PTSD Treatment for Incarcerated Men and Women: WPP
Study examining the psychological response to group Cognitive Processing Therapy (CPT) in incarcerated men and women with Post-traumatic stress disorder (PTSD). The study will be conducted in male and female incarcerated populations and will include 2 groups of 10 individuals for both CPT and Therapist-facilitated Support Group in both populations (i.e., 80 participants total; 40F/40M, four CPT groups of 10 (2 Female (F)/2 Male (M)); four Therapist-facilitated Support groups of 10 (2F/2M)). The study will run for up to 2 years. Participants can expect to be participating in study for up to 22 weeks.
NCT05432817 — PTSD
Status: Recruiting
http://inclinicaltrials.com/ptsd/NCT05432817/
Advancing Peer Support Programming to Address PTSD and Trauma Among Canadian Public Safety Personnel and Veterans
A prospective cohort study design will be implemented across four sectors and multiple organizations sites to evaluate implementation and impact of the apps. Pre/post impact data will be collected over a six-month implementation period to assess whether the apps lead to increased Public Safety Personnel outreach to peer support (primary outcome), and to increased mental health literacy, and decreased mental distress (secondary outcomes). Recruitment will take place at three levels; 1) organizations (including knowledge users/organization champions), 2) peer support providers, and 3) public safety personnel employed within each participating organization. Sources of implementation and impact data for the six-month trial will include: 1) app utilization data, 2) knowledge user/organization champion interviews, 3) surveys with public safety personnel, 4) focus groups with peer support providers, and 5) implementation costs. Analysis will focus on both implementation and effectiveness to address the research questions related to the impact of the apps, as well as how the process and context of implementation shapes effectiveness.
NCT05429619 — Post Traumatic Stress Disorder
Status: Active, not recruiting
http://inclinicaltrials.com/post-traumatic-stress-disorder/NCT05429619/
Enhancing the Efficacy of Evidence-Based PTSD Treatment Via Microbiota-Directed Prebiotic Supplementation
Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder, which results from exposure to traumatic events. Veterans are more than twice as likely to suffer from PTSD compared to civilians. Current interventions for the treatment of PTSD are evidence-based psychotherapies, such as Cognitive Processing Therapy (CPT). Therefore, we plan to compare Cognitive Processing Therapy (CPT) with and without a novel prebiotic bar designed to beneficially modulate the microbiota to determine the utility of this combined approach to positively impact PTSD symptoms. We will conduct a 12-week randomized, double-blind, placebo-controlled, cross-sectional trial in veterans with PTSD. Participants will be randomized to receive CPT + prebiotic or CPT + placebo. They will be provided a supply of prebiotic or non prebiotic bars for 12 weeks. At three different time points, participants will complete questionnaires and complete questionnaires and produce a stool sample ( weeks 1,2, and 12). All participants will be recruited from the two-week in-person Intensive Outpatient Program (IOP) at the Rush Road Home Program, where they will be receiving CPT.
NCT05424146 — Post Traumatic Stress Disorder
Status: Completed
http://inclinicaltrials.com/post-traumatic-stress-disorder/NCT05424146/
Neural Connectivity Before and After Each of the Three Treatment Phases of Trauma-focused Therapy for Adolescent Posttraumatic Stress
Posttraumatic stress disorder in adolescence impairs neurobiological networks underlying cognitive, social and emotional skills. Neuroimaging research that seeks to identify the neural mechanisms of treatments for PTSD could lead to novel treatments, but progress has been slow using current methods. The proposed study uses an innovative approach to identify neural mechanisms of specific phases of trauma-focused therapy for youth with PTSD, allowing a new understanding of brain changes associated with the process of therapy.
NCT05423444 — PTSD
Status: Recruiting
http://inclinicaltrials.com/ptsd/NCT05423444/
PTSD Clinical Team Research Clinic (PCT Research Clinic)
Part of the IRB_00136053 study was to look at the effectiveness of Warrior Renew and Warrior Renew+EAL interventions. Furthermore, demographic information on Veteran participants will be analyzed.
NCT05422768 — PTSD
Status: Active, not recruiting
http://inclinicaltrials.com/ptsd/NCT05422768/
A Phase 2, Multi-center, Multi-arm, Randomized, Placebo-controlled, Double-blind, Adaptive Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Potential Pharmacotherapeutic Interventions in Active-Duty Service Members and Veterans With PTSD
This is a Phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for PTSD utilizing an adaptive platform trial design. Participants are randomized among the multiple cohorts in the study and the resulting randomization enables sharing/pooling of control participants, where all interventions may be compared to a common control (placebo). This master protocol describes the default procedures and analyses for all cohorts; treatment-specific procedures will be described in the Master Protocol cohort-specific appendices. Individual cohorts may have additional eligibility requirements, safety and efficacy procedures, or endpoints, which will be described in corresponding intervention-specific clinicaltrials.gov records.
