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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT03846323 Completed - Clinical trials for PTSD in Family Members of ICU Patients

Liberalization of Visiting Policies in ICU for Reducing High Risk of Post-traumatic Stress Disorder

OPEN-UNIT
Start date: April 18, 2009
Phase: N/A
Study type: Interventional

This was a cluster randomized study of an ICU level intervention to reduce high risk of post-traumatic stress disorder (PTSD) in family members of ICU patients. Participating ICUs had restrictive visiting policies (i.e., <6 hours/day) before randomization. After an observational period and a washout period, participating ICUs were randomized either to maintain their visiting policies or to liberalize their visiting policies (24 hours a day, 7 days a week.)

NCT ID: NCT03846154 Completed - Clinical trials for Posttraumatic Stress Disorder

Reintegrating Children Living at Landfills in Burundi Into Society by Means of a Comprehensive Family Program Addressing Maltreatment and Mental Health Symptoms

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

Children living at the landfills of Bujumbura are often exposed to maltreatment, including emotional neglect and physical abuse, and traumatic experiences. Furthermore, they grow up in severe poverty. Addressing trauma-related mental health issues and aggressive behaviour by Narrative Exposure Therapy (FORNET), familial communication by family visits, interaction difficulties of children by a group intervention, poverty by financial support and economic training for mothers, medical problems by medical assistance, legal conflicts by legal advice, and providing access to school, we aimed at reintegrating those children within the Burundian school system and improving familial relationships. The investigators want to provide evidence, that mental health interventions are an integral part of assisting children and families affected by poverty and violence.

NCT ID: NCT03845985 Completed - Clinical trials for Alcohol Use Disorder

Piloting "Signs of Safety": A Deaf-Accessible Therapy Toolkit for Alcohol Use Disorder and Trauma

Start date: June 3, 2019
Phase: N/A
Study type: Interventional

The U.S. Deaf community - more than 500,000 Americans who communicate using American Sign Language (ASL) - experiences nearly triple the rate of lifetime problem drinking and twice the rate of trauma exposure as compared to the general population. Although there are validated treatments for alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD) in hearing populations, there are no evidence-based treatments for any behavioral health condition that have been validated for use with Deaf clients. To address these barriers, the study team has developed "Signs of Safety", a Deaf-accessible therapy toolkit for treating AUD and PTSD. The study team's ongoing aims are to conduct a two-arm pilot RCT of "Signs of Safety" and to collect data on feasibility, preliminary clinical outcomes, and potential mediators and moderators of outcome.

NCT ID: NCT03841773 Terminated - PTSD Clinical Trials

A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD

RECOVERY
Start date: March 7, 2019
Phase: Phase 3
Study type: Interventional

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) - a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible patients will have a telephonic visit at week 2 and then return regularly to the study clinic for monthly visits for assessments of efficacy and safety.

NCT ID: NCT03840369 Completed - Clinical trials for Stress Disorders, Post-Traumatic

Pathophysiological Understanding and Treatment of PTSD: an rTMS Approach

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

In Canada, the prevalence of PTSD is approximately 12%, similar to Canadian military personnel. Current treatments for PTSD are limited in efficacy and durability - indicating a dire need for novel interventions in this population. Transcranial magnetic stimulation (TMS) has a high degree of safety and has been studied as an intervention for many mental health and neurological conditions; even showing initial promise for PTSD. We propose to study this further in a randomized sham controlled trial of TMS for PTSD.

NCT ID: NCT03833531 Completed - Clinical trials for Posttraumatic Stress Disorder (PTSD)

Effectiveness of PTSD-treatment Compared to Integrated PTSD-PD-treatment in Adult Patients With Comorbid PTSD and CPD

PROSPER-C
Start date: June 1, 2018
Phase: N/A
Study type: Interventional

The goal of PROSPER-C is to study effectiveness of ImRs compared to integrated SFT-ImRs in treatment-seeking, adult patients with comorbid PTSD and Cluster C Personality Disorder (CPD).

NCT ID: NCT03833453 Recruiting - Clinical trials for Posttraumatic Stress Disorder (PTSD)

Effectiveness of PTSD-treatment Compared to Integrated PTSD-PD-treatment in Adult Patients With Comorbid PTSD and BPD

PROSPER-B
Start date: June 1, 2018
Phase: N/A
Study type: Interventional

The goal of PROSPER-B is to study effectiveness of EMDR compared to integrated DBT-EMDR in treatment-seeking, adult patients with comorbid PTSD and Borderline Personality Disorder (BPD).

NCT ID: NCT03828656 Enrolling by invitation - Clinical trials for PostTraumatic Stress Disorder

NightWare Open Enrollment Study

NWOES
Start date: February 1, 2019
Phase: N/A
Study type: Interventional

This study will provide measures 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: NCT03827057 Active, not recruiting - Clinical trials for Traumatic Brain Injury

RECONsolidation of Traumatic Memories to ResOLve Post Traumatic Stress Disorder (RECONTROLPTSD)

RECONTROLPTSD
Start date: June 12, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Posttraumatic Stress Disorder (PTSD) is a common cause of morbidity in combat veterans, but current treatments are often inadequate. Reconsolidation of Traumatic Memories (RTM) is a novel treatment that seeks to alter key aspects of the target memory (e.g., color, clarity, speed, distance, perspective) to make it less impactful, and reduce nightmares, flashbacks, and other features of PTSD. The memory is reviewed in the context of an imaginal movie theater, presenting a fast (~45 sec) black and white movie of the trauma memory, with further adjustment as needed so the patient can comfortably watch it. Open and waitlist studies of RTM have reported high response rates and rapid remission, setting the stage for this randomized, controlled, single-blind trial comparing RTM versus prolonged exposure (PE), the PTSD therapy with the strongest current evidence base. The investigators hypothesize that RTM will be non-inferior to PE in reducing PTSD symptom severity post-treatment and at 1-year follow up; will achieve faster remission, with fewer dropouts; will improve cognitive function; and that epigenetic markers will correlate with treatment response. The investigators will randomize 108 active or retired service members (SMs) with PTSD to ≤10 sessions of RTM or PE, affording power to test our hypotheses while allowing for ≤ 25% dropouts. The investigators will use an intent to treat analysis, and the Clinician Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, or DSM5 (CAPS-5), conducted by blinded assessors, will be the primary outcome measure. Secondary measures of depression (PHQ-9), anxiety (GAD-7), sleep (PSQI), and functional status (WHOQOL-100), will be assessed pre- and post-treatment, and at 2, 6, and 12 months. ANOVA will compare symptom severity over time within and between groups. The investigators will track comorbid TBI, anticipating it will not adversely impact response. More effective therapies for PTSD, with and without TBI, must be developed and evaluated. RTM is safe and promising, but requires testing against evidence-based interventions in well-designed randomized clinical trials (RCTs). The full study can be conducted either in person or via secure video conferencing.

NCT ID: NCT03822598 Completed - Depression Clinical Trials

Promoting Asylum-seeking and Refugee Children's Coping With Trauma

Start date: June 20, 2017
Phase: N/A
Study type: Interventional

A short term trauma-focused cognitive- behavioral program to reduce trauma-related mental health problems among asylum-seeking and refugee children. The main hypothesis of the study is that the TRT program significantly improves mental health (i.e. reduces symptoms of post-traumatic symptoms, depression and generalized anxiety and increases perceived quality of life (Qol) in the intervention group compared to the waiting-list control group.