188 Clinical Trials for Various Conditions
This study evaluates the effects of an accelerated schedule of theta-burst stimulation, termed accelerated intermittent theta-burst stimulation (aiTBS), on the neural networks underlying explicit and implicit suicidal cognition in inpatients with major depressive disorder.
The main purpose of this cross-sectional study is to generate data to support the psychometric properties of the Suicide Ideation and Behavior Assessment Tool (SIBAT) and validate its use in participants at imminent risk of suicide.
This study will test a model of providing treatment to Latinx/Hispanic youth, who experience suicidal thoughts and behavior, and their caregivers. An affirmative and culturally relevant treatment will be provided to all youth and half of the families will be assigned to the additional support of a community health worker (CHW). Youth symptoms and family engagement to treatment will be followed for nine months. The potential benefit of adding the CHW intervention will be assessed.
This is an open enrollment study to collect data for the optimization of smartphone-based algorithms for the early detection of mental health and suicidal risk in a student population. Approximately 2000 students, ages 8-23, will be recruited by therapists across 30 schools and mental health centers.
Few empirically-based treatment models exist for adolescent suicide attempters post psychiatric hospitalization, despite the fact that managed care has limited the role of hospitalization to stabilization, rather than remission. This study will test the efficacy and initial outcomes of Attachment Based Family Therapy (ABFT) as an aftercare model to further gains made in inpatient treatment and reduce risk factors for future suicide attempts.
Suicide is a leading cause of death for youth 10-24, and nearly ΒΌ of adolescents report nonfatal suicidal thoughts and behaviors (STB). However, traditional interventions (e.g., multi-session therapy protocols) are contingent upon (1) access to treatment, (2) involvement of parents/guardians (hereafter parents), and (3) disclosure of risk to treatment providers. Unfortunately, adolescents are frequently hesitant to disclose STB to healthcare providers and parents for reasons including shame, stigma, and fear of hospitalization, with even lower rates of disclosure among queer youth-including those with diverse genders and sexualities- who are at disproportionately high risk for STB. Related to these concerns, most youth at risk for suicide, as well as other mental health challenges, do not access any mental healthcare. Self-guided, brief digital interventions may be a powerful adolescent suicide prevention tool. With their relative accessibility-they can be completed privately, at home, for at no cost-such interventions are well-suited for youth not accessing traditional care. Thus, effective digital adaptation of brief suicide prevention interventions is a promising frontier for adolescent suicide prevention. A strong candidate for digital adaptation is the Safety Planning Intervention (SPI), a brief (\~5-10 minute) single-session intervention shown to significantly reduce STB in adults. In the SPI, people at risk for suicide receive brief education about suicidal thoughts and crises before developing a personalized, one-page plan with skills and resources to use during future suicide crises, when it is difficult to think clearly. There is strong evidence across several randomized control trials (RCTs) that SPI reduce suicidal behaviors in adults compared to those who received treatment as usual. Despite widespread use in outpatient and acute clinical settings across ages, there is a paucity of adequately-powered RCTs testing whether the SPI (in any format) reduces STB in adolescents. Emerging evidence supports the SPI can work well in digital format among adolescents. In qualitative studies, adolescents with a history of STBs reported that they would be comfortable using a digital safety plan and feel it would be helpful to them in a crisis, emphasizing easy access and customizability as useful features. Building on this work, I created a digital, self-guided SPI specifically for use in online studies of high-risk adolescents. Preliminary research (approved by DU IRB# 1505797) suggests that youth find this self-guided digital SPI "very helpful" and nearly half actually use the safety plan in the next month. Moreover, using a standardized coding system, quality of self-guided safety plans mirrored the quality seen in clinician-guided, adult SPI. However, it remains unclear whether the SPI in any format can reduce STB in adolescents. This project will test the ability of a self-guided SPI, compared to a suicide psychoeducational control intervention, to increase self-efficacy to avoid suicidal behaviors and to reduce suicidal thoughts and suicidal behaviors in adolescents over a 3-month follow-up period. The investigators hypothesize that compared to the control condition, adolescents who receive the SPI will report greater self-efficacy to avoid suicidal action and reduced STB at the 3-month follow-up assessment. If hypotheses are supported, this study will provide strong, high-quality evidence in favor of the potential of highly accessible, digital self-guided SPIs to prevent suicidal behavior in adolescents. In this case, distribution of such an intervention at scale could be a powerful tool for reducing STBs in adolescents.
