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162 Post-Traumatic Stress Disorder Trials near Tampa, FL
Power is an online platform that helps thousands of Post-Traumatic Stress Disorder 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 PowerThe goal of this clinical trial is to learn if receiving Prolonged Exposure Therapy for PTSD in massed format (multiple sessions weekly) is as effective as receiving it with sessions once per week among veterans with PTSD and substance use disorder in intensive outpatient substance use treatment. The main questions it aims to answer are:
* Will the massed format help participants complete and benefit from Prolonged Exposure in terms of PTSD symptoms?
* Will it help participants reduce substance use? Participants who are in intensive substance use treatment will be asked to complete Prolonged Exposure with either weekly sessions or multiple sessions per week.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
200 Participants Needed
Therapist-Assisted Self-Management Program for PTSD
Tampa, FloridaThis trial tests a program called EMPOWER that helps veterans who have completed PTSD therapy manage their own symptoms with some help from a therapist. It aims to maintain or improve their mental health and reduce the number of therapy sessions they need.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:18+
Sex:All
90 Participants Needed
Brazilian Jiu Jitsu vs. Yoga for PTSD
Tampa, FloridaPost-traumatic stress disorder (PTSD) is a disabling anxiety disorder that may occur after witnessing a traumatic event, and that evokes a combination of intrusion and avoidance symptoms, negative alterations in cognitions and mood, and alterations in arousal and reactivity1.
The primary objective of this pilot randomized controlled trial is to estimate and compare the effects of the practice of Brazilian Jiu Jitsu (BJJ) vs. hatha yoga vs. a waitlist control condition in influencing symptoms of PTSD, related comorbidities, post-traumatic growth, and quality of life among U.S. service members/veterans with current symptoms of PTSD. In addition, objective measurements (comparisons) of stress and sleep quality will be made through the collection and evaluation of salivary alpha amylase, hair cortisol, and actigraphy, a non-invasive way to measure activity cycles.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Age:18 - 44
Sex:Male
72 Participants Needed
Medical Cannabis for Chronic Pain
Tampa, FloridaThis trial will investigate if medical cannabis can effectively reduce pain and improve quality of life for patients with chronic conditions. The study will gather data through an online questionnaire about patients' use of cannabis and its effects. Medical cannabis interacts with the body's natural system to help manage pain and other symptoms. Medical cannabis has been increasingly studied and used as an alternative treatment for managing chronic pain, with numerous studies supporting its potential benefits.
Stay on current meds
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:7+
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Breastfeeding, Suicidality, Psychosis, Others
200000 Participants Needed
Guilt Reduction vs Cognitive Processing Therapy for PTSD
Tampa, FloridaTrauma-related guilt is common and impairing among trauma survivors, particularly among Veterans with posttraumatic stress disorder (PTSD). The investigators' work shows that a brief treatment targeting trauma-related guilt, Trauma Informed Guilt Reduction Therapy (TrIGR), can reduce guilt and PTSD and depression symptoms. Whether TrIGR is no less effective than longer, more resource heavy PTSD treatments disseminated by by VA, like cognitive processing therapy (CPT), is the next critical question that this study will seek to answer. 158 Veterans across two VA sites will be randomized to TrIGR or CPT to evaluate changes in PTSD, depression, guilt and shame symptoms across the two treatments.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Substance Use, Psychosis, Others
158 Participants Needed
Present Centered Psychotherapy for PTSD
Tampa, FloridaPTSD is one of the most prevalent mental health conditions affecting Veterans who have served since 9/11. Veterans with posttraumatic stress disorder (PTSD) report difficulty controlling impulsive aggression (IA). An inability to manage one's emotions (emotion dysregulation) is an underlying mechanism of IA. Reducing IA and increasing use of PTSD evidence-based psychotherapies are two critical missions for the Veterans Health Administration. The proposed research supports these missions by comparing a 3- session emotion regulation treatment (Manage Emotions to Reduce Aggression) to a control group in order to determine if MERA can reduce IA and prepare Veterans for PTSD treatment. By enhancing Veterans' abilities to cope with trauma-related emotions and feel equipped to initiate PTSD treatments, this research aims to help Veterans decrease IA and ultimately recover from PTSD.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 64
