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Stress Disorders, Traumatic clinical trials

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NCT ID: NCT03808727 Completed - Clinical trials for PTSD, Post Traumatic Stress Disorder

Massed Cognitive Processing Therapy for Combat-related PTSD

Start date: March 5, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if cognitive processing therapy (CPT) delivered in a massed format (MCPT) is as effective as standard delivery of CPT. MCPT will be delivered in an intensive outpatient setting (12 sessions in 5 days) composed of both group and individual sessions. Standard delivery of CPT consists of 12 sessions over 6 weeks and involves only individual sessions. Assessment of PTSD and related symptoms will be conducted at pre-treatment and 1 month and 4 months following treatment in both conditions. Additionally, in order to compare the treatment groups at the same point in actual time, each group will be assessed at the one month posttreatment time point for the other condition.

NCT ID: NCT03796936 Recruiting - Clinical trials for Traumatic Brain Injury

3MDR to Treat PTSD With mTBI (3MDR)

3MDR
Start date: January 11, 2019
Phase: Phase 2
Study type: Interventional

Background and Purpose: Posttraumatic stress disorder (PTSD) and mild traumatic brain injury (mTBI) are persistent and frequently comorbid complications of recent combat. There is no proven treatment for mTBI, and standard treatments for PTSD frequently achieve only transient, modest impact. Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR) is a novel treatment for PTSD combining aspects of virtual reality exposure therapy (VRET) and Eye Movement Desensitization and Reprocessing (EMDR), within the Computer Assisted Rehabilitation Environment (CAREN). The added benefit of the eye movement (EM) component of EMDR is controversial; the purpose of this pilot study is therefore to: 1) obtain an initial estimate of the efficacy of 3MDR in service members with comorbid PTSD and mTBI, and 2) determine the impact of EM on treatment response. The investigators hypothesize that 3MDR will significantly improve symptom severity, both with and without EM. Population: Participants will be active or retired service members with a history of mTBI who meet criteria for probable PTSD on the PCL5. It is anticipated that participants will be recruited through the Center for Neuroscience and Regenerative Medicine (CNRM) Recruitment Core and the National Intrepid Center of Excellence (NICoE). Design type and procedures: This is a pilot, controlled clinical trial in which all 20 participants with comorbid PTSD and mTBI receive 10 sessions (3 preparatory, 6 3MDR treatment, and 1 conclusion), but will be randomized to either include EM (EM+) or not (EM-). In the preparatory sessions, the therapist will help each participant select 2 songs and 14 pictures to be used in their treatment sessions. The therapist will help the participant rate the pictures from least to most impactful. Each 3MDR treatment session will start by playing the first song, to bring them back to the time of their trauma. This will be done while the participant walks on the CAREN's embedded treadmill through the 3MDR virtual environment (VE) projected onto the system's curved screen. This is followed by a display of one of their pictures, a manifestation of their trauma, which they directly face and walk down a hallway toward, until the picture looms before them. The therapist, standing next to the participant along the treadmill's edge, will query the participant about what the picture means to them, how it makes them feel, etc., while the CAREN operator superimposes key words (said by the participant) over the picture, which the therapist later asks the participant to read aloud. Then, for ~60 seconds, the EM+ group will see a red ball "bounce" across the screen in front of the picture, and a number appears on the ball as it touches the screen's edge. The participant will be asked to recite each number aloud. This element is absent for EM- participants. All participants repeats these procedures for 5-7 pictures in each 3MDR treatment session; the pictures used will be agreed upon by therapist and participant, targeting more impactful pictures, whether repeats or new, in later sessions. The pictures are followed by playing the second song, chosen to bring the participant back to present day. The participant will walk at a comfortable pace throughout the session, with each session lasting typically ~60 minutes. The primary outcome measure will be change in PCL-5 score from pre- to post-intervention, with additional measures at 3 and 6 months.

NCT ID: NCT03795987 Completed - Ptsd Clinical Trials

Traumatic Nightmares Treated by NightWare (To Arouse Not Awaken)

TNT/NW
Start date: February 7, 2019
Phase: N/A
Study type: Interventional

This study will provide preliminary estimates of safety and efficacy of the NightWare digital therapeutic system (iPhone + Apple watch + proprietary application) for the treatment of nightmare disorder associated with post-traumatic stress disorder (PTSD)-related sleep disturbance and the impact of improved sleep with the NightWare digital therapeutic system. The investigators hypothesize that the NightWare digital therapeutic system will significantly improve sleep quality in participants with PTSD-Related nightmares and poor sleep quality.

NCT ID: NCT03788278 Not yet recruiting - Clinical trials for Post-traumatic Stress Disorder

An Advanced Digital Phenotype System Among People Suffering From Post-traumatic Stress Disorder

Start date: August 20, 2019
Phase:
Study type: Observational [Patient Registry]

Psychiatric diagnosis is based mainly on questioning the patient and subjective impression rather than a quantitative assessment. The assessment is usually done with long time intervals between assessments and arbitrary in relation to the clinical course of the disorder. Post-traumatic stress disorder has physiological, physical, and behavioral manifestations. These changes appear as a response to different situations during the day and can be measured directly and indirectly in order to obtain an objective, quantitative and fuller picture of the severity and changes in the disorder. This is a non-interventional pilot study, using a system that collects data through wearable sensors and smartphone over a long period of time for patients suffering from PTSD and enables data analysis and characterization of a personal digital phenotype using a dedicated algorithm. Based on this pattern, the investigators will attempt to support the establishment of the PTSD diagnosis. During the course of the study, the therapeutic procedure will not be affected by the study and will be independent of the research.

