This study will investigate treatments for insomnia in Veterans who have posttraumatic stress disorder (PTSD). The purpose of this study is to compare a brief behavioral treatment for insomnia (BBTI) to a treatment that helps promote relaxation (progressive muscle relaxation training or PMRT). The investigators will examine improvements in psychosocial functioning and insomnia severity. The investigators will also examine whether treatment gains last over time and whether suicidal ideation decreases following insomnia treatment.
NCT05780177 — Posttraumatic Stress Disorder
Status: Recruiting
http://inclinicaltrials.com/posttraumatic-stress-disorder/NCT05780177/
Investigating the Feasibility and Efficacy of a Novel Sensory-based Psychoeducation Program for Military Veterans With Posttraumatic Stress Disorder
SENSE-PTSD is an randomized controlled trial (RCT) which will evaluate the feasibility and efficacy of a novel, sensory-based psychoeducational program for improving psychological, functional, sensory, and cognitive outcomes in Canadian military veterans with posttraumatic stress disorder (PTSD).
NCT05766241 — Posttraumatic Stress Disorder
Status: Not yet recruiting
http://inclinicaltrials.com/posttraumatic-stress-disorder/NCT05766241/
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.
NCT05517304 — Stress Disorders, Post-Traumatic
Status: Recruiting
http://inclinicaltrials.com/stress-disorders-post-traumatic/NCT05517304/
Couple's Retreats for PTSD: Healing the Impacts of Trauma in Texas Veteran Families
Posttraumatic stress disorder (PTSD) increases the risk for conflict and dissatisfaction in romantic relationships. Accelerated, Intensive, Multi-Couples Cognitive Behavioral Conjoint Therapy (AIM-CBCT) is a behavioral treatment that targets reducing PTSD symptoms and improving relationship functioning. The treatment is delivered over two days using an intensive, outpatient group (between 2 to 6 couples) format. Previous research has found that AIM-CBCT for PTSD decrease PTSD symptoms and improves relationship functioning in military veterans and service members with combat-related PTSD. The present study examines whether these original findings can be replicated in a broader military/Veteran sample of up to 80 couples. The investigators predict that AIM-CBCT for PTSD will be associated with significant decreases in PTSD symptoms, depression, and anxiety in Veteran/military service members, significant decreases in mental health symptoms in their romantic partners, and an increase in couple's satisfaction for both the Veteran/service members and their partners. Couples who agree to participate in the research study will be asked to participate in a 60-mintute pre-retreat meeting, the two-day retreat in which AIM-CBCT for PTSD will be delivered, and a 60-minute post-retreat check-in meeting. Additionally, each member of the couple will be asked to complete measures on their trauma history, mental health symptoms, and relationship functioning at baseline and at two and four weeks after the retreat.
NCT05274061 — Posttraumatic Stress Disorder
Status: Terminated
http://inclinicaltrials.com/posttraumatic-stress-disorder/NCT05274061/
Background: If disorders that occur immediately after a trauma are not treated, they may become chronic and turn into severe health problems. Objectives: This study was conducted with children who had spent time in an intensive care unit and their parents to examine the development of posttraumatic stress disorder (PTSD) in both children and parents. Methods: The study was a cross-sectional study. A total of 110 children, 98 mothers and 80 fathers were included in the study.
NCT05186844 — Posttraumatic Stress Disorder
Status: Completed
http://inclinicaltrials.com/posttraumatic-stress-disorder/NCT05186844/
Efficacy and Safety of Stellate Ganglion Block for Post-traumatic Stress Disorder in Veterans
Posttraumatic Stress Disorder (PTSD) is a debilitating condition that affects about 15% of Veterans. Current treatments for Veterans with PTSD include medications and psychological therapies that help to process and desensitize to traumatic events. While effective for many, these treatments do not work for all patients, and many may refuse them. Stellate Ganglion Block (SGB), established to treat pain and other conditions, has shown promise for PTSD: early small studies show it may work fast and greatly reduce symptoms. However, data from larger studies are not clear about SGBs effects. A definitive trial is needed, especially for the Veteran population. This large, well-powered, randomized, sham-controlled trial of SGB for PTSD will assess the short-term efficacy of this intervention, the durability of the effects and the safety of the treatment. Additionally, this study will provide critically important information about biological effects of SGB and potential mechanisms of action. This timely study is critical to help VA clinicians better decide about the merits of SGB for PTSD.
