The Effects of the Safe and Sound Protocol on PTSD Symptoms and Anxiety
The Safe and Sound Protocol (SSP) is a passive acoustic intervention that is designed as a "neural exercise" to promote efficient regulation of autonomic state. Prior research has shown that the SSP can improve autonomic function, auditory hypersensitivities, and emotion regulation in individuals with Autism Spectrum Disorders. This observational pilot study is being conducted to establish methods for an upcoming randomized controlled trial to test the utility of the SSP for trauma treatment. This study will enroll clients at the Spencer Psychology clinic who are set to take part in SSP under the supervision of their therapist. Because the therapists have participated in the design of the protocol and will participate in data collection and analysis, SSP will be considered a research procedure. In addition to taking part in SSP, subjects complete a set of questionnaires and have their pulse measured before starting the SSP intervention, after having completed 2/5 hours of the SSP, one week after completing all 5 hours of the SSP, and one month after completing the SSP intervention. The investigators will also pull relevant information from Spencer Psychology's medical records to document diagnosis, track client progress during study, and augment self-reported demographics. Clients who are receiving psychotherapy but not the SSP will be recruited as a comparison group.
NCT04999852 — Anxiety
Status: Completed
http://inclinicaltrials.com/anxiety/NCT04999852/
A Phase 2, Open Label Study of the Safety and Effectiveness of MDMA-assisted Therapy for Participants With Posttraumatic Stress Disorder
This Phase 2, Open Label study will provide supportive data on the safety and effectiveness of MDMA-assisted therapy in participants with posttraumatic stress disorder (PTSD). This study will be conducted at a single study site in Vancouver, BC. There will be at least 2 co-therapy pairs. The study will enroll up to 20 participants The Preparatory Period will consist of three 90-minute non-drug Preparatory Sessions. A flexible divided dose of MDMA, will be administered during the Treatment Period with manualized therapy in up to two open-label Study Drug Sessions. During the Treatment Period, each Study Drug Session is followed by three 90-minute Integrative Sessions of non-drug therapy. The Study Drug Sessions are scheduled roughly 3 to 5 weeks apart.
NCT04968938 — Posttraumatic Stress Disorder
Status: Withdrawn
http://inclinicaltrials.com/posttraumatic-stress-disorder/NCT04968938/
A Comparison of Prolonged Exposure Therapy, Pharmacotherapy, and Their Combination for PTSD: What Works Best, and for Whom
Posttraumatic Stress Disorder (PTSD) remains a salient and debilitating problem, in the general population and for military veterans in particular. Several psychological and pharmacological treatments for PTSD have evidence to support their efficacy. However, the lack of comparative effectiveness data for PTSD treatments remains a major gap in the literature, which limits conclusions that can be drawn about which of these treatments work best. The current study will compare the effectiveness of PTSD treatments with the strongest evidentiary support - Prolonged Exposure (PE) therapy and pharmacotherapy with paroxetine or venlafaxine - as well as the combination of these two treatments. A randomized trial will be conducted with a large, diverse sample of veterans with PTSD (N = 300) recruited from 6 VA Medical Centers throughout the US. Participants will complete baseline assessments, followed by an active treatment phase (involving up to 14 sessions of PE and/or medication management) with mid (7 week) and posttreatment (14 week) assessments, and follow-up assessments at 27 and 40 weeks. Study outcomes will include PTSD severity, depression, quality of life and functioning, assessed via clinical ratings and self-report measures. Further, a range of demographic and clinically relevant variables (e.g., trauma type/number, resilience) will be collected at baseline and examined as potential predictors or moderators of treatment response, addressing another gap in the PTSD treatment literature. These data will be used to develop algorithms from predicting the optimal treatment for individual patients (i.e., "personalized advantage indices"; PAIs). Effectiveness of the treatments will be compared using multilevel modeling. PAIs will be developed by conducting bootstrapped analyses to select variables that predict or moderate outcomes (clinician rated PTSD severity at Week 14), followed by jacknife analyses to determine the magnitude of the predicted difference (representing an individual's "predicted advantage" of one treatment over the others).
NCT04961190 — Posttraumatic Stress Disorder
Status: Recruiting
http://inclinicaltrials.com/posttraumatic-stress-disorder/NCT04961190/
Randomized Trial of Prolonged Exposure (PE) vs. PE With PE Coach Among Veterans With PTSD
Thousands of mental health mobile applications (apps) are available but limited research has been conducted on their effectiveness. VA has been a leader in mental health mobile app development and must research whether these apps work, and if so, how? PE Coach is a well-designed treatment companion app to one of the most researched, efficacious psychotherapies for PTSD (prolonged exposure), a treatment that has been broadly disseminated throughout VA mental health clinics. Research suggests that VA therapists find the app helpful in supporting patients. Preliminary results suggest that Veteran patients prefer to receive therapy withPE Coach and Veterans complete more recovery-oriented homework when they do. This study will randomize 124 Veterans with PTSD to treatment with or without PE Coach. The project will evaluate the effect of the app on PTSD-related functioning, quality of life, and PTSD symptoms. The investigators will test whether the app improves functioning and symptoms, increases homework, and reduces drop out.
