Crisis Response Planning for Military Personnel (ASPIS/CRP)

Moderators of the Effectiveness of Crisis Response Planning (CRP) for Military Personnel

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.

Study Overview

• Status: Recruiting
• Conditions: Suicidal Ideation; Suicide Threat; Suicidal
• Intervention / Treatment: Behavioral: Crisis Response Planning; Behavioral: Treatment as Usual

• Study Type: Interventional
• Enrollment (Estimated): 700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristen H Walter, PhD; Phone Number: 619-540-4108; Email: kristen.h.walter.civ@health.mil
• Study Contact Backup: Name: Pia R Khandekar, PsyD; Phone Number: 619-532-9264; Email: pia.r.khandekar.civ@health.mil

Study Locations

• United States
  • California
    • San Diego, California, United States, 92134
      • Recruiting
      • Naval Medical Center San Diego
      • Contact: Pia R Khandekar, PsyD; Phone Number: 619-532-9264; Email: pia.r.khandekar.civ@health.mil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Crisis Response Planning; 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; Crisis Response Planning (CRP) is a brief psychotherapeutic intervention.; Other Names: CRP
Active Comparator: Treatment as Usual; 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; Standard care provided for patients at risk for suicide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: United States Naval Medical Center, San Diego
• Collaborators: Ohio State University; Naval Health Research Center
• Investigators: Principal Investigator: Kristen H Walter, PhD, Naval Health Research Center

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 10, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: June 30, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation
• Other Study ID Numbers: NMCSD.2022.0058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No