NCT05795764

Brief Summary

The study is a randomized trial comparing outcomes of active duty service members who present to the emergency department at risk for suicide and receive care from providers trained in crisis response planning versus those providing treatment as usual.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
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

Study Progress64%
Jun 2023Dec 2027

First Submitted

Initial submission to the registry

March 10, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

June 21, 2023

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

4.3 years

First QC Date

March 10, 2023

Last Update Submit

November 13, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Self-Injurious Thoughts and Behaviors Interview (SITBI-R)

    Assessment of suicide attempts

    Through study completion, an average of 1 year

  • Scale for Suicidal Ideation (SSI)

    Assessment of suicidal ideation; 19 items rated on a scale 0-2, higher scores indicate greater suicidal ideation severity

    Through study completion, an average of 1 year

Study Arms (2)

Crisis Response Planning

EXPERIMENTAL

CRP is a brief psychotherapeutic intervention that can be provided to patients at risk of suicidal behavior. When using the intervention, a provider works with the patient (1) to conduct a narrative assessment of the events preceding suicidal thoughts or behavior, and (2) to develop a personalized plan for identifying and managing distress that could escalate to a suicide attempt. The CRP, which is typically handwritten by the patient on an index card, includes personal warning signs of distress, emotion regulation strategies, reasons for living, and contact information for friends/family as well as professional (psychological/medical) and emergency resources.

Behavioral: Crisis Response Planning

Treatment as Usual

ACTIVE COMPARATOR

Existing clinical practices in the emergency department include the following elements recommended by the VA/DoD Clinical Practice Guidelines: (1) all patients are screened for suicidal ideation at every visit; (2) for those with positive screens, a suicide risk assessment interview is conducted by a mental health professional; (3) a safety planning form with means restriction (such as the Stanley-Brown; Stanley \& Brown, 2012) is completed; and (4) patients are referred for follow-up mental health treatment as needed. Other elements of TAU could include behavioral and psychotropic interventions, referrals to specialty mental healthcare, and admission for psychiatric inpatient care.

Behavioral: Treatment as Usual

Interventions

Crisis Response Planning (CRP) is a brief psychotherapeutic intervention.

Also known as: CRP
Crisis Response Planning

Standard care provided for patients at risk for suicide

Treatment as Usual

Eligibility Criteria

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

You may qualify if:

  • Active duty service members
  • \>18 years old
  • Present to the emergency department at NMCSD with a primary concern related to suicidal ideation, plan, intention, or attempt, or are assessed as being at elevated risk of suicidal behavior
  • Able to understand and speak English
  • Able to provide consent

You may not qualify if:

  • Unable to provide informed consent due to impaired mental status (e.g., acute intoxication, psychosis, mania, altered consciousness)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naval Medical Center San Diego

San Diego, California, 92134, United States

RECRUITING

Related Publications (1)

  • Walter KH, Khandekar PR, Kline AC, Miggantz EL, Otis NP, Glassman LH, Thomsen CJ, Brock G, Bryan CJ. Comparison of crisis response planning and treatment as usual for active duty service members at risk for suicide: Study protocol for a stepped-wedge cluster randomized trial in a military treatment facility. Contemp Clin Trials Commun. 2024 Dec 6;42:101407. doi: 10.1016/j.conctc.2024.101407. eCollection 2024 Dec.

MeSH Terms

Conditions

Suicidal Ideation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Kristen H Walter, PhD

    Naval Health Research Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 10, 2023

First Posted

April 3, 2023

Study Start

June 21, 2023

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

November 15, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

This study is one of five studies part of a consortium, referred to as ASPIS. All de-identified demographic and clinical data collected as part of the ASPIS projects will be available as raw individual-level data for sharing with external researchers working at an institution with a Federalwide Assurance (FWA) for the Protection of Human Subjects. ASPIS data will therefore be available for secondary analytic purposes. Names and institutions of persons either given or denied access to data will be tracked by our Administrative Core and will be available upon request from the sponsor. ASPIS data will not be available for data sharing until after all ASPIS projects are complete and the primary outcomes for each project are published.

Shared Documents
STUDY PROTOCOL, ICF

Locations