Clinical Research Directory

Enhancing the Effectiveness of Prolonged Exposure Among Suicidal Individuals With PTSD

The long-term goal of this study is to reduce suicidal thoughts and behaviors among treatment-seeking individuals who also have posttraumatic stress disorder (PTSD). Prolonged exposure (PE) and crisis response plan (CRP) have demonstrated empirical support for reducing suicide attempts as compared to treatment as usual. However, no studies to date have assessed their effectiveness when used in combination. In light of this knowledge gap, the primary objective of this study will be to test the effectiveness of PE augmented with CRP as compared to PE with care as usual (self-guided treatment plan), an active comparator, for the reduction of suicide ideations and attempts for individuals with comorbid PTSD.

Systematic Redesign of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)

Trauma-focused cognitive behavior therapy (TF-CBT) has the strongest evidence of any clinical intervention for youth trauma but is rarely adopted in the education sector - the most common setting for youth mental healthcare. Use of TF-CBT in schools is limited by (1) problems with its usability (e.g., rigid structures, complicated patient identification workflows) and (2) provider perceptions that some core elements (e.g., exposure) are not contextually appropriate for schools; both of which hinder provider and student engagement with TF-CBT. Our preliminary studies identified that TF-CBT demonstrates "below average" usability, suggesting that many providers are likely to experience it as excessively onerous (e.g., due to lengthy sessions, low caregiver engagement). Without a systematic process for redesign, treatment adaptations made to improve intervention-setting fit can be reactive and risk omitting their core elements or functions. Locally driven, user focused redesign of TF-CBT for schools that maintains its core functions can enhance the accessibility and impact of evidence-based trauma treatment for youth. In light of the need for usable, contextually appropriate, and engaging interventions for youth trauma, the current project will iteratively adapt TF-CBT for use by school-based providers (e.g., school counselors, school social workers) via the University of Washington ALACRITY Center's (UWAC) Discover, Design/Build, Test (DDBT) approach and methods drawn from the field of human-centered design.

Trauma Intervention to Optimize PrEP Among Women Who Inject Drugs

The goal of this randomized controlled trial is to test the effectiveness of "TIARAS," a trauma intervention designed to reduce HIV acquisition risk among women who inject drugs (WWID). To be eligible for this study, participants must have been prescribed pre-exposure prophylaxis (PrEP), a medication taken to prevent HIV, at Prevention Point Philadelphia, a large harm reduction agency located in Philadelphia (PA, USA), or Courage Medicine, a nonprofit health services clinic located in Philadelphia (PA, USA). Enrollment in this study lasts for 12-months so that we can see if TIARAS reduces HIV risk immediately after the intervention ends and whether these effects last over time. During the first 3 months, participants engage in contingency management (CM), an evidenced-based intervention to reduce drug use and HIV risk. We will use CM to encourage engagement in PrEP care as well as stimulant/opioid abstinence. Also during the first 3-months, participants are randomly assigned to complete expressive writing exercises to address a previously undisclosed trauma or neutral writing exercises. Half of the participants will be assigned to the trauma writing group and the other half will be assigned to the neutral writing group. To understand the impact of TIARAS on HIV risk, we will collect and analyze data from surveys, interviews, and biological specimen during the 12-month study period. Our main questions are: * Does participation in TIARAS reduce HIV risk among WWID? * If observed, how long do beneficial effects last? * How and why do WWID experience benefits from TIARAS?

Trauma-Informed Care for Smoking Cessation for Pregnancy

Trauma-informed approaches have been shown to support recovery from other substance use disorders and involve four key elements: (1) Realizing the prevalence of trauma and pathways to recovery, (2) Recognizing symptoms of trauma, (3) Responding by embedding knowledge of trauma into practices and policies and (4) Resisting re-traumatization (the 4Rs). In close partnership with Breathe California and a public safety-net clinic in San Francisco that serves primarily racial and ethnic minoritized (REM) pregnant women, the 4Rs along with the Ask, Advise, Assess, Assist and Arrange (the 5As) evidence-based intervention for tobacco cessation that is delivered by health care professionals and is a US Public Health Services clinical practice guideline for treating tobacco will be used to create and implement a smoking cessation intervention for pregnant women with experiences of trauma.

Early Life Stress and Depression: Molecular and Functional Imaging

Severe childhood adversity accounts for a large portion of psychiatric illness, and an increased risk for major depressive disorder (MDD). For some individuals, childhood adversity has negative psychological and medical consequences; others preserve mental and physical health despite such experiences (they are resilient). In spite of this, little is known about the neurobiological mechanisms related to childhood adversity, especially oxidative stress abnormalities in the brain. To fill this gap, this study combines functional, structural, and molecular imaging approaches to examine the role of oxidative stress abnormalities related to childhood adversity.

