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54 Psychological Trauma Trials Near You
Power is an online platform that helps thousands of Psychological Trauma patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerProlonged Exposure Therapy for PTSD
Columbus, Ohio
The long-term goal of this study is to reduce suicidal thoughts and behaviors among treatment-seeking individuals who also have posttraumatic stress disorder (PTSD). Prolonged exposure (PE) and crisis response plan (CRP) have demonstrated empirical support for reducing suicide attempts as compared to treatment as usual. However, no studies to date have assessed their effectiveness when used in combination. In light of this knowledge gap, the primary objective of this study will be to test the effectiveness of PE augmented with CRP as compared to PE with care as usual (self-guided treatment plan), an active comparator, for the reduction of suicide ideations and attempts for individuals with comorbid PTSD.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Substance Use Disorder, Imminent Suicide Risk, Impaired Mental Status
100 Participants Needed
This trial aims to see if injecting a local anesthetic into the neck can help military personnel and veterans with PTSD when combined with standard therapy. The treatment targets the nerves that control stress responses to reduce anxiety symptoms. Participants will receive therapy and be randomly assigned to get the injection at different times. This method has been investigated in previous trials for its potential to reduce PTSD symptoms, showing some promise in symptom reduction.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
85 Participants Needed
The overall purpose of this study is to evaluate the efficacy of an intervention designed to prevent nurse suicide. This randomized controlled trial will test the modified Interactive Screening Program (mISP) alone and the mISP combined with a program called MINDBODYSTRONG.
The mISP is a method of screening to detect clinicians at moderate to high risk for suicide and referring them for treatment through an encrypted anonymous on-line platform. MINDBODYSTRONG© is an adaptation of a well-tested cognitive-behavioral skills building intervention (also known as COPE in the literature) that provides a cognitive-behavior theory-based approach to decrease depression, anxiety and suicidal ideation and improve healthy lifestyle beliefs and behaviors in at-risk populations. MINDBODYSTRONG© will involve eight self-paced computerized sessions designed specifically for nurses and clinicians. Nurses will be recruited nationally through the professional nursing organizations and health systems.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Low Suicide Risk, Under 18, Prior Participation, Others
849 Participants Needed
Babies with single ventricle congenital heart disease (SVCHD) are often diagnosed during pregnancy. While prenatal diagnosis has important clinical benefits, it is often stressful and overwhelming for parents, and many express a need for psychological support. HeartGPS is a psychological intervention for parents who receive their baby's diagnosis of SVCHD during pregnancy. It includes 8 sessions with a psychologist, coupled with tailored educational resources, and a personalized care plan. The intervention focuses on fostering parent psychological adjustment and wellbeing, and supporting parents to bond with their baby in ways that feel right for them. Through this study, the investigators will learn if HeartGPS is useful and effective for parents and their babies when it is offered in addition to usual fetal cardiac care. The investigators will examine the effects of the HeartGPS intervention on parental anxiety, depression, and traumatic stress; fetal and infant brain development; parent-infant bonding; and infant neurobehavioral and neurodevelopmental outcomes. The investigators will also explore mechanisms associated with stress biology during pregnancy, infant brain development and neurodevelopmental outcomes, and parent and infant intervention effects.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:DiGeorge Syndrome, Untreated Psychiatric, Others
50 Participants Needed
Acceptance and Commitment Therapy for Traumatic Brain Injury
Pittsburgh, Pennsylvania
The primary objective of this multi-site randomized clinical trial (RCT) is to compare Acceptance and Commitment Therapy Integrated Vestibular Rehabilitation (ACTIVE) with usual care vestibular rehabilitation (VESTIB CONTROL) in 250 individuals with mTBI-related vestibular symptoms attributable to mild traumatic brain injury (mTBI) treated at one of two sites (1) the University of Pittsburgh Medical Center, or (2) the Intrepid Spirit Center, Carl R. Darnall Army Medical Center, Fort Hood, Texas. Both interventions will be delivered weekly over 4 weeks. Assessments will be administered prior to the start of treatment (Baseline) and at 4-weeks, 3- and 6-months following the completion of treatment.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 49
Key Eligibility Criteria
Disqualifiers:Vestibular Disorder, Neurological Disorder, Cervical Spine Injury, Others
250 Participants Needed
Neurofeedback Training for Maternal Distress
Detroit, Michigan
The proposed study will collect novel data evaluating the feasibility of the NFB training program delivered in an outpatient mental health setting and its influence on mothers' overall sense of well-being, and further investigate whether enhanced well-being is associated with positive changes in emotion regulation capacities, trauma-related mental health symptoms, parenting behaviors and attitudes, and infant behavioral outcomes (i.e., crying, fussing) among postpartum mothers with a history of childhood trauma and clinically concerning trauma-related mental health symptoms.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 60
Key Eligibility Criteria
Disqualifiers:Pregnancy, Untreated Mental Illness, Epilepsy, Others
Must Not Be Taking:Benzodiazepines, Narcotics, Cannabis
20 Participants Needed
Narrative Exposure Therapy for PTSD in Homeless Women
Chicago, Illinois
Homelessness and associated traumas disproportionately affect women. The biopsychosocial health consequences of untreated trauma are profound. PTSD frequently co-occurs with other chronic health conditions, including substance use disorders (SUD). Co-morbid PTSD and SUD (PTSD+SUD) is common and difficult to treat, resulting in severe morbidity and premature mortality among women experiencing homelessness. Executing this study will help to address the disproportionate PTSD+SUD comorbidity burden, which drives health inequities in the growing population of women experiencing homelessness within and beyond Chicago.
