View clinical trials related to Stress Disorders, Traumatic.
Filter by:The purpose of this study is to examine measures of GrimAge clock in SOF members undergoing treatment for PTSD/TBI using CSB.
In partnership with the Veterans Affairs (VA) Palo Alto Health Care System and Stanford University, this study aims to evaluate clinical outcomes, assess implementation feasibility, and health economics of MDMA-assisted therapy in the treatment of posttraumatic stress disorder (PTSD). Through a randomized comparison of MDMA-assisted therapy versus Cognitive Processing Therapy (CPT), a VA gold standard treatment for PTSD, the proposed study will set the stage for understanding the potential use and application of MDMA-assisted therapy for PTSD within the VA system.
Posttraumatic stress disorder (PTSD) is associated with increased rates of prescription opioid misuse, high-risk opioid use, illicit use of substances, and overdose (Meshberg-Cohen et al., 2021) Some research has demonstrated that among individuals with opioid use disorder (OUD), 92% report exposure to a traumatic event (Mills et al., 2005). Approximately 41% of those with OUD have a lifetime history of PTSD and 33.2% of individuals with OUD meet current diagnostic criteria for PTSD, indicating very high rates of PTSD among people with co-occurring OUD (Mills et al., 2006, 2007). PTSD also prospectively increases risk for OUD after exposure to opioids (Hassan et al., 2017). Medications for opioid use disorder (MOUD) are evidence-based pharmacological interventions for OUD (methadone, buprenorphine, naltrexone) to manage pain and withdrawal (Leshner & Mancher, 2019). Though effective, dropout from MOUD programs is high (Mokri et al., 2016; O'Connor et al., 2020). It is also common in substance use disorder (SUD) treatment settings not to treat PTSD (Norman & Hien, 2020), though concurrent PTSD and MOUD treatment is associated with higher continuation in MOUD programs compared to no PTSD treatment (Meshberg-Cohen et al., 2019; Schacht et al., 2017). Despite this, there is little data regarding efficacy or effectiveness of specific trauma-focused PTSD treatments among patients in MOUD programs. Combined with effective cognitive-behavioral techniques for substance use disorder (SUD), evaluation of brief, trauma-focused interventions for PTSD has substantial potential to improve care for individuals with PTSD receiving MOUD. The present study will begin to address this need by evaluating the feasibility, acceptability, and initial efficacy of Written Exposure Therapy (WET) for PTSD integrated with harm reduction skills for managing SUD symptoms among a sample of patients receiving MOUD [Written Exposure Therapy-Integrated (WET-I)]. WET is a five-session treatment for PTSD requiring limited therapist training and minimal patient burden (Sloan & Marx, 2019). WET has shown comparable outcomes to gold-standard interventions for PTSD, with improved retention rates (Sloan et al., 2018). WET has marked potential within this population, especially given that many clinicians in SUD programs do not have specialized training in PTSD treatments (Killeen et al., 2015). Using a multiple baseline single case experimental design (SCED), 6 participants with current PTSD and current or past OUD will be recruited from MOUD treatment programs to engage in 5 weekly sessions of WET-I. Participants will complete an intake assessment to establish PTSD and OUD diagnoses and will be randomized to a 3- or 5-week baseline assessment period. Weekly assessments of symptoms (i.e., PTSD, anxiety, depression), substance craving and use, quality of life, and compliance with MOUD treatment will be completed during the baseline, treatment, and one-month follow-up phase. During the treatment phase, participants will also complete weekly measures of therapeutic alliance and will provide feedback on treatment credibility and treatment satisfaction. Aim 1: To examine feasibility and acceptability of WET-I among participants in MOUD treatment with co-occurring PTSD/OUD. Feasibility of WET-I will be demonstrated via treatment retention and completion. Acceptability of engaging in WET-I in tandem with MOUD treatment will be demonstrated via high patient credibility ratings of WET-I and high treatment satisfaction ratings. Aim 2: To determine if WET-I can significantly reduce symptoms of PTSD, anxiety, and depression in participants with comorbid PTSD and OUD and to monitor changes in drug use behaviors and craving over the treatment period. Participants will report reliable clinical improvement in symptoms (PTSD, anxiety, depression) and quality of life during the treatment phase and post-assessment without corresponding increases in substance use behavior or craving, and these improvements will be maintained at follow-up.
