Clinical Research Directory

Assessment of the Preventive Effect of Defusing on Traumatic Kindling

The exposure to a potential traumatic event (PTE) is common in the general population. This exposure may lead to psychiatric disorders such as acute stress disorder (ASD) and post-traumatic stress disorder (PTSD). Previous exposure to PTE is a well-known risk factor for ASD and PTSD. This may rely on the so called "kindling" which consists in a increasing sensitization of thememory circuits and emotional regulation through this previous and/or repeated exposure. An early psychological intervention may prevent these diseases or at least decrease the symptoms and improve functional functioning. Defusing is an early and brief psychotherapeutic interview technique which aims at encouraging a victim exposed to a PTE to express her/his own experience concerning the PTE. Some preliminary results reported that defusing could alleviate the emotional distress induced by a PTE. The PREDEKIT study hypothesizes that defusing prevents the sensitization (kindling) induced by a potentially traumatic event. This study is a prospective, randomized, controlled, multicenter trial with blinded outcome assessment. Participants can be included in the study they are exposed to a PTE and tif they can receive a defusing intervention in the very early phase following the PTE (first 24 hours). The test group will receive defusing while the control group will receive First Psychosocial Aid Primary and secondary outcomes will assess emotional distress, intrusive symptoms, physiological outcomes relevant for the stress response (blood pressure, heart rate, electrodermal activity). The last evaluation takes place 1 month after the PTE

Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL)

This study will examine the safety and efficacy of TNX-102 SL to reduce ASR symptoms and behavioral changes among patients presenting to the emergency department (ED) after motor vehicle collision (MVC). Specifically, the investigators will perform the Optimizing Acute Stress reaction Interventions with TNX-102 SL (OASIS) Trial, a double-blind placebo-controlled randomized clinical trial (RCT) to determine if TNX-102 SL initiated in the ED in the hours after MVC to high risk individuals, treats/reduces acute stress reaction (ASR)/acute stress disorder (ASD) symptoms (primary outcome), improves neurocognitive function, and prevents/reduces posttraumatic stress (PTS) symptoms (secondary outcomes) long term. 180 participants will be randomized, receive study drug in ED and be discharged with a 2-week drug supply. Prior to initial dose of study drug administration, and during the hours, days, and weeks after participants will receive serial longitudinal assessments of psychological and somatic symptoms, neurocognitive function, and adverse events.

Adolescent Stress and Substance Intervention Subsequent to Trauma

The long-term goal of this study is to address the adoption of the new trauma center requirement to establish best practices of screening for acute stress with an intervention to prevent both adolescent PTSD and substance use. The investigators will develop, refine, and pilot test the Adolescent Stress and Substance Intervention Subsequent to Trauma (ASSIST) video interventions that build upon the American College of Surgeons Committee on Trauma guidelines to improve mental health care during and after hospitalization for traumatic injury. The aims are: PHASE I - Primary Aim 1: To develop and refine two ASSIST video interventions for adolescents and parents admitted to a level 1 pediatric trauma center. PHASE II * Primary Aim 2a: To evaluate the feasibility, acceptability and implementation potential of the ASSIST video interventions. * Primary Aim 2b: Develop the ASSIST implementation protocol using a national advisory panel of pediatric trauma center leaders. Participants in PHASE 1: Parent and child duo: * Review storyboards for the video interventions * Participate in qualitative interviews at hospital admission and 1 month following discharge Pediatric trauma center clinical staff members: \- Complete qualitative interviews Participants in PHASE II: Parent and child duo: * Shown their own video interventions * Complete assessments at admission and 1-, 2-, 3- months after discharge

EMDR Flash Group Protocol for Earthquake Survivors

This pilot randomized controlled trial evaluated the preliminary effects of the online EMDR Flash Group Protocol among adults affected by the 2023 Kahramanmaraş earthquakes in Türkiye. Participants were randomly assigned to either the EMDR Flash Group Protocol or a waitlist control group. The primary outcome was change in posttraumatic stress symptoms measured by the PTSD Checklist for DSM-5 (PCL-5). Secondary outcomes included depression, anxiety, and stress symptoms measured by the Depression Anxiety Stress Scale-21 (DASS-21). Outcomes were assessed at baseline and at 3-month follow-up.

