12 Clinical Trials for Various Conditions
The purpose of this single groups trial is to (Aim 1) determine relationships between alcohol use, suicidal thoughts and behaviors (STBs), and behavioral economic decision-making in a community sample (N = 100) of alcohol using adults who are 18 years of age or older, (Aim 2) is to determine factors that predict engagement with a remote intervention (computer based training for cognitive behavioral therapy; CBT4CBT) for alcohol and its effects on alcohol use, STBs, and decision-making with those same adults. Participants will complete a baseline assessment and be given access for remote, self-guided CBT4CBT modules for alcohol use. Following this, participants will remotely complete three follow-up assessments over three months. This will allow for determination of incidence and predictors of alcohol use and STBs and determination of predictors of engagement and efficacy of a remote intervention for alcohol use in both samples.
Across multiple models of suicide risk, hopelessness and perceptions of social relatedness (i.e., lack of social connection/thwarted belongingness, perceived burdensomeness) have emerged as candidate mechanisms that maintain STBs. Although these mechanisms have garnered strong empirical support in predicting STBs, there has been virtually no integration with interventions aimed for individuals at acute risk for suicide. Thus, the overarching goal of the present proposal is to evaluate a mechanism-focused intervention that explicitly targets two core mechanisms implicated in the maintenance of STBs: hopelessness and negative perceptions of social relatedness. Given that the period immediately following hospital discharge presents the highest risk for suicide attempts and up to 70% of patients admitted for a suicide attempt do not attend their first outpatient appointment, the intervention will be evaluated on an inpatient unit. Additionally, most of the extant interventions for STBs are administered across multiple sessions (i.e., 4 sessions and up to one year); however treatments of this length are unlikely to be feasible in acute care settings. Fortunately, very brief suicide prevention interventions, are effective in reducing future suicide attempts and increasing the likelihood of attending follow-up treatments. Additionally, single-session interventions (not suicide specific) have been shown to reduce hopelessness immediately and at a one-month follow-up. The present study is an RCT comparing a novel Single Session Mechanism Focused Intervention (SSMFI) for STBs to treatment-as-usual (TAU) on a psychiatric inpatient unit for patients admitted for suicidal ideation or attempt. The engagement of the putative processes (hopelessness and negative perceptions of social relatedness) that maintain STBs will be assessed, along with the feasibility and acceptability of SSMFI for STBs on an inpatient psychiatric unit.
Study objective is to compare neuropsychiatric adverse events in subjects treated with varenicline or placebo in a controlled setting where both groups are experiencing nicotine withdrawal.
Individuals at high-risk of suicide vary substantially from one another. Over time, risk factors for suicide may change within the same individual. Despite these differences, most treatments for suicidal thoughts assume that the same intervention works equally well for all individuals at high-risk of suicide. Intensive longitudinal data combined with network science, integrated with coaching, could be used to personalize suicide prevention interventions to make them more effective and efficient. This K23 Career Development application involves refining and testing a novel personalized treatment for individuals at high-risk called PeRsonalizEd Clinical Intervention for Suicidal Events or PRECISE. PRECISE leverages idiographic statistical techniques adopted from network science applied to ecological momentary assessment data to inform the tailoring of Safety Planning and skills from Dialectical Behavior Therapy, two existing evidence-based treatments for suicide. In Aim 1, a user-centered design approach will be used to refine PRECISE. Following the refinement of the intervention, informed by data from a case series in Aim 1, the investigators will then conduct a randomized controlled trial comparing two different intensities of personalization. In the low-intensity arm, the 8-week treatment will be tailored based on an initial two-week burst of ecological momentary assessment and one idiographic model. In the high-intensity arm, participants complete eight weeks of ecological momentary assessment and idiographic models are generated between each session. Coaches use the idiographic models to identify an individuals' drivers of suicidal thoughts and conduct behavioral chain analyses to tailor specific skills to then teach, shape, and reinforce in their individual clients. Assessments are completed pre-treatment, 8-weeks post-enrollment, and 16-weeks enrollment. The investigators hypothesize that both arms will demonstrate clinically significant reductions in suicidal ideation, but the high-intensity arm will be superior to the low-intensity arm in reducing ideation. Furthermore, the investigators anticipate that increases in effective emotion regulation skills and reductions in negative affect will account for the decrease in suicidal ideation. As individuals learn more effective emotion regulation strategies, they will experience less distress and thereby lower levels of suicidal ideation. This project is responsive to Objective 3.2 of the NIMH Strategic Plan and is integrated with a mentored research training plan focused on 1) suicide specific rigorous clinical trials, 2) user centered design in digital health, and 3) applications of network science to intensive longitudinal data. The project and training goal will support the Candidate's overarching goal to become a clinician-scientist engaged in independent research on personalized, impactful, rapid acting suicide prevention interventions for at risk adults.
