NCT05722197

Brief Summary

Crisis Response Planning is an efficacious, one-session intervention that increases positive affect, decreases negative affect and psychiatric hospitalizations, and reduces suicide attempts by 76% among Servicemembers. Crisis Response Planning is hypothesized to reduce suicidality by identifying a variety of personalized strategies that are designed to strengthen and/or promote emotion regulation processes.Research in nonmilitary samples suggests the effectiveness of emotion regulation strategies varies across situations. The applicability of these findings to suicidality among Servicemembers is unknown. Improved understanding of what strategies work under which circumstances and for whom will significantly advance our ability to prevent suicide among Servicemembers. Hypotheses include:

  1. 1.Use of self-management strategies, thinking about reasons for living, and seeking social support at time t will be associated with significant reductions in suicidal ideation at time t+1.
  2. 2.Use of distraction, reappraisal, and interpersonal emotion regulation strategies at time t will be associated with significant reductions in suicidal ideation at time t+1.
  3. 3.Affect intensity and social context will significantly moderate the time-lagged effects of Crisis Response Planning and emotion regulation strategy use on suicidal ideation.
  4. 4.Distinct profiles of demographic (e.g., gender, age), historical (e.g., prior suicide attempts), and psychological characteristics (e.g., emotion dysregulation, symptom severity) will predict who experiences a decrease in suicidal ideation following the use of Crisis Response Planning and emotion regulation strategies.
  5. 5.(Exploratory): Individuals who utilize their Crisis Response Planning more frequently and perceive Crisis Response Planning as more effective will be more likely to engage in mental health treatment at follow-up.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
334

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Jan 2022

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 Progress86%
Jan 2022Jan 2027

Study Start

First participant enrolled

January 23, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 30, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2027

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

5 years

First QC Date

January 30, 2023

Last Update Submit

February 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Suicidal Ideation - Ecological Momentary Assessment

    Participants are asked a series of six questions assessing current suicidal ideation. Scores range from 0 to 24, with higher scores indicative of more severe suicidal ideation.

    Change over 28 consecutive days

Secondary Outcomes (1)

  • Scale for Suicide Ideation

    baseline, 1,2,3,6,9, and 12 months after baseline

Study Arms (1)

Crisis Response Plan and Lethal Means Counseling

EXPERIMENTAL

All participants will complete a narrative suicide risk assessment, collaboratively develop a Crisis Response Plan, and receive lethal means counseling. The Crisis Response Plan will include the following sections: (1) identifying personal warning signs for suicide; (2) identifying self-regulation strategies for reducing emotional distress; (3) identifying reasons for living; (4) identifying sources of social support; and (5) accessing professional crisis services. Participants will handwrite the plan on an index card, sheet of paper, or another similar medium. After completing the Crisis Response Planning, researchers will conduct lethal means counseling to develop a plan for restricting or limiting access to potentially lethal methods of suicide.

Behavioral: Crisis Response Planning and Lethal Means Safety Counseling

Interventions

Crisis Response Planning is an efficacious, one-session intervention that increases positive affect, decreases negative affect and psychiatric hospitalizations, and reduces suicide attempts by 76% among Servicemembers

Crisis Response Plan and Lethal Means Counseling

Eligibility Criteria

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

You may qualify if:

  • Currently serving in any Branch or Component of the U.S. military
  • \>18 years old;
  • Score ≥ 5 on the Scale for Suicidal Ideation and/or endorse a suicide attempt, aborted attempt, or interrupted attempt within the past month on the Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R)
  • Ability and willingness to complete research-related activities remotely
  • Regular access to an Android or Apple smartphone that is compatible with the ecological momentary assessment application

You may not qualify if:

  • Engagement in mental health treatment within the past year (including taking psychotropic medications)
  • A psychiatric or medical condition that preventing providing informed consent or from participating in the treatments (e.g., psychosis, mania, acute intoxication); or - Expecting to separate from the military within 90 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43214, United States

RECRUITING

MeSH Terms

Conditions

Suicidal IdeationTreatment RefusalEmotional Regulation

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehaviorTreatment Adherence and ComplianceHealth BehaviorSelf-ControlSocial Behavior

Central Study Contacts

Lauren Khazem, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

January 30, 2023

First Posted

February 10, 2023

Study Start

January 23, 2022

Primary Completion (Estimated)

January 23, 2027

Study Completion (Estimated)

January 23, 2027

Last Updated

February 19, 2026

Record last verified: 2026-02

Locations