Group Health Research Institute
Seattle, Washington, 98102, United States
NCT Number: NCT01924936
In the United States in 2010, 38,000 people died from suicide and it is our nation's 10 leading cause of death. Suicide prevention is a national priority and yet secondary prevention programs targeting those most at risk are lacking. The purpose of the current research is to develop and pilot test three promising suicide prevention programs that, if found acceptable to high-risk individuals, could be further evaluated and eventually offered broadly and affordably to the public.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Seattle, Washington, 98102, United States
Reducing the risk of suicide attempt and suicide is a public health priority. There has been no substantial decrease in suicide for the past two decades. Prevention efforts to date have focused on primary (e.g. public service announcements) and tertiary (e.g. interventions following suicide attempt) methods. Secondary or indicated prevention has been relatively unexplored. Secondary prevention requires both accurate screening methods and effective interventions. These essential elements are now available. Our recent research demonstrates that responses to the suicidal ideation item of the PHQ depression scale are a powerful predictor of subsequent suicide attempt and death. Availability of the PHQ in electronic medical records creates an opportunity for accurate population-level screening. Dialectical behavior therapy (DBT) has strong evidence of tertiary efficacy for preventing suicide attempts in clinical populations. Brief outreach tertiary interventions such as caring messages have some evidence for preventing suicide attempts. These clinical or tertiary prevention interventions provide the best available evidence for use in building secondary prevention programs. Resulting programs could then be linked to population-level screening data in electronic medical records. The first goal of the research plan is to adapt DBT and caring messages to fit delivery models suitable for the large numbers of at-risk patients identifiable in healthcare settings. The second goal is to evaluate the feasibility, acceptability, and safety of these alternative online suicide and self-injury secondary prevention programs. Online delivery models are suitable because they are scalable and can be provided securely, cheaply, and utilizing existing systems in healthcare. Three brief online interventions will be evaluated: caring email (CE); CE + DBT online program; and CE + DBT online program + coach. Each intervention will supplement usual care among high- risk patients identified via PHQ depression scales collected at outpatient primary care and mental health visits. Intervention content will be drawn from the principles of DBT and caring messages. The study design will be additive in order to examine alternative intervention models that vary widely in resources required for large- scale delivery. However, these interventions will require vastly fewer resources than in-person or telephone interventions. The project will involve intervention feasibility (pretesting, N=60) and acceptability and safety testing (pilot, N=400). Acceptability wll be assessed by patient intervention engagement levels (requiring the large pilot sample) and qualitative/formative intervention feedback from patients. Safety will be assessed via rates of psychiatric hospitalizations and self-injury diagnoses in the medical record in the intervention conditions compared to those receiving just continued usual care. Results of the pilot study will inform the design of a full-scale effectiveness trial examining the impact of one or more of these interventions on risk of suicide attempt and/or suicide death.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
DBT online program involving three DBT skills taught across three lessons. The DBT online program will be based on a brief DBT skills intervention previously developed and pilot tested by Dr. Whiteside. This DBT online program will provide far greater clinical intensity than Intervention 1 and will be delivered with a widely-used modular software platform suitable for an R-34 project.
Time frame: One Year
For each intervention, we define one or more specific acceptability measures. These measures will be assessed using data from the electronic medical record and/or the intervention website. For each measure, we define a benchmark acceptability rate that we believe is necessary to proceed to further evaluation in a full-scale effectiveness trial. As discussed below, the proposed sample size will allow us to estimate these acceptability rates with confidence limits of approximately +/-9%. Consequently, we will establish "observed" benchmark rates that account for this level of precision. We do not propose to compare acceptability rates across intervention groups. Our objective is not comparison but description: to assess whether the observed acceptability rate for each intervention exceeds our threshold for proceeding to a full-scale evaluation.
Time frame: One Year
Electronic medical records will be used to ascertain all suicide attempts and all psychiatric hospitalizations in each of the three intervention groups. Chi-square statistic will be used to determine whether any observed difference in rates of adverse outcomes exceeds that expected by chance. In addition, each of these events will be reviewed by study investigators (Whiteside and Simon) to assess possible relationship to the intervention program.
Kaiser Permanente
Other
Pilot Study of Online Interventions for Population-based Suicide
Acronym: NMN_SSIP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05282225
Behavior, Behavioral Symptoms
Ann Arbor, Michigan, United States
View Trial DetailsNCT05202756
Behavior, Behavioral Symptoms
Providence, Rhode Island, United States
View Trial DetailsNCT05427734
Alcohol Abuse, Alcohol Use Disorder
Seattle, Washington, United States
View Trial DetailsNCT04140149
Behavior, Behavioral Symptoms
Winnipeg, Manitoba, Canada
View Trial Details