ASPIS/CRP: Crisis Response Planning for Military Personnel

Sponsor

United States Naval Medical Center, San Diego (U.S. Fed)

Overall Status

Not yet recruiting

CT.gov ID

NCT05795764

Collaborator

Naval Health Research Center (U.S. Fed), Ohio State University (Other)

700

Enrollment

Location

Arms

57.2

Anticipated Duration (Months)

12.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Suicidal Suicide Threat Suicidal Ideation	Behavioral: Crisis Response Planning Behavioral: Treatment as Usual	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

700 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Mar 27, 2023

Anticipated Primary Completion Date :

Sep 30, 2027

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Self-Injurious Thoughts and Behaviors Interview (SITBI-R) [Through study completion, an average of 1 year]
Assessment of suicide attempts
Scale for Suicidal Ideation (SSI) [Through study completion, an average of 1 year]
Assessment of suicidal ideation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Naval Medical Center San Diego	San Diego	California	United States	92134

Sponsors and Collaborators

United States Naval Medical Center, San Diego
Naval Health Research Center
Ohio State University

Investigators

Principal Investigator: Kristen H Walter, PhD, Naval Health Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kristen Walter, Principal Investigator, United States Naval Medical Center, San Diego

ClinicalTrials.gov Identifier:

NCT05795764

Other Study ID Numbers:

NMCSD.2022.0058

First Posted:

Apr 3, 2023

Last Update Posted:

Apr 4, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Suicide

Suicidal Ideation

Study Results

No Results Posted as of Apr 4, 2023