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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT03505749 Completed - Clinical trials for Post Traumatic Stress Disorder

A Trauma Informed Adaptation of Mindfulness-Based Relapse Prevention for Women in Substance Use Treatment

Start date: June 18, 2018
Phase: N/A
Study type: Interventional

More than 90% of women in substance use treatment report history of physical and/or sexual trauma, and up to 60% meet criteria for both substance use disorder (SUD) and Post Traumatic Stress Disorder (PTSD). PTSD typically precedes onset of SUD, with substances used as a means to cope with physiological, psychological, and emotional symptoms resulting from the trauma. Women with PTSD experience greater severity of addiction symptoms, readmit into treatment more frequently than women without PTSD, and tend to have poorer treatment outcomes. Due to increased risk for exacerbation of PTSD on SUD severity and treatment success, and the specific vulnerabilities and needs of women with this comorbidity, SUD treatments that target both substance use and trauma recovery are needed. However, few interventions target both SUD and PTSD concurrently, and fewer still are specific to women. Mindfulness-Based Relapse Prevention (MBRP) has been shown to decrease craving, relapse rates, and quantity/frequency of use across several substances, and has shown acceptability in diverse populations. MBRP integrates mindfulness practices with cognitive behavioral and exposure-based approaches to increase self-regulatory skills while experiencing triggers previously associated with substance use, including challenging affective states such as those common to experienced trauma. Adapting MBRP to incorporate trauma education and treatment approaches has the potential to effectively treat women with the dual vulnerabilities of trauma history and SUD. The current study is thus designed to determine feasibility, acceptability, and initial efficacy of an adapted Trauma-Informed Mindfulness-Based Relapse Prevention (TI-MBRP) intervention for women in substance use treatment settings who have PTSD. TI-MBRP integrates trauma education and treatment approaches drawn from Cognitive Processing Therapy (CPT) into the standard MBRP protocol to provide a trauma-informed approach to treating women in substance use treatment settings. The current proposal will evaluate TI-MBRP, using a randomized, pre-post design, with 100 women in residential substance abuse treatment. Participants will be randomly assigned to participate in a 4-week TI-MBRP intervention or to continue with treatment as usual (TAU). Assessments will be collected pretest, posttest, and at one-month follow-up. Data from this study will lay the groundwork for a larger scale clinical trial to determine the efficacy of TI-MBRP.

NCT ID: NCT03503981 Recruiting - Depression Clinical Trials

Examining Change Mechanisms in Psychotherapy

CAMP
Start date: September 15, 2017
Phase:
Study type: Observational

This research project seeks to acquire a deeper understanding of the complex influences of common factors and specific ingredients in psychotherapy. By using frequent process-outcome measures, it will address individualized mechanisms of change in psychotherapy by assessing both between and within patient change processes, using a wide spectrum of change indicators.

NCT ID: NCT03503526 Completed - Clinical trials for Stress Disorders, Post-Traumatic

Trauma-focused Group Music and Imagery With Traumatized Women

Start date: August 13, 2015
Phase: N/A
Study type: Interventional

This study is a mixed methods randomized controlled trial (Wait List Control), that investigates the effects of Group Music and Imagery (GrpMI) therapy in the treatment of women suffering from Post Traumatic Stress Disorder (PTSD) or Complex PTSD. The aim is to detect if the intervention has an effect on PTSD symptoms, dissociation, quality of life, and the capability of regulating the autonomic nervous system (ANS).

NCT ID: NCT03502564 Completed - Clinical trials for PostTraumatic Stress Disorder

Integrated Treatment for Co-occurring Eating Disorders and Posttraumatic Stress Disorder

Start date: October 22, 2015
Phase: N/A
Study type: Interventional

Although psychotherapy for eating disorders (EDs) can be effective, approximately 50% of those who complete a course of the best available therapy continue to have significant ED symptoms at the end of treatment. Posttraumatic stress disorder (PTSD) commonly co-occurs with EDs and is thought to be one reason why some individuals do not remit from their ED with best available treatment or relapse following treatment. In particular, ED behaviours can function as coping methods for PTSD symptoms, and thus interfere with successful and lasting ED recovery. The main objective of this initial treatment trial is to determine whether a concurrent treatment approach, in which PTSD symptoms are treated at the same time as ED symptoms, provides an advantage over standard ED treatment by successfully alleviating PTSD symptoms. Forty participants who have both an ED and PTSD will be assigned to receive either (1) standard ED psychotherapy alone or (2) standard ED psychotherapy concurrent with PTSD psychotherapy. After treatment, participants will be followed for a period of 6 months to determine whether improvements made during therapy are maintained after treatment. ED and PTSD symptoms, as well as concomitant symptoms (e.g., anxiety and depression) will be assessed immediately before and after treatment, as well as 3 and 6 months after treatment.

NCT ID: NCT03498599 Recruiting - Anxiety Disorders Clinical Trials

Neuroimaging of Pavlovian Fear Conditioning Processes in Patients With Pathological Anxiety

Start date: August 1, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to use functional magnetic resonance imaging to investigate how the human brain learns to form associations between neutral and emotional stimuli. The study is based on the basic principles of Pavlovian conditioning. When someone learns that a neutral stimulus (such as the sound of a bell) predicts an unpleasant stimulus (such as a mild electrical shock), the neutral stimulus takes on the properties of an emotional stimulus. The investigators are interested in the neural processes involved in this learning in people with a clinical anxiety disorder and posttraumatic stress disorder (PTSD).

