants will attend 10 daily CPT sessions over two consecutive weeks. The suicide risk intervention, whether CRP or usual care, is introduced during the intake session and reviewed during treatment. Optional booster sessions are also available. Throughout the study, participants will complete baseline assessments, daily therapy sessions, and ecological momentary assessment EMA surveys for four weeks. Follow-up assessments will occur at 1, 3, 6, 9, and 12 months after treatment. Researchers will monitor PTSD symptoms using the PTSD Checklist for DSM-5 and track suicidal thoughts and behaviors with several interviews and scales. The study aims to identify early indicators of treatment response and understand which parts of CRP are most helpful to participants. Safety and progress will be carefully observed during and after the study period.

Age: 18Years +All GendersPhase Not Applicable
1 location
S

Actively Recruiting

Healthy Volunteer

This clinical trial focuses on military service members or retirees aged 18 to 65 with post-traumatic stress disorder PTSD. It aims to compare the effects of combining Massed Prolonged Exposure PE, a type of behavioral therapy for PTSD, with a stellate ganglion block SGB, which is an injection of a local anesthetic in the neck, against Massed PE combined with a sham injection. The study also seeks to understand how differences in psychophysiological responses during the exposure therapy relate to treatment outcomes. Participants will receive ten 90-minute Massed PE sessions conducted by qualified therapists over two weeks, Monday through Friday, involving about four to six hours of treatment daily including therapy and out-of-session assignments. Between the first and second PE sessions, participants will be randomly assigned to receive either a one-time SGB injection using 6.5cc of Ropivacaine or a sham injection of normal saline. After the initial treatment, participants may have three booster sessions offered at 1, 3, and 7 weeks post-treatment. Qualified medical personnel will administer the injections under standard procedures with monitoring during and after the procedure. Throughout the study, participants will undergo assessments before, during, and after treatment, including follow-ups at 1, 3, and 6 months after completing PE. The main outcomes measured include changes in PTSD symptoms using the Clinician-Administered PTSD Scale and the PTSD Checklist. Additional evaluations include questionnaires on depression, anxiety, and trauma-related thoughts, as well as psychophysiological measures such as skin response, heart rate, and movement during the two-week treatment period. Participants in the sham injection group will be offered the active SGB after the one-month assessment. The total study duration includes treatment and follow-up assessments lasting several months.

Age: 18Years - 65YearsAll GendersPhase 2
2 locations
I

Actively Recruiting

Healthy Volunteer

This research aims to enhance resiliency and optimize readiness in military personnel, specifically targeting soldiers in the 3rd Security Force Assistance Brigades SFABs. These specialized Army units operate under high stress and demanding conditions, requiring strong individual resiliency. The study compares a new Acceptance and Commitment Training ACT-based program with usual resilience training to see how well each supports psychological flexibility and readiness during training and deployment. The trial is sponsored by The University of Texas Health Science Center at San Antonio and involves 600 soldiers stationed at Fort Hood, Texas. Participants will be randomly assigned to one of two groups. One group receives the standard resilience training called Master Resilience Trainer MRT, focusing on mental toughness and character strengths without booster sessions. The other group attends a 2-day psychological flexibility training workshop based on ACT, which teaches acceptance, mindfulness, and coping strategies to improve adaptability under stress. This group may also join four optional monthly booster sessions to reinforce the training concepts. Throughout the 16-month study period, soldiers will complete assessments measuring resilience using the Connor-Davidson Resilience Scale CD-RISC at baseline, after training, before deployment, and at regular 4-month intervals. The study tracks psychological flexibility, coping skills, and stress adaptation to evaluate training effects. Researchers will monitor participants ability to maintain readiness and adapt positively to operational stressors during and after deployment.

Age: 18Years +All GendersPhase Not Applicable
1 location
L

Actively Recruiting

Healthy Volunteer

Researchers are studying the Life Force training program, a group-based skills training designed for active-duty Soldiers. This program aims to enhance mental toughness and reduce harmful and high-risk behaviors. The study compares participants who receive the training to those in a control group to see who benefits most from these skills-based strategies. The training focuses on key skills like support building, persistence, adversity management, accountability, and emotional control. Participants are randomly assigned to either the Life Force training group or a control group. The training group attends five group sessions led by skilled trainers, while the control group receives standard care without training. Both groups complete a baseline survey and follow-up surveys at 6 and 12 months. Surveys gather information on risky behaviors, performance, mental toughness, military readiness, job satisfaction, career plans, and overall role functioning. Throughout the study, participants complete 15-20 minute surveys assessing their behaviors and functioning over a 12-month period following the baseline. An AI algorithm is used to identify those most likely to benefit from the training. The research team monitors outcomes related to high-risk behaviors, performance, mental toughness, and suicide-related behaviors to evaluate the programs impact compared to no intervention.