Sex:All
Key Eligibility Criteria
Disqualifiers:Suicidal, Homicidal, Bipolar, Psychotic, Others
204 Participants Needed
Stellate Ganglion Block for PTSD
Tampa, FloridaThis trial tests if an injection near neck nerves can help Veterans with chronic PTSD who need alternative treatments. The injection may calm overactive nerves, reducing PTSD symptoms quickly. This method has been explored for treating various conditions, including PTSD, with mixed evidence.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 80
Sex:All
Key Eligibility Criteria
Disqualifiers:Psychosis, Substance Dependence, Thyroid Disease, Others
Must Not Be Taking:Centrally Acting Medications, Opiates
360 Participants Needed
Cognitive Behavioral Training for PTSD and Alcoholism
Bay Pines, FloridaThe present study seeks to increase understanding of Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD) among veterans, an important public health concern. We will study the effects of regulatory deficits and sleep disturbance on the dynamic course of PTSD and AUD. The study will investigate whether a short, computerized training in the laboratory will alter maladaptive response biases and reduce associations between sleep disturbance, affect and behavioral dysregulation, AUD symptoms, and PTSD symptoms in the real world.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 60
Sex:All
Key Eligibility Criteria
Disqualifiers:Psychosis, Severe AUD, Suicidal Ideation, Others
250 Participants Needed
Methylone for PTSD
Orlando, FloridaThis study is evaluating the safety and efficacy of methylone in adults with PTSD. The study is conducted in two parts.
* Part A is open-label and will enroll up to 15 participants with PTSD
* Part B is randomized (1:1:1), single-blind and will enroll up to 45 participants with PTSD
Eligible participants will enter a 3-week Treatment Period (Part A) or 4-week Treatment Period (Part B) where they will receive methylone once weekly. Following the Treatment Period, participants will enter a 6-week Follow-up Period (Part A) or 8-week Follow-up Period (Part B).
No Placebo Group
Trial Details
Trial Status:Recruiting
Age:18 - 70
Sex:All
Key Eligibility Criteria
Disqualifiers:Other DSM-5 Disorders, Cardiovascular, Others
60 Participants Needed
Non-invasive Nerve Stimulation for Sleep Difficulties in PTSD
Gainesville, FloridaPeople often have difficulty sleeping. Reasons are many. But, difficulty falling and staying asleep are common issues. Sleep difficulties are common in disorders such as Post Traumatic Stress Disorder. Current treatments for sleep difficulties are not effective for everyone. Better treatments are needed. In this study, the investigators are testing two nerve stimulation locations that may impact brain function in such a way that sleep is improved.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 55
Sex:All
Key Eligibility Criteria
Disqualifiers:Neurological Conditions, Schizophrenia, Untreated Sleep Apnea, Others
104 Participants Needed
Emotion & Attention Training for TBI and PTSD
Gainesville, FloridaPoor emotion recognition has been associated with poor quality of interpersonal relationships, loss of employment, behavioral problems, reduced social reintegration, social isolation and even suicide. Deficits in emotion recognition are common in traumatic brain injury (TBI) and in post-traumatic stress disorder (PTSD) but these deficits have not been well studied in Veterans with both mild TBI (mTBI) and PTSD. Currently there are no interventions for emotion recognition in Veterans with mTBI and PTSD, and interventions for severe TBI have lacked training of both facial and vocal emotion recognition. In a preliminary study of an innovative combination of facial and vocal modalities, a multimodal affect recognition training (MMART) showed promise but lacked attention training that is an essential component in recognizing emotions in our daily lives. Given the need to improve relationships and productivity in Veterans with mTBI and PTSD, a study is needed to determine the effectiveness of a MMART combined with attention training.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:25 - 50
Sex:All
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Bipolar, Chronic Diseases, Others
20 Participants Needed
Non-invasive Nerve Stimulation for PTSD
