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112 active trials for PTSD

Open Label Multi-Site Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD

This multi-site, open-label, Phase 2, lead-in study assesses the safety and effect of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in participants diagnosed with at least severe posttraumatic stress disorder (PTSD). Therapy teams that have been identified and trained to work on the sponsor's planned Phase 3 studies will treat at least one open-label participant in this study. The study will be conducted in up to N=60 participants. A flexible dose of MDMA, followed by a supplemental half-dose unless contraindicated, is administered during the Treatment Period with manualized psychotherapy in three open-label 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, the change in Clinician Administered PTSD Scale for DSM 5 (CAPS-5) from Baseline. Exploratory measures will address specific symptoms, or behavior that is sometimes related to PTSD. Drug safety will be assessed by measuring blood pressure, heart rate and body temperature during experimental sessions, collecting adverse events and measuring suicidal thoughts or behaviors with the Columbia Suicide Severity Rating Scale (CSSRS). This study will compare the effects of three open-label 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 lactose, followed 1.5 to 2 hours later by a supplemental half-dose (40 mg or 60 mg). Total amounts of MDMA to be administered per Experimental Session range from 80 mg to 180 mg.

Start: October 2017

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

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.

Start: August 2020

Effectiveness of Trauma Management Therapy and Prolonged Exposure Therapy

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).

Start: February 2020

Effect of tDCS Timing on Safety Memory in PTSD

The primary purpose of this study is to investigate the effects of tDCS timing on safety memory in PTSD. A total of 90 participants will be randomized equally across one of three groups: One group receiving active stimulation during extinction and sham during consolidation One group receiving sham stimulation during extinction and active during consolidation One group receiving sham stimulation both during extinction and consolidation This study will also include an online sub-study focused on contextual processing along the PTSD spectrum. A maximum of 500 participants will be recruited using an online, panel-based platform.

Start: November 2019

IPT-A for Adolescents With PTSD Symptoms

In the present study, the investigators propose to 1) adapt Interpersonal Psychotherapy for Adolescents (IPT-A) as an intervention for adolescents who report elevated symptoms of posttraumatic stress disorder (PTSD) and/or meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for PTSD; and 2) conduct a small open pilot study of IPT-A for PTSD. Ten adolescents ages 13 to 18 who meet DSM-5 criteria for a PTSD diagnosis or have elevated symptoms of PTSD (Child PTSD Symptom Scale [CPSS-5] ? 31) will be treated with 14-16 weeks of an adapted version of IPT-A. If participants have evidenced a decrease in PTSD symptoms (CPSS-5 < 31) they will also receive 3 months of once a month maintenance treatment and be assessed by a clinician evaluator at the conclusion of the 3 monthly sessions. If participants have not evidenced a decrease in PTSD symptoms (CPSS-5 ? 31), they will be referred for alternative treatments in the community and be assessed by a clinician evaluator 3 months following the completion of IPT-A. All evaluations and therapy sessions will be done over telehealth platform until able to be done in person.

Start: August 2019

PTSD Help - a Randomized Controlled Trial of a PTSD Mobile Health App

Due to an increase in PTSD patients seeking treatment in the Danish mental health sector and the addition of Complex PTSD to the ICD-11, there is a need to increase the effectiveness of existing treatments for PTSD. mHealth interventions have been shown to be effective in reducing PTSD symptoms with small to moderate effect sizes. Therefore, the implementation of a mHealth intervention designed for psychiatric PTSD patients as a supplement to therapy may increase treatment outcome. As no studies to date has explored the effects of mHealth interventions in the Danish mental health sector the feasibility and effect of this type of intervention needs testing. The study's primary hypothesis is that PTSD patients in a Danish psychiatric outpatient setting will want to use a mHealth application as a supplement to care as usual (CAU). The secondary hypothesis is that PTSD patients will benefit from using a mHealth application as a supplement to CAU The study is an investigator-initiated randomized controlled feasibility trial investigating PTSD help combined with CAU compared to CAU for adults with PTSD. Eighty patients will be recruited and receive either the mHealth intervention combined with CAU or CAU alone. Primary outcome is the ratio of eligible patients that agree to participate in the study and the level of user compliance. Secondary outcome data consists of exploratory data on PTSD help on PTSD symptom severity, level of psychological distress, sleep quality, dissociation symptoms, therapy readiness, quality of life, disability levels, recovery and rumination. This study may help increase the investigator's knowledge of possible benefits of, as well as potential barriers to, the implementation of mHealth tools. It may also provide a cost-efficient means to increase therapy outcomes and decrease the duration of suffering for PTSD patients in the Danish psychiatric sector.

