Treatment Trials

5 Clinical Trials for Various Conditions

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COMPLETED
Treatment Study for Non-Suicidal Self-Injury
Description

The overall aim of this study is to begin establishing an effective treatment for individuals who engage in non-suicidal self-injury (NSSI), as there are currently no evidence-based treatments that directly target this problematic behavior. Existing treatments that have demonstrated initial promise in reducing NSSI consist of many skills embedded in complex programs; therefore, the skill(s) responsible for improvements in NSSI are not clear. Procedures that focus on one's emotions, particularly that aim to increase emotional awareness and engagement in cognitive reappraisal (i.e., a way of thinking that lessens emotions), may be critical in effective NSSI treatment. The specific goals of this study are to investigate the effects of two specific emotion-focused treatment elements on NSSI. Participants will be ten individuals who meet the proposed Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5; American Psychiatric Association) criteria for NSSI disorder and engage in NSSI to reduce or escape from negative emotions. Two core modules of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al., 2011) will be adapted and delivered with the aim of reducing participants' non-suicidal self-injurious thoughts and behaviors. Each treatment module will consist of four 50-minute individual weekly sessions of emotion awareness training or cognitive reappraisal. The study will use a single-case experimental design, and phase change will be determined based on each participant's changes in non-suicidal self-injurious thoughts and behaviors.

COMPLETED
Treating Self Injurious Behavior: A Novel Brain Stimulation Approach
Description

The purpose of this study is to explore the tolerability and effectiveness of transcranial direct current stimulation (tDCS) as a potential treatment for non-suicidal self-injury (NSSI). Individuals who engage in frequent NSSI will be randomized to 12 administrations of an active vs. inactive form of tDCS, paired with an Attention Training Technique task, over a two-week period. Functional MRI may be performed before and after this two week period. NSSI urges and behaviors will be monitored before, during, and after the period of tDCS administrations.

COMPLETED
Zero Suicide Plus KICKS
Description

Integrating Intergenerational Cultural Knowledge Exchange with Zero Suicide is an innovative study in a Southwestern tribal nation that incorporates Zero Suicide into Indian Health Services (IHS) primary care settings. The goal of this study is to determine the effectiveness of Zero Suicide plus a cultural component (ZS+) (experimental group) compared to Zero Suicide (ZS) alone (control group) on suicidal ideation, behaviors, and resiliency in a randomized control trial of 138 AI youth ages 12-24 at two rural IHS clinics on the Pueblo of San Felipe. The long-term goal of this study is to determine which is more effective at reducing suicidal ideation and behaviors and increasing resiliency, ZS+ or ZS alone. Year 1 will focus on training providers on the Zero Suicide model and manualizing the Katishtya Intergenerational Culture Knowledge Seminars (KICKS) curriculum that was piloted and positively evaluated over the past three summers as a cultural module to improve the adoption and acceptability of Zero Suicide. Years 2-4 will focus on participant recruitment, assignment to experimental and control groups, and implementation. Year 5 will focus on data analysis and dissemination. Data will be collected from all experimental and control group participants at 4 time points: baseline, 12-weeks, 6-months and 9-months to explore the effects of the intervention over time. The central hypothesis is that ZS+ will be more effective then ZS alone. The investigators propose three aims: (1) Specific Aim 1: Using Community Based Participatory Research (CBPR), partner with tribal stakeholders and researchers to formally manualize the KICKS cultural module for Zero Suicide (ZS+); (2) Specific Aim 2: To determine if adding a cultural component to the Zero Suicide model is more effective at reducing risk factors and increasing resiliency in AI youth than Zero Suicide alone; and (3) Specific Aim 3: Determine the essential features of the KICKS module for adaptation by other tribes and disseminate the model.

COMPLETED
TMS for Suicidal Crisis in Active Duty SMs
Description

The purpose of this study is to determine if the use of Transcranial Magnetic Stimulation (TMS) provides rapid reduction and sustained attenuation of suicidal crisis. TMS is a treatment for suicidal crisis that is quicker, less invasive, better tolerated, and with fewer side effects than current treatments such as Electroconvulsive Therapy (ECT) and medication therapies. There will be 6 months of follow-up, in order to establish the ongoing and lasting therapeutic effect of TMS.

TERMINATED
Study of Efficacy and Safety of MIJ821 in Addition to Comprehensive Standard of Care on the Rapid Reduction of Symptoms of Major Depressive Disorder in Subjects Who Have Suicidal Ideation With Intent
Description

Study of efficacy and safety of MIJ821 in addition to comprehensive standard of care on the rapid reduction of symptoms of Major Depressive Disorder (MDD) in subjects who have suicidal ideation with intent