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PTSD clinical trials

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NCT ID: NCT04760418 Completed - PTSD Clinical Trials

Trauma and Trauma-Focused Therapy in the University of Kentucky SMART Clinic

Start date: May 26, 2021
Phase: N/A
Study type: Interventional

Opioid misuse is a national public health epidemic. More than 130 people in the United States die each day following an opioid overdose, and over 2 million people meet criteria for an opioid use disorder (OUD). Medication-assisted treatment (MAT), which involves use of medication (buprenorphine, methadone, naltrexone) in combination with behavioral therapy or counseling, is the most effective intervention for OUD. Yet, MAT remains less than optimally effective, particularly for patients with psychiatric comorbidity [6]. Novel approaches are needed to improve long-term outcomes for OUD patients. Psychological trauma and posttraumatic stress disorder (PTSD) are highly prevalent among individuals with OUD. Over 90% of adults with OUD report a lifetime history of trauma. Among OUD patients engaged in MAT, nearly 20% report experiencing at least one new traumatic event each month, and nearly a third meet criteria for a co-occurring diagnosis of posttraumatic stress disorder (PTSD). Several studies have linked new incidents of trauma as well as the presence of PTSD to poorer MAT engagement and poorer treatment outcomes, including treatment interruption and premature dropout. Preliminary evidence suggests that engaging in trauma-focused treatment for PTSD concurrent with MAT may result in better long-term adherence to medication for OUD. However, recent evidence finds that fewer than half of patients with PTSD in MAT receive any trauma-focused treatment, and even fewer receive evidence-based interventions. Trauma-focused treatments that concurrently address symptoms of PTSD and substance abuse using an integrated approach have been recommended over traditional substance abuse interventions for patients with this complex dual diagnosis presentation. Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE) is a 12-session evidence-based cognitive-behavioral therapy that integrates exposure therapy for PTSD with cognitive-behavioral skills for addressing problem substance use. COPE has demonstrated efficacy for reducing symptoms of PTSD and substance use disorder across multiple trials. Most samples have included patients with alcohol use disorder or mixed substance use disorder diagnoses. The proposed pilot study would collect preliminary feasibility data to support the first trial of COPE for patients with OUD (and other substance use disorders) who are currently engaged in MAT. As such, a primary aim of the current pilot is to obtain patient feedback regarding the acceptability and applicability of COPE for patients with PTSD receiving MAT treatment through the Supportive Medication Assisted Recovery Treatment (SMART) Program within the University of Kentucky (UK) Department of Psychiatry, an outpatient buprenorphine clinic. The investigators believe that it is critical to engage patients directly in the process of intervention development/refinement to determine how an existing evidence-based intervention like COPE might be modified to best fit the unique needs of patients receiving MAT.

NCT ID: NCT04714359 Completed - PTSD Clinical Trials

A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD

MAPPUSX
Start date: March 8, 2021
Phase: Phase 3
Study type: Interventional

This multi-site open-label study assesses the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in participants who were enrolled in a parent study for treatment of posttraumatic stress disorder (PTSD). The study will be conducted in up to N ≈ 100 participants. Participants will receive a flexible dose of MDMA, followed by a supplemental dose, unless contraindicated, during the Treatment Period with manualized psychotherapy in three monthly Experimental Sessions. This ~12-week Treatment Period is preceded by three Preparatory Sessions. During the Treatment Period, each Experimental Session is followed by three Integrative Sessions of non-drug psychotherapy. The Primary Outcome measure is the change in PTSD Checklist (PCL-5) for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) from Visit 3 is assessed at Visit 16. This study will compare the effects of three manualized Experimental Sessions of psychotherapy assisted by flexible doses of MDMA. Initial doses per Experimental Session include 80 mg or 120 mg of MDMA compounded with mannitol and magnesium stearate alone (mannitol and magnesium stearate), followed 1.5 to 2 hours later by a supplemental dose (40 or 60 mg). Total amounts of MDMA to be administered per Experimental Session range from 80 mg to 180 mg.

NCT ID: NCT04597450 Completed - PTSD Clinical Trials

Lu AG06466 in Participants With Post Traumatic Stress Disorder (PTSD)

Start date: September 30, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the effect of Lu AG06466 after multiple doses of 30 milligrams (mg) in participants with PTSD.

