View clinical trials related to Stress Disorders, Post-Traumatic.
Filter by:The purpose of this research is to determine if a brief treatment method is effective for preventing posttraumatic stress disorder (PTSD) and a number of other concerns following injury.
Leveraging veterans' intimate relationships during treatment for posttraumatic stress disorder (PTSD) has the potential to concurrently improve PTSD symptoms and relationship quality. Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) is a manualized treatment designed to simultaneously improve PTSD and relationship functioning for couples in which one partner has PTSD. Although efficacious in improving PTSD, the effects of CBCT on relationship satisfaction are small, especially among Veterans. Pharmacological augmentation of bCBCT with intranasal oxytocin, a neurohormone that influences mechanisms of trauma recovery and social behavior, may help improve the efficacy of bCBCT. The purpose of this randomized placebo-controlled trial is to compare the clinical and functional outcomes of bCBCT augmented with intranasal oxytocin (bCBCT + OT) versus bCBCT plus placebo (bCBCT + PL). The investigators will also explore potential mechanisms of action: communication, empathy, and trust.
The goal of this type I hybrid effectiveness-implementation trial is to test a family strengthening (FS) model delivered through multiple family groups (MFG) combined with a virtual peer mentoring program called TeenAge Health Consultants (Virtual TAHC) aimed at addressing emotional and behavioral problems among youth born in the U.S. to parents resettled as refugees. The specific aims of the study are: Aim 1: To systematically adapt an evidence-based family strengthening (FS) model delivered through multiple family groups (MFG) combined with a peer mentoring program (Virtual TAHC) (Goal 1). Aim 2: To assess preliminary short- and long-term impact of the combination intervention (MFG + Virtual TAHC) on behavioral emotional disorders (aggressive behavior, antisocial behaviors, anxiety, depression, and Posttraumatic Stress Disorder [PTSD]) related to intergenerational trauma among SGRC in the trial (Goal 2). Aim 3: Utilizing mixed methods and applying the Exploration, Preparation, Implementation, Sustainment (EPIS) framework, examine implementation strategies, facilitators, and barriers of the RRF4H intervention (Goal 3). Participants will receive: 1. Family strengthening intervention delivered through multiple family groups (MFG) where children and one of their biological parents will participate in 16 weekly group sessions to discuss common problems and how to address them. 2. The youth in the intervention will participate in a peer mentorship program called TeenAge Health Consultants (TAHC) consisting of 16 weekly virtual sessions where they interact with other youth to learn about important topics including how to deal with conflict, stay out of trouble, deal with stress, avoid drugs and other topics. Researchers will compare the intervention group to a control group that will receive the usual care to see if the intervention group shows improvement in symptoms compared to the usual care group.
The VA wants to understand what type of integrative and whole health approaches are helpful for Veterans. The study is comparing two primary care based mental health treatments, a mindfulness class that teaches mindfulness meditation and a problem-solving class that teaches problem-solving skills and how to build resilience, for Veterans who are experiencing symptoms of anxiety, depression, and/or PTSD. The goal of the study is to understand if the classes reduce symptoms of anxiety, depression, and/or PTSD and increase overall functioning.
Participation in post traumatic stress disorder observational study serves as a crucial contribution to advancing medical knowledge and refining the care provided to individuals facing similar health challenges. The primary objective centers on a meticulous examination of trial completion rates and voluntary withdrawals within this distinct patient population.
Post-Traumatic Stress Disorder (PTSD) is a mental disorder that may develop in people who have been exposed to a traumatic event, including actual or threatened death, serious injury, or sexual violence. Exposure to a traumatic event is defined as directly experiencing the event, learning about the event, or repeated exposure to details of the event. PTSD is often accompanied by other psychiatric and physical comorbidities, both of which are associated with elevated healthcare costs. Depression, psychosis and suicide rates are consistently reported in greater proportion of PTSD patients. Despite the overwhelming impact of PTSD and comorbid depression, there is a shortfall of effective treatments with few side effects that target the broad range of symptoms, including depression. Psilocybin has been studied for the treatment of depression, anxiety, tobacco and alcohol use disorders, obsessive-compulsive disorder, end of life depression and anxiety, demonstrating safety and efficacy for a variety of indications, with no significant adverse events occurring during the course of treatment and follow-up. Notably, in a participant group distinguished by long-standing, moderate to severe major depressive disorder, two doses of psilocybin-assisted therapy were found to be as effective in antidepressant effects as 6 weeks of daily escitalopram, a commonly used SSRI. Promising results found in these studies have led to psilocybin recently receiving breakthrough designation from the US FDA for its potential therapeutic effect in the treatment of depression. Based on previous research, psilocybin has demonstrated a favorable safety profile and has shown preliminary efficacy against depression as well as other symptoms that typically affect patients with PTSD. Unlike traditional SSRIs which are associated with treatment-resistance and addiction, psilocybin requires few doses to improve a wide-range of symptoms and has not been linked with physical dependence. Furthermore, the effect of other psychedelics can vary greatly and may potentially exacerbate existing conditions.
