Active clinical trials for "Stress Disorders, Post-Traumatic"

This study is open to people aged 18 to 65 who have post-traumatic stress disorder. The purpose of this study is to find out whether a medicine called BI 1358894 improves symptoms in people with post-traumatic stress disorder. Participants are put into 2 groups randomly, which means by chance. Participants take BI 1358894 or placebo as tablets every day for 2 months. Placebo tablets look like BI 1358894 tablets but do not contain any medicine. Participants are in the study for about 3 months. During this time, they visit the study site about 8 times and get about 4 phone calls from the trial staff. During the study, participants answer questions in interviews and complete questionnaires so the doctors can check whether their symptoms change. The doctors also regularly check participants' health and take note of any unwanted effects.

Mild traumatic brain injury (mTBI) is the signature wound of Veterans returning from the operations in Iraq and Afghanistan (i.e., OIF/OEF/OND), with up to 20 percent experiencing persistent post-concussive symptoms. Among Veterans with mTBI, the majority also experience stress-based psychopathology (e.g., depression, post-traumatic stress disorder, and/or generalized anxiety disorder) and chronic pain. To cope with distress, pain, and other difficulties, Veterans often turn to maladaptive avoidant coping strategies which offer short term relief but exacerbate/maintain mental health problems and have detrimental long-term effects on social, occupational, and community reintegration. Unfortunately, Veterans face important barriers to seeking mental health treatment, including stigma and logistical issues. This proposal aims to examine 1) the impact of a Veteran-centered, non-stigmatizing, 1-day "life skills group workshop" on overall distress and reintegration; and 2) the mechanisms by which this treatment might work as well as possible influences on treatment efficacy.

The main objective of this study is to discern if an Occupational Therapy Driving Intervention (OT-DI) improves fitness to drive abilities of Combat Veterans and also investigate if results leads to reduced driving errors on the driving simulator and an on-road test. The driving behavior of 260 Combat Veterans will be studied on a driving simulator at baseline after which they will be randomized into control and intervention groups. The intervention group will receive sessions of Occupational Therapy Driving Intervention by a trained driving rehabilitation specialist. The control group on the other hand will receive driving safety education sessions by a driving safety professional. Both groups will be evaluated for driving performance on the driving simulator to ascertain whether there have been changes in the number of driving errors at two and three months upon enrollment. Caregiver responses on driving behavior of Combat Veteran and public driving records from The Department of Motor Vehicles will be analyzed to for changes in number of driving errors.

This is a pilot randomized controlled trial (RCT) for Veteran participants with alcohol use disorder co-occurring with mild traumatic brain injury and/or post-traumatic stress disorder. The treatment intervention is repetitive Transcranial Magnetic Stimulation (rTMS) and the goal is to reduce alcohol craving with this treatment. The study will enroll 20 Veteran participants. Half of these participants will receive real rTMS and half of the participants will receive placebo rTMS. rTMS treatment will be provided over 10 sessions that will occur once every weekday for 2 weeks. Veteran participants will then complete follow-up phone calls to further evaluate alcohol craving and other symptoms.

During the PICTURE trial a short narrative therapy (narrative exposure therapy adapted for primary care) for patients with posttraumatic stress disorder (PTSD) after intensive care treatment is to be carried out by their general practitioner (GP). During regular practice hours, this is often difficult. For this reason, we are investigating whether the regular treatment can be improved by a specially trained GP. The aim of the study is to investigate the effects and applicability of a short version of an established narrative therapy for patients with posttraumatic stress disorders after intensive medical treatment. Three months after discharge from the intensive care unit, the diagnosis of a PTSD symptoms is verified and the patients are randomized into two groups. In the treatment group, the physician will perform three 45-minute therapy sessions with the patient within 6 weeks. During the first session a list of the most intense events - both positive and negative - in the life of the patient is drawn on the basis of a life line, with the stay at the intensive care unit being one of these events. The second session deals with the experience during intensive care in detail, led by the GP. During the third session, another event from the patient's life will be discussed in the same manner. This way, the different components (cognitions, emotions, body reactions, context information) can be reconnected and classified into the patient's own biography. Between the therapy sessions, a conversation between the GP and the psychologist will take place to support the GP during the therapy. In order to monitor the patient's safety and compliance, standardized telephone calls between the patient and the GP practice are regularly carried out every 2-3 weeks in between therapy sessions up to the first data collection after 6 months (T1). In the control group there are three doctor-patient contacts, too, which content is based on the patient's symptoms. This group thus receives the standard therapy which is customary in practice.

