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Stress Disorders, Traumatic clinical trials

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NCT ID: NCT06146049 Not yet recruiting - Clinical trials for Post Traumatic Stress Disorder

Exploring Clinical Study Experiences of People With Post Traumatic Stress Disorder

Start date: December 2024
Phase:
Study type: Observational

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.

NCT ID: NCT06143982 Recruiting - Clinical trials for Post-traumatic Stress Disorder

Effectiveness of a Brief Intensive Trauma Treatment for Adolescents With (s)PTSD: a Multi-center RCT

Start date: October 5, 2022
Phase: N/A
Study type: Interventional

The primary objective of this study is to examine the effectiveness of a Brief Intensive Trauma Treatment (BITT) for adolescents with (s)PTSD.

NCT ID: NCT06141876 Not yet recruiting - Depression Clinical Trials

Evaluation of Psilocybin-Assisted Psychotherapy in Treating Severe Depression in Patients With PTSD

SUMMIT-90
Start date: December 15, 2023
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT06139159 Recruiting - Anxiety Disorders Clinical Trials

CRISOL Mente: A Multilevel Community Intervention to Reduce Mental Health Disparities Among Latinos

Start date: November 10, 2023
Phase: N/A
Study type: Interventional

Latinos in the U.S. experience significant disparities in access to mental health services due to lack of health insurance, language barriers, low availability of bilingual providers, mental health stigma, and fear of deportation. There is an urgent need to identify low-cost, culturally appropriate interventions to reduce mental health disparities among this population. This project will address that need by implementing and testing CRISOL Mente, a multi-level, culturally-congruent community intervention to improve the mental health of the Latino population in Philadelphia.

NCT ID: NCT06138522 Recruiting - Clinical trials for Post-traumatic Stress Disorder

Qualitative Study on the Perception of Changes in the Psychotherapy of Traumatized Young People

TRAUMADOPSY
Start date: November 30, 2023
Phase:
Study type: Observational

The clinic of psychological trauma in adolescents still requires further development, whereas it is well documented in adults. This clinic is complex, because it must take into account the nature and type of trauma (recent or not, intentional or not, situations of abuse or sexual violence, etc.), the impact on development, the contexts (social, cultural and family) in which the trauma occurs, and the various vulnerability factors associated with it. This complexity has implications for psychotherapeutic management, which needs to be tailored to the specific clinical profiles of adolescents. Several studies have evaluated psychotherapy for traumatized adolescents, showing a positive short-term effect on the reduction of post-traumatic stress symptoms, whatever the type of psychotherapy. Few studies, however, have analyzed the therapeutic process and the common factors of change, linked mainly to the therapeutic alliance, the patient's experience and the therapist's role: key factors of change according to the international literature. In this context, the patient's experience of his or her psychotherapeutic follow-up is a source of information that has long been neglected, even though it seems essential for better investigating and understanding the complexity of the processes at play in trauma psychotherapy.

NCT ID: NCT06136481 Not yet recruiting - Depressive Symptoms Clinical Trials

The Feasibility of Cognitive Process Therapy in Earthquake-affected Population With Mental Health Problems in Türkiye

Start date: March 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06135090 Not yet recruiting - Clinical trials for Posttraumatic Stress Disorder

Testing a Peer-led Trauma-focused Intervention for Significant Others of Those With BPD

Start date: February 1, 2024
Phase: Phase 1
Study type: Interventional

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).

NCT ID: NCT06130501 Recruiting - Clinical trials for Posttraumatic Stress Disorder

tAN for PTSD and OUD in Buprenorphine Therapy

Start date: June 14, 2024
Phase: N/A
Study type: Interventional

The goal of this research study is to investigate the effects transcutaneous auricular neurostimulation (tAN), as delivered through the Sparrow Ascent device, on helping people with co-occurring posttraumatic stress disorder (PTSD) and opioid use disorder (OUD) start and continue buprenorphine treatment. The main questions it aims to answer are: - Does the tAN help participants with OUD and PTSD remain in buprenorphine therapy for three months after starting use of the device (i.e., randomization to treatment condition)? - Do participants find the Sparrow Ascent device to be acceptable and use it? - Do participants find the Sparrow Ascent device to be tolerable and comfortable to use? - Do participants find the Sparrow Ascent device to be easy to use with their buprenorphine therapy? - Do participants follow the minimum recommended dose schedule for the Sparrow Ascent device most of the time? Participants will complete a baseline assessment to make sure that they are eligible to participate in the study. The assessment captures information about demographics, substance use and treatment history, opioid withdrawal symptoms and craving, difficult life experiences and PTSD symptoms, mental health and treatment history, quality of life, and recovery resources. After the assessment is complete and the participant has been inducted on buprenorphine as part of standard care in the clinic, they are randomized to one of two treatment conditions: active tAN and placebo. Participants are trained on how to use the device and return for 12 weekly research visits to check on recent substance use and craving, PTSD symptoms, and their experience using the device. After 12 weeks of using the device, participants will complete a post-active treatment assessment that is nearly identical to the baseline assessment to see if there have been changes in these areas. Researchers will access the medical record to determine whether there is a current prescription for buprenorphine at three months and six months after randomization.

NCT ID: NCT06129981 Not yet recruiting - Clinical trials for Post-traumatic Stress Disorder

TREATMENT OF POST-TRAUMATIC STRESS DISORDER USING AUGMENTED IMAGINATION EXPOSURE PSYCHOTHERAPY WITH VOCAL FEEDBACK: AN ACCEPTABILITY STUDY

TRAUMAVOICE
Start date: November 30, 2023
Phase: N/A
Study type: Interventional

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).

NCT ID: NCT06117306 Not yet recruiting - Clinical trials for Post-Traumatic Stress Disorder

MDMA-assisted Massed Prolonged Exposure for PTSD

MDMA-PE
Start date: January 2, 2024
Phase: Phase 3
Study type: Interventional

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.