PTSD clinical trials — recruiting now

The overall objective of the proposed study is to determine if lofexidine (LFX) as an adjunct to buprenorphine (BUP) treatment improves symptoms of both opioid use disorder (OUD) and Post-Traumatic Stress Disorder (PTSD). Other study objectives are to compare the safety, tolerability, and efficacy of BUP treatment alone, to BUP treatment with adjunct LFX, on measures of OUD and PTSD symptoms in Veterans with both prognosis .

The goal of this clinical trial is to test the efficacy of a novel integrative cognitive-behavioral intervention in patients with posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD). Specific Aim 1: Examine the efficacy of CPT-RP, as compared to RP alone, in reducing alcohol frequency (percent days drinking) and quantity (drinks per drinking day) as measured by the Timeline Follow-Back (TLFB). Specific Aim 2: Examine the efficacy of CPT-RP, as compared to RP alone, in reducing PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS-5). Specific Aim 3: Use ecological momentary assessment (EMA) to evaluate intervention effects on daily alcohol-related cognitions and behaviors through real-time associations with PTSD symptomatology and distress tolerance. Researchers will compare integrative CPT+RP with RP-alone to see if CPT+RP is more efficacious in reducing alcohol use and PTSD symptom severity.

Pilot study of the feasibility and utility of an early, in-hospital multidisciplinary intervention in ICU survivors at risk for psychological and physical problems post-ICU stay

The goal of this study is to find the most effective and efficient version of the THRIVE app. The THRIVE app is the first app-based preventative intervention that has been found to reduce alcohol misuse and posttraumatic stress in people who have recently experienced sexual assault. In this trial, participants are randomly assigned to receive different versions of the THRIVE app to compare their impact. The THRIVE app is currently only available to participants in this study.

The purpose of this study, entitled "Psychological trauma, post-traumatic stress disorder, and resilience in adults with congenital heart disease in a large population sample", is to evaluate for exposures during a lifetime with congenital heart disease that may be associated with higher likelihood of developing PTSD. Primary aim: \- Identify individual patient characteristics (medical, psychosocial, socioeconomic, etc.) that are associated with a diagnosis of PTSD. Secondary aims: * Calculate the prevalence of those meeting PTSD criteria in the ACHD population using the "gold standard" diagnostic clinician interview, while using the same data to validate a PTSD screening self-report survey in the ACHD population. * Determine the role of resilience in ACHD patients using a validated screening survey to assess its protective role toward PTSD. Hypotheses: * There are certain exposures (e.g. post-surgical pain, ICU delirium, bullying due to CHD) that are associated with a higher incidence and odds of meeting PTSD criteria. * "Gold standard" diagnostic interviews will most accurately estimate the prevalence of PTSD in ACHD which has been overestimated on prior screening-based studies, although the scope of the problem is still great. * Patients with a higher resilience score will show an association with a lower risk of PTSD.

This study aims to examine the effectiveness of group-delivered Guided Written Exposure Therapy for Complex Post-Traumatic Stress Disorder (GWE-C) among Chinese adolescents through a randomized controlled trial. A total of 120 participants will be recruited, with 60 randomized to the GWE-C group and 60 randomized to the supportive therapy (ST) group. The GWE-C intervention will consist of 7 to 10 group sessions. The primary outcome, assessed by the International Trauma Questionnaire (ITQ), will be measured at baseline, post-treatment, 1-month follow-up, and 3-month follow-up.

The purpose of this study is to test the hypothesis that the anti-depressant and anti-suicidal effects of the N-methyl-D-aspartate receptor (NMDAR) antagonist Ketamine is critically dependent on stimulation of Alpha-Amino-3-Hydroxy-5-Methyl-4-Isoxazole Propionic Acid receptors (AMPAR).

The purpose of this study is to examine the use of a brief transdiagnostic treatment for anxiety disorders and (post-traumatic stress disorder (PTSD) in South Africa. The intervention will be delivered by non-specialist providers (e.g., nurses) in primary care clinics. The brief intervention group will be compared to an enhanced standard care control group.