This study is designed to provide information on whether the drug MDMA, combined with Cognitive Processing Therapy (CPT), is safe and helpful for people with Post Traumatic Stress Disorder (PTSD). PTSD is a serious debilitating disorder that negatively impacts a person's daily life, and can result in diminished functioning, fractured relationships, inability to maintain employment, substance abuse, depression, and suicide risk. People who suffer from PTSD relive their traumatic experience(s) through nightmares and flashbacks, have difficulty sleeping, and feel detached or estranged. CPT is a manualized treatment for PTSD, which has the participant make meaning of the traumatic event and its impact on their life. CPT is one of the treatments with the best evidence for the treatment of PTSD to date. Clients with PTSD discuss how they believe the trauma has impacted them, and the therapist teaches the client skills to challenge areas where they are "stuck" remembering the traumatic event. MDMA is a drug commonly used recreationally that has been increasingly studied because of its ability to reduce the impact of PTSD symptoms. The effects of MDMA are reduced fear, enhanced communication, trust and introspection, and increased empathy and compassion. The effects of MDMA create a state that enhances the positive effects of therapy by increasing the ability to tolerate negative emotions and allowing clients to stay engaged in therapy without being overwhelmed by the intense emotions surrounding the memories of traumatic events. It is believed that MDMA may help promote the effects of CPT. Given the properties of MDMA, specifically in inducing the ability to stay with emotion and challenging cognitions, these effects are especially relevant to the mechanisms of CPT. This is a pilot study exploring CPT integrated with MDMA-assisted psychotherapy for treatment of PTSD. This study will enroll 10 participants diagnosed with PTSD, who will undergo a 2-month course of psychotherapy that includes CPT integrated with MDMA-assisted psychotherapy. Participants will go through CPT sessions, and two doses of MDMA will be used as an adjunct to psychotherapy. Since this is the first time that CPT is being combined with individual MDMA-assisted psychotherapy for PTSD, the researchers are interested in gathering preliminary information about the blending of these two therapeutic approaches.

Many people who have posttraumatic stress disorder (PTSD) also struggle with problematic alcohol or drug use (substance use disorders [SUD]). Patients with both conditions prefer PTSD be treated alongside SUD. However, clinicians don't know if treatments that have been found to help those with PTSD work as well for people who also have SUD. This often leads to delaying PTSD treatment or using psychotherapies without research support. Trauma-focused psychotherapy (TFT) is the type of psychotherapy for PTSD that has been studied most often among people with both PTSD and SUD. It reduces symptoms of PTSD and substance use, although it might not work as well in those who have SUD as those who do not. Further, many patients with both PTSD and SUD do not complete TFT. Another strategy for treating PTSD is non-trauma-focused psychotherapy (NTFT). One NTFT, Present Centered Therapy, has been found to reduce symptoms of PTSD and more patients are able to complete NTFT than are able to finish TFT. However, no one has studied how well Present Centered Therapy works among patients who also have SUD. We will test which approach (TFT of NTFT) is better for reducing symptoms of PTSD and which is more likely to be completed by patients with both PTSD and SUD at VA healthcare facilities. We will also test to see whether some participants did better than others, so we can learn how to individualize treatment recommendations to patients. Participants will be assigned by chance to either TFT of NTFT. Patients assigned to TFT will receive either Prolonged Exposure or Cognitive Processing Therapy; both are weekly psychotherapies focused on addressing thoughts and/or memories related to their trauma. Those assigned to NTFT will receive Present Centered Therapy, a weekly psychotherapy in which patients learn about how PTSD relates to their current difficulties and problem solve current life difficulties. All participants will also receive SUD treatment. Participants will answer questions about their symptoms and experience with treatment before, right after they finish, and three and six months after they finish PTSD treatment. At the end of the study we will compare which treatment approach worked better to decrease PTSD symptom severity and which treatment patients were better able to complete. We will also track other outcomes that are important to patients (e.g., how they are doing in their relationships).

The study evaluates the effect of hyperbaric oxygen therapy on veterans with combat-associated PTSD in an double blind sham control study.

A majority of residents in low income communities have been exposed to a potentially traumatic event, and up to half (30-50%) of trauma-exposed residents in safety net clinical settings meet criteria for posttraumatic stress disorder (PTSD). Despite this, only 13% receive treatment. Poor access to PTSD treatment is due to a shortage of mental health specialists. This study aims to evaluate the implementation and effectiveness of a brief, cognitive-behavioral intervention for posttraumatic stress disorder (PTSD)-Skills Training in Affective and Interpersonal Regulation (STAIR)- that will be offered in Boston Medical Center (BMC)'s primary care clinics as the new standard of care following integrated behavioral healthcare (IBH) therapist training. In response to clinician capacity concerns and the impact of the COVID-19 pandemic, we will be offering the intervention in both clinician-administered and self-paced, web-administered formats. The evidence base suggests that STAIR, delivered both synchronously (in-person/telehealth STAIR) and asynchronously (webSTAIR), is associated with significant improvements in PTSD and depression symptoms.

Emergency responders protect the public despite occupational hazards that threaten their mental health. The Pitt Center for Emergency Responder Wellness will be a clinical innovation hub that: 1) delivers accessible interventions for promoting mental health and overall wellbeing; 2) trains the next generation of students to provide mental health care for emergency responders; and 3) informs scientific understanding of post-trauma recovery processes. Goals for the seed phase are to establish our team and collect pilot data to demonstrate feasibility and initial clinical impact.