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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT05327504 Recruiting - Clinical trials for Posttraumatic Stress Disorder

Written Exposure Therapy for Veterans With SUD and PTSD

WET
Start date: September 26, 2022
Phase: N/A
Study type: Interventional

The proposed project will evaluate the efficacy of written exposure therapy (WET) among Veterans engaged in substance use disorder (SUD) treatment, who present with co-occurring posttraumatic stress disorder (PTSD). While SUD treatment programs traditionally do not address PTSD, effective trauma treatments have been used successfully among those with substance use comorbidities. WET is a brief trauma-focused intervention shown to effectively treat PTSD. In a recent acceptability and feasibility pilot study among Veterans with co-occurring SUD and PTSD, results showed a decrease in PTSD symptoms among participants receiving WET. The goal of the present study is to improve outcomes for Veterans who present for SUD treatment with comorbid SUD/PTSD.

NCT ID: NCT05323318 Recruiting - COVID-19 Clinical Trials

Neuropsychological Sequelae and Long COVID-19 Fatigue

PostCoV2Psy
Start date: April 1, 2022
Phase:
Study type: Observational

An association of fatigue with post-viral neuropsychological disturbs has been reported. Among patients hospitalized with COVID-19 there is an increased incidence of anxiety and depression symptoms. In addition, a quarter of patients experience at least mild symptoms of acute post traumatic stress disorder. (Mazza, M. G. et al 2020). The prevalence of chronic fatigue syndrome had a correlation with post-traumatic stress disorder (PTSD) in a study conducted after the outbreak of the COVID-19 in Iran (Silmani et al, 2021), that showed 5.8% of subjects suffering from PTSD after 6 months of SARS-CoV-2 infection onset. In this Study we propose to use a tool to quantify the degree of physical and psychological fatigue in post-COVID-19 patients, and assess the correlation of fatigue with the neuropsychiatric sequelae in hospitalized and non hospitalized patients.

NCT ID: NCT05314829 Recruiting - Clinical trials for Post Traumatic Stress Disorder

Trauma Treatment in Norwegian Child Advocacy Centers

Start date: August 1, 2020
Phase:
Study type: Observational

Norwegian child and advocacy centers´ core activities include both forensic services (e.g., forensic interviews) and follow-up services (e.g., treatment), aiming to coordinate the different services involved in each case to prevent additional burdens for youth in already vulnerable situations. However, a recent study indicates that very few receive follow-up after the forensic interview and that the follow-up in most cases includes one-time or occasional support and only in rare cases treatment. In the same study, youth receiving follow-up in the CAC in Oslo revealed significantly higher levels of common mental health problems than a comparable community sample, yet lower than clinical samples, indicating that many youths in CACs may be falling between different services within the health care system, not necessarily receiving the help they need elsewhere. The current project will investigate four issues related to these knowledge needs; 1. How do children and parents experience receiving trauma treatment at child advocacy centers? 2. What predicts treatment effects? 3. What is the prevalence of symptoms of burnout and secondary traumatic stress among employees working in child advocacy centers, and can training in evidence-based treatment prevent burnout and secondary traumatic stress?

NCT ID: NCT05313334 Recruiting - Clinical trials for Posttraumatic Stress Disorder

GAMBIT Task With PTSD and Healthy Control Participants

GAMBIT
Start date: November 18, 2022
Phase: N/A
Study type: Interventional

This is a pilot study of a digital training task called GAMBIT. This study will be the first to examine potential relationships between GAMBIT task completion and brain circuit flexibility, behavior, and symptoms in participants with PTSD.

NCT ID: NCT05294835 Recruiting - Depression Clinical Trials

Ketamine and Epigenetic Aging

Start date: April 1, 2022
Phase: Phase 2
Study type: Interventional

This is a prospective, clinical pilot study (n=20) to evaluate the impact of a ketamine treatment for Major Depressive Disorder (MDD) or Post Traumatic Stress Disorder (PTSD) on epigenetic aging by the TruAge epigenetic age laboratory test.

NCT ID: NCT05274230 Recruiting - Clinical trials for Stress Disorders, Post-Traumatic

Sustaining Remission From PTSD Using Tuned Vibroacoustic Stimulation (TVS) Following MDMA-Assisted Psychotherapy

Start date: December 8, 2021
Phase: N/A
Study type: Interventional

The purpose of this research is to examine a wearable device called Apollo that emits gentle vibrations found to benefit mood, energy, and focus. We want to understand how it affects outcomes related to MDMA-assisted psychotherapy for PTSD including depression, anxiety and emotion regulation. This study will test whether regular use of the Apollo wearable improves rates of sustained symptom remission in PTSD following MDMA-assisted psychotherapy over the course of two years

NCT ID: NCT05269459 Recruiting - PTSD Clinical Trials

Safety and Efficacy of Cannabidiol (CBD) for Symptoms of PTSD in Adults

Start date: December 1, 2022
Phase: Phase 2
Study type: Interventional

Double-blind placebo controlled study of Cannabidiol (CBD) for symptoms of PTSD in adults using liquid structure(TM) Formulation (Nantheia ATL5(TM)). Subjects complete 3 weeks of baseline data collection including assessments of activity and sleep. Intervention is Nantheia ATL5 or placebo. Dose is initiated at 400mg BID and maintained over 8 weeks. Standardized symptom profile measurements, clinician assessments, laboratory testing, collection of inflammatory biomarkers, and suicide screening is completed throughout. Age- and gender-matched healthy population subjects are enrolled and complete baseline data collection only. All subjects may complete optional procedures of driving assessments and functional MRI (fMRI).

