A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate the Efficacy of Electrical Vestibular Nerve Stimulation (VeNS), Compared to a Sham Control for Treatment of Post- Traumatic Stress Disorder (PTSD)
Trial title: A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate the Efficacy of Electrical Vestibular Nerve Stimulation (VeNS), Compared to a Sham Control for Treatment of PTSD The aim of this study: To better evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS) as a method of treating PTSD, as compared to a sham control. Allocation: Randomized to either active device or control device usage. Endpoint classification: Efficacy Study Intervention Model: Parallel Assignment in 1:1 active to control allocation Sample size: The aim is to recruit a total of up to 300 participants. The study will last 12 weeks in total for each subject.
NCT05242367 — Post Traumatic Stress Disorder
Status: Recruiting
http://inclinicaltrials.com/post-traumatic-stress-disorder/NCT05242367/
Reducing Attention Bias Variability Using Attention Control Training With Feedback Among Individuals With Posttraumatic Stress Disorder
The purpose of this study is to explore the efficacy of Attention Control Training with the inclusion of feedback for Post Traumatic Stress Disorder (PTSD). It seems that the most efficient ABMT method to balance attention bias variability (ABV) among individuals with PTSD is Attention Control Training (ACT). This type of training is designed to balance attention allocation towards threat-related and neutral stimuli. A few studies have further shown that this training type succeeds in balancing the aberrant fluctuations in attention bias observed in patients with PTSD, and that this leads to a reduction in PTSD symptoms (Badura-Brack et al., 2015). The purpose of the current study is to examine the efficacy of ACT that also includes feedback. Specifically, we intend to test whether the inclusion of feedback on top of standard ACT may enhance training efficacy in reducing ABV and in reducing PTSD symptoms.
NCT05242263 — PTSD
Status: Completed
http://inclinicaltrials.com/ptsd/NCT05242263/
Sudarshan Kriya Yoga for Canadian Veterans With Post-Traumatic Stress Disorder: A Nation-wide Effectiveness and Implementation Evaluation
We plan to study the reach, effectiveness, adoption, implementation, and maintenance of the virtually-delivered Sudarshan Kriya Yoga (v-SKY) intervention. We will study effectiveness by comparing the effects of v-SKY to a waitlist control in a randomized controlled trial (RCT) with Canadian military and RCMP veterans with PTSD. Effects of the intervention on PTSD symptom severity, depression, pain, anxiety, and quality of life will be evaluated. We will evaluate the reach, adoption, implementation, and maintenance of the v-SKY intervention amongst veterans, SKY instructors, health professionals, and administrators by interviewing RCT participants, instructors, health professionals, and administrators that work with veterans. Evaluating implementation of a virtual intervention is relevant in both pandemic and post-pandemic contexts where virtual interventions may continue to be more available and possibly preferred by patients and clients.
NCT05235828 — Pain
Status: Recruiting
http://inclinicaltrials.com/pain/NCT05235828/
MDMA-Assisted Therapy 6 to 12 Months After Childbirth for People With Co-occurring Opioid Use and Post Traumatic Stress Disorders
This is an open-label study of the use of MDMA Assisted Therapy for postpartum people with co-occurring Post Traumatic Stress Disorder (PTSD) and Opioid Use Disorder (OUD). The study protocol has been adapted from the Phase 3 studies sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS) for PTSD. Due to the high rate of concurrence of PTSD and OUD, people with OUD may experience great benefit from the treatment of their PTSD with MDMA-assisted therapy based on the phase 2 and 3 studies for PTSD. Use of MDMA-assisted therapy in this population has the potential to be of benefit for their OUD and maternal- infant attachment. This study will serve to explore the feasibility and safety of offering MDMA-assisted therapy for treatment of PTSD in postpartum people with opioid use disorder. The CAPs 5 (PTSD) is the primary outcome, the Timeline Follow-Back (TLFB) for opioid use is the secondary outcome and other assessments of opioid use disorder, effects on maternal-infant attachment, social connectedness and other mental health outcomes are exploratory. The study will be conducted at the University of New Mexico Health Sciences Center located in Albuquerque New Mexico. In addition to northern New Mexico being an epicenter of the current opioid use disorder epidemic in the United States there is a long-standing history of multigenerational use of illicit opioids in many communities of northern New Mexico. There are high rates of opioid use disorder on pregnancy and accompanying Neonatal Opioid Use Withdrawal Syndrome (NOWS) in Albuquerque, Santa Fe, and surrounding communities.
NCT05219175 — Stress Disorders, Post-Traumatic
Status: Active, not recruiting
http://inclinicaltrials.com/stress-disorders-post-traumatic/NCT05219175/
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) to Reduce Post Traumatic Stress Disorder (PTSD) Symptoms in World Trade Center (WTC) Responders
This study seeks to conduct a randomized, double-blind pilot study, to determine whether the Transcutaneous Auricular Vagus Nerve Stimulation and study procedure are feasible and acceptable for use with World Trade Center responders with Post Traumatic Stress Disorder.