No Placebo Group
Trial Details
Trial Status:Recruiting
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Listed
50 Participants Needed
PATH Program for Burnout
Chicago, Illinois
The investigators propose to develop and test the effectiveness of PATH (Peer Advanced Training in Harm reduction) as an educational workforce intervention for improving peer recovery support specialists' (PRSS) harm reduction (HR) service delivery ability and quality and as a PRSS workforce and service system support. The PATH intervention combines (a) virtual education and (b) case-based consultation. The investigators hypothesize that PATH will improve organizational-level PRSS burnout, additional workforce outcomes, and HR service quality.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
100 Participants Needed
Problem-Solving Training for Concussion
Buffalo, New York
This trial is testing a new treatment called PST-Concussion to help Veterans with mild traumatic brain injury manage their symptoms. The study aims to see if this treatment can reduce psychological distress and improve overall functioning. If successful, it could offer a practical way to support Veterans' recovery. Problem-solving treatment (PST) has been previously explored as a method to help service members with mild traumatic brain injury manage their symptoms.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Moderate To Severe TBI, Psychotic Disorder, Others
134 Participants Needed
Autonomic Modulation Training for Stress
Mississauga, Ontario
Police officers are exposed to hazardous, disturbing events that impose stress and long-term trauma. Upwards of 15-26% of public safety personnel (PSP) report one or more mental health symptoms. Accumulated stress and posttraumatic stress injuries (PTSI) result in chronic physical and mental health disorders including anxiety, depression, substance abuse, and cardiovascular disease. PTSI are related to reduced occupational performance, absenteeism, and risky behaviour, with implications for both police and public safety. Recent empirical evidence and government reports highlight a mental health and suicide crisis among various PSP sectors in Canada. Prior research forms an urgent call for evidence-based programs that build resilience and wellness capacity to prevent PTSI symptoms before they manifest as severe, chronic, diagnosable disorders. The current study addresses the limited effectiveness issues associated with existing interventions for PTSI among PSP and also considers sex and gender as central determinants of health.
Advances in physiology and neuroscience demonstrate that resilience is maintained by the healthy functioning of psychophysiological systems within the body. Objective biological measures have shown that chronic stress and trauma disrupt both psychological and physiological functioning, eroding resilience and reducing wellness capacity. Traditional interventions to build resilience among PSP have not adequately addressed the physiological underpinnings that lead to mental and physical health conditions, as well as burnout and fatigue following trauma. Together with previous empirical research lead by the NPA, the current proposal addresses this gap in PSP intervention research by employing Autonomic Modulation Training (AMT), a biological approach to building resilience and wellness capacity among PSP exposed to PTSI. Prior research shows that core AMT techniques effectively reduce psychophysiological stress and mental health symptoms in clinical and non-clinical populations. Further, research has shown that AMT techniques improve police health and occupational performance when completed during scenario-based, in-person training.
