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PTSD clinical trials

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NCT ID: NCT05700279 Recruiting - Chronic Pain Clinical Trials

Preventing the Development of Chronic Pain: Treating PTSD at Acute Pain Onset

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Although most people recover from acute pain (such as pain caused by injury, surgery, repetitive motion, or unknown causes), many people do not fully recover and will experience chronic pain. Untreated posttraumatic stress disorder (PTSD) appears to be a key risk factor for the transition from acute pain to chronic pain. However, few published studies have addressed the issue of preventing the transition from acute to chronic pain via PTSD reduction. This project will aim to test whether trauma-related PTSD symptoms can be reduced using either Stellate Ganglion Block (SGB) treatment or Cognitive Processing Therapy (CPT), and whether reducing PTSD symptoms can prevent the transition from non-injury based acute pain to chronic pain.

NCT ID: NCT05693805 Recruiting - PTSD Clinical Trials

Feasibility of Remote Tai Chi

Start date: June 22, 2023
Phase: N/A
Study type: Interventional

In the proposed trial, the investigators plan to refine interventions, then conduct a small randomized trial to provide critical information to inform a future large-scale randomized efficacy trial of Tai Chi for Post Traumatic Stress Disorder (PTSD) and chronic pain. Building on the combined experience the proposed study will progress in new directions to: 1. Adapt, refine, and standardize two 12-week treatment protocols (Tai Chi and a Wellness control condition) for Veterans diagnosed with PTSD and chronic musculoskeletal pain during Phase One. Tai Chi and Wellness interventions will be adapted for delivery via a videoconferencing platform for the population and piloted in a 'dry run'. 2. Determine the feasibility and acceptability of a remotely delivered randomized trial of these two interventions and the assessment protocols during Phase Two. 3. Utilize information from this trial to plan and design a large randomized control study evaluating the efficacy of Tai Chi compared to Wellness for improving outcomes for Veterans with PTSD and chronic musculoskeletal pain.

NCT ID: NCT05683132 Recruiting - Insomnia Clinical Trials

Treatments in Women Veterans With Insomnia and PTSD

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

This pilot trial will compare trauma-informed Cognitive Behavioral Therapy for Insomnia (CBT-I) to a psychoeducational intervention in women Veterans with comorbid insomnia and posttraumatic stress disorder (PTSD). The CBT-I intervention includes trauma-informed adaptations to an insomnia treatment and the psychoeducational intervention is modeled after usual care in a VA Women's Mental Health Clinic. The study objectives are to: 1) Iteratively refine the structure and materials of trauma-informed CBT-I in preparation for a pilot trial, 2) Pilot test the effects of trauma-informed CBT-I on PTSD treatment readiness and engagement in a sample of women Veterans, and 3) Examine potential mechanisms underlying variations in PTSD treatment readiness and engagement over time among women Veterans. Women 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 PTSD treatment readiness, perceived barriers to PTSD treatment, and sleep and mental health symptoms. Then Veterans who meet all eligibility criteria will be randomly assigned to trauma-informed CBT-I (n=25) or the psychoeducational intervention (n=25). 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=50) will have 2 follow-up assessments (post-treatment and 3-months). The follow-up assessments will collect information on PTSD treatment readiness, perceived barriers to PTSD treatment, and sleep and mental health symptoms. Chart reviews will be conducted 6-months post-treatment to assess number of PTSD treatment appointments attended (treatment engagement measure). Qualitative interviews will be conducted to identify mechanisms underlying PTSD treatment engagement.

NCT ID: NCT05646732 Recruiting - PTSD Clinical Trials

Targeting the Default Mode Network: A TMS-fMRI Study

Start date: August 2, 2023
Phase: N/A
Study type: Interventional

In post-traumatic stress disorder (PTSD), intrusive, traumatic, autobiographical memories lead to anxiety symptoms. Recent work suggests a new repetitive pulse transcranial magnetic stimulation (rTMS) brain target that might bring relief. Since this proposed target is not well understood, the goal of the study is to use functional magnetic resonance imaging (fMRI) to identify the brain regions and networks that change with rTMS stimulation at this target area in PTSD patients. Ultimately, this would lead to a personalized approach to rTMS treatment of PTSD based on brain imaging that can be used in a future clinical trial. Participants will be asked to complete psychological testing and questionnaires as well as an initial MRI and two separate TMS-fMRI sessions. Total participation time across all visits is estimated to be five to six hours. Research participation will take place at VA Palo Alto as well as at Stanford University.

