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93 active trials for Posttraumatic Stress Disorder

Effectiveness of Basic Body Awareness Therapy in Post-traumatic Stress Disorders: A Randomized Clinical Trial

The aim of this randomized controlled clinical trial is to assess the effectiveness of Basic Body Awareness Therapy online in patients' survivors of Covid-19, health workers and women suffering from gender based violence regarding post-traumatic stress disorder in comparison with treatment as usual. The study will be multicentric in base Hospital Igualada and University of Lleida. The participants will be survivors of Covid-19 that had been inpatient in intensive care and health workers in first line with pandemia as doctors, nurse, physiotherapist, etc. More else, a new context emerge regarding gender based violence during the lockdown time. Outcomes variables will be measured regarding post-traumatic stress disorder, anxiety, depression, pain, quality of life and sleep. Fifty-four patients will be randomly assigned to a control group that will follow treatment as usual. The intervention group that will be received the same treatment adding Basic Body Awareness Therapy. The intervention will last 3 months twice a week at online format. At first month the intervention consisted of 12 movements and 15 min for sharing reflections about experiences. During the subsequent sessions, the treatment will be in group of 8 participants using the same methodology online. If the conditions of pandemia allow, the group will be presential in the health center at last month. Data analysis will performed using ANOVA of variables intragroup with repeated measurements. The analyses of the effects between groups will be performed throught ANOVA intergroup.

Start: September 2021

Recovery Learning for Adolescents After Traumatic Experiences

Most children who have been removed from their family home and placed under the care of a Local Authority have been exposed to many frightening experiences, including witnessing violence, not being fed or cared for, or being abused. These experiences can lead to significant emotional difficulties. One such difficulty is posttraumatic stress disorder (PTSD), which can involve symptoms like having constant "flashbacks" of scary experiences, and a constant feeling of being in danger. This can have a big effect on children's lives. Yet, it is still not clear how to help young people in care who are experiencing high PTSD symptoms. One idea the researchers have is to use a group-based online programme which has successfully helped other young people who have been exposed to different kinds of stressful experiences (for example, war). To test whether this programme could help children in care too, the researchers first need to see whether social workers have the time to check in with a child about PTSD symptoms? whether young people and their carers are willing to be involved in a research project which will test out the treatment programme? and whether mental health workers might face any problems when delivering the programme. This project aims to answer these questions. The researchers will train social workers to complete an 8-question interview with 10-17 year olds in care, which will measure symptoms of PTSD. If the young person is experiencing high symptoms, they will be invited to take part in a research project. If they would like to join the project, children will be randomly selected to take part in the online group programme, or be given care-as-usual. The group programme involves the young person taking part in five weekly meetings held online, where they will learn skills to reduce their distress, and be supported to work through their difficult memories. Their carers will also take part in two online meetings which will teach them how to support their young person.

Start: August 2020

EMDR Therapy Following After a Myocardial Infarction Induced Posttraumatic Stress Disorder

Acute cardiac syndromes (ACS) can often result in debilitating and persistent psychological symptoms. A key question involves whether optimal treatment of ACS-induced posttraumatic stress disorder (PTSD) reduces PTSD symptoms and thereby may offset the risk of recurrent or worsening cardiovascular disease. ACS-induced PTSD 1) is prevalent, 2) features symptoms unique to internal ongoing somatic threat, with fears and worries that can be distinguished from PTSD resulting from external causes, 3) is persistent, 4) is associated with negative physical and emotional consequences, and 5) has not been the subject of randomized-controlled treatment trials (RCT). There is preliminary evidence suggesting that patients with cardiac-disease induced PTSD might particularly profit from EMDR. Nevertheless, this possibility has not been tested in ACS-induced PTSD. Currently, patients with ACS-induced PTSD are not routinely offered trauma-focused therapies, with a lack of scientific evidence likely being one major reason for this omission. If our proposed RCT shows that EMDR can be an effective treatment for patients with ACS-induced PTSD, EMDR could be routinely implemented as first-line treatment. The RCT outcomes might inform larger trials to test whether poor prognosis in terms of major adverse cardiovascular events can be improved through EMDR in patients with ACS-induced PTSD.

