The Effects of Expressive Writing Following Traumatic Childbirth
The goal of this clinical trial is to test a brief psychological intervention given to individuals in the first days following childbirth who have experienced a potentially stressful childbirth. The treatment is aimed at preventing post-traumatic stress disorder following childbirth and promoting maternal-infant bonding. In the days following childbirth, participants will be asked to write about their childbirth experience or a neutral event for three consecutive days, for around 15 minutes each day. Additionally, they will complete a short survey before and after the intervention about their birth experience and mental health. Around 2 months postpartum, participants will take part in mental health and physiological assessments, and in a brief play session with their infant.
NCT05662423 — PTSD (Childbirth-Related)
Status: Recruiting
http://inclinicaltrials.com/ptsd-childbirth-related/NCT05662423/
Transcendental Meditation in Veterans and First Responders With PTSD
The present study is part of a Phase 3 multi-site clinical trial that will recruit veterans and first responders diagnosed with PTSD, where they will be randomized to receive either Transcendental Meditation (TM) or Present Centered Therapy (PCT). Five assessments will be conducted, at: 1) baseline, 2) midpoint, 3) posttreatment, 4) three months posttreatment and 5) six months posttreatment. All assessments will be completed using remote HIPAA-compliant videoconferencing. The study protocol at NYSPI/Columbia will also include Magnetic Resonance Imaging (MRI) before and after treatment to elucidate neural predictors and mechanisms of these two treatment approaches. Enrollment will include veterans and first responders with PTSD. Both TM and PCT will be provided by trained staff receiving weekly supervision. This trial is funded by the David Lynch Foundation and will recruit approximately 360 veterans and first responders over a three-year period.
NCT05645042 — PTSD
Status: Recruiting
http://inclinicaltrials.com/ptsd/NCT05645042/
The Effects of a Single Bout of Aerobic Exercise on Emotion Regulation and Cognitive Control in Individuals With Clinically Significant Post-Traumatic Stress Disorder Symptoms
The goal of this study is to investigate the effects of a single bout of aerobic exercise on neurophysiological indices of emotion regulation and cognitive control in individuals with clinically significant PTSD symptoms. In this proposed study, 50 adult females with clinically significant PTSD symptoms will be randomized into two groups: a 20-minute moderate-to-vigorous intensity aerobic exercise group, or a 20-minute silent sitting control group. Prior to and following the exercise/sitting session, participants will complete a letter flanker task and an emotion regulation picture viewing task while their electrical brain activity is continuously recorded via electroencephalogram (EEG). Utilizing a multimodal assessment approach, cognitive control will be measured using behavioral (i.e., accuracy, reaction time) and neurophysiology (i.e., error-related negativity; ERN). Emotion regulation will be measured using self-reported and neurophysiological indices of emotional reactivity (i.e., late positive potential; LPP).
NCT05643716 — PTSD
Status: Recruiting
http://inclinicaltrials.com/ptsd/NCT05643716/
Is Olfaction the Key to PTSD
Participants arriving to the ED following a potentially traumatic event such as a motor vehicle accident will be recruited into the study. Inclusion criteria: aged 18-65, Hebrew as a first language, no current psychiatric disorder. Exclusion criteria: loss of consciousness, unable to understand study procedure. Participants will answer self report questionnaires in the ED. They will be invited for a follow up interview 2 weeks and six months post trauma. Between 2 weeks and 6 months they will be folllowed up via online questionnaires. At the interviews, they will encounter 20 different olfactory stimuli, answer self-report questionnaires, and a clinical interview assessing Axis 1 disorders and PTSD will be completed. At six month, participants with PTSD will be offered therapy in the embedded RCT. Patients will receive VRET (Virtual reality exposure therapy) with or without olfaction.
NCT05640882 — PTSD
Status: Not yet recruiting
http://inclinicaltrials.com/ptsd/NCT05640882/
Evaluation of a Rumination Intervention for Individuals With PTSD: A Case Series
After a traumatic event, it is common for thoughts to run through our minds over and over again. Typically, these include unanswerable questions like "why did this happen to me?", "what if I had done something differently?" Dwelling or ruminating on the past like this is often unhelpful and research has shown that it increases our chances of developing posttraumatic stress disorder (PTSD), a debilitating stress reaction. Once PTSD is in place, research shows that ruminating keeps the disorder going. It is unknown to what extent targeting rumination with an intervention to reduce its recurrence may help to alleviate PTSD symptoms. While rumination interventions using evidence-based cognitive behavioural therapy (CBT) have shown highly promising results in depression and anxiety research, no previous study has evaluated a stand-alone rumination intervention for individuals with PTSD. The aim of this study is to examine the impact of a one-session online Rumination Intervention designed to reduce rumination in a small sample of 14 individuals who are currently awaiting treatment for PTSD in a British national mental health (NHS) service. The study will explore whether the Rumination Intervention reduces PTSD-related rumination, as well as PTSD and depression symptoms. It will also investigate how feasible and acceptable the intervention is for participants. If the findings are promising, the intervention could be tested in a larger clinical study in the future. Results may help inform online interventions for PTSD.