The study will adapt and deploy a digital Behavioral Activation app with mobile sensing, supported by health coaches, that encourages youth to engage in positive activities. The study has the potential to offer a low-cost and scalable behavioral intervention that may decrease risk of suicide among at-risk youth. This research will examine specifically whether an intervention involving an app called Vira, combined with health coaching (GET ActivE) can improve enjoyment for teens coping with depression. Research participants will be randomly assigned to one of two study intervention. One study intervention involves a) downloading an app called Vira and engaging by responding to a daily question, and b) participating in a conversation via text, phone, or messages through an appt with a health coach. The health coach will use the Vira app and principles from evidence-based therapy and behavior change to provide users with insights to sustain well-being and better manage risk factors for suicidal thoughts and behaviors such as depressed mood and behavioral withdrawal. The second study intervention involves downloading an app called EARS and responding to a daily question.
The primary aim of the project is to test the efficacy of BCBT delivered via a digital platform (i.e., smartphone) to Servicemembers with recent suicidal ideation and/or suicide attempts presenting to primary care clinics. Given existing challenges of scaling empirically-supported treatments/interventions for suicidality with fidelity, this project could lead to markedly expanded access to BCBT, along with improving our understanding about what intervention strategies are most effective and how they can be delivered with meaningful fidelity. Aviva, the digital version of BCBT, was developed for use with patients across the full spectrum of healthcare settings, including primary care. Aviva is not an emergency alert system, rather a digital platform for delivery of the full scope of BCBT treatment components. An open-label single group Phase I clinical trial has demonstrated the safety, tolerability, feasibility, fidelity, and potential efficacy of Aviva, with participants completing modules over 8 weeks, and follow-up assessments at weeks 1, 4, and 8. Subsequent refinements included the addition of technical features that would allow patients to revisit and/or repeat previously completed modules, along with integration of more characters for delivering video vignettes and greater opportunities for skills practice and treatment engagement. These modifications have further enhanced Aviva safety, tolerability, and fidelity, consistent with the original BCBT protocol. Not only is it hypothesized that Aviva will result in significantly larger reductions in severity of suicidal ideation than participants randomized to the control condition, but also that greater app engagement will be negatively correlated with severity of suicidal thinking. Moderators and mediators (i.e. suicidal beliefs, wish to live, impulsive decision-making) of intervention effects will also be examined. The study will be conducted at the primary care clinics at Fort Carson, with a goal of enrolling 720 patients across a two-year timeframe. Participants will be identified using each clinic's existing suicide risk assessment methods, including the PHQ-9 suicide risk item and a score of 1 or higher on the CSSRS Screener (Recent). Participants will be randomly assigned to one of two treatment conditions, Aviva or control (i.e., development of a safety plan consistent with local procedures and policies, along with referral for standard mental health care and suicide risk management in accordance with local policies and procedures). In an effort to address potential performance bias specific to smartphone use, participants in the control condition will download the Suicide Safety Plan app to their smartphones. Those in the Aviva condition will also complete weekly check-ins with Project 2 research clinicians to review treatment adherence, identify and respond to any logistical/operational problems, and respond to any unexpected emergencies and/or participant safety concerns. Participants will have up to five data points: baseline, 3, 6, 9, and 12 months. All data available from all participants and all time points will be included in the analyses, consistent with the intent-to-treat principle. Across our two previous clinical trials and our in-progress RCT, attrition during the first 12 months postbaseline was \<30% and we anticipate similar rates in this trial.
A non invasive treatment study including participants at risk for suicide attempts and undergoing neurofeedback training. Neurofeedback is controlling your brain activity in real time inside the scanner.
The study will compare the effectiveness of two relatively brief and scalable evidence-based interventions: the Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+), a suicide-specific intervention that helps people prevent suicidal crises from escalating, and Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI), a psychotherapeutic crisis intervention treatment for suicidal adolescents that teaches youth skills to prevent suicidal crises and addresses interpersonal problems that lead to suicidal crises. The results will inform the future standard of care for youth at risk for suicide presenting in the ED setting. This project focuses on suicidal youth ages 12-19 in three ethnically and racially diverse urban areas: Philadelphia, Pennsylvania; Baltimore, Maryland; and upper Manhattan/lower Bronx in New York City.