NCT04959695 — Posttraumatic Stress Disorder
Status: Recruiting
http://inclinicaltrials.com/posttraumatic-stress-disorder/NCT04959695/
A Phase 2b, Randomized, Double Blind, Two Arm Study to Investigate the Effects of BNC210 Tablet Formulation Compared to Placebo in Adults With Post-Traumatic Stress Disorder (PTSD)
The purpose of this study is to assess the effects of BNC210 compared to placebo on PTSD symptom severity as measured by CAPS-5 Total Symptom Severity Scores.
NCT04951076 — Post-Traumatic Stress Disorder
Status: Completed
http://inclinicaltrials.com/post-traumatic-stress-disorder/NCT04951076/
PTSD Prevention Using Oral Hydrocortisone in the Immediate Aftermath of Trauma
There is currently no evidence-based intervention for individuals exposed to trauma that is designed to aid recovery and prevent the development of post-traumatic stress disorder (PTSD). This randomized control trial proposes to test a one-time prophylactic treatment for the prevention of symptoms of PTSD and related mental health disturbances and the promotion of resilience using a single dose of hydrocortisone (HCORT) or placebo, administered within six hours of trauma exposure. People at risk for PTSD have demonstrated low cortisol levels before and in the aftermath of traumatic exposures and lower cortisol levels have also been observed in combat veterans with PTSD. Administering HCORT at the time of trauma would help boost the body's natural stress recovery systems to facilitate resilience. Participants who present to the emergency department following trauma exposure and report high distress, panic, anxiety or dissociation will be invited to participate in this clinical trial. 220 trauma survivors will be randomized and recruited at two locations: Mount Sinai Hospital in New York City, US, and a civilian/military hospital in Tel Hashomer, Israel. Trauma survivors will be assessed at 2, 6, 12 and 28 weeks post-treatment. HCORT closely resembles cortisol produced in the adrenal glands and released during stress. It is hypothesized that HCORT treatment will result in an accelerated decline in the presence and severity of PTSD and related mental health symptoms compared to the placebo group. Blood samples will be collected for analysis of potential biomarkers to obtain more information about the mechanisms of action of this intervention. The information obtained will be relevant in determining whether early intervention with a single dose of HCORT, compared to placebo, administered within several hours following trauma exposure, will reduce the risk of developing PTSD in trauma survivors.
NCT04924166 — PTSD
Status: Recruiting
http://inclinicaltrials.com/ptsd/NCT04924166/
The Efficacy of Traumatic Memory Modification Using a Memory Reconsolidation Procedure Under Propranolol Among Adolescents With Post-traumatic Stress Disorder
The aim of this study is to demonstrate the effectiveness of propranolol in blocking reconsolidation by reducing PTSD symptoms in the short and long term in adolescents with PTSD for more than 3 months.
NCT04921982 — Post Traumatic Stress Disorder
Status: Not yet recruiting
http://inclinicaltrials.com/post-traumatic-stress-disorder/NCT04921982/
Effectiveness of Trauma Therapy Using Prolonged Exposure for the Treatment of Post-traumatic Stress Disorder (PTSD) in Patients With Comorbid Psychotic Disorder
Effectiveness of trauma therapy using prolonged exposure for the treatment of post-traumatic stress disorder (PTSD) in patients with comorbid psychotic disorder
NCT04911010 — Schizophrenia
Status: Recruiting
http://inclinicaltrials.com/schizophrenia/NCT04911010/
Adding Trauma-focused Psychotherapy to Ketamine Treatment for Chronic PTSD: A Pilot Study
The current pilot project will evaluate the efficacy of adding Written Exposure Therapy (WET) to a course of repeated IV ketamine infusions in improving PTSD symptoms and maintaining symptom improvement in patients with chronic PTSD. WET is a brief, 5-session evidence-based written trauma-focused therapy without in between-session assignments, with demonstrated efficacy and low dropout rates in patients with PTSD. WET will be administered to all eligible participants; the first WET sessions will be interleaved with the last two ketamine infusions to take advantage of a window of increased neuroplasticity potentially induced by repeated ketamine infusions. WET will be administered on different days as the ketamine infusions.
NCT04889664 — PTSD
Status: Completed
http://inclinicaltrials.com/ptsd/NCT04889664/
A Randomized Placebo-controlled Trial of Methylphenidate in Veterans With a Diagnosis of Post Traumatic Stress Disorder and Recent Cerebral Stroke.
Veterans with post-traumatic stress disorder (PTSD) have an increased risk of developing ischemic stroke. Veterans enduring PTSD face difficulties in managing their PTSD severity after suffering from a stroke. Currently, clinical trials in PTSD exclude patients with stroke and patients with significant premorbid psychological conditions like PTSD are usually excluded from stroke clinical trials. Methylphenidate (MPH) is a central nervous system stimulant that can improve PTSD symptoms: avoidance behaviors, social withdrawal, hyperarousal, and working memory. MPH can also improve post-stroke outcomes: mood, activities of daily living, and motor functioning. In clinical trials for PTSD or stroke, MPH has been shown to be well-tolerated with minimal adverse events. The high prevalence of PTSD in Veterans with stroke provides strong justification for development of interventions that effectively and simultaneously target both conditions. The overarching goal of our proposal is to understand how MPH improves PTSD severity in Veterans with comorbid stroke.
NCT04885257 — Stroke
Status: Recruiting
http://inclinicaltrials.com/stroke/NCT04885257/