NCT ID: NCT03777800 Completed - Depression Clinical Trials

Body Therapy for War Veterans With Post Traumatic Stress Disorder (PTSD)

Start date: January 14, 2019
Phase: N/A
Study type: Interventional

The present study is a randomized, controlled trial that compares a certain type of body therapy, called ManuVision, to treatment as usual (TAU) in war veterans with posttraumatic stress disorder (PTSD). The purpose of the study is to determine whether participation in the body therapy treatment by war veterans who have PTSD, will reduce symptoms of PTSD and depression, and improve quality of life, function level and body awareness. Study hypotheses state that the ManuVision approach, compared to the treatment as usual, will be more effective at reducing the PTSD symptoms experienced by veterans because it will help the veterans learning to become aware of, accept the PTSD symptoms, reading their own emotional state and gain body awareness and subsequently have emotional control and improved coping mechanism when PTSD symptoms arise. The awareness, accept and improved coping mechanisms means that the nervous system is not under the same pressure and that PTSD symptoms therefore may be reduced.

NCT ID: NCT03777553 Completed - Clinical trials for Posttraumatic Stress Disorder

Narrative Exposure Therapy (NET)

NET
Start date: June 13, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to learn more about Narrative Exposure Therapy for Justice Involved Veterans. This pilot study will examine the feasibility of this intervention in a justice-involved veteran population, and will see whether the intervention needs to be tailored to best meet their needs. The investigators will examine whether the intervention impacts key clinical outcomes, including posttraumatic stress disorder symptoms, as well as on measures of moral injury, anger, depression, suicidality, and aggression.

NCT ID: NCT03777020 Completed - Clinical trials for Post Traumatic Stress Disorder

Service Dog Training Program for Military Veterans With PTSD

Start date: August 22, 2019
Phase: N/A
Study type: Interventional

Post-traumatic stress disorder (PTSD), an invisible wound of war, affects approximately 20%1 of the 18.5 million U.S. veterans and places them at higher risk for impaired biopsychosocial functioning. PTSD symptom severity (PTSDSS) is significantly correlated with stress and psychosocial consequences of inability to regulate emotions, control impulsive behaviors, and function within family and society. Alarming veteran PTSD rates and its insidious effects demand empirically validated treatment programs. More than a million veterans receive new diagnoses of each year. VA PTSD therapy programs reach only 1% of veterans. Nearly 35% of veterans do not respond to widely used psychotherapy and pharmacotherapy treatments. Training a service dog (SD) is a novel rehabilitative animal-assisted intervention that shows promise in other populations. This project evaluates the efficacy of a service dog training program (SDTP) as an alternative and adjunctive treatment and rehabilitative option for veterans with PTSD.

NCT ID: NCT03770156 Completed - Clinical trials for Post-Traumatic Stress Disorder

Terrorist Attack - Continuity of Care

CUMP75
Start date: January 22, 2020
Phase:
Study type: Observational

On November 13th 2015, a terrorist attack killed 129 victims in Paris. An emergency crisis unit (CUMP) has been activated in Paris in the days following the attack and a subunit was in charge to answer to the phone calls of victims and their relatives. The same emergency crisis unit have been activated for the terrorist attack in London, 2017 june 3, terrorist attack in Barcelone 2017 august 17-18, terrorist attack in Strasbourg 2018 December 11 The purpose of this observational study is to document the evolution of psychiatric symptoms among subjects who called the CUMP and to collect information about the type of medical or non-medical care they were seeking for.

NCT ID: NCT03764033 Active, not recruiting - Moral Injury Clinical Trials

A Novel Posttraumatic Stress Disorder Treatment for Veterans With Moral Injury

IOK
Start date: August 12, 2019
Phase: N/A
Study type: Interventional

The objective of this project is to test the efficacy of an individual treatment for post-traumatic stress disorder (PTSD) stemming from moral injury called Impact of Killing (IOK), compared to a present-centered therapy (PCT) control condition, and to determine the rehabilitative utility of IOK for Veterans with PTSD. The first aim is to test whether IOK can help improve psychosocial functioning for Veterans, as well as PTSD symptoms. The second aim is to determine whether IOK gains made by Veterans in treatment are durable, as measured by a six-month follow-up assessment. Veterans who kill in war are at increased risk for functional difficulties, PTSD, alcohol abuse, and suicide. Even after current PTSD psychotherapies, most Veterans continue to meet diagnostic criteria for PTSD, highlighting the need for expanding treatments for PTSD and functioning. IOK is a treatment that can be provided following existing PTSD treatments, filling a critical gap for Veterans with moral injury who continue to suffer from mental health symptoms and functional difficulties.

NCT ID: NCT03761732 Completed - Clinical trials for Post Traumatic Stress Disorder

Islamic Trauma Healing: Feasibility Study

Start date: October 15, 2018
Phase: N/A
Study type: Interventional

This study will examine the initial feasibility of a program called Islamic Trauma Healing by conducting a small feasibility study (N = 26) of Islamic Trauma Healing in Somalia on key targets of PTSD, depression, somatic symptoms, and quality of life. The hypothesis is that those in Islamic Trauma Healing will show a reduction of PTSD symptoms, depressive symptoms, and somatic symptoms and show improvement in quality of well-being. Feasibility will also be examined by examining at retention, satisfaction, and community feedback.