The purpose of this study is to test whether an individual coaching program called Social Engage Coaching (or 'Engage Coaching' for short) helps adults age 60 and older feel more connected to other people in ways that matter to them. Procedures include participating in a Social Engage Coaching program, research assessments with surveys, and assessments completed on a cell phone. Engage Coaching involves individual sessions with a trained Engage Coach (up to 10 sessions) that are designed to help participants improve social relationships and well-being. All subjects will receive the scheduled baseline and follow-up interviews by the research team. These interviews will be conducted at study start, mid-way through the program at 8 weeks and after completing the program at 16 weeks. Interviews will be via Zoom/phone as well as surveys done online.
Financial hardship is an important risk factor for suicide. However, to date there are no evidence-based interventions to help individuals improve their financial situation and thus reduce suicide risk. The aim of our study is to develop a 24-week, peer-led intervention to reduce financial hardship for individuals experiencing financial difficulties and suicide risk, and to test whether it is feasible, acceptable to clients and achieves its desired effect. The intervention will support participants to address their financial difficulties (e.g., debt, inability to meet basic needs) by coaching them on financial management techniques, facilitating a financial wellness plan, and connecting them with community- based financial supports (e.g., free financial counseling). The intervention will be facilitated by trained peer coaches. The intervention will consist of three phases: (1) intensive; (2) intermediate; and (3) follow-up. The 6-week intensive phase will include 6 weekly group sessions and 4 one-on-one coaching sessions. The intermediate phase will consist of 3 biweekly group sessions and either 3 biweekly or 2 monthly one-on-one coaching sessions, based on participant preference. The follow-up phase will include 3 monthly group sessions and either 3 monthly or 6 biweekly one-on-one coaching sessions, also depending on participant preference. This study will obtain input from stakeholders to develop the intervention (Step 1), pilot it with a small sample of participants (n=10; Step 2), use this information to revise the intervention (Step 3), test it in a larger sample of individuals with financial hardship and suicide risk (n=48; Step 4), and prepare a final version of the intervention manual (Step 5). To date, the study has completed Steps 1-3. The main outcome of this study will be a manualized intervention to lessen financial hardship as a risk factor for suicide.
The nation's trauma care system, which includes trauma center hospitals \& emergency departments, is where over 30 million Americans receive care after traumatic injuries each year. Injury victims are diverse patients who suffer from complications of the initial injury as well as from multiple complex medical \& mental health conditions. Currently, high-quality patient-centered care is not the standard of care throughout US trauma care systems. Injured trauma survivors treated in trauma care systems frequently receive fragmented care that is not coordinated across hospital, emergency department, outpatient, \& community settings. Post-injury care is frequently not individualized to integrate the patient's most pressing post-traumatic concerns \& preferences into medical decision making. The investigators, as a group of front-line trauma center providers, patients, researchers \& policy makers, have been working together for over a decade to integrate patient-centered care into US trauma care systems. The investigators began this work by asking groups of injured patients the key patient-centered question: "Of everything that has happened to you since your injury, what concerns you the most?" The investigators developed scientifically sound assessment tools that allowed us to follow patient concerns after injury hospitalization. In May of 2011, the investigators convened an American College of Surgeons' policy summit that addressed mental health \& patient-centered care integration across US trauma care systems. As part of this policy summit, patient members of our team presented their experiences of traumatic injury \& recovery. While giving injured patients a "voice" at the summit, these narratives did not move surgical policy makers to develop mandates or guidelines for patient-centered care. In contrast, presentations that included information from randomized comparative effectiveness trials \& standardized outcome assessments convinced surgical policy makers to develop US trauma care system policy mandates \& best practice guidelines for post-traumatic stress disorder \& alcohol use problems. Our team now realizes that in order to optimally integrate patient-centered care into US trauma care systems, the investigators must use the best scientific methods that capture the highest-quality data. This PCORI proposal aims to demonstrate that a patient-centered care management treatment that addresses patient's post-injury concerns \& integrates patient concerns \& preferences into medical decision making, while also coordinating care, can improve outcomes of great importance to patients \& their caregivers, front-line providers \& policy makers. This proposal directly addresses two PCORI patient-centered research questions: "After a traumatic injury, what can I do to improve the outcomes that are most important to me?" \& "How can front-line providers working in trauma care systems help me make the best decisions about my post-injury health \& health care?"
The investigators hope to see if a commonly used drug such as ketamine could help depressed ER patients feel better and improve their mood quickly.
The purpose of this study is to develop, refine, and pilot test an augmenting cognitive behavior relapse prevention intervention (CBT-RP) for suicidal, depressed, and alcohol/substance abusing adolescents. No hypotheses are being tested, but it is expected that CBT-RP in addition to treatment as usual will result in improved outcomes relative to treatment as usual alone.
