Designing clinical trials to assess the impact of pharmacological treatment for suicidal ideation/behavior: Issues and potential solutions

Suicide is a serious and growing public health concern yet randomized controlled trials (RCTs) that inform pharmacologic treatment remain limited. We emphasize the overall need for such trials and review the literature to highlight examples of trials that have aimed to study patients at elevated risk of suicide. We discuss key examples of existing psychotropic […]

Overlapping patterns of suicide attempts and non-suicidal self-injuries in adults: A prospective clinical cohort study

Objective: An overlap of non-suicidal self-injuries (NSSIs) and suicide attempts (SAs) is observed in young cohorts, but there are few robust prospective studies for adults. We compared 1-year outcomes in adults with different self-harm patterns: NSSI only, NSSI + SA, and SA only. Methods: 793 patients (67% women) consecutively presenting with NSSI (17%) or SA (83%) at […]

Caring e-mails for military and veteran suicide prevention: A randomized controlled trial

Objective The purpose of this multisite study was to conduct a randomized controlled trial of an e-mail version of the caring letters (CL) suicide prevention intervention to determine whether the intervention is efficacious in preventing suicide behaviors among U.S. service members and veterans. Method Psychiatric inpatients (N = 1,318) were recruited from four military medical centers and […]

Motivational interviewing to address suicidal ideation: A randomized controlled trial in veterans

Objective Although the months following discharge from psychiatric hospitalization are a period of acute risk for veterans, there is a dearth of empirically supported treatments tailored to veterans in acute psychiatric hospitalization. Method We conducted a randomized controlled trial to test the efficacy of Motivational Interviewing to Address Suicidal Ideation (MI-SI) that explored and resolved […]

Clinical trials for rapid changes in suicidal ideation: Lessons from ketamine

Rapid-acting treatments for suicidal thoughts are critically needed. Consequently, there is a burgeoning literature exploring psychotherapeutic, pharmacologic, or device-based brief interventions for suicidal thoughts characterized by a rapid onset of action. Not only do these innovative treatments have potentially important clinical benefits to patient populations, they also highlight a number of methodological considerations for suicide […]

Implementing the interpersonal theory of suicide to improve outcomes in suicidal adolescents: A pilot trial

Introduction The Interpersonal Psychological Theory of Suicide proposes two constructs that serve as a final common pathway to suicidal ideation: thwarted belongingness and perceived burdensomeness. There have been few translations of this theory to clinical care. This study aimed to address this limitation by targeting burden cognitions with novel interventions. Methods A pilot clinical trial […]

Effects of lithium on suicide and suicidal behaviour: A systematic review and meta-analysis of randomised trials

Aims: Lithium has long been believed to reduce the risk of suicide and suicidal behaviour in people with mood disorders. Previous meta-analyses appeared to support this belief, but excluded relevant data due to the difficulty of conducting meta-analysis of rare events. The current study is an updated systematic review and meta-analysis that includes all eligible […]

Stepped care for suicide prevention in teens and young adults: Design and methods of a randomized controlled trial

Background Suicide is the second‑leading cause of death among adolescents and young adults in the United States, with rates rising over much of the last decade. The design, testing, and implementation of interventions to prevent suicide in this population is a public health priority. This manuscript outlines the design and methods for a research study […]

Caring texts, a strength-based, suicide prevention trial in 5 Native communities: Research design and methods

Background Despite their intrinsic strengths and resilience, some American Indian and Alaska Native (AI/AN) communities experience among the highest rates of suicide of any racial and ethnic group. Caring Contacts is one of the only interventions shown to reduce suicide in clinical trials, but it has not been tested in AI/AN settings. Objective To compare […]

Rates and predictors of deterioration in a trial of internet-delivered cognitive behavioral therapy for reducing suicidal thoughts

Objective It is necessary for suicide prevention interventions to demonstrate safety. One important aspect of safety is evidence that deterioration rates are low. No studies have examined deterioration of suicidal ideation in the context of an internet-based cognitive behavioral therapy (CBT) intervention to reduce suicidal ideation. A secondary analysis of the outcomes of an online […]

Feasibility of peer-delivered suicide safety planning in the emergency department: Results from a pilot trial

Objective: The emergency department (ED) is an important site for suicide prevention efforts, and safety planning has been identified as a best practice for suicide prevention among ED patients at increased suicide risk. However, few ED clinicians are prepared to assess suicide risk or guide patients in the creation of safety plans. This study was […]

Long-term effects of the family check-up on suicidality in childhood and adolescence: Integrative data analysis of three randomized trials

This study employed integrative data analysis techniques to examine the long-term effects of the family check-up (FCU) on changes in youth suicide risk using three randomized prevention trials, including one trial initiated in early childhood and two initiated in early adolescence. Data were harmonized across studies using moderated nonlinear factor analysis, and intervention effects were […]

Computerized-adaptive vs. traditional ratings of depression and suicidal thoughts: An assay sensitivity pilot study in a ketamine clinical trial