Gainesville, FloridaIn this study, our objective is to determine the effect of two different nerve stimulation types in changing sleep architecture.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 55
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Psychiatric Illness, Drug Abuse, Others
221 Participants Needed
Combined Metacognitive Training for mTBI/PTSD
Gainesville, FloridaThis trial will test a new treatment combining goal management and computer-based attention training for Veterans with mild brain injuries and PTSD. The goal is to improve their focus, problem-solving skills, and daily functioning. The study will compare in-person and telehealth delivery methods. Goal Management Training (GMT) has been previously tested for improving cognitive functioning in individuals with PTSD.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:30 - 55
Sex:All
Key Eligibility Criteria
Disqualifiers:Learning Disability, Neurological Disease, Alcohol Abuse, Others
Must Not Be Taking:Seizure Meds, Antidepressants
63 Participants Needed
BXCL501 for Acute Stress Disorder
Jacksonville, FloridaThis study will examine the safety and efficacy of BXCL501 to reduce ASR symptoms and behavioral changes among patients presenting to the Emergency Department (ED) after Motor Vehicle Collision (MVC). Specifically, the investigators will perform the BXCL501 (BASIS) Trial, a double-blind placebo-controlled Randomized Controlled Trial (RCT) to determine if BXCL501 (dexmedetomidine hydrochloride sublingual film) initiated in the ED in the hours after MVC to high risk individuals, treats/reduces ASR/ASD symptoms (primary outcome), improves neurocognitive function, and prevents/reduces posttraumatic stress (PTS) symptoms (secondary outcomes) long term. 100 participants will be randomized, receive study drug in ED and be discharged with a 2-week drug supply. Prior to initial dose of study drug administration, and during the hours, days, and weeks after participants will receive serial longitudinal assessments of psychological and somatic symptoms, neurocognitive function, and adverse events.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:18 - 65
Sex:All
100 Participants Needed
Psychoeducational Intervention for PTSD
Davie, FloridaNova Southeastern University and the Veterans trust through this line of research will strengthen community engagement and awareness for the need to recognize and provide treatment models for veterans diagnosed with PTSD. The goal is to improve self-regulatory mechanisms within the racecar simulated-environment with the hope it translates to real-life scenarios.
The design is a single-case approach with the application of range-bound changing criterion design. It will include elements of stress-inoculation therapy, cognitive processing therapy, optimal zones of functioning, biofeedback and psychological skills training. This particular design will allow for the collection and identification of the idiosyncratic differences between each participant which will guide how the data are collected and the tailoring of the intervention.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Asthma, Emphysema, COPD, Heart Disease, Others
4 Participants Needed
Lifestyle Intervention for PTSD-Related Heart Disease Risk
Fort Lauderdale, FloridaThis project examines the impact of a healthy lifestyle intervention, specifically designed for adults with posttraumatic stress and identified cardiovascular risks.
Stay on current meds
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Cannot Exercise, Others
216 Participants Needed
PROSOMNIA Sleep Therapy for Chronic Insomnia
Hollywood, FloridaThis clinical trial aims to evaluate the safety and efficacy of PROSOMNIA Sleep Therapy (PSTx) for individuals suffering from chronic insomnia, sleep deprivation, and REM sleep disorders. Chronic insomnia, characterized by difficulty falling or staying asleep, significantly affects patients and quality of life, mood, and cognitive function. REM sleep disorders, in which the body struggles to enter or maintain restful REM sleep, can worsen these issues. The trial introduces a novel therapy using anesthesia-induced sleep, targeting sleep homeostasis and improving sleep architecture.
Objectives: The primary goals of the trial are to determine:
1. Whether PROSOMNIA Sleep Therapy increases the quality of REM sleep.
2. Whether PSTx increases the duration of REM and/or NREM sleep.
3. Whether PSTx decreases the time it takes participants to fall asleep (sleep onset latency).
Participants will receive ONE (1) PROSOMNIA Sleep Therapy session lasting between 60-120 minutes. Each session uses Diprivan/Propofol to induce sleep, and is monitored via an EEG to ensure proper sleep stages, particularly REM sleep.
