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Stress Disorders, Post-Traumatic clinical trials

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NCT ID: NCT04231578 Completed - Clinical trials for Posttraumatic Stress Disorder

Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction)

HOPES
Start date: March 31, 2020
Phase: N/A
Study type: Interventional

Posttraumatic stress disorder (PTSD) is a common and disabling condition associated with intimate relationship problems and mental health problems in partners of those with PTSD. Recognizing the need to improve access to evidence-based interventions for those with PTSD and their families, our team has developed an Internet-delivered, self-help intervention to improve PTSD, enhance relationships, and improve partners' mental health: Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction). Couple HOPES presents text and video-based content across seven self-help intervention modules, with modest support from paraprofessional coaches. Although the Couple HOPES platform has been developed, it remains uncertain whether Couple HOPES is feasible, usable, and efficacious in reducing PTSD and enhancing intimate relationship functioning. The proposed project aims to refine and finalize Couple HOPES with couples that include a veteran, service member or first responder with significant PTSD symptoms. This project includes initial testing of the intervention's preliminary efficacy, safety, and feasibility in a series of 10 couples (Phase 1), then in an uncontrolled trial of 20 couples (Phase 2), and then a randomized clinical trial comparing its efficacy to a delayed intervention control condition in 70 couples. Potential benefits of this study include couples learning new skills to reduce PTSD symptoms and enhance relationship functioning, although this is not guaranteed. Risks include participants finding the assessments distressing, or possible worsening of PTSD symptoms or relationship functioning. These risks will be mitigated by continuous monitoring of PTSD symptoms, relationship functioning, and adverse events, and intervention by study staff.

NCT ID: NCT04228133 Completed - PTSD Clinical Trials

Home-Delivered Attention Control Treatment for Post Traumatic Stress Disorder (PTSD)

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

The aim of the study is to explore the efficacy of home-delivered Attention Control Training (ACT) for Posttraumatic Stress Disorder (PTSD). Three randomized controlled trials have shown that attention bias modification protocols applying attention control training (ACT) aimed to balance attention between threat-related and neutral stimuli are efficient in reducing PTSD symptoms. However, contrary to in-clinic administration, such as applied in the above mentioned studies, home-delivered attention bias modification was not effective in reducing symptoms among treatment-seeking patients. It is crucial to continue examining the efficacy of home-delivered ACT as PTSD entails functional impairments that might impede treatment-seeking patients from reaching to clinics to receive treatment. This could also inform other ABM protocols designated to treat other disorders.

NCT ID: NCT04225130 Completed - Clinical trials for Posttraumatic Stress Disorder

Decreasing Suicide Risk Among Service Members With Posttraumatic Stress

Start date: January 9, 2020
Phase: N/A
Study type: Interventional

In this study, the investigators will conduct a randomized controlled trial (RCT) to evaluate the efficacy of the WET-S + treatment as usual (TAU) compared with TAU among high-risk, suicidal service members with PTSD or posttraumatic stress (PTS) admitted to the Carl R. Darnall Army Medical Center (CRDAMC) acute inpatient psychiatry unit at Fort Hood, Texas. Suicide risk and PTS symptom severity are the primary outcomes. Secondary outcomes include subsequent hospitalizations for suicidal thoughts and behaviors and suicide attempts. Investigators will conduct a needs assessment with stakeholders during the RCT to develop a tool kit for WET implementation in other DoD inpatient psychiatry units.

