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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT05942391 Not yet recruiting - Anxiety Disorders Clinical Trials

Brief-intensive CBT Versus Once-weekly CBT in Anxiety-related Disorders

KOMMA
Start date: December 1, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare brief-intensive cognitive-behaviour therapy (CBT) with regular weekly CBT in people with anxiety-related disorders. The main question to answer is: will brief-intensive CBT improve functioning (work, family, social) more and faster than does regular weekly CBT? Participants will be asked to follow CBT treatment (20 sessions of 45 minutes in both conditions), and participate in 7 measurements with a total duration of 5 hours over 1 year. Researchers will compare: - Brief-intensive CBT: 16 sessions in 2 weeks + 4 follow-up sessions within 3 months - Regular CBT with 20 weekly sessions in 6 months

NCT ID: NCT05927324 Not yet recruiting - Clinical trials for Post-traumatic Stress Disorder

Clinician-Assisted Videofeedback Exposure-Approach Therapy (CAVEAT) Trial

CAVEAT
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

The first study proposed is a small (n= 10 to 12 maximum) open feasibility trial of CAVEAT which is a 16-session manualized brief psychotherapy prototcol that is designed to help mothers of infants and young children, whereby the mothers have been exposed to interpersonal violence (i.e. childhood maltreatment and family violence, intimate and non-intimate partner violence, interpersonal combat and or other forms of terrorism or political violence including physical and sexual assault) and who have developed related post-traumatic stress. The treatment uses an integration and extension of evidence-based techniques: Modified Interaction Guidance, Prolonged Exposure Therapy for PTSD, Child-Parent Psychotherapy, and Minding the Baby, in order to help mothers with post-traumatic dysregulation and difficulty in their maintaining sensitivity during challenging parent-child interactions (i.e. when mothers are confronted with child helpless states, emotion dysregulation, negative affect and child aggression). Outcome measures will initially include: maternal attributions towards her child (i.e. perception of child's personality), maternal-child behavior, and maternal-child symptoms of attachment disturbance and PTSD. This feasibility study is meant to perfect the manual and to prepare for an initial open trial with a larger clinical sample including analysis of pre- and post-intervention measures before further randomized control study can be done.

NCT ID: NCT05894902 Not yet recruiting - Clinical trials for Post Traumatic Stress Disorder

Open-Label Dose-Ranging Study of Oral SM-001 in Healthy Adults

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

Phase I safety and dose finding study of a standardized Ayahuasca analog (SM-001) in healthy adult volunteers

NCT ID: NCT05876481 Not yet recruiting - PTSD Clinical Trials

Evaluation of Psilocybin-assisted Psychotherapy (PaP) for the Treatment of Post-traumatic Stress Disorder (PTSD) in Military Veterans

Start date: June 2023
Phase: Phase 2
Study type: Interventional

Post-Traumatic Stress Disorder (PTSD) is a mental health condition that occurs as a result of a traumatic experience. Symptoms include feeling anxious, flashbacks, nightmares and difficulty sleeping. Several studies indicate that psilocybin-assisted psychotherapy (PaP) may be an effective treatment for a number of mental health conditions. This has led to PaP being designated as a "breakthrough treatment" by the FDA in the US. Despite indications that PaP may hold benefits in treating individuals with posttraumatic stress disorder (PTSD), this remains to be investigated. As such, the present study aims to examine the acceptability, feasibility, safety, and efficacy of PaP (psilocybin administered with psychotherapy) in treating PTSD in military veterans.

NCT ID: NCT05840120 Not yet recruiting - PTSD Clinical Trials

Studying the Clinical Research Experiences of Patients With PTSD

Start date: May 2024
Phase:
Study type: Observational

Clinical research participation percentages haven't always been fully representative of a given demographic. The goal is to find out which aspects of a clinical study may make it more difficult for patients to take part or see it through. The data will be evaluated through different demographic lenses and identify trends that could help improve the experience of future PTSD patients during clinical trials.