Participant Criteria:
Inclusion: Adults aged 18-65 with diagnosed or undiagnosed chronic insomnia or sleep deprivation.
Exclusion: Patients with severe obesity, significant cardiovascular, neurological, or psychiatric conditions, or those with an ASA status above II.
Study Design: This trial is non-randomized, single-arm and open-label, with all participants receiving the PSTx. The trial does not include a comparison group, as the focus is on evaluating the immediate, direct effects of the therapy.
Participants will undergo continuous EEG monitoring during therapy sessions, allowing researchers to track brain activity and sleep stages in real-time. This method ensures that sleep cycles, particularly REM sleep, are optimized for therapeutic benefit.
Therapy Methodology:
PROSOMNIA Sleep Therapy leverages anesthesia to mimic natural sleep patterns and enhance the efficiency of REM sleep. Diprivan/Propofol is used to induce REM sleep, while EEG monitoring tracks and maintains proper sleep architecture throughout the session. The therapy promotes the clearance of adenosine, a compound that builds up during wakefulness and drives the need for sleep. Adenosine is cleared during REM sleep, reducing sleep pressure and improving cognitive function.
Outcome Measures:
Primary Outcomes: Researchers will measure the increase in REM sleep duration, improvement in sleep quality (via self-reported questionnaires), and a reduction in sleep onset latency.
Secondary Outcomes: These include changes in mood, cognitive function, and blood serum uric acid levels. Patient-reported outcomes will also be tracked through tools like the PROSOMNIA Sleep Quiz, which is specifically designed for PSTx.
Significance: Chronic insomnia and REM sleep disorders affect millions globally, leading to cognitive impairment, mood disturbances, and poor overall health. Traditional treatments, including pharmacological approaches and Cognitive Behavioral Therapy for Insomnia (CBT-I), often provide suboptimal results for many individuals. PSTx offers a novel, therapeutic approach to restoring sleep balance and enhancing the overall quality of sleep, particularly for those who have not responded to conventional treatments.
Study Process:
Recruitment and Baseline Assessments: Participants undergo a comprehensive sleep assessment, including sleep questionnaires and polysomnography, to establish a baseline for sleep quality and duration. Blood serum uric acid levels will also be measured to track any biochemical changes due to therapy.
Therapy Sessions: Only one (1) PROSOMNIA Sleep Therapy session will be administered, with the session lasting between 60-120 minutes. Diprivan/Propofol is used to induce sleep, and EEG will monitor brain activity to ensure the proper balance of sleep stages.
Post-Therapy Follow-up: Follow-up assessments will occur at 24 hours, 7 days, and 30 days post-treatment. Researchers will analyze the therapy effects on REM sleep, mood, cognitive function, and other health indicators.
Potential Implications: If successful, this trial could revolutionize how we treat sleep disorders by targeting the underlying mechanisms of sleep pressure and REM sleep disruption. PROSOMNIA Sleep Therapy may offer a safe, effective, and immediate alternative for patients who have exhausted other treatment options.
Key Concepts:
Homeostatic sleep drive, (Process S), caused by adenosine buildup during wakefulness, is disrupted by chronic insomnia. This impacts cognitive function health and recovery. Anesthesia-induced REM sleep via PSTx helps regulate this homeostatic sleep stage, offering deeper and more restorative sleep compared to other sleep therapies. The study uses statistical methods like ANOVA and Chi-square to measure outcomes.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Age:18 - 65
Sex:All
100 Participants Needed
Accelerated TMS for PTSD
Tallahassee, FloridaThis study will test the clinical efficacy of an accelerated TMS (accel-TMS) protocol that rapidly addresses PTSD symptoms with 1 week (25 sessions over 5 days) of condensed treatment.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Substance Use, Schizophrenia, Pregnancy, Others
Must Not Be Taking:Tricyclics, Clozapine
132 Participants Needed
Personalized TMS-fNIRS for PTSD
Tallahassee, FloridaThe intent of this study is to establish technical feasibility in a clinical population (PTSD, with or without mild TBI) of personalized TMS-fNIRS technology. Thereby demonstrating the utility of transcranial magnetic stimulation - functional near-infrared spectroscopy (TMS-fNIRS) technology as a direct measure of frontal brain activity, potentially replacing the indirect motor threshold procedure that may lead to improper dosing of TMS.
