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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT06100731 Recruiting - Clinical trials for Post Traumatic Stress Disorder

tDCS and Inhibitory Control in PTSD

Start date: October 27, 2023
Phase: N/A
Study type: Interventional

Large samples (~2,000/yr) of adult undergraduate students at a large southern university will be pre-screened via the University of Kentucky SONA System (IRB#43626) to identify and recruit adult female participants who report a history of IPV and probable PTSD to participate in a one-day lab study. After completing an IRB-approved informed consent, participants will complete a brief psychiatric diagnostic interview and a battery of questionnaires. They will then complete three blocks of the Stop Signal Task (SST). Participants will be randomized (double-blind, stratified by PTSD diagnosis and psychotropic medication use) to receive 15-min of active or sham multifocal tDCS targeting the rIFG. tDCS will be delivered offline for 11.5-mins after block 1 of the SST and online for 3.5-mins during block 2 of the SST. Sham stimulation will be identical to active tDCS, but electrical current will only be ramped in/out at the beginning and end of the 15-mins. The third block of the SST will be completed after tDCS. Lastly, participants will complete a pictorial trauma-related symptom provocation task. Participants will be compensated with course credit.

NCT ID: NCT06096740 Not yet recruiting - PTSD Clinical Trials

Psychotherapy Effects on Reward Processing in PTSD

PERPP
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to identify how trauma-focused psychotherapy changes the function of brain circuitry in posttraumatic stress disorder (PTSD) and how this mediates improvements in the diminished ability to experience positive emotions following a traumatic or extremely stressful life event. In this instance, the investigators will be using cognitive processing therapy (CPT), a widely-utilized and evidence-based treatment for PTSD.

NCT ID: NCT06094933 Not yet recruiting - Clinical trials for Posttraumatic Stress Disorder

Randomized Clinical Trial of MARI

MARI
Start date: October 1, 2024
Phase: N/A
Study type: Interventional

Difficulty controlling anger is the most commonly reported reintegration concern among combat Veterans, especially those with a diagnosis of posttraumatic stress disorder (PTSD). Problematic anger is associated with significant functional impairment. In the current project, the investigators will compare the Mobile Anger Reduction Intervention (MARI) with a health education mobile intervention (HED) among Veterans with PTSD and problematic anger. Participants will be randomized to the MARI or HED condition. The hypothesis is that participants in the MARI condition will experience greater anger reductions and functional improvements relative to the HED condition.

NCT ID: NCT06093906 Not yet recruiting - Clinical trials for Major Depressive Disorder

Positive Processes and Transition to Health (PATH)

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The R33 will be a randomized controlled trial to replicate changes in the targets (unproductive processing, avoidance, reward deficits) from the R61 phase in a larger sample of 135 participants who have experienced a destabilizing life event involving profound loss or threat, report persistent stressor-related symptoms of PTSD and/or depression, and are elevated on symptoms related to 2 of the 3 therapeutic targets. Additionally, this study will examine Positive Processes and Transition to Health (PATH)'s impact on stressor-related psychopathology in comparison to Progressive Muscle Relaxation (PMR). In the R33 phase, the investigators will examine changes in target mechanisms predicting improvements in PTSD and depressive symptoms, as well as feasibility and acceptability. Patients will receive 6 sessions of PATH or PMR (with 2 boosters, if partial responders). Primary targets will be assessed at pre-treatment, week 3, post-treatment, and at 1- and 3-month follow-up; secondary targets at pre-treatment, weekly during treatment, post-treatment, and at 1- and 3-month follow-ups.

NCT ID: NCT06088303 Not yet recruiting - Clinical trials for Stress Disorders, Post-Traumatic

Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication

AWARE
Start date: September 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06081309 Completed - Clinical trials for Stress Disorders, Post-Traumatic

EEG Personalized Transcranial Magnetic Stimulation (eTMS) for Post-Traumatic Stress Disorder

Start date: November 20, 2023
Phase: N/A
Study type: Interventional

This is an open-label safety pilot study of the Electroencephalogram (EEG) Transcranial Magnetic Stimulation (eTMS) treatment for Post-Traumatic Stress Disorder (PTSD). The recruitment goal is 30 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 10 in-office visits that take place over 21 total days. Two eTMS treatment sessions are administered during each office visit.

NCT ID: NCT06077474 Recruiting - Clinical trials for Post-Traumatic Stress Disorder in Children

Validation of the Turkish Version of PTSD-RI-5

Start date: October 5, 2023
Phase:
Study type: Observational [Patient Registry]

The aim of this study is to investigate the adaptation and validity of the DSM-5 PTSD-RI -5 scale in patients who have been exposed to traumatic events. Thus, a scale useful for the diagnosis and follow-up of PTSD will be presented to the Turkish population.

