NCT07507786

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
61mo left

Started Oct 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2031

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2031

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

4.9 years

First QC Date

March 25, 2026

Last Update Submit

May 5, 2026

Conditions

Suicide

Keywords

suicide preventionsafety planning interventionimplementation science

Outcome Measures

Primary Outcomes (6)

  • 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.

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

  • 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.

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

  • 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.

    Throughout Part 1 of study completion, an average of 1 month

  • 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.

    Throughout Part 1 of study completion, an average of 1 month

  • Acceptability of PSP Intervention

    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.

    Throughout Part 1 of study completion, an average of 1 month

  • Beck Scale for Suicide Ideation

    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.

    Baseline and 1, 3, and 6-month follow-up

Secondary Outcomes (3)

  • Suicide-Related Coping Scale

    Baseline and 1, 3, and 6-month follow-up

  • Safety Plan Rating Scale

    Baseline and 1, 3, and 6-month follow-up

  • Safety Plan Use Scale

    Baseline and 1, 3, and 6-month follow-up

Study Arms (2)

Personalized Safety Plans

EXPERIMENTAL

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.

Behavioral: Personalized Safety Plans

Safety Plans as Usual + Calls

ACTIVE COMPARATOR

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 of how safety plans are created. 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.

Behavioral: Safety Plans as Usual + Calls

Interventions

Personalized Safety PlansBEHAVIORAL

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.

Personalized Safety Plans
Safety Plans as Usual + CallsBEHAVIORAL

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.

Safety Plans as Usual + Calls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Boston, Massachusetts, 02130-4817, United States

Location

MeSH Terms

Conditions

SuicideSuicide Prevention

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Jaclyn Kearns, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaclyn Kearns, PhD

CONTACT

(857) 364-4417Jaclyn.Kearns@va.gov

Brian P Marx, PhD

CONTACT

(857) 364-6071brian.marx@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome Assessors will be independent from the Study Team and will be masked to participants' treatment condition.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: In Part I of the study (case series), all Veterans psychiatrically hospitalized for suicide will receive Personalized Safety Plans and will be assessed at baseline, post-treatment, and at 1 month post-discharge. Personalized Safety Plans will be iteratively refined based on qualitative interviews at the end of treatment with participants and in consultation with clinicians, stakeholders, and mentors. In Part 2 of the study (pilot RCT), Veterans psychiatrically hospitalized for suicide who are eligible will be randomized to Personalized Safety Plans or Safety Plans as Usual + Calls. Participants will complete the assigned intervention condition and will be assessed at baseline, post-treatment, and at 1, 3, and 6 months post-discharge.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2026

First Posted

April 2, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

August 31, 2031

Study Completion (Estimated)

September 30, 2031

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)