The aim of the proposed study is to test if a web-based delivery of AMT for police officers can build resilience and wellness capacity, and reduce symptoms of PTSI with similar effectiveness as in-person training. An additional novel scientific contribution of the current proposal includes an examination of sex and gender in baseline biological presentation of PTSI among police, and in response to a resilience building intervention.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Non-canadian Officers, Administrators, Civilians, Others
250 Participants Needed
Nature-Based + Virtual Mindfulness for Stress in Healthcare Workers
Bethesda, Maryland
This trial aims to reduce stress in healthcare workers treating COVID-19 patients by combining outdoor activities with online mindfulness exercises. The goal is to see if this combination is more effective than either approach alone.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Acute Psychiatric Condition, Hearing Impairment
90 Participants Needed
IOK Therapy for PTSD
Durham, North Carolina
The objective of this project is to test the efficacy of an individual treatment for post-traumatic stress disorder (PTSD) stemming from moral injury called Impact of Killing (IOK), compared to a present-centered therapy (PCT) control condition, and to determine the rehabilitative utility of IOK for Veterans with PTSD. The first aim is to test whether IOK can help improve psychosocial functioning for Veterans, as well as PTSD symptoms. The second aim is to determine whether IOK gains made by Veterans in treatment are durable, as measured by a six-month follow-up assessment. Veterans who kill in war are at increased risk for functional difficulties, PTSD, alcohol abuse, and suicide. Even after current PTSD psychotherapies, most Veterans continue to meet diagnostic criteria for PTSD, highlighting the need for expanding treatments for PTSD and functioning. IOK is a treatment that can be provided following existing PTSD treatments, filling a critical gap for Veterans with moral injury who continue to suffer from mental health symptoms and functional difficulties.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
101 Participants Needed
Self-Help Intervention for Depression and PTSD
Durham, North Carolina
It is important to provide support and resources for the many post-9/11 Veterans with mental health symptoms and poor psychosocial functioning who do not engage in psychotherapy. One of the biggest reasons post-9/11 Veterans do not seek treatment is a preference to handle problems on their own. This study examines a self-help intervention that teaches Veterans healthy coping strategies they can use on their own and how to seek out recovery support services such as mental health treatment or whole-person care if they decide to do so in the future. This study will compare the impact of self-help and standard resources at improving mental health and resource utilization. Two hundred Veterans will complete 6 brief assessments across 40 weeks.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Bipolar, Schizophrenia, Psychotherapy, Others
Must Not Be Taking:Psychotropics
200 Participants Needed
Intensive Therapy for PTSD
Durham, North Carolina
Posttraumatic stress disorder (PTSD) is prevalent among Veterans and effective evidence-based psychotherapies (EBPs) for PTSD have been implemented within the Veterans Health Administration (VHA). However, retention in PTSD EBPs is poor. Premature dropout is associated with worse clinical outcomes and greater healthcare utilization. Delivery of PTSD EBPs in a massed format, typically three or more days per week delivered within a month, have shown promise for increasing retention. The present study is a pilot feasibility and acceptability study comparing massed PTSD treatment to treatment as usual (e.g., typically weekly treatment).
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:High Suicide Risk, Manic, Psychotic, Others
30 Participants Needed
Mindfulness Training for PTSD
St Louis, Missouri
This trial compares mindfulness meditation and problem-solving skills classes for Veterans with anxiety, depression, or PTSD. It aims to see which method better reduces symptoms and improves overall functioning in 300 Veterans across various locations. Mindfulness-based stress reduction (MBSR) has been studied extensively and shown to improve PTSD symptoms, depression, and overall well-being in veterans.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Cognitive Impairment, Recent Suicide Attempt, Others
300 Participants Needed
Trauma-Informed Care + Community Health Workers for Chronic Kidney Disease
Philadelphia, Pennsylvania
Black and Hispanic people face higher risks of chronic kidney disease (CKD) but have unequal access to the highest-quality kidney care. Black adults with CKD face 1.5 times higher hospitalization risks than non-Black adults with CKD. Once reaching end stage kidney disease (ESKD), Black patients are half as likely to receive a transplant and are often excluded from home dialysis. Structural racism creates complex barriers to optimal CKD care, providing an explanation for these findings. The Penn Medicine IMPaCT Community Health Worker (CHW) program is a rigorously tested approach to employ people from local communities to dismantle structural racism within health care systems and improve outcomes for marginalized patients. This trial will innovate by training CHWs to focus specifically on CKD care for minoritized people. The investigators will also train primary care clinicians caring for CKD patients on how to provide trauma-informed care (TIC). The first aim is to determine the feasibility, acceptability, and reach of a clinic-level TIC training to address the needs and concerns of Black and other minoritized patients. The second aim will be to conduct a three arm trial comparing individuals in usual care to individuals randomized to either our tailored CHW intervention in conjunction with clinic-level TIC training or to clinic-level TIC intervention only. The investigators will examine whether patients in the intervention arms have greater improvements in quality of life (primary). The investigators will also explore the impact of the interventions on patient activation, hospitalizations, and ESKD treatment preferences.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Kidney Transplant, Dialysis, CHW Enrollment, Others
150 Participants Needed
Trauma-Focused Interventions for HIV Prevention in Women Who Inject Drugs
Philadelphia, Pennsylvania
The goal of this randomized controlled trial is to test the effectiveness of "TIARAS," a trauma intervention designed to reduce HIV acquisition risk among women who inject drugs (WWID). To be eligible for this study, participants must have been prescribed pre-exposure prophylaxis (PrEP), a medication taken to prevent HIV, at Prevention Point Philadelphia, a large harm reduction agency located in Philadelphia (PA, USA), or Courage Medicine, a nonprofit health services clinic located in Philadelphia (PA, USA).