NCT ID: NCT06073964 Completed - Clinical trials for Post-Traumatic Stress Disorder

GBV, Primary Trauma & Trauma Resilience & Understanding Self-help Therapy Utilization in Uganda

GBV
Start date: November 23, 2022
Phase: N/A
Study type: Interventional

The goal of this community-based interventional study was to determine the effectiveness of the 'Trauma Resilience & Understanding Self-help Therapy' (TRUST) in managing domestic violence & primary trauma among formerly Internally Displaced Persons (fIDPs) in northern Uganda. The main questions it aimed to answer were: - What was the level of utilization and short-term effects of the TRUST intervention on the experiences of domestic violence and high levels of primary trauma among fIDPs living in northern Uganda who would have been using TRUST within their communities after completing the training in the community-based TRUST utilization? - What were the clinical indications of the TRUST intervention and psychological operators among fIDPs living in northern Uganda who would have been using TRUST within their communities to manage their experiences of domestic violence and high levels of primary trauma? Participants found to have experienced domestic violence in the last one year and were having high levels of primary trauma were randomly assigned to the intervention group that was trained in the utilization of the TRUST within their communities and then followed up for 12 weeks (TRUST group). The investigators then compared the results obtained from the TRUST group with those attained from an age and gender cross-matched control group of fIDPs who were not trained in the utilization of the TRUST within their communities (Control group). This was done to see if the community-based utilization of the TRUST intervention changed the levels of primary trauma & experiences of domestic violence among its users (TRUST group) when compared to the non-users (Control group).

NCT ID: NCT06073886 Not yet recruiting - Depression Clinical Trials

Personalized Brain Stimulation to Treat Chronic Concussive Symptoms

Start date: January 2024
Phase: Phase 2
Study type: Interventional

The goal of this study is to investigate a new treatment for chronic symptoms after concussion or mild traumatic brain injury in people aged 18-65 years old. Chronic symptoms could include dizziness, headache, fatigue, brain fog, memory difficulty, sleep disruption, irritability, or anxiety that occurred or worsened after the injury. These symptoms can interfere with daily functioning, causing difficulty returning to physical activity, work, or school. Previous concussion therapies have not been personalized nor involved direct treatments to the brain itself. The treatment being tested in the present study is a noninvasive, personalized form of brain stimulation, called transcranial magnetic stimulation (TMS). The investigators intend to answer the questions: 1. Does personalized TMS improve brain connectivity after concussion? 2. Does personalized TMS improve avoidance behaviors and chronic concussive symptoms? 3. Do the improvements last up to 2 months post-treatment? 4. Are there predictors of treatment response, or who might respond the best? Participants will undergo 14 total visits to University of California Los Angeles (UCLA): 1. One for the baseline symptom assessments and magnetic resonance imaging (MRI) 2. Ten for TMS administration 3. Three for post-treatment symptom assessments and MRIs Participants will have a 66% chance of being assigned to an active TMS group and 33% chance of being assigned to a sham, or inactive, TMS group. The difference is that the active TMS is more likely to cause functional changes in the brain than the inactive TMS.

NCT ID: NCT06070766 Recruiting - Clinical trials for Major Depressive Disorder

RIVER At Home Ketamine Protocols

Start date: October 1, 2023
Phase:
Study type: Observational

Multiple site studies with the recruitment of other sub-investigators and sites. It's sobering to consider how chronic illness makes us more vulnerable to suicidal thoughts and behavior. However, the existence of multiple risk factors also means that there are numerous ways to intervene. Addressing and improving even one risk area will reverberate and improve other areas and the quality of life. RIVER Foundation is completing a 500-participant pilot study researching the safety of oral and nasal ketamine at home with no therapy. The pilot study examined three psychological scales: P.H.Q. 9, G.A.D. 7, and PCL5 scores. The interim report will be available in Nov 2023 with a final report in June 2024. The lack of knowledge for the average medical practitioner makes ketamine a boutique medicine, often costly and unaffordable to those in need. Yet daily medical providers are eliminating ketamine as a choice in the treatment of chronic conditions. The pilot study demonstrated the who, and where. The who, was adults with a chronic condition. The pilot study demonstrated the majority of those who could use ketamine are not receiving it due to cost. According to the 500-participant study, ketamine is safe and effective for at-home use thus demonstrating the where (at home with no supervision).