NCT ID: NCT05268965 Recruiting - Clinical trials for Post-traumatic Stress Disorder

Study of Affective Forecasting Skills in Post-traumatic Stress Disorder

TRAUPA
Start date: February 28, 2022
Phase:
Study type: Observational

Post-traumatic stress disorder (PTSD) is associated with a marked tendency to have exaggerated and persistent negative beliefs and expectations about oneself or the world . Although posttraumatic stress symptoms have been shown to be associated with a tendency to negatively anticipate the future, affective forecasting skills (i.e., the ability to predict one's own emotional reactions in response to a future event) have never been explored in PTSD . The hypothesis that the PTSD is associated with a negative affective forecasting bias, characterized by a tendency to predict more intense emotional responses to future negative events.

NCT ID: NCT05268367 Recruiting - Clinical trials for Stress Disorders, Post-Traumatic

Reclaiming Your Life After Sexual Trauma

Start date: March 31, 2022
Phase: N/A
Study type: Interventional

Mental contamination-an internal experience of dirtiness evoked in the absence of physical contact with an external source-has been linked to the development and maintenance of posttraumatic stress disorder (PTSD) following exposure to sexual abuse or assault (Adams et al., 2014; Badour et al., 2013; Brake et al., 2017). Mental contamination has been associated with greater PTSD severity (Rachman et al., 2015) and higher elevations in specific PTSD symptom clusters (particularly those of intrusive re-experiencing, negative cognitions/mood, and arousal/reactivity; Brake et al., 2019; Fergus & Bardeen, 2016). Additionally, trauma-related mental contamination has been linked to a number of negative posttraumatic emotions such as shame, guilt, disgust, and anger (Fairbrother & Rachman, 2004; Radomsky & Elliott, 2009). Despite clear and consistent links between mental contamination and problematic posttraumatic outcomes following sexual trauma, there is a dearth of research investigating how existing or promising new interventions for PTSD impact mental contamination. Written Exposure Therapy (WET) is a five-session treatment for PTSD that was designed to be both brief and easy to administer (Sloan et al., 2012). According to Sloan and colleagues' (2012) protocol, sessions broadly involve 30-minute exposures in which the patient writes about the events of their trauma in detail, followed by 10 minutes of discussing the exposure with the therapist. This treatment protocol has minimal therapist involvement, no homework assignments, and shorter treatment sessions. Research shows that WET is efficacious among different samples (e.g., survivors of motor vehicle accidents and combat veterans), has low dropout rates, treatment satisfaction is high, and the gains seen by participants after completion are maintained at follow-up (Sloan et al., 2012, 2013, 2018; Thompson-Hollands et al., 2018, 2019). Given these factors, WET has the potential to be a useful intervention in reducing symptoms of PTSD among a sample of survivors of sexual trauma. Given its relevance to this trauma population, a test of this intervention for its impact on reducing trauma-related mental contamination is also needed. The current study will use Single Case Experimental Design to isolate and evaluate the effects of WET in reducing both PTSD symptoms and trauma-related mental contamination among individuals with PTSD resulting from sexual trauma. Aims: Explore whether participants demonstrate reductions in mental contamination and PTSD symptoms in response to 5 sessions of WET. Visual inspection analysis and statistical methods will be used to draw conclusions regarding the effects of the interventions on PTSD symptoms and mental contamination.

NCT ID: NCT05267665 Recruiting - Clinical trials for Posttraumatic Stress Disorder

Family Involvement in Treatment for PTSD (FIT-PTSD): A Brief, Feasible Method for Enhancing Outcomes, Retention, and Engagement

Start date: July 1, 2022
Phase: N/A
Study type: Interventional

Although effective treatments for PTSD exist, high rates of treatment dropout and sub-optimal response rates remain common. Incorporating family members in treatment represents one avenue for improving outcomes and providing Veteran-centered care, and surveys of Veterans in outpatient VA PTSD care indicate that 80% desire family involvement. The VA has invested many years and millions of dollars on the dissemination of Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) for PTSD. A family-based intervention that complements these two first-line treatments would capitalize on existing treatment infrastructure while also potentially boosting outcomes and retention. Preliminary testing of the proposed Brief Family Intervention (BFI) resulted in 50% less dropout from CPT/PE among Veterans whose family members received the BFI. There was also a large impact on PTSD symptoms at 16 weeks (d = 1.12) in favor of the BFI group. The goal of this study is to test the effectiveness of the BFI among a fully-powered sample. One hundred Veteran-family member dyads (n = 200) will be recruited. Veterans will be beginning a course of usual-care CPT or PE at one of two VA sites. Family members will be randomized to receive or not receive the BFI, a two-session psychoeducational and skills-based protocol. PTSD symptom severity and treatment retention will be the primary outcomes. Assessments will be conducted by independent evaluators at baseline, 6-, 12-, 18-, and 26-weeks. Veterans whose family members receive the BFI are expected to have lower dropout and a greater rate of change in their PTSD symptoms compared to Veterans whose family members do not receive the BFI. If the BFI is found to increase the effectiveness of and retention in CPT/PE, it will be a highly appealing option for incorporating families into Veterans' PTSD care.