NCT05212714 — Stress Disorders, Post-Traumatic
Status: Completed
http://inclinicaltrials.com/stress-disorders-post-traumatic/NCT05212714/
on the Daily Activity, Sleep Pattern, and Stress Level of Military Veterans With PTSD
The study aims to investigate the effects of a service dog on military veterans with post traumatic stress syndrome (PTSD). The investigators will use non-invasive measures of the physiological responses, data obtained via dairy keeping, accelerometer data estimating activity and sleep patterns, and baseline information including psychological measures validated for this specific population.
NCT05208008 — Stress, Emotional
Status: Active, not recruiting
http://inclinicaltrials.com/stress-emotional/NCT05208008/
Pilot Test of Intranasal Oxytocin as an Enhancer of Brief Couples Therapy for PTSD
In 2019 VA mandated that all Veterans seeking mental health care have access to flexible family mental health services in VA (VHA directive 1163.04). This study aims to respond to this mandate by further improving an evidence-based PTSD treatment designed to decrease PTSD symptoms and improve relationship satisfaction for Veterans and their romantic partners. Brief Cognitive-Behavioral Conjoint Therapy (B-CBCT), an 8-session dyadic psychotherapy for PTSD, has been found to significantly reduce PTSD symptoms, but the effects of B-CBCT on relationship satisfaction are less reliable and robust. Pharmacological augmentation of psychotherapy utilizing intranasal oxytocin, a neurohormone that influences mechanisms of trauma recovery and social behavior, may help improve relationship satisfaction outcomes. If successful, the proposed study will advance knowledge of strategies for improving Veterans' quality of life by improving their intimate relationships along with PTSD symptoms.
NCT05207436 — Post Traumatic Stress Disorder
Status: Completed
http://inclinicaltrials.com/post-traumatic-stress-disorder/NCT05207436/
A Novel Acceptance-based Treatment for Insomnia in Veterans With Post-Traumatic Stress Disorder
This randomized trial will compare a novel treatment, Acceptance of the Behavioral Changes to Treat Insomnia (ABC-I) to Cognitive Behavioral Therapy for Insomnia (CBT-I) among Veterans with comorbid Post-Traumatic Stress Disorder (PTSD) and insomnia disorder. ABC-I combines the behavioral components of CBT-I with components of another behavioral therapy (Acceptance and Commitment Therapy) and has been shown to improve treatment adherence. The study objectives are: 1) to evaluate the benefits of ABC-I in reducing post-traumatic stress disorder (PTSD) symptoms among Veterans with comorbid PTSD and insomnia disorder compared to CBT-I, and 2) to evaluate the effectiveness of ABC-I in improving insomnia symptoms and sleep quality among Veterans with comorbid PTSD and insomnia disorder as compared to CBT-I. Veterans with insomnia and comorbid PTSD who receive care at Sepulveda and West Los Angeles facilities will be recruited for the study. Those who pass an initial eligibility screen will be enrolled and written informed consent will be obtained. A baseline assessment will be completed that includes measures of sleep, PTSD, and quality of life. Veterans who meet all eligibility criteria will be randomly assigned to the ABC-I (n=100) or CBT-I (n=100) treatment. Both treatments will be provided in 5 one-on-one sessions by a trained instructor who is supervised by a behavioral sleep medicine specialist. All randomized participants (n=200) will have 3 follow-up assessments (post-treatment, 3-months, and 6-months after randomization). The follow-up assessments will collect information on PTSD symptoms, insomnia symptoms and sleep quality.
NCT05194930 — Insomnia
Status: Recruiting
http://inclinicaltrials.com/insomnia/NCT05194930/
BioWare to Enhance Treatment for Alcohol Use Disorder and Posttraumatic Stress Disorder
This study examines the ability of an innovative telehealth technology system to enhance Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE) talk-therapy for individuals with posttraumatic stress disorder (PTSD) and alcohol use disorder.
NCT05187364 — Alcohol Use Disorder
Status: Completed
http://inclinicaltrials.com/alcohol-use-disorder/NCT05187364/
Assessing and Enhancing Social Support to Improve Treatment Outcomes Among Veterans With PTSD (CDA 19-208)
Posttraumatic stress disorder (PTSD) is a common and impairing problem among Veterans, many of whom first seek treatment in primary care settings. PTSD is linked to reduced quality of life and increased rates of suicide. Additionally, social support, defined as the availability of others to provide emotional or practical support when needed, is frequently poor for Veterans with PTSD. For Veterans with PTSD, poor social support negatively impacts PTSD treatment engagement and outcomes, interfering with PTSD recovery. There is a need for additional brief, primary care-based treatments for PTSD that also work to improve social support in traumatized Veterans. The proposed research seeks to evaluate and refine such an intervention and establish a protocol for routinely measuring social support to inform treatment. This intervention and measurement protocol will likely improve Veterans' mental health and social relationships.
NCT05187156 — Posttraumatic Stress Disorder
Status: Withdrawn
http://inclinicaltrials.com/posttraumatic-stress-disorder/NCT05187156/