NCT ID: NCT03498482 Completed - Clinical trials for Posttraumatic Stress Disorder

Adressing PTSD Symptoms and Aggressive Behavior in Vulnerable Children in Burundi

Start date: March 15, 2017
Phase: N/A
Study type: Interventional

Children either living in the streets of Bujumbara or that are similarly affected by extreme poverty or violence are regularly exposed to traumatic events. Additionally, they often find themselves in situations where engaging in violent behavior appears to be useful or even necessary for survival. The Narrative Exposure Therapy for violent offenders (FORNET) aims to reduce both PTSD symptoms and aggressive behavior. It helps the children to anchor fearful experiences and potential positive emotions linked to violent behaviour in the past. Additionally, visions for the future are developed in order to enable reintegration into the family. The investigators want to provide evidence, that FORNET effectively reduces PTSD symptoms and ongoing aggressive behavior which in change facilitates reintegration into society.

NCT ID: NCT03496714 Withdrawn - Clinical trials for Psychoeducation on Safety Behaviors and How to Fade Them

Online Psychoeducation for the Prevention of PTSD

Start date: February 1, 2020
Phase: N/A
Study type: Interventional

Research on decreasing safety behaviors in therapy has been restricted to treatments for other anxiety disorders and has not included PTSD. In order to address this gap and to develop a widely accessible, cost-effective prevention, an internet-based, three-arm randomized secondary PTSD prevention trial is proposed. Self-help psychoeducation on common reactions to trauma and eliminating safety behaviors will be employed for participants who have recently experienced a traumatic event. Participants will be randomized to receive (a) psychoeducation on trauma symptoms only, (b) combined psychoeducation on trauma symptoms and eliminating safety behaviors, or (c) monitoring only control. All participants will monitor safety behaviors and trauma symptoms weekly for eight weeks. Psychoeducation materials will be handouts and videos administered online via REDCap. It is hypothesized that participants in both psychoeducation conditions will have a lower incidence of PTSD, threat appraisal, and safety behaviors than participants in the monitoring-only control. It is also hypothesized that participants who receive combined psychoeducation on trauma symptoms and fading safety behaviors will have a lower incidence of PTSD, threat appraisal, and safety behaviors at Weeks 4 and 8 than will participants who receive psychoeducation on trauma symptoms only or participants in the monitoring-only control. It is further hypothesized that the effects of combined psychoeducation on preventing PTSD and threat appraisal will be mediated by decreased use of safety behaviors. Finally, it is hypothesized that combined psychoeducation on trauma symptoms and fading safety behaviors will be more effective in preventing PTSD for participants with higher levels of safety behaviors or threat appraisal at baseline. If effective, this secondary prevention program could be distributed widely to people who have recently experienced a trauma to prevent their development of PTSD.

NCT ID: NCT03493243 Completed - Clinical trials for Post Traumatic Stress Disorder

Teenagers After London Terrorist Attack

AVAL
Start date: March 14, 2018
Phase:
Study type: Observational [Patient Registry]

- Context: Since March 2012, several terrorist attacks have been perpetrated in France (Toulouse, Montauban, Paris, Nice ...). In March 2017, 53 french teenagers were victims in a terrorist attack in London (Westminster Bridge). - Main goal = to estimate the psycho-traumatic impact and to describe cares and management of high school students, victims of the terrorist attack in London on 2017, March the 22nd. - 3 secondary objectives: 1) Clinical (occurrence of Post Traumatic Stress Disorders or other disorders); 2) Epidemiological (risk factors for developing disorders, avoiding care); 3) Preventive and therapeutic.

NCT ID: NCT03491007 Terminated - Clinical trials for Posttraumatic Stress Disorder

Neurosteroids in PTSD - Biomarkers to Therapeutics

Start date: July 8, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this research is to determine if a study medication called Dehydroepiandrosterone (DHEA) helps to reduce PTSD symptoms in OEF/OIF/OND Veterans. In addition to finding out if DHEA is effective for treating PTSD symptoms, this research seeks to determine if DHEA is effective in treating other symptoms, such as depression and anxiety. Depression and anxiety are symptoms that are frequently present in Veterans who are experiencing PTSD. Another purpose of this research is to takes pictures of the brain using magnetic resonance imaging (MRI) and blood levels of various small molecules including neurosteroids and also proteins, which may be affected by the study drug and/or related to symptoms in Veterans with PTSD. This study seeks to determine if DHEA is changed to other compounds after it is taken by mouth and the safety and effectiveness of DHEA in Veterans with PTSD. This is an "add-on" study and Veterans enrolled in the study will continue to take all of their current medications without any changes (also called "usual care"), and DHEA or a sugar pill (also called a "placebo") will then be added to their current medication regimen.

NCT ID: NCT03489122 Terminated - Clinical trials for Post Traumatic Stress Disorder

A Randomized Control Trial Treating Depression With Yoga and Coherent Breathing Versus Walking in Veterans

Start date: January 11, 2022
Phase: N/A
Study type: Interventional

The proposed study addresses a gap regarding the need for effective Major Depressive Disorder (MDD) treatments and the 40% of individuals treated with antidepressant medications that do not achieve full remission. This study tests a novel approach for treating MDD in a Randomized Control Trial (RTC) using yoga versus walking interventions to correct an imbalance in the Autonomic Nervous System; an over active Sympathetic Nervous System (fight or flight) an underactive Parasympathetic Nervous System (PNS) (rest, renewal and social engagement) and associated under activity in the neurotransmitter, gamma aminobutyric acid (GABA). This novel approach is complimentary to the use of antidepressant medications that primarily target the monoamine systems. Low activity in the PNS and GABA systems are also found in MDD, PTSD, and Alcohol Use Disorder, disorders representing a high healthcare burden in the Veteran population. This intervention has potential to provide relief for MDD and other disorders relevant the Veteran population