NCT05169190 — Post-traumatic Stress Disorder
Status: Recruiting
http://inclinicaltrials.com/post-traumatic-stress-disorder/NCT05169190/
Neurofeedback for Post-Traumatic Stress Disorder (N-PTSD). A Randomized Trial of Neurofeedback.
A two-arm randomized pilot of standard neurofeedback and a waiting list for patients with treatment resistent PTSD.
NCT05123690 — Post-traumatic Stress Disorder
Status: Recruiting
http://inclinicaltrials.com/post-traumatic-stress-disorder/NCT05123690/
Acceptability and Feasibility of Apollo Wearable System, Tuned Vibroacoustic Stimulation (TVS) in Veterans With a History of Post-traumatic Stress Disorder (PTSD)
The proposed investigation is an open label pilot study intended to establish the acceptability and feasibility of the Apollo in a population of Veterans. Exploratory data regarding biological signatures will also be collected.
NCT05019651 — PTSD
Status: Completed
http://inclinicaltrials.com/ptsd/NCT05019651/
Assessment of Post-traumatic Stress Disorder (PTSD) in Patients Monitored for Cytomegalovirus (CMV) Seroconversion During Pregnancy, Without Ultrasound Signs or With Non-serious Ultrasound Signs of Maternal-fetal CMV Infection.
Reports of maternal seroconversion to CMV during pregnancy can be extremely stressful. This virus is little known to the general public and searching for information on the Internet quickly leads to a consultation of a site mentioning the risk of severe psychomotor retardation in the event of prenatal cytomegalovirus infection. The psychological repercussions in the event of prenatal CMV infection with criteria of severity, leading or not to a request for IMG, is undeniable, but no study has investigated the consequences of seroconversion to CMV without transmission of the virus to the patient fetus, or in the case of transmission without criteria of seriousness, on the patient's experience during and after her pregnancy. Such a study would, if necessary, improve the care and support of these future mothers
NCT04658810 — Pregnancy Related
Status: Completed
http://inclinicaltrials.com/pregnancy-related/NCT04658810/
Self-regulation of Prefrontal Cortex During Emotional Cognitive Control in PTSD
Deficits in emotional cognitive control are present in a number of clinical psychiatric populations including depression, anxiety, and PTSD. Deficits in this domain of function limit one's ability to focus attention on goal-directed activities while inhibiting reactions to irrelevant emotional stimuli, and this contributes to the symptoms of these disorders and makes individuals less likely to be successful in existing treatments. The left dorsolateral prefrontal cortex (LDLPFC) and its connectivity with other regions (i.e., dorsal anterior cingulate cortex, ventromedial prefrontal cortex, insula, amygdala) is thought to play a central role in facilitating emotional cognitive control. However, past research has primarily utilized correlational approaches that limit conclusions about the directionality of these relationships. Enhancing our understanding of the neural underpinnings of emotional cognitive control could be valuable for informing treatment for populations with deficits in these processes, such as adults with PTSD. The current study utilizes a neuromodulatory approach called real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) whereby participants observe their own neural activity in the moment and are taught to self-regulate this activity. Adult volunteers, who have been diagnosed with PTSD, will be trained to increase neural activity in LDLPFC while involved in mental tasks involving emotional cognitive control processes. The mental tasks will include counting, remembering words, or planning events while viewing negatively-valenced emotional words (e.g., kill, death, threat). Participants in this study will complete a non-randomized LDLPFC rtfMRI-nf protocol to assess tolerability and feasibility of the protocol in a clinical population of interest. Resting-state fMRI scans and behavioral testing sessions will take place before and after rtfMRI-nf. The specific aims are to examine the impact of LDLPFC rtfMRI-nf on: (1) LDLPFC activity during emotional cognitive control, (2) LDLPFC functional connectivity with other brain regions during rest, and (3) cognitive control task performance. As this study is meant to be preliminary, the target sample size is not powered to detect statistical significance for these measures. However, effect size estimates will be calculated to provide potential justification for future work with this protocol in this clinical population. To these ends, this study will use rtfMRI-nf to examine preliminary evidence of a novel protocol to regulate LDLPFC activity in adults diagnosed with PTSD. This research will improve our understanding of emotional cognitive control and demonstrate whether this is a modifiable target for intervention in this clinical population of interest.
NCT04543513 — PTSD
Status: Withdrawn
http://inclinicaltrials.com/ptsd/NCT04543513/