The Detection of Acute Risk of Self-injury Project: Protocol for an Ecological Momentary Assessment Study Among Individuals Seeking Treatment

Background Nonsuicidal self-injury (NSSI) is a major mental health concern. Despite increased research efforts on establishing the prevalence and correlates of the presence and severity of NSSI, we still lack basic knowledge of the course, predictors, and relationship of NSSI with other self-damaging behaviors in daily life. Such information will be helpful for better informing mental health professionals and allocating treatment resources. The DAILY (Detection of Acute rIsk of seLf-injurY) project will address these gaps among individuals seeking treatment. Objective This protocol paper presents the DAILY project’s aims, design, and materials used. The primary objectives are to advance understanding of (1) the short-term course and contexts of elevated risk for NSSI thoughts, urges, and behavior; (2) the transition from NSSI thoughts and urges to NSSI behavior; and (3) the association of NSSI with disordered eating, substance use, and suicidal thoughts and behaviors. A secondary aim is to evaluate the perspectives of individuals seeking treatment and mental health professionals regarding the feasibility, scope, and utility of digital self-monitoring and interventions that target NSSI in daily life. Methods The DAILY project is funded by the Research Foundation Flanders (Belgium). Data collection involves 3 phases: a baseline assessment (phase 1), 28 days of ecological momentary assessment (EMA) followed by a clinical session and feedback survey (phase 2), and 2 follow-up surveys and an optional interview (phase 3). The EMA protocol consists of regular EMA surveys (6 times per day), additional burst EMA surveys spaced at a higher frequency when experiencing intense NSSI urges (3 surveys within 30 minutes), and event registrations of NSSI behavior. The primary outcomes are NSSI thoughts, NSSI urges, self-efficacy to resist NSSI, and NSSI behavior, with disordered eating (restrictive eating, binge eating, and purging), substance use (binge drinking and smoking cannabis), and suicidal thoughts and behaviors surveyed as secondary outcomes. The assessed predictors include emotions, cognitions, contextual information, and social appraisals. Results We will recruit approximately 120 individuals seeking treatment aged 15 to 39 years from mental health services across the Flanders region of Belgium. Recruitment began in June 2021 and data collection is anticipated to conclude in August 2023. Conclusions The findings of the DAILY project will provide a detailed characterization of the short-term course and patterns of risk for NSSI and advance understanding of how, why, and when NSSI and other self-damaging behaviors unfold among individuals seeking treatment. This will inform clinical practice and provide the scientific building blocks for novel intervention approaches outside of the therapy room that support people who self-injure in real time. International Registered Report Identifier (IRRID) DERR1-10.2196/46244

Assessment criterion "candidate" Feedback This is a good candidate with strong publications, two masters degrees, and some awards. The motivation of the candidate can be classified as high. His previous publishing activities are exactly in the field of the proposal now submitted and thus represent a continuation of skills and knowledge already acquired. Furthermore, the candidate has an excellent network of supporters. The candidate has made significant contributions to the field of study of NSSI to date. This has included first-author publications in some mid-to high-impact journals. He has worked closely (and published with) recognized NSSI experts in the United States as well as in his local Universities. His training has included an advanced degree in statistics as well as Ph.D.'s in both psychology and public health. He has brought in two high paying grants/awards, at least one of which had an international call for applications. He has had a number of smaller awards as well. There is clearly evidence of emerging international scientific reputation with a clear upward trajectory for the candidate. The candidate has meaningful contributions to the state of the art, which are properly acknowledged in the scientific community in the form of scholarly peer-reviewed publications. Further, there is impact beyond publications, such as being included as an early-career collaborator with an Austrian group for trigger evaluation of non-suicidal self-injury in online networks, and being invited to Vienna to develop a curriculum for school-based prevention for nonsuicidal self-injury. The candidate is developing his scientific independence. Score: 6,25 Applicant: Glenn Kiekens Application number: 12ZZM21N 24 juni 2020 Assessment criterion "project"

