Clinical Trials Logo

Stress Disorders, Traumatic clinical trials

View clinical trials related to Stress Disorders, Traumatic.

Filter by:

NCT ID: NCT04264520 Terminated - Clinical trials for Post Traumatic Stress Disorder

Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women

Start date: June 5, 2020
Phase: N/A
Study type: Interventional

The current study aims to test a brief computer-assisted intervention (psychoeducation + skills) for pregnant women with elevated PTSD symptoms. In this open trial pilot feasibility study, 20 pregnant women in their first trimester will be invited to participate in the study if they endorse elevated PTSD symptoms. Oxytocin and cortisol will be measured at baseline, one month post-intervention, three months post-intervention, and post-delivery to inform the relationship between these hormones, PTSD symptoms, and peripartum/postpartum outcomes. In addition to receiving the psychoeducation + skills intervention during their first trimester, women will be offered a "booster session" intervention following delivery to enhance utilization of skills during a critical period for maternal mental and physical health outcomes.

NCT ID: NCT04264026 Recruiting - Clinical trials for Post Traumatic Stress Disorder

MDMA-Assisted Psychotherapy in Veterans With Combat-Related, Refractory PTSD

VALLMDMA_001
Start date: July 29, 2021
Phase: Phase 2
Study type: Interventional

This will be a single-site, open-label phase 2 study designed to test the feasibility of administering MDMA in conjunction with psychotherapy for combat-related treatment-resistant PTSD in US military veterans currently enrolled in VA. MDMA will be given in conjunction with structured psychotherapy in three single-dose psychotherapy sessions in a hospital setting over the course of 12 weeks, along with preparatory and integration psychotherapy sessions in-between each active-dose session. The overall objective of this study is to evaluate the risks, benefits, and feasibility of MDMA used in conjunction with manualized psychotherapy, on reduction of symptoms, or remission of PTSD, as evaluated by standard clinical measures, in a VA Healthcare System. The primary outcome measure for the study is the Clinician-Administered PTSD Scale (CAPS-5), a semi-structured interview used in the majority of clinical trials for PTSD, which will be assessed at baseline, primary endpoint, and at the long-term 12-month follow-up visit. Secondary safety and efficacy measures will also be collected. The planned duration of this study is 1-3 years, with each active treatment period lasting approximately 12 weeks, along with a long-term follow-up 12 months after the last active-drug session.

NCT ID: NCT04251624 Recruiting - Clinical trials for Post Traumatic Stress Disorder

Investigating the Use of Goal Management Therapy in Improving Cognitive Functioning in Public Safety Personnel With PTSD

Start date: November 1, 2019
Phase: N/A
Study type: Interventional

This study examines the efficacy of Goal Management Therapy (GMT) - a well-established cognitive remediation strategy aimed at improving goal-directed behaviors that are dependent on basic cognitive processes and on executive functioning - among public safety personnel with post-traumatic stress disorder.

NCT ID: NCT04244864 Recruiting - Depression Clinical Trials

Cross-sectoral Collaboration in Multidisciplinary Treatment of Trauma-affected Refugees

Start date: February 3, 2020
Phase: N/A
Study type: Interventional

INTRODUCTION Trauma-affected refugees are at high risk of developing mental health problems including post-traumatic stress disorder (PTSD) and depression. In addition to traumatic stress, refugees are furthermore subject to a range of post-migration stressors e.g. unemployment, poor finances and language difficulties. These stressors can moderate or exacerbate mental health outcomes in refugees. Cross-sectoral collaboration and coordination of municipal social interventions and regional mental health services are currently limited. The overall aim of this study is to investigate the effect of a psychosocial treatment with a focus on social stressors in an integrated cross-sectoral collaboration with the municipality for trauma-affected refugees MATERIALS AND METHODS The study is being conducted at Competence Centre for Transcultural Psychiatry (CTP) in Denmark. Included in the study are refugees with post-traumatic stress disorder (PTSD), who are unemployed and attending a municipal job centre in one of the five collaborating municipalities. Approximately 200 patients will be included. The randomised controlled trial is comparing treatment as usual (TAU) comprising 10 sessions with a medical doctor (pharmacological treatment and psycho-education) and 16-21 sessions with a psychologist (manual-based cognitive behavioural therapy) with add-on of the social intervention. Overall, the intervention seeks to integrate working with social stressors alongside treatment for trauma-related mental health problems. This is done in two ways; by a cross-sectoral collaboration with municipality through collaborative meetings and by a systematic focus on social stressors during the treatment. The primary outcome is functioning, measured by WHODAS 2.0 12 item version together with a variety of secondary outcomes measuring mental health symptoms, quality of life and degree of social stressors. RESULTS The study is expected to bring forward new perspectives and knowledge on psychosocial treatment of trauma-affected refugees as well as cross-sectoral collaboration.

