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The purpose of this clinical trial is to learn whether existing treatments for posttraumatic stress disorder (PTSD) can be improved. Two treatments for PTSD, cognitive processing therapy (CPT) and prolonged exposure (PE) will be studied. CPT and PE are effective treatments that are widely available, but interventions are needed to improve patient outcomes in these treatments. The investigators have developed an Adjunctive Writing intervention for Amplifying Response and Engagement (AWARE), which was designed using health communication strategies to enhance CPT and PE by improving communication between patients and therapists about patients' experiences in treatment. This research will investigate whether adding AWARE to CPT and PE will lead to better treatment outcomes compared to CPT and PE provided as usual without AWARE. AWARE includes a brief writing task asking patients about their experiences in treatment, as well as guided therapist responses to improve patient-therapist communication about patients' experiences in treatment. In the first phase of the study (case series phase), CPT or PE with AWARE will be provided to four adults with PTSD to pilot test adding AWARE to CPT and PE, seek patient and provider feedback, and refine AWARE. The first four participants who enroll will be part of the case series and will receive CPT or PE with AWARE. Then, in the second phase of the study, the randomized controlled trial (RCT) phase, the investigators will enroll 50 more adults with PTSD who will be randomly assigned (like flipping a coin) to receive CPT/PE as usual or CPT/PE with AWARE. It is expected that 25 participants will be randomized to CPT/PE with AWARE and 25 participants will be randomized to receive CPT/PE provided as usual. The goals of the RCT phase are to study whether AWARE is acceptable to patients, whether it is feasible to add AWARE to CPT and PE, and whether adding AWARE to CPT and PE improves patient-therapist communication and treatment outcomes compared to CPT/PE as usual.
This study effects the effects of transcutaneous cervical vagal nerve stimulation (tcVNS) or a sham control on brain, physiology, and PTSD symptoms in Veterans with posttraumatic stress disorder (PTSD). Veterans undergo brain imaging and physiological measures in conjunction with traumatic scripts before and after three months of twice daily treatment with tcVNS or sham stimulation at home.
Cognitive Processing Therapy (CPT) is highly effective in randomized controlled trials, but its effectiveness drops substantially in standard clinical practice, largely due to therapist "drift" from fidelity to the protocol. What remains unknown is which components of CPT training yield high therapist fidelity. Thus, there is a critical need to use empirical approaches to identify the most effective components of CPT training and to develop an adaptive training model for CPT by testing sequences of empirically-supported training strategies. The long-term goal of this research is to develop a sustainable model of therapy training that is personalized to the needs of the therapist trainee. The overall objective of this application is to empirically optimize an adaptive model for CPT training. The rationale is that developing an adaptive training model will improve efficiency and personalization, yield higher fidelity, and ultimately improve Veteran outcomes. We expect that completion of this project will produce an adaptive CPT training program that yields high therapist fidelity. Improving CPT fidelity in VHA will have a positive impact on the health and wellbeing of Veterans with PTSD.
This is a randomized, sham controlled study of the Electroencephalogram (EEG) based Transcranial Magnetic Stimulation (eTMS) treatment for Post-Traumatic Stress Disorder (PTSD). The recruitment goal is 110 participants who are United States Military veterans or first responders (e.g., firefighters, police, paramedics, etc.). The Study includes an EEG recording in order to determine the optimal treatment parameters for the eTMS system, followed by 15 in-office visits that take place over 21-28 total days. Two eTMS treatment sessions are administered during each office visit.
A substantial majority of Veterans with posttraumatic stress disorder (PTSD) continue to suffer even with the best current medications. Progress in developing more effective medications is hampered by the substantial variability within Veterans with PTSD, meaning the most effective medication likely varies from individual to individual. New scientific tools to help identify distinct subgroups of Veterans with PTSD who are likely to respond to specific medications could help improve treatment in this population. Research has indicated that a specific subgroup of Veterans with PTSD with a high level of anxious arousal may benefit from medications which boost signaling of the neurotransmitter gamma-aminobutyric acid (GABA). This project aims to validate a clinical test to identify these individuals using new computational and neuroimaging methods combined with the medication lorazepam, a positive GABA modulator. The ultimate goal is to use these methods in future clinical trials of new medications to target the best treatments to individual Veterans with PTSD.
The goal of this clinical trial is to learn if training with the Prism system can reduce PTSD symptoms in US military Veterans and civilians with PTSD. Prism is a form of neurofeedback training that uses EEG signals to promote self-regulation of brain function. The main question this study aims to answer is: Does Prism training lead to decreased PTSD symptoms in US Veterans and civilians when used in addition to usual PTSD treatment? Researchers will compare Prism training to a sham training (a look-alike training that does not provide real feedback on brain activity) to see if Prism training decreases PTSD symptoms. Participants will: * Complete two one-hour in-person training sessions a week for about 8 weeks (15 sessions) * Complete two booster training sessions one month and two months after finishing the main training course * Participate in three detailed interviews: one before training, a second after nine weeks of training, and a third one month after the last booster training session (about 20 weeks after the initial visit)
Posttraumatic stress disorder (PTSD) among military service members and veterans is as high as 32% and is the third most service-connected disability, resulting in over $1.5 billion in direct costs over a five-year period. According to Clinical Practice Guidelines, strong evidence exists for psychotherapies, such as prolonged exposure (PE) for PTSD. However, psychotherapies are often met with high drop-out rates, treatment non-compliance, and emotional stress due to trauma recall. A successful approach to reduce drop-out rates and maintain efficacy is to compress psychotherapy into daily, day-long PE sessions. Yet another deficit exists regarding the feasibility of this approach outside of residential treatment facilities, which are typically reserved for the most extreme cases. The newest study from the our team aimed to augment PE residential treatment with a neuromodulatory treatment: image-guided, robot-navigated transcranial magnetic stimulation (IR-TMS). Along with the PE-focused intensive inpatient program (IIP-PE), participants received IR-TMS targeting the right dorsolateral prefrontal cortex (DLPFC) daily for 20 consecutive days. Results demonstrated superiority of the combined IIP-PE/IR-TMS approach, compared to IIP-PE and a sham condition. However, it is not yet established whether a standalone IR-TMS approach will achieve similar results. Our goal is to implement an open-label trial of IR-TMS for PTSD, in which veterans and active-duty service members with PTSD will receive accelerated IR-TMS throughout a 2-week timeframe. Results will be used as a foundation for future extramural funding to scale-up the stand alone IR-TMS intervention for PTSD treatments.
This is a randomized controlled trial of a dyad-centered, doula support and healthcare coordination model of care in a large urban neonatal intensive care unit (NICU), which serves a high-risk, low-income, majority Black population. In addition to doula support and coordination of care in the NICU, there will be a warm handoff to a community doula to continue the support once infants leave the Hospital of the University of Pennsylvania (HUP) NICU.
The goal of this clinical trial is to learn if receiving Trauma-Informed Guilt Reduction (TrIGR) Therapy is as effective as receiving Prolonged Exposure Therapy among veterans with PTSD and trauma related guilt. The main questions it aims to answer are: Will TrIGR be comparable to PE in terms of PTSD symptom reduction? Will it TrIGR be comparable to PE in improving functioning and reducing depression symptoms? Will it be superior in improving trauma-related guilt and shame?
The 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.