NCT05625126 — Posttraumatic Stress Disorder
Status: Active, not recruiting
http://inclinicaltrials.com/posttraumatic-stress-disorder/NCT05625126/
Adaptation of the Primary Care Intervention for PTSD for Children Aged 6 to 11
This study will implement a brief Post-traumatic Stress Disorder (PTSD) intervention for children, the Primary Care Intervention for PTSD (PCIP) delivered through telehealth (computer or smartphone delivery), to 10 youth age 6-11 and their caregivers. Mixed methods (qualitative and quantitative) randomized pilot feasibility trial (n=10 to treatment and 10 to waitlist control) to refine the intervention, study procedures, and explore effectiveness. Following RE-AIM guidelines, the investigators will assess: 1. Reach: patient participation in intervention delivery (out of all those asked to participate) and retention rate (out of all those who consented to participate and completed at least two intervention sessions) 2. Adoption: patients and their parents/guardians will complete screening and intervention satisfaction ratings. To understand patient experiences with the intervention and to identify and explain positive or negative treatment mechanisms or effects, the investigators will conduct post-intervention semi-structured interviews with the participating patients, their parents/guardians, and with providers. This treatment ranges from 1-4 sessions which last 50 minutes per session. The first session will cover psychoeducation about PTSD symptoms in children that can be delivered to the parent or both the parent and child. The first session will also teach the parent and child a breathing technique to combat the physiological impact of PTSD in children. The subsequent sessions will be tailored to meet the needs of the child's most distressing PTSD symptom cluster including hyper arousal, negative changes in cognition and mood, avoidance, re-experiencing. Each session contains coping skills that the parent and child can learn together. There is also material for parents to address behavior problems in youth. This treatment will be delivered via telehealth.
NCT05606172 — Post-traumatic Stress Disorder
Status: Recruiting
http://inclinicaltrials.com/post-traumatic-stress-disorder/NCT05606172/
Developing and Validating an Integrative Model Incorporating Mindfulness-based Resilience Intervention to Address Post-Traumatic Stress Disorder in People Living With HIV
The goal of this randomised controlled trial is to evaluate the efficacy of an integrated intervention program on post-traumatic stress disorder (PTSD) symptoms and related physiological and psychological indicators of people living with HIV (PLWH). The main question it aims to answer are: - to evaluate the efficacy of the intervention program on PTSD symptoms and related physiological and psychological indicators of PLWH through empirical research. - to analyze the mechanism of the intervention. Eligible PLWH were recruited and randomly divided as intervention group and control group. The efficacy of Trauma Resiliency Mindfulness-Informed Intervention on PTSD symptoms and related physiological and psychological indicators in PLWH was evaluated at baseline, after intervention, and 3 months after intervention through this randomized controlled trial. Researchers compared the intervention group and control group to see if it was feasible and had potential clinical value to introduce the Trauma Resiliency Mindfulness-Informed intervention program into the management of PLWH in China.
NCT05588596 — HIV
Status: Completed
http://inclinicaltrials.com/hiv/NCT05588596/
Examining the Benefit of Equine Assisted Learning for First Responders With Posttraumatic Stress Disorder
This RCT will evaluate the efficacy of Equine Assisted Learning for reducing PTSD symptoms in public safety personnel (e.g., fire fighters, police, nurses, etc.).
NCT05579717 — Posttraumatic Stress Disorder
Status: Recruiting
http://inclinicaltrials.com/posttraumatic-stress-disorder/NCT05579717/
Testing a PTSD m-Health Intervention to Improve Alcohol Treatment Outcomes
The purpose of this study is to learn whether a mobile health application (mHealth App) for posttraumatic stress disorder (PTSD) with brief support can help individuals who are in treatment for alcohol problems.
NCT05564663 — Alcohol Use Disorder
Status: Recruiting
http://inclinicaltrials.com/alcohol-use-disorder/NCT05564663/
Written Exposure Therapy for PTSD: A Pilot Study of a Virtually Delivered Group-Based Intervention
The purpose of this study is to examine whether Written Exposure Therapy (WET) can be effectively delivered virtually and in a group format for the treatment of Post-Traumatic Stress Disorder in a military and police population. The objective of this study is to assess treatment feasibility and acceptability, drop out rates, changes in severity of trauma-related symptoms and symptoms of depression, quality of life, and the need for further trauma-focused treatment (TFT) for the the delivery of WET as a virtual, group based intervention.
NCT05553249 — Post Traumatic Stress Disorder
Status: Enrolling by invitation
http://inclinicaltrials.com/post-traumatic-stress-disorder/NCT05553249/