Transparent Communication to Improve Mental Wellbeing and Attitude Towards Reintegration

Reintegrating those once affiliated with proscribed terrorist groups constitutes significant global challenges due to public stigma, poor awareness of reintegration programmes and resentment towards incentives provided to rehabilitated former members of such groups. Of central concern is the anxiety, trauma and depression suffered alongside distrust for reintegration programmes, including the genuine repentance of former members of the proscribed group. The implication is its risk in exacerbating reoffending. Yet, a gap exists to address this urgent problem. The proposed study seeks to test and pilot the feasibility and acceptability of a novel intervention called Prosociality, Empathy and Awareness Communication to aid rEintegration (PEACE) in improving mental well-being and public attitude towards reintegration. The intervention is a low-intensity intervention lasting approximately 3-5 minutes design to create awareness on the rationale behind reintegration programme, reduce anxiety, depression and foster positive attitude towards reintegration.

Interaction Between Early Trauma and Odor-induced Dopamine Release

This prospective, double-blind, parallel-group controlled trial aims to investigate the consequence of early trauma on dopamine release evoked by positive valence odors.

HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis

Babies with single ventricle congenital heart disease (SVCHD) are often diagnosed during pregnancy. While prenatal diagnosis has important clinical benefits, it is often stressful and overwhelming for parents, and many express a need for psychological support. HeartGPS is a psychological intervention for parents who receive their baby's diagnosis of SVCHD during pregnancy. It includes 8 sessions with a psychologist, coupled with tailored educational resources, and a personalized care plan. The intervention focuses on fostering parent psychological adjustment and wellbeing, and supporting parents to bond with their baby in ways that feel right for them. Through this study, the investigators will learn if HeartGPS is useful and effective for parents and their babies when it is offered in addition to usual fetal cardiac care. The investigators will examine the effects of the HeartGPS intervention on parental anxiety, depression, and traumatic stress; fetal and infant brain development; parent-infant bonding; and infant neurobehavioral and neurodevelopmental outcomes. The investigators will also explore mechanisms associated with stress biology during pregnancy, infant brain development and neurodevelopmental outcomes, and parent and infant intervention effects.

A Comprehensive Third-generation Intervention for People With Psychosis and Post-traumatic Stress Symptoms

Existing data suggest that both trauma and Post-Traumatic Stress Disorder (PTSD) are very common among individuals with psychosis. The presence of PTSD symptoms in psychosis is associated with worse clinical outcomes and poorer social functioning. However, PTSD is a poorly attended and poorly studied condition among this population. Research to date indicates that trauma-focused treatments are safe and effective for PTSD, even when psychotic comorbidity is present. Recent systematic reviews of psychological interventions for trauma in psychosis found that are effective in reducing trauma symptoms, suggesting that they should be implemented in front-line services. Nonetheless, larger confirmative trials are required to form robust conclusions.The aim of this project is to examine the efficacy of comprehensive third-generation protocol for people with comorbid trauma and psychosis.

The Effect of Dual Attention in an EMDR Intervention

Research to date indicates that trauma-focused treatments are safe and effective for PTSD, even when higher-risk comorbidities (e.g., psychosis or substance use) are present. In particular, there are data pointing to the efficacy of prolonged exposure therapy and eye movement desensitization and reprocessing (EMDR) therapy. Clinical practice guidelines specifically recommend trauma-focused treatment with exposure and/or cognitive restructuring components. Regarding EMDR interventions, there are increasing results supporting its efficacy. Some interesting clinical advantages presented by EMDR as opposed to cognitive-behavioral therapies are 1) the efficacy found despite less exposure to the traumatic memory, 2) the exclusion of homework, 3) as well as the rapid reduction in subjective disturbance produced even after a single session of EMDR therapy. However, the mechanisms producing the improvement and, in particular, the effect of bilateral stimulation are not precisely known. More research is needed in this regard since bilateral stimulation is the most controversial part and with less evidence found. In addition to this, there are very few studies that have analyzed the differential efficacy of the presence or absence of bilateral stimulation or of the different types of stimulation possible. As for the comparison between types of stimulation (bilateral with eye movements, or focusing on a fixed point), greater treatment effects have been found for EMDR with fixation on an immobile hand compared to eye movements. The aim of this study is to examine the effectiveness of a comprehensive intervention protocol for people who have experienced traumatic events and present post-traumatic symptomatology. In addition, this study will compare the efficacy of traumatic memory processing with and without dual attention.