Personalized TMS-fNIRS technology will guide therapy for depression, post-traumatic stress disorder (PTSD), and/or traumatic brain injury (TBI)
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 70
Sex:All
Key Eligibility Criteria
Disqualifiers:Schizophrenia, Substance Use, Severe TBI, Others
Must Not Be Taking:Tricyclics, Clozapine
60 Participants Needed
Brain Stimulation for PTSD
Tallahassee, FloridaThe goal of this study is to develop and test a novel pathophysiology of PTSD by integrating sensory cortical (SC) and amygdala-PFC dysfunctions into a tripartite Sensory-Prefrontal-Cortex-Amygdala (SPA) model.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 50
Sex:All
Key Eligibility Criteria
Disqualifiers:Major Medical Illness, Neurological Disorder, Others
Must Not Be Taking:Psychoactive Medications, Calcium Channel Blockers
160 Participants Needed
CPT + rTMS for PTSD
Tallahassee, FloridaThe purpose of this study is to examine the benefits of combining repetitive Transcranial Magnetic Stimulation (rTMS) coupled with Cognitive Processing Therapy (CPT) in treating combat-related Posttraumatic Stress Disorder (PTSD) symptoms. The study will also examine change in depression, psychosocial functioning, and neurophysiological (i.e., electroencephalography and magnetic resonance images) measures.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 60
Sex:All
Key Eligibility Criteria
Disqualifiers:Epilepsy, Substance Use, Psychotic Disorder, Others
Must Not Be Taking:Seizure-threshold Lowering Drugs
330 Participants Needed
STAIR-NT for PTSD and Substance Abuse
Tallahassee, FloridaDuring this 36-month R34 trial, eight study phases are proposed to adapt an evidence-based post traumatic stress disorder (PTSD) intervention (STAIR-NT) and layer it into a methadone maintenance treatment (MMT) program (START Treatment and Recovery centers) in New York City for use among individuals engaged in stimulant-opioid polysubstance use. The study aims to adapt STAIR-NT to a massed treatment schedule. Once an adapted protocol is complete, it will be tested for feasibility, acceptability, and short-term polysubstance and PTSD symptomology outcomes in a pilot randomized control trial (RCT) of 80 participants. Participants who screen eligible and consent will be randomized 1:1 to the adapted STAIR-NT intervention or treatment as usual (TAU) using randomization blocks of two and two and four via a computer-generated randomization sequence. Participants assigned to the intervention will receive the adapted massed delivery of STAIR-NT by trained counselors.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
80 Participants Needed
SLS-002 for PTSD
Miami, FloridaThis is a Phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for Post Traumatic Stress Disorder (PTSD) utilizing an adaptive platform trial (APT) design.
Intervention D - SLS-002 will assess the safety and efficacy of SLS-002 in participants with PTSD.
Please see NCT05422612 for information on the S-21-02 Master Protocol.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:18 - 65
Sex:All
200 Participants Needed
Fluoxetine for PTSD
Miami, FloridaThis is a Phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for PTSD utilizing an adaptive platform trial design.
Intervention A - Fluoxetine will assess the safety and efficacy of fluoxetine in participants with PTSD.
Please see NCT05422612 for information on the S-21-02 Master Protocol.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65
Sex:All
Key Eligibility Criteria
Must Not Be Taking:Fluoxetine
200 Participants Needed
Daridorexant for PTSD
Miami, FloridaThis is a Phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for PTSD utilizing an adaptive platform trial design.