Start: November 2020

Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder and Borderline Personality Disorder (PTSD-BPD)

Posttraumatic Stress Disorder (PTSD) and Borderline Personality Disorder (BPD) are two mental health conditions that often occur together (i.e., PTSD-BPD), with comorbidity rates as high as 58%. PTSD-BPD is associated with even greater functional impairment and higher healthcare burden than either disorder alone. There are surprisingly few treatments available for this clinical profile, despite its association with major negative health outcomes, cost, and morbidity. There is a pressing need to innovate treatments that can effectively and efficiently treat PTSD-BPD. The existing treatments used for PTSD-BPD are lengthy, laborious, resource-intensive, and require that participants cease all suicidal behaviours prior to treatment. Furthermore, no integrated treatment has been innovated to address the specific mechanisms underpinning this comorbidity. We propose to examine an adapted version of a first-line PTSD intervention, Cognitive Processing Therapy (CPT) plus Suicide Risk Management (SRM), as a briefer (12 sessions) and more efficient treatment alternative that strategically targets shared mechanisms underpinning PTSD and BPD. The purpose of this uncontrolled study is to collect initial safety and efficacy data on this adapted treatment. Knowledge gleaned from this study will have significant direct clinical implications. Potential risks of the study include individual distress, suicide risk, and residual PTSD and BPD symptoms post-treatment. To minimize risk, study therapists will closely monitor participants using the suicide risk assessment and management protocol. Using this protocol, if participants remain distressed after a therapy session or psychological interview they will be encouraged to discuss their distress with their study assessor or therapist and coached to implement strategies to reduce their distress. If they express self-harming or suicidal urges the study assessor or therapist will implement a standardized protocol to monitor and address any escalations in risk. Potential benefits of this study include reductions in participants' PTSD, BPD and other mental health symptoms. Additionally, the study may benefit others by improving the treatment repertoire for PTSD-BPD with a more succinct treatment that can also be utilized for individuals with suicidal behaviours.

Start: September 2021

Using mHealth to Improve Emotional Recovery After Pediatric Injury

Nearly 300,000 U.S. children experience injuries that require them to be hospitalized this year. These children, and their caregivers, are at high risk for emotional and behavioral problems, as well as poor quality of life. Trauma centers in the US have good outcomes for survival and physical recovery, but they typically do not have programs to address the emotional and behavioral needs of families. The purpose of this project is to develop a service that achieves this and that can serve as a good model for trauma centers to use. This project will develop, evaluate, and test CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies) to address the behavioral and emotional needs of caregivers and children.

Start: May 2021

Predicting SSRI Efficacy in Veterans With PTSD

This is a research study to examine the effectiveness of a brief screening method that may predict which people with posttraumatic stress disorder (PTSD) are most likely to show a positive response to selective serotonin reuptake inhibitor (SSRI) medications. Participants will be recruited over approximately 3.25 years, until at least 94 participants complete the 17 week study.

Start: September 2019

Targeted Strategies to Accelerate Evidence-Based Psychotherapy (EBP) Implementation in Military Settings

This study will evaluate a program designed to increase military treatment facilities' use of Prolonged Exposure (PE), an evidence-based psychotherapy for PTSD. The results will determine whether this program increases PE use and improves patient outcomes compared to conventional provider training in PE, and feedback from clinic leaders and staff will be used to gauge program usability, identify successful components, and refine program for expansion.

Start: January 2019

Neuroeconomics of Social Behavior Following Trauma Exposure

This study will use a neuroeconomic paradigm with state-of-the-art imaging protocols to probe abnormal social reward processing underlying social withdrawal in symptomatic trauma-exposed women. By also gathering self-report measures of social anhedonia, performance on non-social and social reward valuation tasks, and measures of real-world social functioning including social network size, we aim to specify how alterations in social reward processing result in social withdrawal and functional impairment.

Start: November 2017

Telephone Delivery of Cognitively Augmented Behavioral Activation (CABA)

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.