This study capitalizes on an opportunity to formally evaluate local adaptations of "Keeping Foster and Kinship Parents Supported and Trained" (KEEP), an evidence-based foster parent intervention, to reduce mental health disparities among child welfare-involved youth and improve care quality and long-term outcomes for Native, Hispanic/Latino, Black/African American, and sexual and gender minority youth. The knowledge gained from the study will impact all current and future large-scale implementations of KEEP and will bolster our scientific understanding the impact of KEEP on youth mental health outcomes.
The COVID-19 pandemic has resulted in increased workload and concerns about personal and family safety for frontline healthcare workers (HCWs), which can lead to decreased well-being and worsening mental health. Sleep disruption is particularly prevalent among HCWs providing frontline COVID-19 care. It can have direct consequences on their cognitive and emotional functioning, as well as on patient safety. Cognitive Behavioral Therapy for insomnia (CBTi) is a first-line treatment for insomnia. It has been shown to improve sleep health and wellbeing in the general population. However, there are significant barriers to delivering CBTi to frontline HCWs, including limited availability of trained sleep therapists and high costs. To address this, a Canada-wide randomized controlled trial is developed to determine the effectiveness of a digital CBTi program on the sleep health, mental health, wellness, and overall quality of life of frontline HCWs caring for COVID-19 patients. This study may provide an easily accessible and scalable sleep health intervention that can be included as part of a national and global response to the COVID-19 pandemic.
There are 636,000 self-reported cases of sexual assault annually in Canada, and nine out of ten persons who have experienced sexual assault are women. Cognitive and behavioural therapies (CBT) are the treatment of choice for many psychological problems arising from sexual assault. However, accessing CBT is a significant challenge, especially for women who have experienced sexual assault who may be ashamed and not disclose the sexual assault. Online CBT is an effective option to circumvent these barriers. In addition to being accessible and less resource-intensive, studies report that patients are less inhibited and that the online environment provides greater emotional safety. There is also a growing body of evidence that online CBT programs requiring little or no contact with a mental health professional are effective, this having been demonstrated primarily with individuals with anxiety and mood disorders. But when it comes to treating the psychological symptoms of sexual assault in potentially vulnerable individuals, can we really suggest a self-care approach? There is no direct empirical evidence to support such a recommendation, and it is this important question that this project wishes to address. To compare the effectiveness, acceptability and user engagement in a self-managed treatment platform with or without the support of a therapist to reduce post-traumatic symptoms, depression and insomnia in people who have suffered one or more sexual assaults, 204 victims of sexual assault experiencing significant distress will be recruited and randomly assigned to either the self-managed or the therapist-assisted online treatment condition. Participants will complete measures assessing post-traumatic stress disorder, insomnia, depression, anxiety, and maladaptive beliefs before, during, after and 3 months after treatment. Secondary outcome will be and appreciation of the online treatment measures by a self-report questionnaire and a semi-structured interview. If effective in reducing symptoms, this treatment would offer the potential to support a self-care approach to treating a wide range of psychological symptoms resulting from sexual assault. The self-managed online platform would fill a service gap deplored by this population.
Patients who complete prolonged exposure and cognitive processing therapy, the treatments for posttraumatic stress disorder (PTSD) with the most empirical support, continue to express a need for mental health treatment. A therapist-assisted self-management program for patients who have completed one of these two treatments and achieved symptom improvement has the potential to meet patients' stated treatment needs, maintain or build upon their PTSD symptom reductions, increase their confidence in managing their symptoms, and reduce the number of mental health appointments that they need to attend. Further, reducing the number if mental health sessions attended by completers of these time and resource intensive psychotherapies will increase the likelihood that their implementation in regular-practice clinics will be maintained.
This randomized, double-blind, single-site phase II 2-arm study will investigate the safety and preliminary efficacy of MDMA-assisted therapy compared with low dose d-amphetamine-assisted therapy on the severity of PTSD symptoms in participants aged 18 years and older with PTSD of at least moderate severity.
The primary objective of this research is to collect pilot data that demonstrates that proposed neural, psychophysiological and subjective markers measured before, during, and after treatment change over the course of Prolonged Exposure therapy (PE) for posttraumatic stress disorder (PTSD). The aims of the study are to: (1) examine theoretically informed mechanisms as pretreatment predictors of PE treatment efficacy, (2) characterize how neural, psychophysiological, and subjective markers measured before, during, and after treatment change over the course of PE, and (3) examine proposed mechanisms of change as measures of PE treatment efficacy. This is a longitudinal study of predictors of exposure therapy efficacy that will be conducted within the context of a standard 10 session PE treatment trial, with independent multimodal assessment batteries administered at pre-treatment, mid-treatment, post-treatment, and at 1-month follow-up. This data will be used to support a future NIMH and/or VA grant submission.
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).