Despite the high risk of suicide among LGBTQ+ Veterans, there is currently no suicide-focused intervention for this population. This study will refine and pilot Qnnections, a novel group-based suicide prevention intervention that aims to increase social connection and functioning in this population. The project will involve Veterans with lived experience in further refining Qnnections, and then will examine feasibility and acceptability of Qnnections and of study procedures in a pilot randomized clinical trial.
Youth involved in the juvenile justice system evidence disproportionately high rates of suicidal thoughts and behavior (STB) and non-suicidal self-injury (NSSI) compared to adolescents in the general population. It is estimated that upwards of 50% of justice-involved youth (JIY) in secure facilities report NSSI and suicide attempts.1-3 Suicide attempts are estimated to be between two and four times more frequent in incarcerated JIY than adolescents in the community,4 and the rates of STB in JIY are higher than non-JIY in the community. The overwhelming majority of JIY are not placed in secure facilities and almost all incarcerated youth are eventually released to the community.5 Consequently, STB is a major concern of JIY residing in the community and it is critical that this population has access to evidence-based treatment for STB and NSSI. Contributing to the problem, racial and ethnic minority youth are disproportionately represented among JIY6 and JIY are more likely to reside in neighborhoods with limited resources,7 including restricted access to community mental health treatment.8,9 Further, most community mental health providers who treat JIY have not been trained in evidence-based interventions that are specifically designed to treat NSSI and STB; this often leads to JIY experiencing prolonged periods of NSSI and/or STB.10 Training community mental health providers who serve JIY in the detection and treatment of NSSI and STB has promise to decrease the overall suicide risk for JIY. The primary goal of this application is to train community providers in established, core strategies for adolescent STB and NSSI.11 The training program has been used in two clinical trials, refined for inpatient psychiatric and Emergency Department providers, and modified for use in community practice. Our Primary Aim is to implement a systems-level intervention focused on increasing access to evidence-based treatment strategies specifically designed to treat STB and NSSI behaviors for the JIY referred to outpatient care by the RIFC. First, the investigators will conduct a stepped wedge cluster randomized trial with 9 Rhode Island CMHAs who serve JIY. After all sites complete a Usual Care phase, three CMHAs per year will be randomized to the Preparation Phase to receive training in evidence-based strategies for NSSI and STB, using a training program called COPES,11 developed by the MPI for inpatient psychiatry units and Emergency Departments, transported to CMHAs by Consultant and consistent with recommendations in SAMHSA's Youth Suicide Treatment Guide.13 Agencies then move into Implementation Phase for consultation and support followed by a Sustainment phase. Second, guided by the Reach Effectiveness-Adoption Implementation Maintenance (RE-AIM) framework, the investigators will conduct qualitative interviews and administer agency and provider demographic questionnaires and organizational readiness measures with CMHA providers and administrators to identify system-, agency-, and provider-level factors that promote or hinder the uptake and sustainment of evidence-based treatment for STB and NSSI at CMHAs serving JIY. At the provider level, the investigators hypothesize that training in the use of evidence-based treatment strategies for STB and NSSI will: a) significantly increase the use of these strategies and b) the quality of their delivery will be in the "acceptable" range during the Sustainment Phase. At the client/patient level, the investigators hypothesize that the intervention will keep families engaged more than Usual Care phase, increase sessions attended, and reduce rates of adolescent STB and NSSI that require emergency psychiatric care. At the systems level, the investigators hypothesize that the training program will be sustained for at least one year, and up to 3 years, by CMHA administrators. The investigators will also examine factors that may affect the effectiveness of uptake and sustainment of the training program, i.e., organizational readiness, climate, and leadership at each CMHA.