This project aims to adapt, implement, and evaluate a Dialectical Behavior Therapy skills training group intervention for aging adult family caregivers of person with Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD) to reduce suicidality. By adapting this modality, the investigators will provide a scalable intervention tailored for this high-risk population, maximizing the public health impact and improving suicide prevention.
The purpose of this pilot study is to refine and then assess the feasibility, acceptability, and target engagement of Acute Youth Connect - a network health intervention for adolescents leaving acute psychiatric care with suicide-related concerns.
The study will rigorously evaluate whether synchronous, within-visit telemental health evaluation and intervention services can successfully overcome poor access to behavioral health and substandard suicide-related care in emergency departments (EDs), including evaluating the impact on system metrics, a primary goal of RFA-MH-20-226. Notably, the study will surpass this primary requirement, because it will extend understanding of the relative added value of the ED-SAFE post-visit telephone intervention and will create knowledge about key factors related to implementation and sustainment.
The purpose of this study is to test a comprehensive, male-oriented, online screening and referral (Screening for Mental Health; SMH) and male-oriented online information and referral intervention program (Man Therapy; MT) to improve mental health and wellbeing with a focus on prevention of suicide and help-seeking behaviors among middle-aged men. The online programs will be offered together to maximize the effect on reducing suicide behavior and increasing mental health help-seeking behaviors for men. If successful in decreasing suicide behavior and ideation and increasing suicide help-seeking behavior, this intervention could be scaled up to contribute to a reduction in suicide behaviors and deaths across the country.
Suicide was responsible for almost 40,000 deaths in 2011 in America. It is still singularly difficult to predict who is going to commit suicide and how to establish adequate interventions. Growing evidence supports the view that suicide is associated with poor decision making. Suicide is hypothesized to be triggered by stressful situations that create overwhelming psychological pain in an individual who chooses to terminate his/her own life, disregarding all future consequences. We have previously demonstrated rewarding impulsive choice common to both recent suicide attempters and suicidal depressed patients (1). Consistent with these findings, we hypothesize that high frequency repetitive transcranial magnetic stimulation (rTMS) of the left prefrontal cortex will improve impulsive response tendencies as measured by the delay discounting procedure, and this in turn will be associated with a faster resolution of suicidal ideation. To these effects we will be using a randomized control trial of rTMS in adult inpatients at the Psychiatric Research Institute (PRI) hospitalized for acute suicidality. At the conclusion of these studies, we will have tested the value of decision making in the development of suicide ideation and behavior, as well as piloted the use of rTMS in the treatment of these patients.
This study looks to implement a novel intervention (STAT-ED) for children who screen positive to suicide ideation. The intervention looks to collect data from several different measures and then randomize participants into one of two groups: a control group where the participant will be set up with a mental health referral from a psychiatric social worker; or if randomized into the STAT-ED intervention, the adolescent and parent will receive a brief motivational interview, barrier reduction discussion, referral and limited case management by the study social worker to enhance outpatient mental health follow up after discharge from the ED. The hypothesis of the study is patients who are randomized into the STAT-ED intervention group will have a significantly higher rate of initiating mental health treatment and will attend more mental health treatment sessions in the two months after the ED visit compared with adolescents in the control group. Secondary aims of this study look to determine whether the effectiveness of the STAT-ED intervention differs by age, gender, or ethnicity; and evaluate predictors and mediators of mental health treatment engagement.
The primary aim of the proposed study is to compare the efficacy of cognitive therapy (CT) with the efficacy of an enhanced usual care (EUC) intervention for reducing the rate of suicide ideation (SI) and the severity of depression and hopelessness among older men. The investigators expect that suicidal older men randomly assigned to the CT intervention condition will have a lower rate of SI during the follow-up period than participants assigned to the control condition.
The investigators propose to test the efficacy of a brief, readily accessible, and personalized treatment called the Safety Planning for Military (SAFE MIL; Stanley and Brown, 2012).
The purpose of this study is to compare two different kinds of follow-up care and their effects on psychiatric service use and psychological well-being. This randomized, controlled trial of subjects discharged from the psychiatric emergency services to outpatient care receive traditional hospital-based outpatient clinic referrals (treatment as usual) or appointments for community-based follow-up by a mobile crisis team.