The aim of the study is to test the pilot effectiveness of Cognitive Processing Therapy (CPT) in decreasing psychological distress and post-traumatic stress disorder (PTSD) symptoms and increasing well-being in earthquake survivors in Türkiye, using randomized controlled trial study design, which is considered the gold standard in research for evaluating the effectiveness of interventions. This pilot study will help to identify any further adaptations required prior to further effectiveness testing in a large cluster randomized controlled trial. Study hypothesis: Hypothesis 1: The participants who receive the CPT will have a significantly higher decrease in PTSD symptoms compared to the participants in the care-as-usual control group at the post-assessment. Hypothesis 2: The participants who receive the CPT will have a significantly higher decrease in depressive symptom severity compared to the participants in the care-as-usual control group at the post-assessment. Hypothesis 4: The participants who receive the CPT will have a significantly higher decrease in anxiety severity compared to the participants in the care-as-usual control group at the post-assessment. Hypothesis 5: The participants who receive the CPT will have a significantly higher increase in well-being compared to the participants in the care-as-usual control group at post-assessment.
This project involves developing and piloting a peer-led intervention focused on posttraumatic stress symptoms for the family members and significant others of people with borderline personality disorder. The project involves collaborating with The Sashbear Foundation who will be delivering the trauma response program (TRP) that was developed by the investigative team to its network. In phase 1 of this project, the investigators will evaluate the first delivery of the TRP at The Sashbear Foundation and solicit feedback from peer-facilitators and recipients who consent to research participation. In phase 2 of this project, the investigators will evaluate the efficacy, acceptability, and safety of the delivery of the next two to four TRPs delivered at The Sashbear Foundation consisting of up to approximately 10 group members (maximum number of TRP recipient research participants in phase 2 is 40).
We now have many pharmacological and psychotherapeutic treatments for patients suffering from Post Traumatic Stress Disorder (PTSD), including cognitive and behavioral therapy (CBT) by reactivation of traumatic memories. Despite remarkable initial efficacy, only one-third of patients treated with CBT show lasting clinical improvement. On the other hand, the associated drop-out rates vary from 17% to 33%, which may be linked to the difficulty of the task, which implies reactivating the traumatic memory (Bradley et al. 2005). Alternative treatments for PTSD include blocking chemo-facilitated memory reconsolidation with a beta-blocker, propranolol. Briefly, reconsolidation theory posits that a recalled memory becomes unstable again before consolidating again into long-term memory, hence the term "reconsolidation". During this phase of transitory plasticity, the memory can be modulated, in particular its emotional charge. The use of propranolol has shown its benefit during this phase in patients suffering from PTSD (Brunet et al, 2018). However, the use of this facilitated chemo therapy is limited to patients with no contraindication to taking beta-blockers. In this context, a non-medicinal alternative to attenuate the emotional strength of the memory has a therapeutic interest. One of the ways in which our emotional experience can be modulated is through the perception of our emotional behavior. According to the theory of self-perception (Bem, 1972) individuals become aware or conscious of their attitudes, emotions and other internal states in part by inferring them from the observation of their own behaviors. Thus when individuals produce sounds or facial expressions typical of specific emotions such as joy, sadness or anger, they will tend to experience an emotional state congruent with their vocal or facial production (Hatfield and Hsee, 1995). Work on the influence of voice perception, in particular, is experiencing a new boom due to technical developments in the fields of acoustic signal processing. In particular, Dr. Aucouturier's team has created a software device to directly modify the emotional tone of speech formulated orally. For example, for "happy" manipulation, the pitch of the voice is changed with a pitch shifting algorithm to make it more positive, the dynamic range of the voice is increased with a compression algorithm to make it more confident, and its spectral content is modified with a high-pass filter to make it brighter. The results of this work (Aucouturier et al. 2016; Rachman et al. 2018; Goupil et al., 2021) showed an emotional vocal feedback effect: the subjective evaluation that participants make of their emotional state after modification by the device goes in the direction of the emotion created by the platform, even though the participants are typically unaware of the operated modulation. The non-detection of the transformation being a necessary condition for observing the effect of VF on the emotional state of the participant. The rationale of this study is to test the use of a real-time vocal transformation paradigm during exposure therapy by reactivation of traumatic memory in imagination in patients. During this therapy, the patient is asked to read aloud the very detailed script of the traumatic event. We want to test whether manipulating the emotional tone of the patient's voice online, when reading, can have a facilitating impact on the process of reducing the emotional charge associated with the traumatic script. In order to justify the use of the audio headphones as well as the microphone, and to ensure us of the non-detectability of the transformation operated on the voice, we will explain to our patients that this device (hearing his voice in a headphone during the session of re-exposure to a memory) aims to increase immersion. Our main objective will be to assess the acceptability of this augmented form of psychotherapy, and our secondary objectives will be to assess its technical feasibility and provide initial elements to assess its effectiveness. The results will be compared with data from the literature on the usual treatment (imaginary exposure therapy, with or without propranolol according to the indications).
The overall objective of this study is to pilot the VASDHS-adapted Emory MDMA-PE Protocol (aE-MDMA-PE) and assess the effect on clinician-rated PTSD symptoms in veterans who receive full-dose MDMA and veterans who receive low-dose MDMA.