Start: September 2019

The PaTHS Descriptive Correlational Longitudinal Study

The primary objective of this study is to measure parent's post-traumatic stress before and after their infant's second palliative heart surgery for single ventricle congenital heart disease. The investigators will use the posttraumatic stress disorder checklist for the DSM-V (PCL-5) to measure levels 2-4 weeks before and after the infant's second heart surgery. The investigators aim to describe the levels at the two-time points, compare the scores, and identify demographic information that correlates with the scores.

Start: March 2021

NightWare Open Enrollment Study

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.

Start: February 2019

Art Therapy qEEG Study for Service Members With a Traumatic Brain Injury and Posttraumatic Stress Symptoms

Service members with post traumatic stress symptoms and traumatic brain injury receive 6 sessions of art therapy, which could help alleviate symptoms. In the art therapy, participants will be provided with a blank paper mache mask template and invited to alter the mask however they wish using a variety of art materials. The therapist will use the art-making process and culminating product to aid in self-reflection, reframe negative thoughts and feelings, and work through traumatic content. Prior to the session start participants will get set up with a mobile qEEG (worn like a hat and backpack). The qEEG will measure brain activity in a non-invasive way throughout the art therapy session to improve understanding of brain activity during the art therapy process.

Start: February 2021

Mobile Mindfulness for Alcohol Use and PTSD Among Veterans

The purpose of the present study is to develop and test a mobile mindfulness intervention for Alcohol Use Disorder and PTSD among OEF/OIF veterans

Start: August 2021

Pilot Study Testing a Web-Based Moral Elevation Intervention for Veterans With PTSD and Moral Injury

Given the prevalence of posttraumatic stress disorder (PTSD) and moral injury in combat Veterans and the limitations to current treatments, novel approaches are needed to target both PTSD and moral injury and directly impact psychosocial growth and functional recovery. One potential way to address this critical need is through moral elevation-a positive emotional state described as feeling uplifted and inspired by others' virtuous actions. This study will pilot a web-based moral elevation intervention with Operations Enduring Freedom, Iraqi Freedom, and New Dawn Veterans who experienced a morally injurious event and with a PTSD diagnosis. If Veterans are willing and able to complete an online moral elevation intervention and it has beneficial effects, then moral elevation could be feasibly utilized as a tool to reverse the negative effects of trauma and facilitate recovery. Data from this study will be used to develop larger clinical trials to test if this intervention significantly improves PTSD symptoms and moral injury distress and enhances social functioning.

Start: March 2020

Neuromodulatory Treatments for Pain Management in TBI

Traumatic brain injury (TBI) and chronic pain are common and serious health problems for military veterans and often co-occur, leading to poor post-deployment adjustment. Pharmacological treatments for pain elevate risk of opioid abuse, and research suggests veterans perceive barriers to existing non-pharmacological, clinic-based treatments. Thus, there is an urgent need to develop pain management approaches that are effective, overcome barriers to care, and are readily usable by Veterans. Evidence suggests that neuromodulatory treatments, grounded in understanding of neurophysiological mechanisms of pain, reduce pain-related symptoms and have the potential to be developed into self-directed treatments through use of mobile technology.

Start: September 2018

SMART-DAPPER: Leveraging the Depression And Primary-care Partnership for Effectiveness-implementation Research Project

Despite carrying the vast majority of the global mental disorder burden, 75% of adults with mental disorders in Low and Middle Income Countries have no access to services. This study will test strategies for integrating first and second line evidence-based depression and trauma-related disorder treatments with primary care services at a large public sector hospital and conduct robust cost and cost-benefit analyses of each treatment to produce a "menu" of cost-benefit options for personalized, integrated mental health care with corresponding effectiveness and implementation values.

Start: August 2020

The Effects of Perioperative Painting Art Therapy (LOM® Solution Centered Art Therapy) in Surgical Patients

The investigators want to study whether the use of painting art therapy has an influence on the quality of life, the complication rate and the general outcome of major abdominal surgery. The painting art therapy is carried out according to the protocol of (LOM® Solution Centered Art Therapy) by trained painting art therapists.