Development of a Culturally Grounded, Trauma-Informed Alcohol Intervention With a Reserve-Dwelling First Nation Group

The objective of this project is to develop and obtain preliminary data on a culturally grounded, trauma-informed alcohol intervention. The specific aims are to (1) use Community-Based Participatory Research methods to deepen partnerships with First Nation through capacity-building and knowledge sharing; (2) collect and apply qualitative data to develop a culturally grounded, trauma-informed alcohol intervention that is focused on historical trauma for use with a First Nation sample; and (3) conduct a pilot RCT study to examine acceptability, sustainability, and initial efficacy data of the intervention compared to waitlist control. This work is important, timely, and innovative. Addressing alcohol use has important implications for the health of Indigenous populations.

Narrative Exposure Therapy for Adults With an Intellectual Disability

The goal of this naturalistic single case series design is to investigate if an adapted Narrative Exposure Therapy protocol can be effective, is feasible, and acceptable for adults with a mile learning disability. Participants will be complete three baseline sessions before taking part in Narrative Exposure Therapy using a manual that has been adapted for people with a learning disability. Trauma symptoms will be measured weekly using the Impact of Events scale adapted for intellectual disabilities. The person's carer will also complete an informant scale related to these symptoms (LANTS-IV). The client will also complete the CORE-LD at pre, and post therapy. Six weeks after the end of the intervention, the client and their carer will be invited to a feedback session to talk about how they found the intervention.

Feasibility and Acceptability of BRIGHT

Refugees and asylum seekers (RAS) face numerous stressors and adversities which put them at risk for developing mental health problems. However, access to adequate mental health care in host countries is limited. To address this problem, the World Health Organization (WHO) introduced Problem Management Plus (PM+), a short, low-intensity psychological intervention administered by non-professionals, aiming to alleviate common mental disorders among crisis-affected communities. The objective of this pilot RCT is to assess the feasibility and acceptability of an adapted version of PM+ for refugees and asylum-seekers. This will inform the design of a definitive RCT and implementation study.

EMDR Therapy in Young Children, a Double-blinded Randomized Controlled Trial

This project aims to answer to the question of EMDR effectiveness in young children and to determine whether or not the therapy effectiveness is related to the level of cognitive functioning in young children. The study requires a total of 60 children, girls and boys, aged 3 to 6 years and presenting disorders related to stressors, anxiety and/or trauma. Participants will be randomly distributed in two groups: "EMDR therapy" (N=30) group or "control therapy" (N=30) group. The study will take place in four stages: 1/ Pre-treatment phase : An evaluation of child's various cognitive and executive functions, child's symptomatology and parental distress is planned in a pre-treatment phase. 2/ Treatment phase : An EMDR therapy or a routine care is administered to the child between 6 to 10 weeks. 3/ Post-treatment phase : A reassessment of child's and parent's symptoms is planned at the end of treatment. 4/ Continuation of treatment: Children who have received control therapy and without symptomatic improvement will be proposed EMDR treatment. These children will receive the same symptomatic assessments at the end of EMDR treatment. A significant reduction in disorders related to trauma or stress and anxiety factors and their symptomatology, as well as comorbid disorders and their symptomatology, is expected in children who received EMDR therapy compared to the group who received a control therapy. These results are expected to be robust over a period of at least 3 months. The positive effects of EMDR on child symptomatology are also expected to be more pronounced in children showing higher levels of cognitive functioning

Lighthouse Parenting Nanai: a Mentalization-based Group Therapy for Caregivers with History of Trauma

The goal of this feasibility randomized controlled trial is to evaluate the effectiveness and acceptability of the Lighthouse Mentalization-Based Treatment Parenting Program (Lighthouse MBT-P) as an intervention for parents at risk of maltreating their children. The study focuses on parents with a history of childhood trauma, aiming to improve parent-child relationships, reduce parenting stress, and ultimately decrease the risk of child maltreatment. The goal of this study is to test how well the Lighthouse Mentalization-Based Treatment Parenting Program (Lighthouse MBT-P) works for parents who may be at risk of harming their children. The program aims to help parents understand and manage their own and their children's emotions better. By improving these skills, the program hopes to reduce stress in parenting and lower the chances of child abuse or neglect. The main questions this study will answer are: * Can parents follow and complete the Lighthouse MBT-P program? * Does the program help lower stress in parenting and improve relationships between parents and their children? Participants in this study will: * Attend weekly group sessions for 12 weeks. These sessions will teach them how to better understand and manage emotions. * Take part in discussions led by trained psychologists. Researchers will compare the results of parents who take part in the Lighthouse MBT-P program with those who receive standard parenting support to see which approach works better.

