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NCT Number: NCT07507786

Rapid Personalization of Safety Plans for Psychiatrically Hospitalized Veterans at High-Risk for Suicide

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.

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Key information

Conditions

Suicide Behavior Behavioral Symptoms Self-Injurious Behavior Suicide Prevention

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817, United States

Location contact

Jaclyn Kearns, PhD

CONTACT

[email protected]

(857) 364-4417

Jaclyn Kearns, PhD

PRINCIPAL_INVESTIGATOR

About this study

Veterans hospitalized in inpatient psychiatry units are eight times more likely to die by suicide than all Veterans who use VA services, with the highest risk period being the first three months post-discharge. Safety Planning is a required component of discharge planning for psychiatrically hospitalized Veterans, yet many safety plans (SPs) are often poorly personalized which significantly limits their effectiveness. Clinicians need better training to personalize SPs and Veterans prefer a personalized intervention that identifies their specific suicide warning signs and adaptive coping skills. Improvements in SP application are critically needed. To address this gap, 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 in a case series (N = 15) and then, consistent with a hybrid I effectiveness-implementation design, evaluated in a pilot randomized controlled trial (RCT; N = 96) comparing PSP to SP as Usual among psychiatrically hospitalized Veterans. In the case series, Veterans will complete assessments at baseline, post-treatment, and at 1 month post-discharge. In the pilot RCT, Veterans will complete assessments at baseline, post-treatment, and at 1, 3, and 6 months post-discharge. The primary goal is to determine PSP's preliminary effectiveness; the secondary goal is to understand the implementation context through feedback from Veterans, clinicians, and stakeholders. The proposed study will provide a foundation for a larger RCT through four aims: 1) iteratively refine PSP, guided by Veteran, clinician, and stakeholder feedback; 2) examine PSP's preliminary effectiveness in reducing suicide ideation, increasing adaptive coping, and increasing SP personalization compared to SP as Usual; 3) identify barriers and facilitators to implementation; and 4) develop a fidelity measure to support future personalization monitoring. The proposed study will be conducted in the Behavioral Science Division of the National Center for PTSD at the VA Boston Healthcare System with support from a collaborative and expert mentorship team. The candidate will pursue five training aims: 1) obtain expertise in treatment adaptation and conducting RCTs with psychiatrically hospitalized Veterans; 2) gain analytic skills to evaluate RCTs; 3) refine clinical expertise in treating suicidal Veterans; 4) acquire fundamentals of implementation science; and 5) engage in professional development to support the transition to an independently funded VA investigator. The proposed study and training directly aligns with the candidate's career goal of becoming a VA clinical trialists who develops, adapts, and tests personalized and implementable interventions to reduce Veteran suicide.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants will be Veterans who are:

  • 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

Exclusion criteria

The exclusion criteria for Veterans in this study are:

  • 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
  • prisoner status

Treatment and study plan

Personalized Safety Plans

Behavioral

Personalized 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

Behavioral

The 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.

Primary outcomes

  1. Columbia-Suicide Severity Rating Scale - Suicide Ideation Duration

    Time frame: Baseline and 1, 3, and 6-month follow-up, an average of 6 months

    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.

  2. Columbia-Suicide Severity Rating Scale - Suicide Ideation Frequency

    Time frame: Baseline and 1, 3, and 6-month follow-up, an average of 6 months

    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.

  3. Feasibility of PSP Intervention

    Time frame: Throughout Part 1 of study completion, an average of 1 month

    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.

  4. Acceptability of PSP Intervention - Patient Satisfaction

    Time frame: Throughout Part 1 of study completion, an average of 1 month

    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.

  5. Acceptability of PSP Intervention

    Time frame: Throughout Part 1 of study completion, an average of 1 month

    In Part 1 (case series), Personalized Safety Plans acceptability will be assessed in the following ways:

    Percent of patients who complete Personalized Safety Plans Percent of patients who drop out of Personalized Safety Plans

    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.

  6. Beck Scale for Suicide Ideation

    Time frame: Baseline and 1, 3, and 6-month follow-up

    In Part 2 (pilot RCT), suicide ideation severity will be measured with the Beck Scale for Suicide Ideation. The Beck Scale for Suicide Ideation has a minimum score of 0 and a maximum of 38. Higher total scores indicate greater suicide ideation severity.

    Longitudinal mixed-effects models with random effects will examine the effect of treatment condition (Personalized Safety Plans, Safey Plans as Usual + Calls) on the primary outcome of suicide ideation severity. 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 severity 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.

Secondary outcomes

  1. Suicide-Related Coping Scale

    Time frame: Baseline and 1, 3, and 6-month follow-up

    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.

  2. Safety Plan Rating Scale

    Time frame: Baseline and 1, 3, and 6-month follow-up

    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.

  3. Safety Plan Use Scale

    Time frame: Baseline and 1, 3, and 6-month follow-up

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Brian P Marx, PhD

CONTACT

[email protected]

(857) 364-6071

Jaclyn Kearns, PhD

CONTACT

[email protected]

(857) 364-4417

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Apr 2, 2026
Registry last updated
May 6, 2026

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.

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