NCT ID: NCT04241094 Completed - Clinical trials for Posttraumatic Stress Disorder

Teaching Loved Ones to Help Veterans Optimize Their PTSD Care and Healing

Start date: November 2, 2020
Phase: N/A
Study type: Interventional

PTSD occurs in as many as 17% of US military Veterans and is associated with a host of negative, long-term consequences to the individual, their families, and society at large. EBPs, such as Prolonged Exposure, result in clinically significant symptom relief for many. Yet, these therapies have proven less effective for military personnel and Veterans and treatment dropout rates are high. The investigators' team surveyed Veterans initiating EBPs for PTSD and a family member across four VA medical centers (N = 598; Project HomeFront). The investigators found that Veterans were more than twice as likely to complete EBPs when loved ones encouraged them to confront distress and that Veterans experienced greater treatment gains when they shared more with their loved ones about their treatment. A couples-based, exposure therapy for PTSD that integrates intimate partners into every session of PE could provide the opportunity to mobilize the whole household in the service of EBP engagement, while extending the goals of therapy beyond symptom reduction to family functioning. The investigators anticipate this intervention will teach couples to embrace a lifestyle that supports confronting trauma-related distress, so the Veteran and his/her family can achieve optimal functional outcomes.

NCT ID: NCT04236986 Active, not recruiting - Clinical trials for Post Traumatic Stress Disorder

Imaging the Neuroimmune System in PTSD

Start date: March 28, 2017
Phase: Phase 1
Study type: Interventional

In this study, individuals with and without post-traumatic stress disorder (PTSD) will undergo one positron emission tomography (PET) scan using the radiotracer [11C]PBR28, which binds to the 18kDa translocator protein (TSPO). A subset of individuals who complete the first PET [11C]PBR28 scan will be invited to complete an inflammatory challenge and second PET [11C]PBR28 scan. Approximately 3 hours prior to the second [11C]PBR28 PET scan, lipopolysaccharide (LPS; endotoxin) will be administered to evoke a robust neuroimmune response. Subjects will also undergo behavioral and cognitive testing. Vital signs, subjective response, and peripheral biomarker levels will be assayed periodically throughout the experimental session. Specific aims: 1) Determine if individuals with PTSD exhibit neuroimmune system disruption relative to well-matched comparators at baseline. 2) Determine if individuals with PTSD exhibit a disrupted neuroimmune response after a classical immune stimulus relative to well-matched comparators. 3) Determine if LPS differentially alters cognitive function, subjective response, or physiological markers in individuals with PTSD compared to well-matched comparators. Hypothesis: Individuals with PTSD will exhibit a suppressed neuroimmune system at baseline and an attenuated neuroimmune response following LPS challenge, relative to matched trauma controls.

NCT ID: NCT04231578 Completed - Clinical trials for Posttraumatic Stress Disorder

Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction)

HOPES
Start date: March 31, 2020
Phase: N/A
Study type: Interventional

Posttraumatic stress disorder (PTSD) is a common and disabling condition associated with intimate relationship problems and mental health problems in partners of those with PTSD. Recognizing the need to improve access to evidence-based interventions for those with PTSD and their families, our team has developed an Internet-delivered, self-help intervention to improve PTSD, enhance relationships, and improve partners' mental health: Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction). Couple HOPES presents text and video-based content across seven self-help intervention modules, with modest support from paraprofessional coaches. Although the Couple HOPES platform has been developed, it remains uncertain whether Couple HOPES is feasible, usable, and efficacious in reducing PTSD and enhancing intimate relationship functioning. The proposed project aims to refine and finalize Couple HOPES with couples that include a veteran, service member or first responder with significant PTSD symptoms. This project includes initial testing of the intervention's preliminary efficacy, safety, and feasibility in a series of 10 couples (Phase 1), then in an uncontrolled trial of 20 couples (Phase 2), and then a randomized clinical trial comparing its efficacy to a delayed intervention control condition in 70 couples. Potential benefits of this study include couples learning new skills to reduce PTSD symptoms and enhance relationship functioning, although this is not guaranteed. Risks include participants finding the assessments distressing, or possible worsening of PTSD symptoms or relationship functioning. These risks will be mitigated by continuous monitoring of PTSD symptoms, relationship functioning, and adverse events, and intervention by study staff.