NCT ID: NCT05645042 Recruiting - PTSD Clinical Trials

Transcendental Meditation in Veterans and First Responders With PTSD

Start date: December 12, 2022
Phase: N/A
Study type: Interventional

The present study is part of a Phase 3 multi-site clinical trial that will recruit veterans and first responders diagnosed with PTSD, where they will be randomized to receive either Transcendental Meditation (TM) or Present Centered Therapy (PCT). Five assessments will be conducted, at: 1) baseline, 2) midpoint, 3) posttreatment, 4) three months posttreatment and 5) six months posttreatment. All assessments will be completed using remote HIPAA-compliant videoconferencing. The study protocol at NYSPI/Columbia will also include Magnetic Resonance Imaging (MRI) before and after treatment to elucidate neural predictors and mechanisms of these two treatment approaches. Enrollment will include veterans and first responders with PTSD. Both TM and PCT will be provided by trained staff receiving weekly supervision. This trial is funded by the David Lynch Foundation and will recruit approximately 360 veterans and first responders over a three-year period.

NCT ID: NCT05643716 Recruiting - PTSD Clinical Trials

The Effects of Exercise on Emotion Regulation and Cognitive Control in PTSD

Start date: March 5, 2024
Phase: N/A
Study type: Interventional

The goal of this study is to investigate the effects of a single bout of aerobic exercise on neurophysiological indices of emotion regulation and cognitive control in individuals with clinically significant PTSD symptoms. In this proposed study, 50 adult females with clinically significant PTSD symptoms will be randomized into two groups: a 20-minute moderate-to-vigorous intensity aerobic exercise group, or a 20-minute silent sitting control group. Prior to and following the exercise/sitting session, participants will complete a letter flanker task and an emotion regulation picture viewing task while their electrical brain activity is continuously recorded via electroencephalogram (EEG). Utilizing a multimodal assessment approach, cognitive control will be measured using behavioral (i.e., accuracy, reaction time) and neurophysiology (i.e., error-related negativity; ERN). Emotion regulation will be measured using self-reported and neurophysiological indices of emotional reactivity (i.e., late positive potential; LPP).

NCT ID: NCT05632770 Recruiting - PTSD Clinical Trials

A Deployment Focused Pragmatic Trial of Optimal Stepped Care Intervention Targeting PTSD and Comorbidity for Acutely Hospitalized Injury Survivors Treated in US Trauma Care Systems

TSOS 8
Start date: January 9, 2023
Phase: N/A
Study type: Interventional

This investigation is a randomized pragmatic trial of a brief stepped care intervention delivered from an acute care medical trauma center that may both reduce the symptoms of posttraumatic stress disorder (PTSD) and diminish emergency department health service utilization.

NCT ID: NCT05598099 Recruiting - PTSD Clinical Trials

Concentrated Exposure Therapy for Post-traumatic Stress Disorder - a Cohort Study

Start date: November 1, 2022
Phase:
Study type: Observational

Post-traumatic stress disorder (PTSD) is a prevalent and disabling condition. Trauma-focused psychotherapy, including cognitive behavioural therapy (CBT), are among the recommended first-line treatment alternatives. However, a substantial proportion of patients decline, drop-out or do not respond to current psychotherapies. Previous research suggests that intensive or concentrated formats of trauma-focused psychotherapy can lead to faster recover and lower attrition, but there are currently few studies of these approaches. The current study will investigate the acceptability. treatment satisfaction and preliminary changes in symptoms after four consecutive days of concentrated CBT for PTSD.

NCT ID: NCT05554094 Recruiting - PTSD Clinical Trials

Psilocybin for the Treatment of Veterans With Post-Traumatic Stress Disorder

Start date: January 1, 2023
Phase: Phase 2
Study type: Interventional

The primary aim of this study is to assess the safety and efficacy of psilocybin-assisted therapy in the treatment of post-traumatic stress disorder in United States military Veterans.

NCT ID: NCT05544110 Recruiting - PTSD Clinical Trials

Precise Transcranial Magnetic Stimulation for Post-traumatic Stress Disorder

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the efficacy and safety of repetitive transcranial magnetic stimulation under precise localization for post-traumatic stress disorder