The purpose of this study is to increase use and availability, as well as assess the feasibility of the ReliefLink (RL) application for use in conjunction with standard care to promote psychological health and prevent suicidal behavior.
The primary objective of this feasibility study is to assess the feasibility, and usability of a software application to deliver targeted interactive exercises to patients recently hospitalized for suicidal ideation or suicide attempts.
Working with patients at risk for suicide is highly stressful for clinicians and often elicits powerful negative emotional responses that may adversely affect suicidal outcomes. A proposed explanation has been that negative emotional responses may result in less empathic communication and unwitting rejection of the patient, which is liable to damage therapeutic alliance. Thus, there is a need for clinician training in effective management of negative emotions towards suicidal patients, which can result in tangible improvement in suicidal outcomes. The training must be web-based, scalable and easy to disseminate, making it available to clinicians everywhere. In this project, the study team will address this critical need by using Virtual Human Interaction (VHI) to train outpatient clinicians in emotional self-awareness (ESA), which includes both recognition of one's own negative emotional responses, and ability to engage in verbal empathic communication with acutely suicidal patients. The study team will conduct a prospective multisite, blinded, randomized trial comparing VHI ESA training with a Control condition, which will assess both clinician-level and patient-level outcomes in 80 outpatient clinician participants (CPs) and 400 of their participating patients (PPs). Using the same VHI scenarios, the ESA group will receive clinician-focused, comprehensive feedback in ESA, while the Control group will assess the VH's suicide risk without receiving the ESA feedback. The study team will measure efficacy of the VHI ESA training on clinicians by comparing ESA feedback and Control CPs' post-training (T2) ESA towards virtual humans, adjusting for pre-training (T1) ESA. The study team will measure the impact of the VHI ESA training on patients' suicidal outcomes by assessing the primary and secondary outcome variables in both CPs and PPs three times: at baseline (T0), after the first post-training treatment session (T3) and one-month post-training (T4). The study team will examine the role of therapeutic alliance as a possible mediator of the relationship between clinicians' ESA and their patients' Suicidal Ideation (SI) and Suicide Crisis Syndrome (SCS). To accomplish this goal, the study team will use the novel validated suicide risk assessment instruments developed in preliminary studies: the Therapist Response Questionnaire - Suicide Form (TRQ-SF), which assesses negative emotional responses to suicidal patients, and the Suicide Crisis inventory (SCI), which assesses the SCS severity and predicts near-term suicidal behavior. For web-based VHI training the study team will use the already tested and disseminated web-based empathy-teaching platform, coupled with an assessment of verbal empathy measured by the Empathic Communication Coding System (ECCS).
The goal of this experiment is to further determine if self-dehumanization is a novel risk factor for suicide. This study will reduce self-dehumanization using a novel re-humanization condition and compare this group to a control group to analyze the pathway between higher perceptions of self-dehumanization, suicidal ideation, and changes in oxytocin concentrations. It is hypothesized that participants randomly assigned to the re-humanized condition will exhibit decreases in suicidal ideation and increases in oxytocin concentrations as compared to the control condition, which will not display significant changes. Further, we will explore if the magnitude of the oxytocin response will partially mediate the change in suicidal ideation.
The goal of this experiment is to further determine if self-dehumanization is a novel risk factor for suicide. This study will induce self-dehumanization using a novel experimental self-dehumanized future condition (i.e., a futuristic paradigm that likens the individual to a machine) and compare this group to a control group to analyze the pathway between higher perceptions of self-dehumanization, suicidal ideation, and changes in oxytocin concentrations. It is hypothesized that participants randomly assigned to the self-dehumanized mechanistic future condition will exhibit temporary increases in suicidal ideation (which will be thoroughly assessed, intervened upon following the induction) and decreases in oxytocin concentrations as compared to the control condition, which will not display significant changes. Further, we will explore if the magnitude of the oxytocin response will partially mediate the change in suicidal ideation.
The goal of this clinical trial is to evaluate an app to help keep teens and young adults with suicidal thoughts safe. The app includes a safety plan created by adolescents and healthcare providers in the clinic, and videos to encourage supportive communication and skills for teens and young adults to stay safe. The main question it aims to answer is whether the use of an app can increase youth suicide-related coping for youth with suicidal ideation, parent suicide prevention self-efficacy, and healthcare provider self-efficacy in suicide management. Researchers will compare usual care to usual care with the app. Participants, including adolescents, their caregivers and healthcare providers, will use the ISSP app (if assigned to that group) and complete three online surveys.