Participants (aged 13-16) will be randomized to: (1) an online, active control group program encouraging feelings disclosure (i.e. supportive therapy single session intervention \[SSI\]), or (2) an online program targeting nonsuicidal self-injury (NSSI; i.e. Project "SAVE"-Stop Adolescent Violence Everywhere-SSI). Investigators will test whether SAVE results in significantly greater: 1. Reductions in NSSI 3 months post-treatment \[primary outcome\] 2. Reductions in self-reported likelihood of future NSSI immediately post-treatment \[secondary outcome\] 3. Reduction in suicide ideation frequency 3 months post-treatment \[secondary outcome\]
Despite efforts to prevent suicide, US rates are climbing, and suicide is the second leading cause of death amongst youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be used to increase engagement with effective interventions such as suicide safety planning. The BRITE suicide safety planning app was developed on evidence-based principles and has undergone rigorous formative development and effectiveness evaluations. However, to optimize its functionality, commercial viability, and scale its implementation, issues related to user engagement need to be addressed. This 4-week Micro-Randomized Trial (MRT) will optimize specific components of ViraBrite, an augmented version of the BRITE suicide safety planning app that integrates automated algorithms (i.e., just in time adaptive intervention features) to facilitate increased engagement with coping skills and pushes safety planning materials to users at periods of high risk (i.e., increases in emotional distress).
The goal of this clinical trial is to learn if a social work led follow up program helps caregivers of youths with suicide risk access mental health resources. Primary aims include: 1. To formalize a mental health follow up protocol that assists youths with engagement of mental health services after a hospital visit. 2. To evaluate and standardize the optimal timing for the follow up phone calls. 3. To assess the proportion of patients with suicide risk who connect with community mental health care within a month after a pediatric emergency department (ED) visit at Johns Hopkins Hospital. 4. To assess the proportion of patients with suicide risk who have repeat ED visits within 3 and 6 months. The primary outcome of interest is the proportion of youths referred to a community provider who successfully connect to community mental health resources 5 to 10 business days after an ED visit. The secondary outcome will involve repeat ED visits within 3 and 6 months.
Despite efforts to prevent suicide, US rates are climbing, and suicide is the second leading cause of death among youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be used to provide a unique understanding of risk factors, including psychological distress, anhedonia and behavioral withdrawal, and sleep disturbance among high-risk individuals. This project aims to enhance the effectiveness of the delivery of preventative health care to youth at risk for suicide by developing a comprehensive digital platform that allows practitioners to integrate mobile sensing data and HIPAA-compliant client communication tools into their management of these young people.
Suicide is the 2nd leading cause of death among adolescents, with the highest risk period for suicide being the month following psychiatric inpatient hospitalization. The investigators propose testing a brief, scalable intervention using evaluative conditioning aimed at reducing suicidal thoughts and behaviors among adolescents during and after inpatient hospitalization. Scalable interventions, such as the one proposed that reduce suicide risk during this markedly high-risk period, could result in large-scale decreases in suicide death.
The overall aim of this pilot study is to conduct a preliminary trial to evaluate the acceptability and feasibility of adding a transdiagnostic, emotion-focused group intervention (the Unified Protocol, UP) to treatment as usual (TAU) in a comprehensive outpatient program for adolescents and young adults with substance use disorders and emotional distress. Only patients seeking services or engaged in care at an existing outpatient program at MGH (the Addiction Recovery Management Service) are eligible for participation.