Enhanced Hippocampal Neuroplasticity for Surfacing of Inaccessible Traumatic Memories in Veterans With PTSD
Hyperbaric oxygen therapy (HBOT) includes the inhalation of 100% oxygen at pressures exceeding one atmosphere absolute. HBOT has been applied worldwide, mostly for chronic non-healing wounds. Our team demonstrated that HBOT induced hippocampal neuroplasticity in veterans with long-standing treatment-resistant PTSD; this led to enhanced memory recovery and significant improvement in PTSD symptoms. Both physical activity, such as aerobic exercise, and cognitive training were shown to support neurogenesis in the hippocampus. Therefore, the current study aims to evaluate whether hippocampal training, induced by physical and cognitive training, will augment the hippocampal neuroplasticity effect of HBOT and further enhance recovery of inaccessible memories in veterans with PTSD. The protocol will include forty male veterans aged 25 to 60 years, with combat-associated PTSD and peritraumatic amnesia, who will receive either HBOT alone or HBOT and hippocampal training. The HBOT protocol will consist of 60 daily sessions, 90-minutes each, five days a week. Hippocampal training will combine physical and cognitive training 3 times per week, prior to HBOT sessions. Detailed psychological evaluation, anatomic and functional MRI, electroencephalogram and autonomic nervous system data will be obtained at baseline, and during and after treatment. The proposed study offers a new approach of biological treatment for memory manipulations. The findings will help elucidate the mechanism of PTSD-related memory impairment and is expected to contribute to the development of biological memory manipulations for treating PTSD and other memory-related conditions.
NCT05883397 — PTSD
Status: Recruiting
http://inclinicaltrials.com/ptsd/NCT05883397/
Efficacy of a Posttraumatic Stress Disorder (PTSD) Intervention for Autistic Adults on Biobehavioral Health
The goal of this single-group clinical trial is to learn about the initial efficacy and feasibility of telehealth-delivered Written Exposure Therapy (WET) for autistic adults with traumatic stress symptoms. The main questions the investigators aim to answer are: - Do symptoms of posttraumatic stress disorder (PTSD) and co-occurring mental health concerns decrease after receiving WET? - Do biobehavioral health outcomes, including objective (Fitbit indicators of activity, sleep, and heart rate) and subjectively-reported health variables (e.g., sleep, pain, health-related quality of life), improve after receiving WET? - How do autistic adults experience WET, and how can this program be modified and enhance in the future in collaboration with autistic adults? Participants will complete the following as part of the study, which is completed entirely over telehealth. - Participants will first complete an initial assessment, involving brief measures of cognition and autistic traits, as well as interviews and questionnaires about PTSD, mental health, and physical health. If eligible, participants will proceed to the following steps: - Eligible participants will then start wearing a Fitbit, to be used for the duration of the study. - Participants will then participate in 5 weekly virtual visits involving the WET protocol, including weekly brief assessment of PTSD and mental and physical health. - Then, participants will complete a sixth virtual visit the following week where PTSD, mental and physical health, and treatment feedback are assessed. - Lastly, participants will complete virtual visits 1 and 6 months later involving re-assessment of PTSD and mental and physical health. Therefore, this is a pre-post single group design, where all participants will receive WET to establish initial efficacy and feasibility. Investigators will also consult with an autistic advisory board throughout the project, and make adaptations as recommended in consultation with autistic adults. The goal is to better understand the initial efficacy and feasibility of WET for supporting autistic adults who have experienced trauma.
NCT05862467 — Trauma
Status: Recruiting
http://inclinicaltrials.com/trauma/NCT05862467/
Enhancing Intensive Transdiagnostic Cognitive Behavioral Therapy for Veterans With PTSD and Anxiety Disorders
The goal of this clinical trial is to compare two different intensive formats of delivering cognitive-behavioral treatment for people with PTSD and anxiety disorders. The main questions it aims to answer are: - Is iTCBT delivered in individual and group formats more effective than TAU in improving anxiety symptoms and quality of life? - For treatment non-responders, is iTCBT-Enhanced more effective than TAU improving anxiety symptoms and quality of life? - Does iTCBT-Individual produce a larger improvement in anxiety and quality of life compared with iTCBT-Group? Participants will undergo several assessments throughout the course of the study. Based on randomization, they will receive: (1) iTCBT in an individual format over a 2-week period, (2) iTCBT in a group format over a 2-day period, or (3) usual care. Those who do not show a response to treatment will receive 4 additional individual therapy sessions.
NCT05843695 — Anxiety Disorders
Status: Recruiting
http://inclinicaltrials.com/anxiety-disorders/NCT05843695/
Empowering Veterans to Self-Manage PTSD Symptoms Following Completion of Trauma-Focused Therapy
Patients who complete prolonged exposure and cognitive processing therapy, the treatments for posttraumatic stress disorder (PTSD) with the most empirical support, continue to express a need for mental health treatment. A therapist-assisted self-management program for patients who have completed one of these two treatments and achieved symptom improvement has the potential to meet patients' stated treatment needs, maintain or build upon their PTSD symptom reductions, increase their confidence in managing their symptoms, and reduce the number of mental health appointments that they need to attend. Further, reducing the number if mental health sessions attended by completers of these time and resource intensive psychotherapies will increase the likelihood that their implementation in regular-practice clinics will be maintained.
