SuicideNCT07507786
Rapid Personalization of Safety Plans for Psychiatrically Hospitalized Veterans at High-Risk for Suicide
A study testing Personalized Safety Plans and Safety Plans as Usual + Calls in people with Suicide, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide
- What is being tested?
- Personalized Safety Plans and Safety Plans as Usual + Calls
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 30 Nov 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
Jaclyn Kearns, PhD, (857) 364-4417, Jaclyn.Kearns@va.gov
Jaclyn Kearns, PhD
About this study
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.
Read the detailed description
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.
- Conditions
- Suicide
- Being tested
- Personalized Safety Plans, Safety Plans as Usual + Calls
- Keywords
- suicide prevention, safety planning intervention, implementation science
- Medical subject headings
- Suicide, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Safety PlansBehavioural
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 + CallsBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Safety Plans as Usual + Calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 1, 3, and 6-month follow-up
Secondary outcomes (3)
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.
Measured: Baseline and 1, 3, and 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.
Measured: Baseline and 1, 3, and 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.
Measured: Baseline and 1, 3, and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Oct 2031 (estimated)
- Study completion30 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jaclyn Kearns, PhD, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507786
- Sponsor's protocol ID
- MHBC-012-25S
- Other IDs
- IK2RD001575-01A1
- Status last verified
- Oct 2026
- First submitted
- 25 Mar 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Personalization of Safety Plans for Psychiatrically Hospitalized Veterans at High-Risk for Suicide
- ClinicalTrials.gov ID
- NCT07507786
- Acronym / sponsor ID
- MHBC-012-25S
- Conditions
- Suicide
- Keywords
- suicide prevention, safety planning intervention, implementation science
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Oct 2031 (estimated)
- Study completion
- 30 Nov 2031 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Personalized Safety Plans | Experimental | Behavioral: Personalized Safety PlansPersonalized 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 | Active comparator | Behavioral: Safety Plans as Usual + CallsThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Safety PlansPersonalized 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. | Behavioural | Personalized Safety Plans |
| Safety Plans as Usual + CallsThe 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. | Behavioural | Safety Plans as Usual + Calls |
Primary outcome
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.
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.
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.
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.
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.
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.
3 secondary outcomes
Suicide-Related Coping Scale
Time frame: Baseline and 1, 3, and 6-month follow-up
Safety Plan Rating Scale
Time frame: Baseline and 1, 3, and 6-month follow-up
Safety Plan Use Scale
Time frame: Baseline and 1, 3, and 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Suicide
Not yet recruiting
A Pre-post Study of a Lethal Means Safety Planning Intervention for Youth at Elevated Suicide Risk in the Emergency Department
Suicidal Ideas, Suicidal Ideation
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
SERENE Low-Intensity Focused Ultrasound for Cognitive Control
Suicidal Ideation, Cognitive Control
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Enrolling by invitation
Pilot Study of a Modified Safety Planning Intervention for Elementary School-Aged Children - Main Study
Suicidal Ideation, Suicidal Behaviors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jaclyn Kearns, PhD principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Safety Plans and Safety Plans as Usual + Calls in people with Suicide, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaclyn Kearns, PhD ((857) 364-4417, Jaclyn.Kearns@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.