The goal of the REVEAL PTSD study is to test how well the Senseye DT works as a diagnostic test for Post-traumatic Stress Disorder (PTSD) in adults 18 and older who are experiencing one or more symptoms that might be related to PTSD. The Senseye DT is software as a medical device (SaMD) and is an iPhone app that administers a series of simple tasks on the phone while recording video during the tasks through the front-facing camera. The videos are analyzed by a an Artificial Intelligence (AI) algorithm to identify physiologic signals that might be indicative of PTSD. Data collected in this study will be used to train and tune the AI algorithm, then test it for accuracy. The main questions this study aims to answer are: 1. How accurate is the Senseye DT in detecting PTSD compared to structured clinical interviews, the current clinical standard for diagnostic testing? 2. How accurately does the Senseye DT predict PTSD severity? 3. How fast is the Senseye DT to use compared to structured clinical interviews? Participants will attend a virtual screening visit via video call to determine eligibility and consent to participate. Once enrolled, participants will attend 2 or 3 additional study visits: * Visit 1: A virtual visit where standard mental health assessments will be given by clinical raters trained in mental health and administering these structured clinical interviews. These assessments include the Structured Interview Guide for the Montgomery-Asburg Depression Rating Scale (SIGMA), the Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A), and the MINI International Neurodiagnostic Interview. The Clinician-Administered PTSD Scale for DSM-5 Revised Version (CAPS-5-R) may also be conducted, if randomly selected. * Visit 2: A visit to use the Senseye DT. For participants near one of the study's physical site locations, this visit will be done in person at the site. For all others, this visit will be conducted virtually. * Visit 3: For participants not randomly selected to have the CAPS-5-R administered at Visit 1, a third and final visit will be scheduled for this assessment. This visit will be conducted virtually. The total expected participation time for enrolled participants is 6-7 hours over the course of 2-3 weeks.

Previous research on the impact of a diary on mental symptoms of PICS, PICS-F, and quality of life in former ICU patients and their relatives has focused specifically on a paper diary. While there has been research on the experiences of former ICU patients, relatives, and ICU nurses regarding the use of a digital diary, it is not known whether this diary has an impact on the psychological well-being and quality of life of former ICU patients and their relatives. A successful implementation of \[the digital diary\] enables this research. The aim of this study is, therefore, to provide an initial impression of the health-related effects of a digital diary on former ICU patients and their relatives.

The goal of this clinical trial is to test an abbreviated, intensive, multi-couple group version of cognitive-behavioral conjoint therapy for PTSD (AIM-CBCT for PTSD) in an active military and veteran population. The main questions it aims to answer are: * Does AIM-CBCT for PTSD improve PTSD symptoms? * Does AIM-CBCT for PTSD improve associated symptoms (e.g., depression), romantic partner distress, and couple relationship satisfaction? Participants will participate in a two-day retreat in which they are taught and practice skills to decrease PTSD symptoms and enhance their relationships. Researchers will compare AIM-CBCT for PTSD to the Prevention and Relationship Education Program (PREP) to determine whether it is superior to an evidence-based relationship education curriculum that is also delivered in a two-day multi-couple group format.

The objective of this study is to develop and pilot test a telehealth-based mental health screening and engagement program that supports parents as their infants transition home from the NICU. The program will use a stepped-care approach to screen parents for depression, anxiety, and PTSD; provide a brief behavioral intervention to those who screen as having at least a low risk of these conditions; and provide a warm hand-off to community mental health services for those at medium to high risk.

