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Crisis Response Planning for Military Personnel (ASPIS/CRP)

Primary Purpose

Suicidal, Suicide Threat, Suicidal Ideation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Crisis Response Planning
Treatment as Usual
Sponsored by
United States Naval Medical Center, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicidal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Naval Medical Center San DiegoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Crisis Response Planning

Treatment as Usual

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Self-Injurious Thoughts and Behaviors Interview (SITBI-R)
Assessment of suicide attempts
Scale for Suicidal Ideation (SSI)
Assessment of suicidal ideation; 19 items rated on a scale 0-2, higher scores indicate greater suicidal ideation severity

Secondary Outcome Measures

Full Information

First Posted
March 10, 2023
Last Updated
June 30, 2023
Sponsor
United States Naval Medical Center, San Diego
Collaborators
Naval Health Research Center, Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT05795764
Brief Title
Crisis Response Planning for Military Personnel
Acronym
ASPIS/CRP
Official Title
Moderators of the Effectiveness of Crisis Response Planning (CRP) for Military Personnel
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2023 (Actual)
Primary Completion Date
September 30, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United States Naval Medical Center, San Diego
Collaborators
Naval Health Research Center, Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal, Suicide Threat, Suicidal Ideation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Crisis Response Planning
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Crisis Response Planning
Other Intervention Name(s)
CRP
Intervention Description
Crisis Response Planning (CRP) is a brief psychotherapeutic intervention.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
Standard care provided for patients at risk for suicide
Primary Outcome Measure Information:
Title
Self-Injurious Thoughts and Behaviors Interview (SITBI-R)
Description
Assessment of suicide attempts
Time Frame
Through study completion, an average of 1 year
Title
Scale for Suicidal Ideation (SSI)
Description
Assessment of suicidal ideation; 19 items rated on a scale 0-2, higher scores indicate greater suicidal ideation severity
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristen H Walter, PhD
Phone
619-540-4108
Email
kristen.h.walter.civ@health.mil
First Name & Middle Initial & Last Name or Official Title & Degree
Pia R Khandekar, PsyD
Phone
619-532-9264
Email
pia.r.khandekar.civ@health.mil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen H Walter, PhD
Organizational Affiliation
Naval Health Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naval Medical Center San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pia R Khandekar, PsyD
Phone
619-532-9264
Email
pia.r.khandekar.civ@health.mil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Crisis Response Planning for Military Personnel

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