Enrollment in this study lasts for 12-months so that we can see if TIARAS reduces HIV risk immediately after the intervention ends and whether these effects last over time. During the first 3 months, participants engage in contingency management (CM), an evidenced-based intervention to reduce drug use and HIV risk. We will use CM to encourage engagement in PrEP care as well as stimulant/opioid abstinence. Also during the first 3-months, participants are randomly assigned to complete expressive writing exercises to address a previously undisclosed trauma or neutral writing exercises. Half of the participants will be assigned to the trauma writing group and the other half will be assigned to the neutral writing group.
To understand the impact of TIARAS on HIV risk, we will collect and analyze data from surveys, interviews, and biological specimen during the 12-month study period. Our main questions are:
* Does participation in TIARAS reduce HIV risk among WWID?
* If observed, how long do beneficial effects last?
* How and why do WWID experience benefits from TIARAS?
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnant, Others
Must Be Taking:PrEP
240 Participants Needed
Community Mental Health Intervention for Latino Mental Health Disparities
Philadelphia, Pennsylvania
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.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Substance Use Disorder, Mania, Psychosis, Schizophrenia, Others
600 Participants Needed
Integrated School-Based Mental Health Program for Student Mental Health Challenges
Columbia, South Carolina
This efficacy trial will evaluate the impact of an enhanced version of the Interconnected Systems Framework (ISFE) on elementary school-based team functioning, including use of evidence-based practices, and student emotional, behavioral, and academic functioning. The original interconnected systems framework (ISF) model was designed to improve the depth and quality of mental health services delivered within multi-tiered systems of support by integrating Positive Behavioral Interventions and Supports (PBIS) and school mental health (SMH) efforts to provide a continuum of high-quality services for students. Preliminary findings from a prior efficacy study show that the ISF improved team functioning and increased identification and services for students in need, particularly among youth of color, when compared to the other two conditions. Moreover, the ISF led to improvements in student social, emotional, and behavioral functioning. The current study builds on these findings by testing an enhanced version of the ISF designed to advance the model by adding/modifying several core components intended to further increase the impacts for youth with significant emotional and behavioral problems and reduce inequities in discipline and student service delivery.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Moderate/severe Intellectual Disability, Others
1208 Participants Needed
Role of Friends in Adolescent Interpersonal Relations
Columbia, South Carolina
The goal of this clinical trial is to investigate how the friendship experiences of maltreated (i.e., abused and/or neglected) and non-maltreated adolescents differentially influence their risk for adverse outcomes. The main questions it aims to answer are:
1. How do the friendships of maltreated adolescents differ from those of non-maltreated adolescents?
2. Which friendship experiences influence the associations between maltreatment and ability to regulate stress, as well as future mental health difficulties and revictimization?
Participants will:
* Attend the initial study visit on the campus of the University of South Carolina with their primary caregiver and a best friend during which they will:
* Complete study questionnaires
* Be connected to a device that records their physical ability to manage stress
* Complete a task during which they will be audio and video recorded and complete a brief assessment rating how they are feeling at different times during task completion
* Depending on which research group they are placed in, be assigned to discuss their experience doing this task with their friend (intervention group) or sit quietly in a room for 5 minutes (comparison group)
* The follow-up study visit will involve completion of study questionnaires online or via mail 6 months later
Additionally, the participant's caregiver and friend will complete study questionnaires.
