Randomized, controlled clinical trial of acoustic stimulation to reduce postconcussive symptoms.

OBJECTIVE: Effective interventions are needed to address postconcussive symptoms. We report the results of randomized, sham-controlled trial of Cereset Research™ Standard Operating Procedures (CR-SOP), a noninvasive, closed-loop, allostatic, acoustic stimulation neurotechnology previously shown to improve insomnia. METHODS: Military service members, veterans, or their spouses with persistent symptoms (Neurobehavioral Symptom Inventory [NSI] Score ≥23) after mTBI 3 months to 10 years ago, were randomized to receive 10 sessions of engineered tones linked to brainwaves (LB, intervention), or random engineered tones not linked to brainwaves (NL, sham control). The primary outcome was change in NSI, with secondary outcomes of heart rate variability and self-report measures of sleep, mood, and anxiety. RESULTS: Participants (n = 106, 22% female, mean age 37.1, 2.8 deployments, 3.8 TBIs) were randomized 1:1 to LB or NL, with no significant differences between groups at baseline. Among all study participants, the NSI declined from baseline 41.0 to 27.2 after (P < 0.0001), with gains largely sustained at 3 months (31.2) and 6 months (28.4). However, there were no significant differences between the LB (NSI declined from 39.9 at baseline to 28.2 post-intervention, 31.5 at 3 months, and 29.4 at 6 months) and NL (NSI declined from 41.5 at baseline to 26.2, 29.9, and 27.3, respectively. Similar patterns were observed for the PCL5 and PHQ-9 and there was no difference in HRV between groups. INTERPRETATION: Ten hours of acoustic stimulation while resting in a zero-gravity chair improves postconcussive symptoms. However, linking tones to brain electrical activity did not reduce symptoms more than random tones. REGISTRATION: ClinicalTrials.gov - NCT03649958.

Combat-Related Post-traumatic Stress Disorder: A Case Report of Virtual Reality Graded Exposure Therapy With Physiological Monitoring in a U.S. Navy Officer and a U.S. Army Officer.

The U.S. Department of Defense (DoD) and the Department of Veterans Affairs (DVA) seek to enhance the efficacy of treatments for warriors with post-traumatic stress disorder (PTSD) secondary to their combat deployments to Iraq and/or Afghanistan. Virtual Reality Graded Exposure Therapy (VR-GET) with arousal control has shown particular promise in reducing the symptom severity of PTSD in combat veterans. In this report, we describe the outcome of VR-GET for the treatment of combat-related PTSD in two combat veterans, neither of whom had received treatment for PTSD in the initial years after their return from combat duty.

An App a Day Keeps the Doctor Away: Guided Education and Training via Smartphones in Subthreshold Post Traumatic Stress Disorder.

Post traumatic stress disorder (PTSD) symptoms are common in military service members (SMs), but stigma can impede treatment initiation. Smartphone applications (apps) are available anywhere, anytime, with the potential to both mitigate the impact of stigma and reduce PTSD symptom severity. We provided 144 SMs or family members, with subthreshold PTSD symptoms (PTSD Checklist [PCL] scores of 28-49), with apps promoting psychoeducation, social engagement, and relaxation and randomized them to 6 weeks of resilience enhancement (brief cognitive-behavioral session, followed by daily text messages directing app use) or a control group (daily text messages of inspirational quotes). Participants (54 percent males, 87 percent SMs) in both groups reported reductions in PTSD, anxiety, and depression symptoms during the 6-week intervention, which were sustained at 3 months, but exhibited partial rebound at 6-12 months. Our preliminary results suggest that app use, with or without specific direction, feasibly and effectively reduces symptom severity. Future studies should consider a longer intervention, enhanced compliance tracking, or boosters to sustain benefits.

GETSmart: Guided Education and Training via Smart Phones to Promote Resilience.

Posttraumatic stress disorder (PTSD) is common in U.S. military service members (SMs) returning from Afghanistan and Iraq. SMs with PTSD symptoms that fall short of meeting full diagnostic criteria also experience devastating effects on their quality of life and daily functioning. Though evidence based treatments are indicated for those meeting diagnostic criteria, less attention has been given to interventions for those with subthreshold symptoms. The advent of novel technologies affords a unique opportunity to meet these intervention needs. Here we describe the feasibility and preliminary findings testing a smartphone-based intervention program to reduce PTSD symptoms in post-deployment SMs. Participants were randomized to a control or intervention condition. Those in the intervention condition engaged in one Skype session and six weeks of daily directive text messages guiding application (app) use. Apps primarily included those developed by the Department of Defense or VA. Participants completed the PTSD Checklist online at baseline, post-intervention, and 3-month follow-up. Overall, participant feedback was positive, regardless of treatment condition. Preliminary findings (with 10% of the overall target population having enrolled) indicate PCL scores decrease significantly from baseline to post-intervention, and these effects are maintained at 3-month follow-up. Additional analyses will be performed upon completion of the study. The present findings demonstrate the feasibility and acceptability of a smartphone-based resiliency training program for those with subthreshold PTSD.

Heart rate response to fear conditioning and virtual reality in subthreshold PTSD.

Posttraumatic stress disorder (PTSD) is a significant health concern for U.S. military service members (SMs) returning from Afghanistan and Iraq. Early intervention to prevent chronic disability requires greater understanding of subthreshold PTSD symptoms, which are associated with impaired physical health, mental health, and risk for delayed onset PTSD. We report a comparison of physiologic responses for recently deployed SMs with high and low subthreshold PTSD symptoms, respectively, to a fear conditioning task and novel virtual reality paradigm (Virtual Iraq). The high symptom group demonstrated elevated heart rate (HR) response during fear conditioning. Virtual reality sequences evoked significant HR responses which predicted variance of the PTSD Checklist-Military Version self-report. Our results support the value of physiologic assessment during fear conditioning and combat-related virtual reality exposure as complementary tools in detecting subthreshold PTSD symptoms in Veterans.