Intervention C - Daridorexant will assess the safety and efficacy of daridorexant in participants with PTSD.
Please see NCT05422612 for information on the S-21-02 Master Protocol.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 65
Sex:All
200 Participants Needed
New Treatments for PTSD
Miami, FloridaThis is a Phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for PTSD utilizing an adaptive platform trial design. Participants are randomized among the multiple cohorts in the study and the resulting randomization enables sharing/pooling of control participants, where all interventions may be compared to a common control (placebo). This master protocol describes the default procedures and analyses for all cohorts; treatment-specific procedures will be described in the Master Protocol cohort-specific appendices. Individual cohorts may have additional eligibility requirements, safety and efficacy procedures, or endpoints, which will be described in corresponding intervention-specific clinicaltrials.gov records.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Suicide Risk, Substance Use, Others
Must Not Be Taking:Psychiatric Medications
800 Participants Needed
Guided Imagery for PTSD
Miami, FloridaPost-Traumatic Stress Disorder (PTSD) affects a significant portion of the population, with about 13 million Americans diagnosed in 2020. Women are twice as likely to have PTSD than men. PTSD will affect 8%, or 8 out of every 100 women, at some stage in their lives. This study will check the effects of guided imagery mindfulness on PCL-5 scores in adult women with PTSD. Participants in this study will complete a PCL-5 pre-test and post-test to check PTSD symptoms before and after 6-weeks of mindfulness sessions. Each participant will engage in 15-minute sessions of guided imagery mindfulness once a week for 6 weeks. Before and after PCL-5 scores will show the effect of guided imagery mindfulness on PTSD symptom severity.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 99
Sex:Female
15 Participants Needed
Mobile App Support for Post-Traumatic Stress Disorder
Miami, FloridaThis study focuses on the mental health challenges faced by the World Trade Center's (WTC) General Responders due to the severe psychological trauma from the WTC collapse. PTSD and depression are among the top mental health conditions affecting these responders. Many members of the WTC Health Program (WTCHP) have relocated to Florida, making up nearly six percent of the cohort. Furthermore, many identify as Latinx, highlighting the need for services in their preferred language to promote health equity. Studies have shown that remotely-delivered, clinician-supported applications (apps) can reduce adverse MH symptoms.
PTSD Coach was developed by the Veteran's Administration as a self-managed mobile app and is available at no cost for Android and Apple devices. The primary focus of PTSD Coach is on managing PTSD symptoms. The app offers coping tools such as relaxation exercises and calming self-talk and effective sleep hygiene practices when needed. A recent review evaluated the self-managed PTSD Coach app and found it to be feasible, acceptable, and effective in reducing PTSD symptoms.
Clinician-Supported PTSD Coach was developed as a brief intervention for Veterans who were unlikely to use a mobile app on their own. Clinician Supported PTSD Coach combines PTSD Coach mobile app with four remotely-delivered 20-30 minute sessions over 8 weeks with a clinician. Studies with Veterans have reported significant reductions in PTSD and depression symptoms, treatment satisfaction and more treatment sessions attended, when compared with typical mental health care. While promising, none of these studies included WTC General Responders or focused on Latinx populations.
Given the promise of these interventions, and the need to provide support for geographically dispersed General Responders in Florida, this study aims to evaluate the feasibility, acceptability, and effectiveness of Clinician Supported PTSD Coach in reducing symptoms of PTSD, depression, anxiety, and sleep disturbances among English and Spanish-speaking WTC General Responders. Participants will be randomly assigned to one of three conditions:
1. Clinician-Supported PTSD Coach
2. Self-Managed PTSD Coach
3. Waitlist Control (no treatment until after follow-up)
Assessments will be conducted at the end of treatment (8 weeks) and at follow-up (12 weeks). The study will measure reductions in PTSD, depression, anxiety, and sleep disturbances at 8 weeks and 12 weeks. It is expected that both Clinician Supported PTSD Coach and Self-Managed PTSD Coach will reduce symptoms, with Clinician Supported PTSD Coach showing larger reductions. In addition, to assess feasibility and acceptability, the study will assess engagement, satisfaction, and barriers in both PTSD Coach app conditions.