Researchers will compare the intervention group (debriefs with a friend) and comparison group (sits quietly for 5 minutes) to see if the presence of and discussion with the friend influences their physical ability to regulate stress and future outcomes.
No Placebo Group
Trial Details
Trial Status:Recruiting
Age:13 - 17
Key Eligibility Criteria
Disqualifiers:Not Listed
120 Participants Needed
Why Other Patients Applied
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
The overall purpose of this study is to understand the role of disrupted sleep in the association of exposure to early life adversity (adverse childhood experiences (ACEs)) with vascular endothelial (dys)function.
In Aim 1 (The Iowa ACEs and Sleep Cohort Study), the investigators will utilize a cross-sectional cohort design with a state-of-the-art translational approach. Participants will be recruited to objectively characterize the degree to which lower sleep quality and quantity contribute to ACEs-related endothelial dysfunction, inflammation, and oxidative stress in young adults using:
1. rigorous at home sleep monitoring using 7-nights of wrist actigraphy and 2 nights of home-based polysomnography to objectively measure sleep quality (sleep efficiency, wakefulness after sleep onset and sleep depth), and total sleep duration,
2. in vivo assessment of endothelial function via flow-mediated dilation testing, and
3. in vitro determination of endothelial cell inflammation and oxidative stress from biopsied endothelial cells. This study to achieve this Aim.
In Aim 2, approximately 70 eligible participants from Aim 1 (The Iowa ACEs and Sleep Cohort Study) will then be randomized to either a 6-week behavioral sleep intervention (cognitive behavioral therapy for insomnia) or a wait-list control to determine the mechanistic contribution of sleep disruption to vascular dysfunction in young adults with moderate-to-high exposure to adverse childhood experiences (ACEs). Following the intervention, participants will again complete:
1. rigorous at home sleep monitoring using 7-nights of wrist actigraphy and 2 nights of home-based polysomnography to objectively measure sleep quality (sleep efficiency, wakefulness after sleep onset and sleep depth), and total sleep duration,
2. in vivo assessment of endothelial function via flow-mediated dilation testing, and
3. in vitro determination of endothelial cell inflammation and oxidative stress from biopsied endothelial cells.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 29
Key Eligibility Criteria
Disqualifiers:Sleep Disorders, Psychiatric Disorders, Cardiometabolic Disease, Others
Must Not Be Taking:Anti-hypertensives, Opiates, Benzodiazepines, Others
70 Participants Needed
Community-based Psychological Services for Mental Health
New York, New York
This trial aims to improve mental health and COVID-19 prevention behaviors among minority and vulnerable groups in New York City by training community workers to provide basic mental health support using Problem Management Plus (PM+).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Acute Suicide Risk, Others
1000 Participants Needed
Psilocybin-Assisted Therapy for Intergenerational Trauma
New York, New York
This is an open-label psilocybin-assisted therapy study that will examine the safety and tolerability of psilocybin-assisted therapy in the offspring of genocide survivors with mood and anxiety disorders.
The study will also investigate the efficacy of psilocybin-assisted therapy in reducing symptoms such as depression, anxiety and stress, as well as changes to the psychological effects of parental exposure to genocide, and changes to psychological resilience.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Genocide Exposure, Stroke, Psychiatric Hospitalization, Others
Must Not Be Taking:Psychiatric Medications, Psychedelics
100 Participants Needed
It is expected that large numbers of healthcare workers will experience a broad range of psychological reactions and symptoms including anxiety, depression, moral distress, and trauma symptoms that will cause both significant suffering as well as occupational and social impairment. The purpose of this study is to find interventions which are helpful in treating psychological distress in healthcare workers caring for COVID-19 patients.
There are two phases of the study. All participants will take part in Phase I, which consists of 4 sessions over a two-week period of either a narrative writing intervention or a medical music intervention. Participants will be randomly assigned to the narrative writing intervention or medical music intervention.