There is a public health need for improved suicide risk assessment tools. This pilot methodology study compared the assay sensitivity of computerized adaptive tests (CAT) of depression and suicidal ideation vs. traditional ratings in a randomized trial subgroup. The last 20 persons to enroll in a published ketamine trial in suicidal depression were studied. This […]

Effectiveness of a suicide prevention module for adults in substance use disorder treatment: A stepped-wedge cluster-randomized clinical trial

Importance  Individuals with substance use disorders (SUDs) are at high risk for suicide. The Preventing Addiction Related Suicide (PARS) module is the first suicide prevention module developed in and for community substance use intensive outpatient programs (IOPs). Objective  To evaluate the effectiveness of PARS on suicide-related outcomes (ie, knowledge, attitudes, and help-seeking behavior) compared with usual care. […]

Study protocol for the Multimodal Approach to Preventing Suicide in Schools (MAPSS) project: A regionally based randomised trial of an integrated response to suicide risk among secondary school students

Background Suicide is the leading cause of death among young Australians, accounting for one-third of all deaths in those under 25. Schools are a logical setting for youth suicide prevention activities, with universal, selective and indicated approaches all demonstrating efficacy. Given that international best practice recommends suicide prevention programmes combine these approaches, and that to […]

Predictors, Moderators, and Mediators associated with treatment outcome in randomized clinical trials among adolescents with depression: A scoping review

Objective  To describe predictors, moderators, and mediators associated with outcomes in RCTs for the treatment of depressive disorders in adolescents. Evidence Review  A scoping review of RCTs for the treatment of depression in adolescents was conducted. Databases searched included MEDLINE, Embase, APA PsycInfo, and CINAHL. Included publications tested predictors, moderators, and/or mediators associated with depression symptom outcomes […]

DUDE – a universal prevention program for non-suicidal self-injurious behavior in adolescence based on effective emotion regulation: Study protocol of a cluster-randomized controlled trial

Background Non-suicidal self-injury (NSSI) has become a substantial public health problem. NSSI is a high-risk marker for the development and persistence of mental health problems, shows high rates of morbidity and mortality, and causes substantial health care costs. Thus, there is an urgent need for action to develop universal prevention programs for NSSI before adolescents […]

Twenty-six years of psychosocial interventions to reduce suicide risk in adolescents: Systematic review and meta-analysis

Background: During adolescence, suicide risk increases; effective treatments are needed to reduce risk. Methods: Databases were searched (1995-2020) for randomized controlled trials (RCTs) concerning psychosocial treatments for suicide prevention in adolescents (10-18 yrs). Data were extracted from the timepoint closest to 6 months. Cohen’s ds were estimated for reducing suicidal ideation (SI), self-harming behaviors (SHB) excluding strictly […]

The impact of family engagement in opioid assisted treatment: Results from a randomised controlled tria

Background: Family interventions in substance use disorders (SUD) treatment is limited despite the evidence for benefits. Providing family interventions is hampered by patient resistance, social stigma, logistics and factors related to the capacity of the treatment programmes. Aims: The purpose of the study was to examine the association between family engagement in treatment, and opioid […]

Ketamine for the acute treatment of severe suicidal ideation: Double blind, randomised placebo controlled trial

Objective To confirm the rapid onset anti-suicidal benefits of ketamine in the short term and at six weeks, overall and according to diagnostic group. Design Prospective, double blind, superiority, randomised placebo controlled trial. Setting Seven French teaching hospitals between 13 April 2015 and 12 March 2019. Eligibility criteria for participants Aged 18 or older with current suicidal ideation, admitted […]

Effect of offering care management or online dialectical behavior therapy skills training vs usual care on self-harm among adult outpatients with suicidal ideation: A randomized clinical trial

OBJECTIVE To compare 2 low-intensity outreach programs with usual care for prevention of suicidal behavior among outpatients who report recent frequent suicidal thoughts. DESIGN, SETTING, AND PARTICIPANTS Pragmatic randomized clinical trial including outpatients reporting frequent suicidal thoughts identified using routine Patient Health Questionnaire depression screening at 4 US integrated health systems. A total of 18 […]

Lethal means counseling, distribution of cable locks, and safe firearm storage practices among the Mississippi National Guard: A factorial randomized controlled trial, 2018-2020

Objectives. To examine whether lethal means counseling and provision of cable locks prompt safe firearm storage relative to control among firearm-owning members of the Mississippi National Guard. Methods. This randomized controlled trial utilized a 2 × 2 factorial design (lethal means counseling vs control, provision of cable locks vs no cable locks). Follow-up assessments took place at […]

Lithium treatment in the prevention of repeat suicide-related outcomes in veterans with major depression or bipolar disorder: A randomized clinical trial

Objective: To assess whether lithium augmentation of usual care reduces the rate of repeated episodes of suicide-related events (repeated suicide attempts, interrupted attempts, hospitalizations to prevent suicide, and deaths from suicide) in participants with bipolar disorder or depression who have survived a recent event. Design, setting, and participants: This double-blind, placebo-controlled randomized clinical trial assessed lithium vs […]