NCT ID: NCT04596891 Completed - PTSD Clinical Trials

Acceptance and Mindfulness Based Exposure Therapy for Survivors of Cardiac Arrest

AMBET
Start date: March 2, 2021
Phase: N/A
Study type: Interventional

The primary goal of this uncontrolled pilot trial is to examine feasibility, acceptability, safety, and preliminary efficacy of a new behavioral treatment for survivors of sudden cardiac arrest with clinically elevated symptoms of post-traumatic stress disorder (PTSD). Participants will be recruited among cardiac arrest survivors enrolled in the observational CANOE research study (CUIMC IRB# AAAR8497). Study participants will be interviewed about their symptoms and evaluated for baseline assessment before receiving eight weekly sessions of an acceptance and mindfulness-based exposure therapy (AMBET). Participants will be additionally evaluated at treatment mid-point (week 4), and at the end of treatment. The treatment and all assessments will be conducted remotely via Zoom. To assess whether patients' physical activity is improved over the course of treatment, participants will be provided with a wearable device (Fitbit wristband) to monitor their physical activity. The specific aims of this study are to: (1) develop an acceptable protocol for an AMBET intervention for survivors of sudden cardiac arrest with elevated PTSD symptoms (2) examine its safety and feasibility in a small sample of 14 patients (3) investigate acceptability and feasibility of the assessments and measurements including physical activity.

NCT ID: NCT04574466 Completed - Depression Clinical Trials

Scaling-up Psychological Interventions With Syrian Refugees in Switzerland (STRENGTHS_CH): RCT

Start date: August 25, 2020
Phase: N/A
Study type: Interventional

The current refugee crisis across the Middle East and Europe has large effects on individual refugees' psychological well-being, as well as on the healthcare systems of countries hosting refugees. For example, in Switzerland patients sometimes have to wait up to 12 months for the specific psychological treatment due to a lack of specialists. To address this problem the WHO has developed Problem Management Plus (PM+), a brief (five sessions), low-intensity psychological intervention, delivered by paraprofessionals, that addresses common mental disorders in people in communities affected by adversity. The effectiveness and implementation of PM+ has never been examined in Switzerland before, this is the aim of the current randomized controlled trial.

NCT ID: NCT04552301 Completed - Asthma Clinical Trials

Assessing Inflammatory and Behavioral Pathways Linking PTSD to Increased Asthma Morbidity in WTC Workers

Start date: August 17, 2020
Phase: N/A
Study type: Interventional

Asthma and post-traumatic stress disorder (PTSD) are the most common conditions in World Trade Center (WTC) rescue and recovery workers. In this study, the study team will evaluate the interplay of biological and behavioral mechanisms explaining the relationship of PTSD with increase asthma morbidity and adapt and pilot test a novel intervention to improve outcomes of WTC workers.

NCT ID: NCT04549493 Completed - PTSD Clinical Trials

Effectiveness of Trauma Management Therapy and Prolonged Exposure Therapy

Start date: February 12, 2020
Phase: N/A
Study type: Interventional

The purpose of this requirement is to identify an effective exposure psychotherapy paradigm for the treatment of Post-Traumatic Stress Disorder (PTSD) in active duty service members and veterans by comparing different exposure psychotherapy modalities. The long-term goal of exposure psychotherapy is to improve the mental health of U.S. service members and veterans with military-related PTSD. Recovery from PTSD will reduce the economic burden not only for those persons experiencing PTSD, but also for the health care system and society as a whole (Galovski & Lyons, 2004).

NCT ID: NCT04510272 Completed - Depression Clinical Trials

Aloud Real-time Reading of ICU Diaries for Prevention of Negative Post-ICU Psychological Outcomes

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

This study will evaluate whether a systematically delivered, patient-oriented real time communication via aloud real time readings of ICU diary entries during patient's ICU stay is feasible

NCT ID: NCT04471207 Completed - PTSD Clinical Trials

Clinical Trial Intelligent Biometrics for PTSD - Clinical Trial

Start date: June 8, 2020
Phase: Phase 1
Study type: Interventional

Posttraumatic stress disorder (PTSD) is a debilitating mental health condition that increases suicide risk and affects up to 20% of military veterans and 8% of the general population. Prolonged Exposure (PE) is a highly effective behavioral (talk therapy) intervention for PTSD. However, dropout rates are high (25-30%) and an estimated one-third of patients who complete PE still report symptoms of PTSD at the end of treatment. This study directly addresses these limitations by using a clinical trial to evaluate the ability of an innovative technology system to improve PE therapy for veterans with PTSD.

NCT ID: NCT04397848 Completed - Depression Clinical Trials

Mental Health Outcomes in Healthcare Workers During COVID-19

Start date: May 14, 2020
Phase:
Study type: Observational

An online survey will be sent to healthcare workers (HCWs) in acute care hospitals to explore a variety of risk factors for negative psychological outcomes and levels of anxiety, depression and post-traumatic stress symptoms using validated scales. It is important to understand the sources of negative psychological impact on HCWs during this COVID-19 pandemic before hospitals and organizations can address and develop support programs to mitigate the stresses experienced by healthcare workers. Addressing and supporting the needs of our HCWs will be paramount in this COVID-19 pandemic and future outbreaks.