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Clinical Trials/NCT05722197
NCT05722197
Recruiting
Not Applicable

Real-Time Assessment of Emotion Regulation Strategies Used by Suicidal Military Personnel

Ohio State University1 site in 1 country334 target enrollmentJanuary 23, 2022

Overview

Phase
Not Applicable
Intervention
Crisis Response Planning and Lethal Means Safety Counseling
Conditions
Suicidal Ideation
Sponsor
Ohio State University
Enrollment
334
Locations
1
Primary Endpoint
Suicidal Ideation - Ecological Momentary Assessment
Status
Recruiting
Last Updated
2 months ago

Overview

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. 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. 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. 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. 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. (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.
Registry
clinicaltrials.gov
Start Date
January 23, 2022
End Date
January 23, 2027
Last Updated
2 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lauren Khazem

Research Assistant Professor

Ohio State University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Arms & Interventions

Crisis Response Plan and Lethal Means Counseling

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.

Intervention: Crisis Response Planning and Lethal Means Safety Counseling

Outcomes

Primary Outcomes

Suicidal Ideation - Ecological Momentary Assessment

Time Frame: Change over 28 consecutive days

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.

Secondary Outcomes

  • Scale for Suicide Ideation(baseline, 1,2,3,6,9, and 12 months after baseline)

Study Sites (1)

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