About this trial
Veterans psychiatrically hospitalized face significantly elevated suicide risk, particularly in the three months post-discharge. While Safety Planning is a required component of discharge planning, many safety plans lack personalization thereby reducing their effectiveness. The proposed intervention, Personalized Safety Plans (PSP), will be developed for rapid delivery on acute inpatient psychiatry units. PSP is a single-session intervention followed by twice monthly brief, personalized coaching sessions during the three-month high-risk discharge period. PSP will be iteratively refined and finalized in a case series (N = 15) then evaluated in a pilot randomized controlled trial (N = 96) comparing PSP to Safety Plans as Usual among psychiatrically hospitalized Veterans. Overall, the study aims to: 1) iteratively refine PSP; 2) examine PSP's preliminary effectiveness in reducing suicide ideation and increasing adaptive coping; 3) identify barriers and facilitators to implementation; and 4) develop a fidelity measure to support future personalization monitoring.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
admitted to VABHS inpatient psychiatry for suicide risk
display sufficient English comprehension and cognitive capacity to understand the study and provide informed consent
have been medically cleared by attending physician
Disqualifiers
current psychosis
current mania
dementia or other significant cognitive impairment
being inaccessible and discharged from the unit less than 48 hours after being identified by study staff
Trial design
Parallel
Treatments tested in this trial
Personalized Safety Plans
BehavioralPersonalized Safety Plans is a single-session (up to 90min) inpatient intervention followed by twice-monthly coaching sessions (up to 30min each) over the three-month high-risk discharge period. The inpatient session uses chain and solution analyses from Dialectical Behavior Therapy to build a shared understanding of the suicide crisis, including vulnerability factors, prompting events, behavioral links, consequences, and solutions. Veterans also identify distal patterns of suicide risk, supporting proactive risk reduction. Chain and solution analyses populate a personalized, actionable safety plan. Follow-up coaching sessions focus on the Veteran's safety plan, including reviewing its personalization, addressing barriers to in-home use, and making necessary updates. Participants will continue to receive inpatient and outpatient treatment as usual.
Safety Plans as Usual + Calls
BehavioralThe comparator condition is Safety Plan as Usual plus attentional control phone calls. Safety Plan as Usual reflect standard clinical practice on the inpatient psychiatry. Per VHA Directives and clinical requirements, all at-risk patients must collaboratively develop a SP and receive a copy prior to discharge. Providers use the suicide narrative alongside questions from the Safety Planning Intervention Manual. Attentional control phone calls are twice-monthly supportive check-ins, matched in frequency to the Personalized Safety Plans coaching sessions, designed to control for time and attention differences between conditions. Participants will continue to receive inpatient and outpatient treatment as usual.
Treatment groups
Trial outcomes
Primary outcomes
Columbia-Suicide Severity Rating Scale - Suicide Ideation Duration
In Part 2 (pilot RCT), suicide ideation duration will be measured using the Columbia-Suicide Severity Rating Scale. Suicide ideation duration is measured on a 1 to 5 scale, with higher scores meaning longer suicide ideation duration. The Columbia-Suicide Severity Rating Scale is a widely used interview measure in suicide prevention clinical trials. Longitudinal mixed-effects models with random effects will examine the effect of treatment condition (Personalized Safety Plans, Safety Plans as Usual + Calls) on the primary outcome of suicide ideation duration. A time by treatment condition (Personalized Safety Plans, Safety Plans as Usual + Calls) interaction will be used to examine if Personalized Safety Plans is associated with greater reductions in suicide ideation duration relative to Safety Plans as Usual + Calls. The investigators will examine if these differences are immediately present at the 1-month follow-up and maintained through the 6-month follow-up.