After Phase I, participants will be re-assessed. Healthcare workers who meet criteria for PTSD will be given the option to participate in Phase II of the study, in which they will be offered a choice between one of two evidence-based treatments for PTSD: Interpersonal Therapy (IPT) or Exposure Therapy (ET). Both treatments are comprised of ten 75-minute sessions scheduled twice weekly. Participants will be allowed to choose a preferred treatment in Phase II. After Phase II participants will complete a final assessment concluding the study. All interventions will be offered using distance technology.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Unstable Illness, Schizophrenia, Others
Must Be Taking:Psychotropics
120 Participants Needed
Cognitive Processing Therapy for PTSD
Osceola, Arkansas
Addiction and trauma exposure are common among the 5.5 million people (1 in 47 adults) in the U.S. who are in prison or under supervision. About 85% of people in prison have a substance use disorder or are there for a drug-related crime, and many have experienced serious trauma before being incarcerated. Posttraumatic stress symptoms (PTSS) are often a result of trauma and are linked to more severe drug use, higher rates of relapse, and increased crime. PTSS and substance use disorder (SUD) each raise the chances of new arrests for people who are justice-involved, showing that addressing trauma and addiction could help reduce repeat offenses and the costs of incarceration. However, treatments for PTSS are rarely available in prisons, and there is little research on whether providing therapy for PTSS in prison can lower drug use, PTSS, or crime after release.
The goal of this clinical trial is to see if trauma-focused group therapy (CPT) provided while in prison, can help people after release from prison. The therapy has been adapted for use in prisons (CPT-CJ) and will be compared to trauma focused therapy delivered via a self-help workbook
This study will:
* test whether a trauma-focused group therapy (CPT-CJ) can reduce post-incarceration drug and alcohol use, mental health issues, and drug-related crime, compared to trauma-focused self-help,
* evaluate a strategy called implementation facilitation, which helps support the use of this therapy in prisons, and
* measure the cost of the therapies and support strategies to help plan for future expansion.
Incarcerated participants (N = 640; 50% female) will be enrolled from \~10 prisons in \~5 states, ensuring variability in population and setting characteristics. They will:
* take surveys and answer questions up to 5 times (before starting treatment, right after getting treatment, right before leaving prison, 3 months after leaving prison and 6 months after leaving prison)
* complete CPT group therapy or self-help therapy
* provide urine samples 3 months and 6 months after leaving prison
Prison stakeholders (e.g., prison staff, prison leadership, governmental officials; N = \~15 per site) who will be purposively sampled based on their role in CPT-CJ implementation will also participate in some surveys.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Early Release, Scheduling Conflicts, Others
640 Participants Needed
Oxytocin for PTSD
Charleston, South Carolina
Posttraumatic stress disorder (PTSD) is a chronic, debilitating condition that disproportionately affects Veterans. Prolonged Exposure (PE) therapy is a "gold standard" treatment for PTSD. However, approximately one-third of Veterans fail to receive an adequate dose of treatment because they prematurely drop out of PE therapy. There is also room to improve PE treatment outcomes. Consistent with the VA Office of Research and Development initiative to develop effective treatments for PTSD, the proposed randomized clinical trial will examine the ability of oxytocin (as compared with placebo) combined with PE to reduce PTSD symptom severity, improve the rate of PTSD symptom reduction, and to enhance PE treatment retention and adherence. This two-site study will leverage the investments made in the nationwide rollout off PE therapy and has the potential to significantly improve mental health care among Veterans, advance the science in this area, and identify mechanisms underlying positive PTSD treatment response. Participants may choose to complete this research study via home-based telemedicine (HBT) care (i.e. service delivery to patients in their homes using consumer friendly, video-conferencing technology). HBT sessions will be delivered via standard desk, laptop computer, tablet, or smartphone using VA approved applications. All procedures that take place via telemedicine will be performed and completed as though they were in-person/in-office
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Psychotic, Bipolar, Suicidal, Pregnancy, Others
Must Be Taking:Psychotropic Medications
185 Participants Needed
HOPE Therapy for Opioid Use Disorder and PTSD
Charleston, South Carolina
This study will test a therapy intervention, HOPE, for individuals with opioid use disorder and posttraumatic stress disorder. Interested individuals will need to be taking medications for opioid use disorder (e.g., suboxone, naltrexone, methadone). Interested participants will complete a 10-12 week therapy, and be asked to complete surveys.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Unmanaged Psychosis, Bipolar, Suicide Risk, Others
Must Be Taking:Medications For OUD
76 Participants Needed
Positive Audio Suggestions for Critical Illness-Related Stress
Rochester, Minnesota
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.