Start: August 2020

Comparing Group Therapies for Veterans With Depression and PTSD

Cognitive behavioral therapy (CBT) is a brief, efficient, and effective psychotherapy for individuals with depressive and PTSD. However, CBT is largely underutilized within Veteran Affairs Medical Centers (VAMCs) due to the cost and burden of trainings necessary to deliver the large number of CBT protocols. Transdiagnostic Behavior Therapy (TBT), in contrast, is specifically designed to address numerous distinct disorders within a single protocol. The transdiagnostic approach of TBT has the potential to dramatically improve the accessibility of CBT within VAMCs and therefore improve clinical outcomes of Veterans. The proposed research seeks to evaluate the efficacy of a group version of TBT (G-TBT) by assessing clinical outcomes and quality of life in VAMC patients with major depressive disorder and PTSD throughout the course of treatment and in comparison to two existing group disorder-specific therapies (G-DST), CBT for Depression and Cognitive Processing Therapy for PTSD.

Start: February 2021

Stress, Adjustment And Growth In Children With Cancer And Their Parents

This proposal examines trauma and growth responses in the childhood cancer experience. It addresses a number of gaps and unanswered questions in the literature, while integrating several distinct but related lines of research. The rationale for this proposal is outlined briefly as follows: Traumatic stress models focused on pathology dominate pediatric psychosocial oncology research despite empiric evidence of low levels of post-traumatic stress in this population. The assumption of 'cancer as a traumatic event' has biased research designs (including lack of control comparisons) to focus on deficits and pathological outcomes. This deficit-oriented approach has stimulated the development of interventions to treat or prevent PTSD, which may be unnecessary or even harmful. Theoretical and empiric evidence suggests that a more common response to traumatic stress is growth and positive change, but posttraumatic growth phenomenon have been understudied in pediatric populations. Cognitive and personality factors are important determinants of PTSD and positive growth outcomes, and some constructs from positive psychology theory may be particularly relevant in children with cancer. Empirically, parents of children with cancer appear to be at higher risk of PTSD/PTSS, although results are not unequivocal, and the same research biases have applied to parental outcomes. This proposal includes assessment of parental PTSS and PTG, both as an outcome and a predictor of child outcomes.

Start: July 2009

Tele-based Psychological Emotional Support for Informal CARegivers of COVID-19 Patients in Intensive Care

The experience of a loved one's stay in a COVID-19 intensive care unit (ICU), either intubated or on respiratory support, forces family caregivers (hereafter 'caregivers') to face core existential fears, such as uncertainty and death. It also poses a serious threat to basic human needs for autonomy, competence, and relatedness, as family caregivers have no control over the illness, and limited prior competence in dealing with critical illness. COVID-19 likely aggravates this experience, as social distancing cuts caregivers off from visiting patients in the ICU, from using their usual social supportive network and the threat of infection extends to caregivers themselves, their children and family. Combined, these extreme circumstances put caregivers in emotional turmoil and in need of psychological support and assistance in managing difficult emotions. ICU caregivers are at risk of developing clinically relevant symptoms of anxiety or posttraumatic stress. During the patient's ICU stay, caregivers experience peri-traumatic distress, such as helplessness, grief, frustration and anger, that may predict later posttraumatic stress disorder (PTSD). Symptoms of anxiety and PTSD may last for months to years after the patient's discharge. Further, caregivers of patients who die in an ICU may be at greater risk of prolonged grief disorder. Supportive interventions may reduce psychological late effects in ICU caregivers, but the primary focus of the majority of interventions has been on communication or surrogate decision making. The CO-CarES study aims to develop and test the feasibility of a tele-delivered psychological intervention to enable caregivers of ICU patients with COVID-19 to better endure the overwhelming uncertainty and emotional strain and reduce the risk of posttraumatic stress and prolonged grief. The study hypothesizes that providing psychological intervention during and after the patients' hospitalization, can decrease peri-traumatic distress during ICU hospitalization and decrease risk of post-traumatic stress, anxiety, depression and perceived stress following discharge, as well as prolonged grief in bereavement. A secondary hypothesis is that changes in emotion regulation mediate effects of the intervention on long-term psychological outcomes.

Start: May 2020