Early Intervention to Prevent Development of PTSD in Burn Survivors and Their Caregivers

The purpose of this clinical trial is to adapt and test a brief patient-caregiver early intervention designed to reduce posttraumatic stress symptoms in hospitalized burn patients and their caregivers. This intervention is a brief, 4-session cognitive-behavioral intervention designed for burn patients and their loved one to complete together, during and after hospitalization. The intervention targets relational communication and functioning through reduction of invalidating, negative statements and avoidant coping by teaching patients and their loved ones to engage in adaptive natural disclosures, supportive responses, and approach coping after the burn trauma. The intervention uses evidence-based psychotherapy techniques, including psychoeducation, motivational interviewing, and skills coaching. The clinical trial will occur in two sequential phases. In the first phase of the study (case series), the intervention will be provided to two burn patient-caregiver dyads (four adults) to pilot test the intervention, seek patient and provider feedback, and refine the intervention. All four adults will receive the intervention. In the second phase of the study, the randomized controlled trial (RCT) phase, investigators will enroll 20 more burn patient-caregiver dyads (40 more adults) who will be randomly assigned (like the flip of a coin) at the dyad level to receive the intervention or a burn survivor-only minimally enhanced usual care psychoeducation control condition (mEUC). The goals of the RCT phase are to study whether the intervention is acceptable to patients, feasible to conduct, and whether the intervention improves burn survivor-caregiver healthy relationship communication about difficult events and treatment outcomes compared to mEUC.

Efficacy of Prazosin in Preventing Post-traumatic Stress Disorder

After a traumatic event such as an accident or an assault, victims may experience intense stress symptoms that may evolve into "post-traumatic stress disorder" (PTSD). It is a frequent and serious pathology, which can be complicated by depression, addiction or suicide. Few means are available to prevent PTSD in people who have just undergone trauma. Prazosin is an antihypertensive drug that blocks α1 adrenaline receptors which could help to stop the vicious circle of stress and prevent the development of the disease. The objective of this study is to demonstrate the efficacy of prazosin to prevent PTSD in patients who visit an emergency department after trauma.

BXCL501 After Stress to Increase Recovery Success

This study will examine the safety and efficacy of BXCL501 to reduce ASR symptoms and behavioral changes among patients presenting to the Emergency Department (ED) after Motor Vehicle Collision (MVC). Specifically, the investigators will perform the BXCL501 (BASIS) Trial, a double-blind placebo-controlled Randomized Controlled Trial (RCT) to determine if BXCL501 (dexmedetomidine hydrochloride sublingual film) initiated in the ED in the hours after MVC to high risk individuals, treats/reduces ASR/ASD symptoms (primary outcome), improves neurocognitive function, and prevents/reduces posttraumatic stress (PTS) symptoms (secondary outcomes) long term. 100 participants will be randomized, receive study drug in ED and be discharged with a 2-week drug supply. Prior to initial dose of study drug administration, and during the hours, days, and weeks after participants will receive serial longitudinal assessments of psychological and somatic symptoms, neurocognitive function, and adverse events.

Respiratory Training in the Treatment of Transdiagnostic Pathological Anxiety

Purpose of the Research: The primary aim of the proposed study is to conduct a randomized parallel-group 2-arm clinical trial investigating capnometry-guided respiratory intervention (CGRI) for pathological anxiety. CGRI aims to raise end-tidal CO2 levels thereby lowering hyperventilation-induced respiratory alkalosis and its associated fear-eliciting somatic reactions. Psycho-education about anxiety and its effects (PsyEd) will serve as a credible control comparator.

Internet-delivered Trauma-focused Cognitive-behavioral Therapy as an Early Intervention After Sexual Trauma

The research aims to assess the practicality and implementation aspects, effectiveness, and processes of change related to Condensed Internet-delivered Prolonged Exposure (CIPE) administered as an early trauma focused intervention after sexual assault. Eligible participants are individuals seeking help at Traumamottagning Centrum för Sexuell Hälsa, Malmö who have been exposed to sexual assualt in the past two months and exhibit psychological symptoms in response to that.

Condensed Digital Prolonged Exposure for Individuals Treated Within Somatic Trauma Care.

The purpose of the study is to investigate the feasibility of implementation aspects, treatment effects and change processes regarding a brief trauma-focused Internet-based CBT treatment, for patients who have been treated in trauma care at Karolinska University Hospital and who exhibit symptoms of psychological consequences of the traumatic event. Another aim is to explore factors (predictors, moderators and mediators) that influence the effect of the treatment, in order to better understand who responds to the treatment.