The BEAR Therapeutic Program for Women

The current study aims to test a novel therapeutic intervention for women who have a history of interpersonal trauma. The Building Empowerment and Resilience (BEAR) Therapeutic group incorporates psychological skills, psychoeducation, and physical empowerment training, all within a therapeutic process. It will be implemented iwith women who have experienced interpersonal trauma (physical, sexual, or emotional abuse/neglect). The investigators aim to understand how this program effects one's self-efficacy and whether the program can reduce rates mental health problems (such as depression and anxiety) and reduce the rates of revictimization. Women who participate in the BEAR group must be able to attend in-person sessions. The control group can be remote.

Youth Experiences and Health Study

This study aims to identify unusual experiences and psychiatric symptoms that indicate a heightened risk for severe mental disorders - especially psychoses. It is important to develop reliable questionnaire methods that are cost-effective in first-stage screening, leading to in-depth assessments and targeted care. However, existing psychosis-risk questionnaires are limited in content, intended for adults, and have been insufficiently tested for actual predictive value. Therefore we will collect a new, large dataset from an unselected group of adolescents entering psychiatric care in three major urban areas of Finland. Comprehensive national health care registers will be used to assess how well the selected experiences and symptoms predict the participants' mental health over the following few years.

CMAP Plus Trauma-focused Cognitive Behavior Therapy for Suicidal Ideation Among Burn Survivors

The study aims to determine whether CMAP Plus TFBCT is feasible and acceptable for burn survivors with suicidal ideations. To identify any barriers to the recruitment of participants. To determine initial data for the primary outcome measure to perform a sample size calculation for a larger trial.

Feasibility Study of a Group Intervention for Youth Wellbeing

Psychological distress, anxiety and depression are common in adolescence, and even more so following traumatic events. On Friday 15 March 2019, two mosques in Ōtautahi, Christchurch were targeted in an act of terrorism, resulting in 71 people being injured and 51 people being shot dead. This has had widespread repercussions in the Muslim and wider community in Christchurch and New Zealand. Uptake of a response pathway set up by community and district health board groups has been low despite reports of high levels of distress in the adolescent population. The proposed study offers a transdiagnostic group treatment approach (ie. Targeting a broad range of emotional difficulties) for teenagers from a community impacted by the March 15th shootings, incorporating well-evidenced transdiagnostic treatment principles into an Islamic Psychology framework to address the local population's need. We will determine the feasibility and effectiveness of this approach in increasing wellbeing in teenagers. We will run gender-specific treatment groups (8 participants in each group) recruited from the community, with one individual session (for information and consent) and 6 group sessions. We will measure symptoms of emotional difficulties, trauma symptoms and functioning at baseline, end of treatment and at 3 months follow-up. In addition, we will check in weekly with participants to monitor for any increased distress. We will also measure parental distress to explore whether an intervention for adolescents has an impact on parental wellbeing.

EMDR Pre-treatment Yoga for Complex Trauma

yoga is a technique of hope. Indeed, it is a practice that specifically combines postures, breathing technique and a state meditative. The combination of these elements produces multiple effects that are exposed to detailed in the publications of Bessel Van der Kolk (Price et al., 2017; Rhodes, Spinazzola, \& van der Kolk, 2016; Van der Kolk, 2014; Van Der Kolk et al., 2014) and whose four main effects are summarized here: * A regulation of the level of vigilance * An improvement in self-awareness * An increased sense of self-efficacy * Improved metacognition, awareness and regulation emotional

Pedopsychiatric and Multidisciplinary Research Devoted to Children Exposed to the Attack in Nice on July 14, 2016

On July 14, 2016, in Nice, children and their families were attacked by the organization "EI". In Nice, 86 deaths, including 10 children, the youngest at 4, were recorded. A number of children, still difficult to assess exactly but over 100, was bereaved. After a traumatic event, multiple clinical consequences may appear in children. Among these consequences, the most common is Post-Traumatic Stress Disorder (PTSD). The aim of the study is to characterize the psycho-social factors of risk and / or protection interfering in the children's future, following the mass trauma of 14 July 2016 in Nice on a sample of pediatric population exposed in comparison of children controls. Ancillary study, entilted "The Physalis Child", prospectively observe the presence or not of non-psychotic acousto-verbal hallucinations (AVH) in the population with PTSD from the "Program 14-7". The main objective of this ancillary study will be to identify factors of social and emotional cognition linked to the presence of non-psychotic HAV within the cohort of children exposed to the mass trauma of July 14, 2016 in Nice but also to any type of individual trauma. Ancillary study, entilted "trail of the 14 July attack", prospectively observe the risk of traumatic reactivation.