No Placebo Group
Trial Details
Trial Status:Recruiting
Key Eligibility Criteria
Disqualifiers:Dementia, Psychotic Disorders, Hearing Impairment, Others
300 Participants Needed
Social-Cognitive Skills Training for Schizophrenia
Minneapolis, Minnesota
Many individuals with serious mental illness have difficulty accurately interpreting interpersonal cues and effectively engaging in social exchanges. Difficulties related to the interpersonal aspects of work can lead to isolation, poor productivity, and job loss. The goals of this study are to: 1) adapt an evidence-based social cognitive skills intervention for work settings and use with Veterans, 2) examine the acceptability of the work focused skills training intervention, 3) assess the feasibility of combining the social cognitive skills training program with supported employment, and 4) examine change on functional outcomes.
The current study will use feedback from veteran and employment specialist stakeholders to adapt an evidence-based social cognitive skills training program, Social Cognition and Interaction Training (SCIT). The intervention will be modified to tailor it to work relationships and to address any unique relationship concerns among Veterans that are identified by stakeholders. SCIT-Work Edition (SCIT-WE) will add: 1) education about work-related social norms; 2) examples of work-related social interactions that require perspective taking and problem- solving; 3) individual sessions with the study therapist to enhance learning and relevance to each participant's goals; 4) structured interactions with the participant's employment specialist to practice skills outside of group; and 5) skill application sessions with the participant's employment specialist that prompt use of skills after training is completed.
SCIT-WE will be developed and piloted in an open trial with 20 Veterans enrolled in the supported employment program at the Minneapolis VA who have a qualifying serious mental illness diagnosis. SCIT-WE will be offered for 2 hours weekly over 13 weeks, when most participants are in the job development and job search phases of supported employment. While participating in the group skills training, participants will have weekly, individual homework review sessions with the group facilitator to promote understanding of the skills and to discuss relevance of the skills to personal goals. Participants also will practice skills weekly with their employment specialist for 10-15 minutes to promote use of skills outside of group sessions. In the 3-months following skills training completion, participants will complete 10 15-minute skills review sessions with their employment specialist to encourage continued skill application in a work setting.
Participants will complete assessments at baseline, before receiving the intervention; 3-months post-enrollment, after participating in a weekly skills training group; and 6-months post-enrollment, after receiving 10 additional individual skills review sessions with their employment specialist. Accessibility will be measured with rate of treatment uptake, rate of treatment completion, and participant attitudes toward the intervention. Feasibility of the intervention will be assessed by examining retention in supported employment and the study at 3- and 6-months post-enrollment. Impact of the intervention will be examined with measures of quality of life, social adjustment, self-efficacy, and work relationship quality. It is hypothesized that the intervention will be acceptable to Veterans. The investigators predict a 50% treatment uptake rate, a 70% intervention completion rate, and positive ratings on measures of satisfaction, interest, and value. The investigators hypothesize that it will be feasible to complete this intervention in combination with supported employment activities. The investigators predict that retention in both skills training and supported employment will be 75% at 3-months post-enrollment and 60% 6-months post enrollment. The investigators hypothesize that positive change will be seen at 3-months post-enrollment and sustained at 6-months post-enrollment on measures of quality of life and social adjustment. The investigators predicted that self-efficacy regarding return to work will be improved at 3-months post-enrollment. The investigators predict that Veterans will report being productive and having positive work relationships 6-months post-enrollment.
The findings will inform the development of a novel intervention targeting the social and functional impairments associated with serious mental illness. The knowledge gained from this study will guide the development of the next generation of interventions. Given that employment is a critical part of recovery, advancement in therapeutic interventions that support Veterans in this process will be of significance.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Traumatic Brain Injury, Neurological Disease, Others
20 Participants Needed
FIRST Psychotherapy for Youth Mental Health Issues
Cambridge, Massachusetts
The study will compare the impact FIRST (a transdiagnostic treatment built upon five empirically supported principles of change) versus usual care outpatient psychotherapy on youths' mental health outcomes and a candidate mechanism of change: regulation of negative emotions.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:7 - 15
Key Eligibility Criteria
Disqualifiers:Suicide Risk, Eating Disorder, Schizophrenia, Autism, Others
212 Participants Needed
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Frequently Asked Questions
How much do Psychological Trauma clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Psychological Trauma clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Psychological Trauma trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Psychological Trauma is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Psychological Trauma medical study?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Psychological Trauma clinical trials?
Most recently, we added Self-Help Intervention for Depression and PTSD, Trauma Treatment + PrEP Navigation for Mental Health Symptoms and PATH Program for Burnout to the Power online platform.
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