NCT ID: NCT05837845 Not yet recruiting - PTSD Clinical Trials

MDMA-assisted Therapy Versus Cognitive Processing Therapy for Veterans With Severe Posttraumatic Stress Disorder

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

In partnership with the Veterans Affairs (VA) Palo Alto Health Care System and Stanford University, this study aims to evaluate clinical outcomes, assess implementation feasibility, and health economics of MDMA-assisted therapy in the treatment of posttraumatic stress disorder (PTSD). Through a randomized comparison of MDMA-assisted therapy versus Cognitive Processing Therapy (CPT), a VA gold standard treatment for PTSD, the proposed study will set the stage for understanding the potential use and application of MDMA-assisted therapy for PTSD within the VA system.

NCT ID: NCT05816304 Not yet recruiting - Depression Clinical Trials

Effectiveness of Digital Cognitive Behavioral Therapy for Insomnia in Frontline Health Care Workers (The HCW-CBTi Study)

HCW-CBTi
Start date: June 1, 2023
Phase: N/A
Study type: Interventional

The COVID-19 pandemic has resulted in increased workload and concerns about personal and family safety for frontline healthcare workers (HCWs), which can lead to decreased well-being and worsening mental health. Sleep disruption is particularly prevalent among HCWs providing frontline COVID-19 care. It can have direct consequences on their cognitive and emotional functioning, as well as on patient safety. Cognitive Behavioral Therapy for insomnia (CBTi) is a first-line treatment for insomnia. It has been shown to improve sleep health and wellbeing in the general population. However, there are significant barriers to delivering CBTi to frontline HCWs, including limited availability of trained sleep therapists and high costs. To address this, a Canada-wide randomized controlled trial is developed to determine the effectiveness of a digital CBTi program on the sleep health, mental health, wellness, and overall quality of life of frontline HCWs caring for COVID-19 patients. This study may provide an easily accessible and scalable sleep health intervention that can be included as part of a national and global response to the COVID-19 pandemic.

NCT ID: NCT05790239 Not yet recruiting - Clinical trials for Post Traumatic Stress Disorder

MDMA-Assisted Therapy for Veterans With Moderate to Severe Post Traumatic Stress Disorder

Start date: October 2023
Phase: Phase 2
Study type: Interventional

This randomized, double-blind, single-site phase II 2-arm study will investigate the safety and preliminary efficacy of MDMA-assisted therapy compared with low dose d-amphetamine-assisted therapy on the severity of PTSD symptoms in participants aged 18 years and older with PTSD of at least moderate severity.

NCT ID: NCT05788302 Not yet recruiting - Clinical trials for Post Traumatic Stress Disorder

Mechanisms Underlying Efficacy of Prolonged Exposure

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

The primary objective of this research is to collect pilot data that demonstrates that proposed neural, psychophysiological and subjective markers measured before, during, and after treatment change over the course of Prolonged Exposure therapy (PE) for posttraumatic stress disorder (PTSD). The aims of the study are to: (1) examine theoretically informed mechanisms as pretreatment predictors of PE treatment efficacy, (2) characterize how neural, psychophysiological, and subjective markers measured before, during, and after treatment change over the course of PE, and (3) examine proposed mechanisms of change as measures of PE treatment efficacy. This is a longitudinal study of predictors of exposure therapy efficacy that will be conducted within the context of a standard 10 session PE treatment trial, with independent multimodal assessment batteries administered at pre-treatment, mid-treatment, post-treatment, and at 1-month follow-up. This data will be used to support a future NIMH and/or VA grant submission.

NCT ID: NCT05766241 Not yet recruiting - Clinical trials for Posttraumatic Stress Disorder

Investigating a Novel Sensory-based Program for Veterans With PTSD

SENSE-PTSD
Start date: April 2024
Phase: N/A
Study type: Interventional

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).