2018 |
Kleiman, Evan |
R34Activity Code Description: To provide support for the initial development of a clinical trial or research project, including the establishment of the research team; the development of tools for data management and oversight of the research; the development of a trial design or experimental research designs and other essential elements of the study or project, such as the protocol, recruitment strategies, procedure manuals and collection of feasibility data. |
Real-Time Intervention For Reducing Suicide Risk.
Project Summary/Abstract Suicide is among the leading causes of death worldwide, and the risk of suicide is highest in the period immediately following discharge from inpatient psychiatric care. Once patients leave inpatient care, the skills learned during treatment may be difficult to use during the highly distressing time leading up to and during suicidal thoughts and behaviors, which may frequently occur during the time immediately after they are discharged. Surprisingly, current treatments are not designed to be effective during a suicide crisis. Interventions that can reduce the risk of suicidal thoughts and behaviors, both in general and specifically during the post-discharge period, should (1) be easily adhered to and (2) be particularly accessible and efficient during a suicide crisis. The goal of this study is to test an innovative new intervention that uses two new technologies, ecological momentary intervention (EMI) and wearable physiological monitoring to deliver the Unified Protocol (UP) - a transdiagnostic cognitive behavioral therapy. Delivery of this brief intervention will happen not just at certain times or when triggered by the participant, but also in response to physiological changes that signal intense distress (i.e., changes in electrodermal activity over a short period). EMI and physiological monitoring are uniquely suited for adherence and accessibility during a suicide crisis because more than 80% of Americans aged 18-49 carry a smartphone with them throughout the day, and because the study will use a physiological monitoring device worn unobtrusively on the wrist like a watch. The UP is uniquely suited for efficacy because it is a short-term, skills-based treatment that focuses on teaching adaptive responses to intense emotion (such as the intense emotion that characterizes a suicide crisis). Moreover, initial findings support the use of an adapted brief UP intervention with suicidal inpatients. The project will have three phases: (1) a small uncontrolled pilot of intervention that will then (2) be modified based on insights gleaned from the pilot, and finally (3) tested in a larger randomized controlled trial (RCT). Participants in the uncontrolled pilot will be 25 inpatients and participants in the RCT will be 150 inpatients (n = 75 each in treatment as usual [TAU] plus intervention and TAU plus assessment [i.e., control] groups) from the Massachusetts General Hospital Inpatient Psychiatric Service. The intervention will consist of four in-person inpatient therapy sessions and smartphone-based EMI with physiological monitoring for the duration of participants' inpatient stay and the high-risk 28-day post-discharge period, as well as several inpatient sessions aimed at delivering core EMI content and training participants on the use of the EMI. The project's long-term aims are to (1) conduct a small pilot test of the intervention, (2) conduct a randomized controlled trial to test the effects of the intervention, and (3) to explore context- specific efficacy of the intervention to inform future studies of personalized interventions.
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0.915 |
2018 — 2019 |
Kleiman, Evan |
R21Activity Code Description: To encourage the development of new research activities in categorical program areas. (Support generally is restricted in level of support and in time.) |
Using Ambulatory Physiological Monitoring to Improve Detection of Harmful Behaviors On Adolescent Inpatient Psychiatry Units
Project Summary/Abstract Harmful behaviors (e.g., harm to self or others) resulting from rapidly increasing distress are unfortunately common experiences on adolescent inpatient units. These harmful behaviors often lead to ?interventions of last resort? like seclusion and restraint, rather than more proactive methods (e.g., de-escalation) that might have been effective before the distress escalated. One way to improve the efficiency and efficacy of inpatient psychiatric care and reduce the use of seclusion and restraint may be to identify distress as early as possible before the distress escalates to the point seclusion or restraint is needed. The current standard of care in adolescent inpatient psychiatry is continual or near-continual physical observation. This is a useful to identify harmful behaviors and intervene accordingly because clinical staff can see these behaviors as they occur. Routine observation on its own is less useful, however, to detect harmful behaviors before they start because distress is not often physically observable in its early stages and adolescents may not be aware of their distress escalating. This means that routine observation misses a critical window of time where proactive interventions may still be highly effective. One way to identify distress early in the process of escalation is to monitor physiological correlates of distress that may be apparent in the early stages of distress before other signs are visible, which would signal a window of time where proactive interventions are still viable options. Psychological distress leads to a physiological state of autonomic nervous system (i.e., sympathetic) arousal associated with preparation to cope such as elevation in heart rate and secretion of sweat. Although not always directly observable, this arousal is present as soon as psychological distress begins to escalate, meaning that these physiological signals of distress may be detectable before other physically-observable signs are apparent. The goal of this study will be to use these physiological signals to detect, as early as possible, psychological distress and the harmful behaviors that distress leads to. Participants will be 100 adolescent inpatients (ages 12 ? 19) at Franciscan Children's Hospital in Brighton, MA who will wear a commercially-available physiological monitoring device (Empatica E4) for the duration of their inpatient stay. Distress will be assessed through self-report (Participants will be asked to press a button on the Empatica E4 whenever they are experiencing distress) and through record review. Harmful behaviors will be assessed through record review. The major specific aim of this study will be to test to what extent physiological correlates of distress predict (a) harmful behaviors above and beyond observation or self-report and (b) clinical interventions to harmful behaviors. Secondary aims of this study will assess acceptability and usability of the wearable devices among patients and clinical staff, which will be used to further inform development of clinical decision-making tools in future studies. This study is the initial step in a long- term line of research that will create a user-friendly, evidence-based tool that can be used on inpatient units as part of a collaborative plan to help clinical staff make decisions about managing harmful behaviors and to help patients better identify their distress.
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0.915 |