Columbia-Suicide Severity Rating Scale - Suicide Ideation Frequency
In Part 2 (pilot RCT), suicide ideation frequency will be measured using the Columbia-Suicide Severity Rating Scale. Suicide ideation frequency is measured on a 1 to 5 scale, with higher scores meaning greater suicide ideation frequency. The Columbia-Suicide Severity Rating Scale is a widely used interview measure in suicide prevention clinical trials. Longitudinal mixed-effects models with random effects will examine the effect of treatment condition (Personalized Safety Plans, Safety Plans as Usual + Calls) on the primary outcome of suicide ideation frequency. A time by treatment condition (Personalized Safety Plans, Safety Plans as Usual + Calls) interaction will be used to examine if Personalized Safety Plans is associated with greater reductions in suicide ideation frequency relative to Safety Plans as Usual + Calls. The investigators will examine if these differences are immediately present at the 1-month follow-up and maintained through the 6-month follow-up.
Feasibility of PSP Intervention
In Part 1 (case series), Personalized Safety Plans feasibility will be assessed in the following way: Percent of patients approached and who agree to enroll Given that Part 1 (case series) is focused on iterative refinement of Personalized Safety Plans, there are no hypotheses related to feasibility. This information will inform Personalized Safety Plans refinement and finalization.
Acceptability of PSP Intervention - Patient Satisfaction
In Part 1 (case series), Personalized Safety Plans acceptability will be assessed in the following way: Client Satisfaction Questionnaire-8 will assess patient satisfaction Given that Part 1 (case series) is focused on iterative refinement of Personalized Safety Plans, there are no hypotheses related to acceptability. This information will inform Personalized Safety Plans refinement and finalization.
Secondary outcomes
Suicide-Related Coping Scale
In Part 2 (pilot RCT), adaptive suicide-related will be measured using the Suicide-Related Coping Scale. The Suicide-Related Coping Scale has a minimum score of 0 and a maximum of 85. Higher total scores indicate greater adaptive suicide-related coping skills. Longitudinal mixed-effects models with random effects will examine the effect of treatment condition (Personalized Safety Plans, Safety Plans as Usual + Calls) on the primary outcome of adaptive suicide-related coping. A time by treatment condition (Personalized Safety Plans, Safety Plans as Usual + Calls) interaction will be used to examine if Personalized Safety Plans is associated with greater increases in adaptive suicide-related coping relative to Safety Plans as Usual + Calls. The investigators will examine if these differences are immediately present at the 1-month follow-up and maintained through the 6-month follow-up.
Safety Plan Rating Scale
In Part 2 (pilot RCT), Safety Plan personalization (also referred to as quality) will be measured using the Safety Plan Rating Scale. The personalization subscale has a score range of -18 and a maximum score of 0. Higher scores indicate greater personalization. Longitudinal mixed-effects models with random effects will examine the effect of treatment condition (Personalized Safety Plans, Safety Plans as Usual + Calls) on the primary outcome of safety plan personalization. A time by treatment condition (Personalized Safety Plans, Safety Plans as Usual + Calls) interaction will be used to examine if Personalized Safety Plans is associated with greater increases in safety plan personalization relative to Safety Plans as Usual + Calls. The investigators will examine if these differences are immediately present at the 1-month follow-up and maintained through the 6-month follow-up.
Safety Plan Use Scale
In Part 2 (pilot RCT), Safety Plan use will be measured using the Safety Plan Use Scale. The Safety Plan Use Scale has a minimum score of 5 and a maximum score of 50. Higher total scores indicate greater use. This scale was developed for this study. Longitudinal mixed-effects models with random effects will examine the effect of treatment condition (Personalized Safety Plans, Safety Plans as Usual + Calls) on the primary outcome of safety plan use. A time by treatment condition (Personalized Safety Plans, Safety Plans as Usual + Calls) interaction will be used to examine if Personalized Safety Plans is associated with greater increases in safety plan use relative to Safety Plans as Usual + Calls. The investigators will examine if these differences are immediately present at the 1-month follow-up and maintained through the 6-month follow-up.
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