Age: 18Years +All GendersPhase Not Applicable
1 location
E

Actively Recruiting

Healthy Volunteer

This research aims to evaluate the effectiveness of the Level Up program, a military-specific life skills training designed for Soldiers arriving at their first duty location. The study focuses on reducing suicide-related behaviors and other harmful actions, improving mental health, boosting job performance, and decreasing early separation from military service. It targets Soldiers at a high-risk transition period to build skills that support mental toughness and resilience during their first year of service. Participants will be randomly assigned to receive either the Level Up program or the ENGAGE training, an existing single session Army bystander intervention. The Level Up program includes a 90-minute live group session during in-processing, access to a mobile app or online platform with interactive exercises on stress management, tactical thinking, and healthy relationships, personalized coaching via messages during the first month, and virtual booster sessions over one year covering practical topics like finances and leadership. ENGAGE training consists of a single 90-minute workshop focused on leadership and confidence in handling confrontations. Throughout the study, Soldiers will complete baseline and follow-up surveys at 1, 3, and 6 months after starting the intervention. Researchers will monitor occurrences of harmful behaviors and suicide-related behaviors for up to 12 months. They will also assess early service separation, job performance, mental health symptoms, emotional well-being, social support, and other psychological factors. The study uses data collected via surveys and app engagement to measure the programs impact on Soldiers health, readiness, and career success.

Age: 18Years +All GendersPhase Not Applicable
1 location
L

Actively Recruiting

Researchers are investigating the long-term safety and effectiveness of Abbotts neurostimulation systems in people with chronic pain. This observational study includes a wide range of participants to reflect real-world use and aims to enroll up to 2,000 subjects across up to 100 centers. The study spans 13 years, covering enrollment, data collection, and study closure, with subjects followed for five years after implantation. Participants will receive one of Abbotts market-released neurostimulation devices, either spinal cord stimulation SCS or dorsal root ganglion stimulation DRG. Individuals scheduled for implantation within 60 days of baseline are eligible. The study is single-arm and open-label, meaning all participants receive the device without randomization or placebo control. During the study, researchers will monitor adverse events, deaths, and device issues at multiple time points from baseline through five years post-implant. Participants will undergo regular safety assessments and provide data on device performance and related outcomes. This comprehensive follow-up will help understand the long-term effects and real-world use of these neurostimulation systems.

Age: 18Years +All Genders
55 locations
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
M

Actively Recruiting

Posttraumatic headache PTH is a frequent and disabling condition following traumatic brain injury TBI, especially common among U.S. military service members and veterans. This trial evaluates the effectiveness of cognitive behavioral therapy CBT for chronic PTH when delivered in person at clinics versus through telemedicine, compared to treatment as usual TAU. The study aims to improve headache-related disability and assess whether telemedicine can provide comparable results across multiple military and VA medical centers. Participants will be randomly assigned to one of three groups Clinic-based CBT CCBT with 8 weekly face-to-face sessions, Telemedicine-based CBT TCBT with 8 weekly sessions delivered remotely using telehealth technology, or TAU where they continue usual clinical care for 8 weeks. Both CBT approaches use a manualized intervention focused on headache awareness, relaxation techniques, and problem-solving. The study includes specific procedures for telemedicine encounters to ensure participant safety and engagement. Throughout the study, participants will complete assessments on headache-related disability using the Headache Impact Test-6 HIT-6, headache diaries, and measures of depression, anxiety, and PTSD at baseline and at 3-month follow-up. Weekly monitoring calls will be conducted for the TAU group to check for adverse events. The total involvement spans the treatment period plus follow-up, with data collected to understand treatment outcomes and participant experiences in a randomized, double-blind design.

Age: 18Years - 70YearsAll GendersPhase Not Applicable
8 locations
N

Actively Recruiting

Researchers are evaluating a non-trauma intervention designed specifically for military veterans and service members who have both posttraumatic stress disorder PTSD and mild to moderate traumatic brain injuries TBI. This study aims to test the acceptability and feasibility of this tailored treatment called Non-Trauma Treatment for TBI and comorbid PTSD T3 PTSD. The study is a pilot involving approximately 20 participants at Fort Hood, Texas. The treatment consists of eight individual psychotherapy sessions, each about 60 minutes long. These sessions focus on relaxation training, recognizing and managing stress, and problem-solving skills. The intervention is behavioral and does not involve trauma-focused therapy. Participants receive the therapy over a period that includes treatment and follow-up assessments. Participants will be involved in various assessments from the start through about six months after treatment, roughly eight months total. The main outcome measured is changes in PTSD symptoms using the PTSD Checklist-DSM-5. Additional evaluations include anxiety, depression, insomnia, alcohol use, and therapy satisfaction. Researchers will also monitor overall mental health and symptom changes with structured interviews and questionnaires. This helps to understand the impact and feasibility of the treatment for these veterans and service members.

Age: 18Years +All GendersPhase Not Applicable
1 location

1-10 of 13

1