NCT ID: NCT04230668 Recruiting - Clinical trials for Posttraumatic Stress Disorder

Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder and Borderline Personality Disorder (PTSD-BPD)

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

Posttraumatic Stress Disorder (PTSD) with co-occurring Borderline Personality Disorder (BPD) (i.e., PTSD-BPD) is common (as high as 58%), debilitating, costly, and limited treatment options available for this population. PTSD-BPD is associated with even greater functional impairment and higher healthcare burden than either disorder alone. There are surprisingly few treatments available for this clinical profile, despite its association with major negative health outcomes, cost, and morbidity. There is a pressing need to innovate treatments that can effectively and efficiently treat PTSD-BPD. The existing treatments used for PTSD-BPD are lengthy, laborious, resource-intensive, and require complete cessation of suicidal behaviors prior to treatment. Furthermore, no integrated treatment has been innovated to deliver the active ingredients to efficiently affect the mechanisms underpinning this comorbidity. The investigators propose to examine an adapted version of a first-line PTSD intervention, Cognitive Processing Therapy, augmented with a Suicide Risk Management, i.e., (CPT+SRM) as a brief (12 sessions) and more parsimonious treatment alternative that strategically targets shared mechanisms underpinning PTSD and BPD. The purpose of this pilot study is to 1) collect initial feasibility, acceptability, and safety data on this adapted treatment, 2) conduct a pilot randomized clinical trial evaluating the efficacy of CPT+SRM versus Treatment as Usual (TAU) + SRM, and 3) evaluate two targets (i.e, improvements in emotional intensity and cognitive dysfunction) as mechanisms leading to change in our primary outcomes. Both treatment conditions will be administered via telehealth. Potential benefits include reduction in participants' PTSD, BPD and other mental health symptoms. Additionally, this work could benefit the community by improving the treatment repertoire for PTSD-BPD. Potential risks include emotional distress, suicidality, and/or self-harm. Participants may experience discomfort and/or distress while discussing participants trauma(s) and mental health. These risks will be mitigated using a suicide risk management protocol which therapists in the assessment of risk and protective factors of suicide, followed by documentation for the decision-making around the management of risk.

NCT ID: NCT04228133 Completed - PTSD Clinical Trials

Home-Delivered Attention Control Treatment for Post Traumatic Stress Disorder (PTSD)

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

The aim of the study is to explore the efficacy of home-delivered Attention Control Training (ACT) for Posttraumatic Stress Disorder (PTSD). Three randomized controlled trials have shown that attention bias modification protocols applying attention control training (ACT) aimed to balance attention between threat-related and neutral stimuli are efficient in reducing PTSD symptoms. However, contrary to in-clinic administration, such as applied in the above mentioned studies, home-delivered attention bias modification was not effective in reducing symptoms among treatment-seeking patients. It is crucial to continue examining the efficacy of home-delivered ACT as PTSD entails functional impairments that might impede treatment-seeking patients from reaching to clinics to receive treatment. This could also inform other ABM protocols designated to treat other disorders.

NCT ID: NCT04209296 Enrolling by invitation - Clinical trials for Major Depressive Disorder

Chart Review of Patients Undergoing Ketamine Infusions

Start date: December 3, 2019
Phase:
Study type: Observational

The Canadian Rapid Treatment Center of Excellence (CRTCE) is a healthcare facility principally focused on providing best practices of intravenous ketamine treatment to adult patients suffering from mental health conditions. The center focuses specifically on treating individuals suffering from major depression disorder, bipolar disorder, post-traumatic stress disorder and obsessive compulsive disorder as their primary diagnosis. Herein, this retrospective analysis aims to look at past data in order to further develop our understanding of ketamine in the use of psychiatry.