Rationale: A substantial proportion of the Intensive Care Unit (ICU) survivors develop psychological impairments due to their ICU admission. Several interventions to mitigate these impairments have been explored but lack a proper effect. Intensive Care Unit-specific Virtual Reality has proven to be potentially effective in treating PTSD and depression-related sequelae in ICU-survivors. Objective: To evaluate the contribution in terms of information provision and patients' perspectives of ICU-VR to prepare lung transplant patients for their future ICU admission Study design: A monocentre randomized controlled study Study population: Lung transplant patients who are on the waiting list and understand the Dutch language. Due to the criteria for lung transplantation, these are 18-71 years of age. Participants need to have signed the informed consent formular. Intervention: The ICU-VR intervention is designed by an interdisciplinary team of intensivists, ICU nurses, a psychiatrist, a psychologist, and a former ICU patient, to expose patients to the ICU environment while offering treatment- and department-related information. During the 12-minute lasting intervention, patients experience different facets of ICU treatment and receive information on the ICU environment, treatment, and workflow. The intervention group will receive this treatment during the appointment with the lung transplantation nurse. The control group will receive the regular hospital preparation care. Primary endpoints: The primary endpoint will be the difference in information provision of the ICU care of lung transplant patients on the waiting list.

Post-traumatic stress disorder (PTSD) affects many people who have experienced traumatic events. A common issue with PTSD is severe sleep disturbances, such as nightmares. Current treatments often do not provide sufficient relief, especially for sleep problems. This study aims to determine whether dexmedetomidine - a medication already used in intensive care - can improve sleep quality in PTSD patients.

The current study will evaluate TF-CBT delivered via tele-health for youth presenting with trauma symptoms via a randomized controlled trial. Goals of the current study are to examine the effectiveness of Tele-TF-CBT delivered by community providers in Puerto Rico in improving youth trauma outcomes. Goals are also to support the feasibility, acceptability, and engagement outcomes of Tele-health delivery.

The Royal Canadian Mounted Police (RCMP), like all public safety personnel (PSP), are frequently exposed to potentially psychologically traumatic events that contribute to posttraumatic stress injuries (PTSI). Addressing PTSI is impeded by the limited available research. The RCMP are working to build evidence-based solutions to PTSI and other mental health challenges facing their members, which by extension will help all PSP, as part of the Canadian Government Federal Framework on Posttraumatic Stress Disorder. A key element is the "Longitudinal Study of Operational Stress Injuries / Étude longitudinale sur les traumatismes liés au stress opérationnel", a study which has been renamed "Risk and Resiliency Factors in the RCMP: A Prospective Investigation", and is referred to as the "RCMP Study" for short. The RCMP Study has been detailed online (www.rcmpstudy.ca) and in a recently published peer-reviewed protocol paper, "The Royal Canadian Mounted Police (RCMP) Study: protocol for a prospective investigation of mental health risk and resilience factors" (https://doi.org/10.24095/hpcdp.42.8.02). The RCMP Study, part of the concerted efforts by the RCMP to reduce PTSI by improving access to evidence-based assessments, treatments, and training as well as participant recruitment and RCMP Study developments to date. The RCMP Study has been designed to (1) develop, deploy and assess the impact of a system for ongoing annual, monthly and daily evidence-based assessments; (2) evaluate associations between demographic variables and PTSI; (3) longitudinally assess individual differences associated with PTSI; (4) augment the RCMP Cadet Training Program with skills to proactively mitigate PTSI; and (5) assess the impact of the augmented training condition (ATC) versus the standard training condition (STC). Participants in the STC (n = 480) and ATC (n = 480) are assessed before and after training and annually for 5 years on their deployment date; they also complete brief monthly and daily surveys. The RCMP Study results are expected to benefit the mental health of all participants, RCMP and PSP by reducing PTSI among all who serve.

This open label, within-subjects dose optimization trial will investigate the optimal number of MDMA-Assisted Therapy treatment cycles (i.e., one MDMA session and three integration sessions) in a sample of U.S. veterans with PTSD. Participants will complete from one to five cycles of MDMA-AT.

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.

Exposure, relaxation, and rescripting therapy (ERRT) is a promising psychological intervention developed to target trauma-related nightmares and sleep disturbances. Though further evidence is needed, ERRT has shown strong support in reducing the number and intensity of nightmares, as well as improving overall sleep quality in both civilian and veteran samples. This study will assess the efficacy in individuals diagnosed with bipolar disorder.

The main aim of the present process-outcome study is to evaluate the feasibility and the effects of an EMDR-IGTP-OTS group intervention on a sample of people with cancer, by using a process-outcome study design, with repeated measures.