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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are investigating the effectiveness of two telemedicine-delivered treatmentscognitive behavioral therapy for insomnia CBT-I and mindfulness-based treatment for insomnia MBTIin adults with mild to moderate traumatic brain injury TBI who also have symptoms of post-traumatic stress and insomnia. The study is a prospective, randomized, single-blind controlled trial including 360 participants, aiming to compare how these treatments reduce insomnia severity and depressive symptoms. Participants are randomly assigned to receive either CBT-I or MBTI, each delivered in six standardized sessions via telemedicine. CBT-I focuses on education about sleep, stimulus control, sleep restriction, relaxation training, and cognitive restructuring over six weeks. MBTI integrates mindfulness meditation practices with behavioral sleep strategies during the same 6-week period. Throughout the study, participants wear an actigraph wrist monitor and keep electronic sleep diaries to track sleep patterns and treatment adherence. Participants will complete assessments including psychosocial questionnaires, neurocognitive testing, sleep diaries, actigraphy, and ambulatory EEG sleep monitoring at baseline, end of treatment, and at 2, 6, and 12 weeks post-treatment. The main outcome measured is insomnia severity using the Insomnia Severity Index. Secondary outcomes include pre-sleep arousal and depressive symptoms. The study monitors participants for a total of 24 weeks after randomization to evaluate treatment effects and safety.

Age: 18Years +All GendersPhase Not Applicable
5 locations
S

Actively Recruiting

Researchers are investigating whether adding Medical Massage Therapy MMT to provider-directed care can shorten the time active-duty service members with subacute lower back pain LBP spend on medically restricted duty. This trial focuses on subacute LBP, a common cause of musculoskeletal injuries among service members, and aims to reduce pain, healthcare use, and improve recovery compared to provider-directed care alone. The study involves 200 participants and addresses the lack of strong evidence for effective LBP treatments. Participants will be randomly assigned to one of two groups one receiving only provider-directed care such as physical therapy, and the other receiving both provider-directed care and weekly MMT sessions by licensed therapists. The treatment period lasts approximately 12 weeks, with participants following their assigned care plan and completing study forms. A final follow-up visit occurs up to four weeks after the last treatment. During the study, participants will undergo regular assessments including pain scales, disability indexes, and questionnaires about pain, work productivity, and sleep quality at baseline, weekly visits, and follow-up. Researchers will monitor medical restricted duty days, medication use, and healthcare utilization. Data collection continues for up to 16 weeks after the baseline visit to evaluate the impact of MMT alongside standard care on recovery and quality of life.

Age: 18Years - 64YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating the effects of a remotely delivered behavioral intervention called Empowered Relief in patients undergoing lumbar spine surgery. This phase II randomized controlled trial aims to determine if Empowered Relief, given early after back surgery, can improve postoperative outcomes compared to a remotely delivered education session. The study also investigates how changes in pain catastrophizing relate to recovery and whether preoperative pain catastrophizing influences treatment response. Participants will be randomly assigned before surgery to one of two groups a single remotely delivered group session of Empowered Relief, which focuses on pain neuroscience education and coping skills, or a single remotely delivered group education session about managing pain and recovery after back surgery. Both sessions are conducted online by licensed healthcare professionals. Participants will complete surveys before surgery and again at 3 and 6 months after surgery to assess outcomes such as pain interference, physical function, disability, pain intensity, and opioid use. Outcome assessments are done by evaluators who do not know the group assignments. Overall, the study will help advance research on non-drug remote strategies to improve quality of life after spine surgery in civilian and military patients.

Age: 18Years - 85YearsAll GendersPhase Not Applicable
4 locations