NCT05797441 — PTSD
Status: Enrolling by invitation
http://inclinicaltrials.com/ptsd/NCT05797441/
Non-Inferiority Trial of Trauma Informed Guilt Reduction Therapy (TrIGR) for PTSD
Trauma-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.
NCT05789329 — PTSD
Status: Recruiting
http://inclinicaltrials.com/ptsd/NCT05789329/
Randomized Placebo-Controlled Trial of Methylphenidate for the Treatment of Post-Traumatic Stress Disorder With Associated Neurocognitive Complaints
Posttraumatic stress disorder (PTSD) is frequently accompanied by difficulty concentrating, poor memory, and inability to keep up with tasks, which negatively impacts a person's ability to function at work and in relationships. Currently available treatments do not fully relieve all symptoms. A published research report showed positive evidence that the stimulant medication methylphenidate was beneficial in treating these problems. This study will evaluate the ability of methylphenidate to treat PTSD and associated neurocognitive complaints in Veterans. An innovative feature is the study's N-of-1 design. In this design, every participant will move back and forth every 4-5 weeks between treatment with methylphenidate and treatment with placebo, in random order and under double-blind conditions, over a 20-week period. The investigators will compare the aggregated change in PTSD and neurocognitive symptoms between periods of treatment with methylphenidate versus placebo. Results will help clinicians to better choose the best treatment for Veterans living with PTSD.
NCT05776056 — Posttraumatic Stress Disorder (PTSD)
Status: Recruiting
http://inclinicaltrials.com/posttraumatic-stress-disorder-ptsd/NCT05776056/
Evaluation of Blended CBT for PTSD in Regular Care: A New Format of Computer-Assisted Trauma-Focused Cognitive Behavioral Therapy: A Randomized Controlled Non-inferiority Trial
A Randomized Controlled Non-inferiority Trial testing if the new experimental Blended Trauma focused cognitive behavioral therapy (B-TF-CBT) for post traumatic stress disorder (PTSD), is non-inferior to gold standard control treatment Prolonged Exposure (PE). Research question and hypothesis Can the blended treatment yield outcomes non-inferior to face-to-face TF-CBT for patients with PTSD when applied in regular health care with regards to PTSD-symptoms, depression, anxiety, sleep problems, quality of life and general functioning? The hypothesis is that the Blended TF-CBT will be non-inferior to standard face-to-face TF-CBT for patients with PTSD, directly after treatment as well as at 12-months follow up. The study will be conducted at 3-6 outpatient clinics in Region Stockholm, Sweden.
NCT05758987 — PTSD
Status: Recruiting
http://inclinicaltrials.com/ptsd/NCT05758987/
I MOVE!+UP: Piloting an Integrated Weight Management Program for Veterans With PTSD
This study seeks to test I MOVE!+UP, which integrates individual evidence-based psychotherapy for PTSD with behavioral weight management among Veterans with a Body Mass Index of at least 30 and meeting criteria for current PTSD. Participants will continue receiving routine primary care and psychiatric care management as indicated, in coordination with the I MOVE!+UP therapist. This study is being conducted to see whether I MOVE!+UP holds promise as a treatment for commonly co-occurring PTSD and high Body Mass Index. Participation will involve attending up to 16 psychotherapy visits that last approximately 1-2 hours over 6 months and attending 2 study assessment visits that last approximately 1-2 hours at enrollment and 6 months. Active participation will take up to approximately 6 months.
NCT05755100 — Overweight and Obesity
Status: Recruiting
http://inclinicaltrials.com/overweight-and-obesity/NCT05755100/
Attention Control Training for the Prevention of PTSD in Firefighters
The study aimed to examine the effect of Attention Control Training (ACT) intervention on reducing PTSD symptoms in firefighters. The study was a randomized controlled trial carried out in Kunming, China, and involved the recruitment of 180 active firefighters as participants. The intervention lasted for an 8-week duration, during which participants participated in ACT exercises delivered through a smartphone application.
NCT05754164 — PTSD
Status: Completed
http://inclinicaltrials.com/ptsd/NCT05754164/
Reducing PTSD Symptoms in First Responders and Frontline Healthcare Workers Through Trauma-focused Treatment in Employee Assistance Programs
This study addresses PTSD symptoms in First Responders and Healthcare workers. Specifically, it tests whether a brief PTSD treatment (talk therapy) effectively treats PTSD when provided to First Responders and Healthcare workers by counselors in Employee Assistance Programs (EAPs). The central hypothesis is that the PTSD treatment, Prolonged Exposure for Primary Care (PE-PC), will reduce PTSD symptoms and improve functioning, compared to EAP Treatment as Usual (TAU).
NCT05751473 — Post Traumatic Stress Disorder
Status: Recruiting
http://inclinicaltrials.com/post-traumatic-stress-disorder/NCT05751473/