NCT ID: NCT04200976 Completed - Clinical trials for Traumatic Brain Injury

Telephone Delivery of Cognitively Augmented Behavioral Activation (CABA)

Tele-CABA
Start date: September 15, 2019
Phase: N/A
Study type: Interventional

Traumatic brain injury (TBI) is highly prevalent and frequently comorbid among Veterans and Service Members. Many of these individuals sustain more than one TBI over the course of their military careers, often with little recovery time between exposures placing them at increased risk for persistent cognitive, psychological, and psychosocial difficulties that impact daily functioning and life satisfaction. The short-term objective of this study is to examine the efficacy of the manualized, 10-week, telephone delivery of Tele-CABA for improving cognitive and adaptive functioning. The long-term objective of this study is to develop an accessible and acceptable intervention that can be broadly disseminated to address the complex rehabilitation needs of Veterans and Service Members. The overall goal of the Tele-CABA intervention is to reduce negative cognitive and psychiatric health outcomes for Veterans and Service Members with a history of TBI, promote personal resilience, and to design an intervention that is accessible and acceptable to patients struggling to recover from TBI.

NCT ID: NCT04188392 Completed - Insomnia Clinical Trials

Pimavanserin for Insomnia In Veterans With Posttraumatic Stress Disorder

PIP
Start date: January 6, 2020
Phase: Phase 4
Study type: Interventional

This preliminary, open-label study assesses the feasibility of 34mg at bedtime for 6 weeks in Veterans with Posttraumatic Stress Disorder and insomnia.

NCT ID: NCT04186962 Completed - Clinical trials for Post-traumatic Stress Disorders

Tetris to Reduce Intrusive Memories in Parents After PICU

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

The purpose of this study is to examine the acceptability and feasibility of a brief behavioural intervention involving Tetris gameplay to prevent intrusive traumatic memories in parents after paediatric intensive care. The present acceptability and feasibility study seeks to answer the following questions: (1) Is this intervention acceptable to parents whose children have been admitted to PICU, (2) how practical is it to deliver the intervention in this setting, (3) willingness of hospital staff to be involved in the recruitment of participants, (4) after having taken part in the intervention themselves would parents have been willing to consent to their child taking part in the intervention, and (5) discover any challenges or barriers in carrying out this study. Furthermore, this study aims to estimate recruitment, withdrawal and dropout rate, in order to act as a preliminary test of the effect of the intervention and inform sample size estimation. The findings from this study will inform the design of a randomised control trial.

NCT ID: NCT04174170 Completed - Clinical trials for Post Traumatic Stress Disorder

Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder

Start date: October 30, 2019
Phase: Phase 3
Study type: Interventional

This will be a 12-week, multicenter, randomized, double-blind trial evaluating the efficacy, safety, and tolerability of fixed-dose brexpiprazole + sertraline combination treatment in adult subjects with post-traumatic stress disorder.

NCT ID: NCT04163341 Completed - Depression Clinical Trials

Tailored Response to Psychiatric Comorbidity to Improve HIV Care Engagement in the United States

TRACE
Start date: October 23, 2020
Phase: N/A
Study type: Interventional

This pilot randomized clinical trial will randomize 60 participants 1:1 to either enhanced usual care or to adapted CETA, a counseling intervention for HIV care engagement plus depression, anxiety, PTSD, and/or substance use.

NCT ID: NCT04152772 Completed - PTSD Clinical Trials

Effect of tDCS Timing on Safety Memory in PTSD

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

The primary purpose of this study is to investigate the effects of tDCS timing on safety memory in PTSD. A total of 90 participants will be randomized equally across one of three groups: 1. One group receiving active stimulation during extinction and sham during consolidation 2. One group receiving sham stimulation during extinction and active during consolidation 3. One group receiving sham stimulation both during extinction and consolidation This study will also include an online sub-study focused on contextual processing along the PTSD spectrum. A maximum of 500 participants will be recruited using an online, panel-based platform.

NCT ID: NCT04124614 Completed - Clinical trials for Post Traumatic Stress Disorder

Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD

Start date: October 17, 2019
Phase: Phase 3
Study type: Interventional

This will be a 12-week, multicenter, randomized, double-blind trial evaluating the efficacy, safety, and tolerability of brexpiprazole + sertraline combination treatment in adult subjects with Post-Traumatic Stress Disorder.