Feedback
The project aims to examine daily predictors of non-suicidal self-injury in 100 individuals who self-injure. The description is clear and the aims are important. Three objectives will be pursued by analysing the same data set. Some of the research gaps identified in the proposal seem somewhat surprising; is there really no research examining the factors that increase the transition from NSSI thoughts to behaviour? All in all, while the project is worthwhile, one is not sure it is sufficient in volume, particularly when one compares it to other applications. Comments made by evaluators include: - The most important issue of this project concerns its feasibility. One feels that two of the three objectives would already be sufficient for a three-year project.
One wonders whether there will be enough observations per participant to run the participant-specific models. Assuming a response rate of 70%, you would have 30*8*.7 = 168 data points, of which you will use 126 for development of the model. A fear is that this is not enough data to get a stable model. - One felt that the incorporation of passive monitoring data is a long shot. The candidate also relies om someone else to do this.
One fully agrees with the research gaps 1-3. These are important issues that the research community needs to address. A very high priority seems to be an individualized, ideographic approach, where risk stratification for NSSI takes place at the level of individuals.
Predicting the acute risk of NSSI thinking and behavior requires a larger number of observations that would need to be evaluated more closely (in hours, days, weeks and months). Objectives: The mobile phone app does not guarantee secure input (keyword: compliance), especially for potentially suicidal patients? The applicant reports in his own publications with his co-authors that 20% are non-compliant: is there already more information on this -are these patients with severe symptoms who would need monitoring most urgently (keyword: prevention)? These questions also apply to other studies with a compliance rate of 62-83%.

juni 2020
Shouldn't this also be systematically checked in DAILY, i.e. i) compliance and ii) percentage participation according to health condition/diagnosis (also according to RDoC)?
A further question would be whether a compliance-independent physiological factor, such as actimetry, should not be additionally collected, which could provide additional information for a prediction.
Minor: Please provide a source for the mobile app -is it open source? The research proposal to investigate the non-suicidal self-injury (NSSI) of young people more intensively is of high clinical relevance. Longitudinal studies of within-subject data over short periods of time over a longer period of time are a very promising approach. The DAILY project submitted here is excellently planned and the applicant meets all criteria for a successful implementation of this innovative proposal.
This proposal raises some very interesting and important questions. It is noteworthy that the applicant raises the problem of ergodicity -or the fact that what is true of a group is not necessarily true of individuals within a group. The reality of the ecological fallacy is the main rationale for conducting this research. While we have considerable research on the characteristics of groups of individuals who engage in NSSI, we really know very little about individuals who engage in NSSI over time. The main concern of NSSI is hospital time/cost and risk of suicide. The first objective relates to developing an individual prediction model for detecting NSSI thoughts and behaviors. The researcher will look at emotional factors, situational factors and some cognitive factors.
There is brief mention of a physiological variable in the form of galvanic skin response, which will be collected using a wearable wireless band. Later in the application it is clarified that the wearable wristband also collects skin temperature, heart rate variability and motion. It is unclear why there is not more emphasis on biological/physiological variables as predictors of behavior and/or thoughts of NSSI.

Applicant: Glenn Kiekens Application number: 12ZZM21N
24 juni 2020 The advantage that physiological variables have is that they are much more objective/reliably measured than emotional or cognitive factors. Additionally, unlike the others, which involve discrete time-points during which data are collected, with large intervals during which data are not collected, physiological variables can be collected continuously. Since the brain is the "final common pathway" for physiology, emotion, cognition and behavior, it seems logical to posit a biological predictor of NSSI thoughts and behaviors and suicidal acts. Prior research has indicated that habituation to aversive stimuli is abnormal in women with NSSI, for instance. One of the collaborators on this project (M. Nock), has published about respiratory sinus arrhythmia differences associated with suicidal ideation. Yet here are no hypotheses about physiological variables. If the research team is going to all the effort to conduct this study and collect physiological data one strongly recommends including that component in the objectives, with a hypothesis.
Noteworthy is that 3 of 5 locations from which recruitment will take place are eating disorder units. Eating disorders frequently affect physiological variables and this is another reason why it will be important to evaluate them. There may be differences in NSSI among patients with different physiological profiles. Objective 2 suffers from the same absence of physiological awareness as objective 1. It is easy to justify that transition from NSSI thoughts to actions would be accompanied by physiological changes. Why not make a hypothesis and test it? Regarding Objective 3, the ecological fallacy makes it particularly relevant to understand if the association between NSSI and suicide attempts that has been found in groups of research subjects is applicable within individuals. Patients who engage in NSSI sometimes communicate that they do it to prevent an act of suicide. Thus, it is not a foregone conclusion that NSSI predicts suicide attempts for any given person. This goal is perhaps the most important in the proposal because it involves the most serious risk to individuals in the NSSI population.