This project aims to fill a significant gap in evidence-based mental health treatments for WTC General Responders. It responds to the WTCHP Scientific Technical Advisory Committee's call for more research on mental health interventions and addresses the critical shortage of rigorously tested app-based remote interventions for dispersed General Responders with PTSD. The study also focuses on Spanish-speaking Latinx General Responders, a group that has not been specifically targeted in previous interventions. The study's findings could lead to the development of readily deployable interventions nationally to meet the mental health needs of WTC responders and survivors, providing a valuable resource for treatment researchers and health care providers.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:All
Sex:All
120 Participants Needed
CBT-I vs. MBTI for TBI-Related Insomnia
Eglin Air Force Base, FloridaThis study is a prospective two-arm, single blind randomized controlled trial design to compare the clinical effectiveness of telemedicine-delivered, 6-session, standardized cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia symptoms and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid Post-Traumatic Stress Symptoms (PTSS) and insomnia symptoms in a 360 patients. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep monitoring) at baseline, at the end of treatment, and at 2-, 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Neurological Diseases, Sleep Apnea, Others
360 Participants Needed
Antidepressants + Therapy for PTSD
Charleston, South CarolinaIndividuals with PTSD are more likely to engage in unhealthy behaviors such as tobacco use, drug use, alcohol misuse, and have high rates of morbidity/mortality. PTSD negatively impacts marriages, educational attainment, and occupational functioning. Some patients with PTSD can be successfully referred to specialty mental health clinics, but most patients with PTSD cannot engage in specialty care because of geographical, financial and cultural barriers and must be treated in primary care. However, policy makers do not know the best way to treat PTSD in primary care clinics, especially for patients who do not respond to the initial treatment choice. There are effective treatments for PTSD that are feasible to deliver in primary care. These treatments include commonly prescribed antidepressants and brief exposure-based therapies. However, because there are no head-to-head comparisons between pharmacotherapy and psychotherapy in primary care settings, primary care providers do not know which treatments to recommend to their patients. In addition, despite high treatment non-response rates, very few studies have examined which treatment should be recommend next when patients do not respond well to the first, and no such studies have been conducted in primary care settings.
This trial will be conducted in Federally Qualified Health Centers and VA Medical Centers, where the prevalence of both past trauma exposure and PTSD are particularly high. The investigators will enroll 700 primary care patients. The investigators propose to 1) compare outcomes among patients randomized to initially receive pharmacotherapy or brief psychotherapy, 2) compare outcomes among patients randomized to treatment sequences (i.e., switching and augmenting) for patients not responding to the initial treatment and 3) examine variation in treatment outcomes among different subgroups of patients. Telephone and web surveys will be used to assessed outcomes important to patients, like self-reported symptom burden, side-effects, health related quality of life, and recovery outcomes, at baseline, 4 and 8 months. Results will help patients and primary care providers choose which treatment to try first and which treatment to try second if the first is not effective.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:18+
Sex:All
700 Participants Needed
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Frequently Asked Questions
How much do Post-Traumatic Stress Disorder clinical trials in Tampa, FL 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 Post-Traumatic Stress Disorder clinical trials in Tampa, FL 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 Post-Traumatic Stress Disorder trials in Tampa, FL 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 in Tampa, FL for Post-Traumatic Stress Disorder 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 in Tampa, FL 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 Post-Traumatic Stress Disorder medical study in Tampa, FL ?
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 Post-Traumatic Stress Disorder clinical trials in Tampa, FL ?
Most recently, we added MOVED for PTSD, Suvorexant for Post-Traumatic Stress Disorder and Psilocybin-Assisted Therapy for Post-Traumatic Stress Disorder to the Power online platform.