Fort Lewis

Researchers are evaluating the effectiveness of two telemedicine-delivered treatments, cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI), in adults with mild to moderate traumatic brain injury (TBI) who also have insomnia and post-traumatic stress symptoms. This prospective, single-blind randomized controlled trial will include 360 participants and aims to improve insomnia symptoms and reduce depressive symptoms. The study focuses on understanding how these therapies impact sleep severity and other related outcomes in this population. Participants will be randomly assigned to receive either a standardized 6-session CBT-I program or a 6-week MBTI program. CBT-I uses behavioral techniques to reduce arousal and improve sleep quality, while MBTI incorporates mindfulness meditation and behavioral strategies such as stimulus control and sleep restriction therapy. Both treatments are delivered remotely via telemedicine. Throughout the study, participants will wear an actigraph wrist monitor and complete electronic sleep diaries to track sleep patterns. Participants will undergo assessments including psychosocial questionnaires, neurocognitive testing, sleep diaries, actigraphy, and ambulatory EEG sleep monitoring at baseline, immediately after treatment, and at 2, 6, and 12 weeks post-treatment. The main outcome measured is the severity of insomnia using the Insomnia Severity Index (ISI). Secondary outcomes include pre-sleep arousal and depressive symptoms. The study also explores neurocognitive function and pre-sleep arousal changes, with safety and adherence monitored throughout the trial.

Researchers are conducting a Phase 2 randomized, double-blinded, placebo-controlled adaptive platform trial to study treatments for Post Traumatic Stress Disorder (PTSD) in active-duty service members and veterans. This trial focuses on evaluating the safety, tolerability, and effectiveness of multiple potential drug treatments using a shared control group to compare interventions. One group in this trial is studying fluoxetine, a medication used to treat PTSD symptoms. Participants in the fluoxetine group will be randomly assigned to receive either fluoxetine or a placebo in a 5:3 ratio during a 12-week treatment period. Fluoxetine dosing starts at 10 mg daily for one week, then increases to 20 mg daily for two weeks, followed by 40 mg daily for two weeks, and then 60 mg daily for the remainder of the trial. Dose reductions are allowed once if needed for tolerability, but doses will not be increased after a reduction. The study includes a 30-day screening period before treatment and a 4-week safety follow-up after treatment. Participants will undergo evaluations including the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) to measure PTSD symptoms and the Columbia Suicide Severity Rating Scale (C-SSRS) to monitor suicidal thoughts or behaviors. These measures will be assessed at the end of the 12-week treatment or at early termination. Safety and tolerability will be closely monitored throughout the study. Total participation involves screening, treatment, and follow-up lasting approximately 16 weeks.

Researchers are conducting a Phase 2 adaptive platform trial to evaluate several potential drug treatments for Post Traumatic Stress Disorder (PTSD) in active-duty service members and veterans. This part of the trial focuses on studying daridorexant, assessing its safety and effectiveness compared to a placebo. The study design allows participants to be randomly assigned to different treatment groups, sharing a common placebo control for comparison. Participants who qualify under the Master Protocol undergo a 30-day screening period before being randomized into the daridorexant group or placebo group in a 5:3 ratio. Those receiving daridorexant take a 50 mg dose once daily, at least two hours after their last meal and within 30 minutes of going to bed. The treatment phase lasts 12 weeks, followed by a 4-week safety follow-up to monitor participants after treatment. Throughout the study, researchers measure changes in PTSD symptoms using the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) over 12 weeks. They also track any new or worsening suicidal thoughts or behaviors via the Columbia Suicide Severity Rating Scale (C-SSRS). The total study participation spans about 16 weeks, including screening, treatment, and safety monitoring periods.

Researchers are conducting a Phase 2 randomized, double-blinded, placebo-controlled trial to evaluate multiple potential drug treatments for Post Traumatic Stress Disorder (PTSD) in active-duty service members and veterans. This adaptive platform trial allows multiple treatment groups to be compared to a shared placebo control group, enabling efficient assessment of safety, tolerability, and effectiveness. The study also incorporates biomarker assessments to help define future participant groups based on biological markers, allowing a multi-stage testing approach including both non-biomarker and biomarker-defined cohorts. Participants will undergo a 30-day screening period, followed by a 12-week treatment period, and then a 4-week safety follow-up. The study includes up to five treatment arms, each testing a different drug or its matching placebo. Treatments include Fluoxetine hydrochloride, Vilazodone hydrochloride, Daridorexant, and SLS-002 administered according to specific dosing schedules ranging from daily oral doses to twice-weekly intranasal sprays. Dose adjustments for tolerability are permitted within predefined limits. New treatment cohorts can be added during the trial, and safety monitoring is overseen by an independent board. Throughout the study, participants will be assessed for changes in PTSD symptoms using standardized clinical scales and monitored for any new or worsening suicidal thoughts or behaviors. Procedures include blood draws, MRI scans, and various clinical evaluations. Data will be reviewed regularly to decide on continuing or stopping treatment arms. The total participant involvement spans approximately 16 weeks, including screening, treatment, and follow-up, with ongoing safety and biomarker analyses to guide future research directions.

Special Operations Forces (SOF) personnel continuously train to maintain peak performance and often need noninvasive therapies to support recovery from their demanding workload. Photobiomodulation therapy (PBMT) is a low-level laser treatment applied to the body to potentially improve healing, recovery, and physical performance. This research evaluates the physiological and behavioral effects of PBMT applied after exercise in SOF operators through a single-blinded randomized controlled trial with a sham control group. Participants will undergo coach-led THOR3 training and be assigned to receive either PBMT or sham PBMT post-exercise. PBMT is delivered at 32-40W to the quadriceps using a LightForce® XLi 40W device with Smart Hand Piece technology, providing treatment three times per week for three weeks. The sham group receives the same procedure without active laser light. Treatment duration is adjusted based on the participant's quadriceps size, lasting approximately 5 to 20 minutes. Throughout the study, participants will complete various performance and strength tests including countermovement jumps and muscle strength measurements at baseline and follow-up visits. They will also report daily pain and fatigue levels using self-reported scales. Sleep and readiness data will be collected via continuous wear of an Oura ring. Researchers will monitor changes in physical performance, recovery, pain, fatigue, and sleep quality over the three-week study period.

Researchers are evaluating the effects of a remotely delivered behavioral program called Empowered Relief on patients undergoing lumbar spine surgery. This trial aims to determine if participating in Empowered Relief early after back surgery can improve postoperative outcomes compared to a remote education program. The study also explores whether changes in pain catastrophizing affect recovery and if pre-surgery pain catastrophizing influences treatment response. The trial randomly assigns patients to one of two groups: a single-session Empowered Relief group class or a single-session Education group class. Both interventions are delivered remotely in group settings via a web-based platform by licensed healthcare professionals. Empowered Relief focuses on pain neuroscience education and cognitive-behavioral pain coping skills, while the Education program provides information on managing pain, preventing future injury, and staying healthy after surgery. Participants will enroll before surgery and complete surveys before surgery as well as at 3 and 6 months after surgery. Outcome assessments, including measures of pain interference, will be conducted by evaluators who do not know group assignments. The study will help advance knowledge on remote non-drug strategies to manage pain and improve quality of life after spine surgery for both civilian and military patients.