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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
VA Office of Research and Development
Study ID
NCT07507786
Status
Not Yet Recruiting

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Conditions

  • Suicide

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Oct 1, 2026
Status verified
May 2026
Primary completion
Aug 31, 2031
Completion
Sep 30, 2031

Study Design

Enrollment
111 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Personalized Safety Plans
    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.
  • Active Comparator: Safety Plans as Usual + Calls
    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.

Primary Outcome Measure

Columbia-Suicide Severity Rating Scale - Suicide Ideation Duration [ Time Frame: Baseline and 1, 3, and 6-month follow-up, an average of 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MABostonMassachusetts02130-4817
Jaclyn Kearns, PhD
(857) 364-4417
Jaclyn Kearns, PhD (PRINCIPAL_INVESTIGATOR)

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