Start: March 2019

Positive Suggestions Via MP3 Messages

The purpose of this study is to assess the use of an audio recording containing positive suggestion as a means to provide needed psychological support to critically ill patients in a feasible and reliable manner.

Start: August 2020

AIMS Medical Outcomes Study

This epidemiologic research is being conducted as an observational prospective case series outcomes study of the use of advanced integrative specialty medical care and its effect on adult and pediatric patients with chronic or serious illnesses or mental health disorders.

Start: July 2020

Clinical Trial Intelligent Biometrics for PTSD - Clinical Trial

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 an effective and proven form of talk therapy 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 Prolonged Exposure (PE) therapy for veterans with PTSD.

Start: June 2020

DDBT Adapted Problem Solving Treatment for Primary Care

Evidence-based psychosocial interventions (EBPI) are rarely used in part because of their design complexity. Although many implementation frameworks do address the importance of EBPI characteristics, adapting and modifying EBPIs to enhance usability has not been a focus. User-centered design (UCD) approaches, which have been successful in creating hardware and software tools that are accessible and compelling to use, have the potential to modify EBPIs so that they are accessible and compelling to clinicians. The investigators hypothesize that UCD driven modifications to EBPI usability (target mechanism) will result in enhanced clinician ability to deliver EBPI elements competently, and that better competence results in better patient reported outcomes. The investigators will modify Problem-Solving Therapy for Primary Care (PSTPC) because it is the EBPI used in Collaborative Care (CC). Our aims are to (1) identify usability problems clinicians encounter with PST-PC (2) create a clinician driven modification of PST-PC and (3) compare the modified version of PST-PC to traditional PST-PC on usability, clinician competence and patient reported outcomes.

Start: July 2019

Key Dimensions of PTSD and ED

This study will test whether endothelial dysfunction could be the early subclinical mechanism by which posttraumatic stress disorder (PTSD) increases cardiovascular disease (CVD) risk, and whether posttraumatic fear-a key component of PTSD-or another PTSD dimension could be the target to offset that risk. The results of this study may help trauma-exposed individuals who are at risk of having CVD events.

Start: November 2019

PPG Project 3 - PET/MRI of the Brain-hematopoiesis-atherosclerosis Axis in PTSD Patients

Project 3 of the PPG grant "Stress and Atherosclerotic Plaque Macrophages A Systems Biology Approach," funded by the NHLBI, examines the relationship between psychosocial stress and atherosclerotic inflammation, cell proliferation and burden using novel PET/MRI. Individuals with post-traumatic stress disorder, trauma controls and healthy controls will be recruited into a two-center clinical study. The study team will use functional MRI to examine the relationship between activation of fear circuits in the brain and relate these data to hematopoietic system activation, and vascular inflammation measured by FDG-PET, and atherosclerotic burden measured by MRI.

Start: November 2017

Implementation of Prolonged Exposure in the Military

This randomized study examines how prolonged exposure (PE) therapy, an evidence-based treatment for posttraumatic stress disorder (PTSD), can be successfully disseminated and implemented in the Army. The study compares two PE training models: Standard PE training, comprised of a 4-day workshop only, and Extended PE training, comprised of a 4-day workshop plus expert case consultation. In addition, patients with posttraumatic stress symptoms receiving psychotherapy from participating providers will be invited to participate. After completing PE training, use of PE components with patients reporting PTS symptoms and clinical outcomes of these participating patients will be monitored for up to 18 months.