NCT05422612 — Post Traumatic Stress Disorder
Status: Recruiting
http://inclinicaltrials.com/post-traumatic-stress-disorder/NCT05422612/
The Effectiveness of Online Revised Written Exposure Therapy for PTSD: A Randomized Controlled Trial
The study aims to examine the effectiveness of the online revised written exposure therapy (WET-R) for PTSD and subclinical PTSD among Chinese adults with a randomized controlled trial. The study will recruit 90 participants, with 60 randomized to the online WET-R group, and 30 randomized to the minimal contact control (MCC) group. The WET-R intervention consists of 5-7 one to one sessions. The primary outcome PTSD Symptom Scale - Interview for DSM-5 (PSSI-5) will be administered on baseline, post-treatment, 1-month follow-up, 3-month follow-up, and 6-month follow-up assessments.
NCT05421494 — PTSD
Status: Recruiting
http://inclinicaltrials.com/ptsd/NCT05421494/
Safety, Feasibility, and Benefits of Transcranial Direct Current Stimulation (tDCS) in Human Subjects With Posttraumatic Stress Disorder (PTSD) Receiving an Exposure-based, Behavioral Therapy
The primary objective of this study is to evaluate the safety, feasibility, and psychological and physiological treatment benefits of transcranial direct current stimulation (tDCS), a noninvasive brain stimulation technique, when delivered in combination with Written Exposure Therapy (WET), for posttraumatic stress disorder posttraumatic stress disorder (PTSD).
NCT05419999 — Post Traumatic Stress Disorder
Status: Active, not recruiting
http://inclinicaltrials.com/post-traumatic-stress-disorder/NCT05419999/
Diet Induced Ketosis for Patients With Posttraumatic Stress Disorder (PTSD), a Feasibility Study
Many patients suffering from posttraumatic stress disorder (PTSD) are resistant to established treatment consisting of psychotherapy. Patients often go years with this debilitating disorder without experiencing sufficient improvement. Approximately 1/3 of patients will drop out of treatment because of psychological burden and overactivation. A novel ketogenic diet treatment could amend established treatment, and potentially upregulate the threshold for exciting neurons in dysfunctional brain regions, mediated through various mechanisms. This may reduce PTSD symptoms, and thus enabling patients to respond to psychological treatment without getting overactivated and unable to process trauma. The purpose of this study is to investigate whether it is possible to carry out a ketogenic diet therapy for patients with PTSD for four weeks.
NCT05415982 — PTSD
Status: Completed
http://inclinicaltrials.com/ptsd/NCT05415982/
Study of the Involvement of Cognitive, Emotional, and Behavioural Self-regulation and Control Capacities in the Modulation of Post-traumatic Stress Disorder Symptomatology in Adults: Processual and Integrative Approach
Non-pathological stress has an adaptive value, allowing a person to prepare for the demands of everyday life and increasing chances of survival in the face of danger. To "cope", the individual responds with behavioural, emotional and cognitive strategies (coping strategies). Coping aims to modify the problem causing the stress (problem-focused coping) or to regulate the emotional responses associated with the problem (emotion-focused coping), or it can be focused on avoidance (psychologically and/or physically avoiding the source of the stress). Coping is therefore not positive or negative per se and the strategies used by an individual can be positively or negatively associated with resilience. Thus, the mechanisms by which coping strategies, whether dispositional or situational, induce resilience or, conversely, the development of symptoms linked to stress and PTSD remain poorly understood. To detect and characterize some of these mechanisms, the present research focuses on high-level capacities closely linked to coping and resilience and involved in stress and psychotrauma, namely cognitive control (notably attentional and executive processes that allow for adaptive control of cognition and behaviour) and emotional regulation (processes allowing the triggering, inhibition, maintenance or modulation of emotions). The global research program includes different studies aimed at analyzing and screening for factors, or complexes of factors, that may be involved in the modulation of PTSD symptomatology in adults, based on a dimensional process-oriented and integrative approach. The present study will examine the relationship between the severity and nature of the symptoms of PTSD (e.g. avoidance) and the different processes considered. The primary objective is to examine the impact of the preferential use of habitual coping strategies (emotion-focused, problem-focused or avoidance-focused coping) on the severity of PTSD symptoms. Another objective is to explore the interrelationships, in the modulation of symptoms, between these (specific) coping strategies and the more general and stable self-regulatory capacities, namely emotional regulation and cognitive control. 50 patients aged between 18 and 65 years, followed for a definite diagnosis of PTSD, will participate and complete a set of self-questionnaires and neuropsychological tests.
NCT05400200 — Stress Disorders, Post-Traumatic
Status: Recruiting
http://inclinicaltrials.com/stress-disorders-post-traumatic/NCT05400200/