Start: October 2012

Can Exercise Improve Therapeutic Learning Among Women With Posttraumatic Stress Disorder

This study aims to test whether aerobic exercise improves the consolidation and subsequent recall of the learned safety memories among adult women with PTSD related to interpersonal violence exposure and whether this effect is mediated by the ability of exercise to increase acute levels of Brain-Derived Neurotrophic Factor (BDNF) and endocannabinoids (eCB). Participants can expect to be on study for up to 90 days, participating in 4 study sessions: Day 1 of Intake Screening, Day 2 of Emotional Learning, Day 3 of Fear Extinction and Exercise, and Day 4 of Recall of Emotional Learning.

Start: May 2020

Effects of Mobile App in House Staff Health and Well-being During COVID-19 Pandemic

Due to the COVID-19 global health pandemic, many people are likely experiencing increased stress. The well-being of physicians in training may be significantly impacted by this pandemic. Meditation is a self-management strategy that can be utilized by anyone to assist with the management of stress. Meditation mobile applications, such as the "Calm" app, can be used to help manage stress, especially during this uncertain time. The investigators propose a prospective evaluation of perceived stress, anxiety, burnout and sleep disturbance in the house staff at Banner University Medical Center Phoenix, with the use of the mobile meditation app, "Calm." The investigatros additionally want to evaluate the feasibility of using the mobile app, including looking at adherence to use of the app and physician satisfaction with use of the app.

Start: May 2020

Tai Chi and Wellness Education for Older Veterans

The primary purpose of this study is to examine physical fitness, PTSD, and satisfaction with a Tai Chi intervention for older (aged 60 and older), sedentary, trauma-exposed veterans, in comparison to a wellness education attention control. Secondary outcomes include physical activity, depression, well-being, late-onset stress, functional status, cognition, and exercise self-efficacy. Outcomes will be examined pre- to post-intervention and in comparison to the control condition.

Start: January 2019

Sleep Architecture in Refugees Diagnosed With PTSD

The aim of this study is to examine sleep architecture in refugees with PTSD. Polysomnography (PSG) will be carried out to study the occurrence of sleep disorders in patients and healthy controls.

Start: April 2018

Local Participatory Systems Dynamics to Increase Reach of Evidence Based Addiction and Mental Health Care

The most common reasons Veterans seek VA addiction and mental health care is for help with opioid and alcohol misuse, depression and PTSD. Research evidence has established highly effective treatments that prevent relapse, overdose and suicide, but even with policy mandates, performance metrics, and electronic health records to fix the problem, these treatments may only reach 3-28% of patients. This study tests participatory business engineering methods (Participatory System Dynamics) that engage patients, providers and policy makers against the status quo approaches, such as data review, and will determine if participatory system dynamics works, why it works, and whether it can be applied in many health care settings to guarantee patient access to the highest quality care and better meet the addiction and mental health needs of Veterans and the U.S. population.

Start: February 2019

Killing Pain - Use of Analgesic, Sedative and Anxiolytic Medication and the Development of Psychiatric Illness in Adolescents

Prescription of analgesic, sedative, and anxiolytic medication for children and adolescents is increasing in Western countries. In recent decades, rates have also increased in Norway, despite a relatively restrictive prescription practice. Analgesics, sedatives, and anxiolytics are among the medications most commonly prescribed to young people by general practitioners and others. Overuse of such medication adversely impacts individual and societal health, social and economic measures. For example, the risk of chronification of pain, development of addiction, and dropout from school and the workforce is high. Epidemiological research has largely failed to integrate vulnerable, young service users' perspectives in planning, interpretation and dissemination of results. This has resulted in limited identification of potential causes for the increasing exposure to prescription and overuse of analgesics and other addictive drugs among of children and adolescents, and the long-term consequences this may have for morbidity and addiction in early adulthood. Knowledge of early risk factors and plausible causal mechanisms is crucial for the development of timely and effective interventions to prevent inappropriate prescriptions in clinical practice. This prospective, longitudinal cohort study examines the use of analgesic, sedative, and anxiolytic medication among about 25,000 children throughout adolescence and young adulthood (1995 to 2020), specifically addressing changes in prescription over time, and early risk factors for the prescription of addictive drugs in adolescence and young adulthood and the subsequent development of mental health disorders.

Start: February 2020

Acupuncture for Post-Traumatic Stress in Combat Veterans

The objective of this study is to determine if acupuncture is an effective treatment option for treating combat Veterans with PTSD.

Start: May 2018