Assessment of Emotion Regulation Strategies Used When Suicidal

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

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.

Study Overview

• Status: Recruiting
• Conditions: Suicidal Ideation; Emotion Regulation; Treatment Refusal
• Intervention / Treatment: Behavioral: Crisis Response Planning and Lethal Means Safety Counseling

• Study Type: Interventional
• Enrollment (Estimated): 334
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren Khazem, PhD; Phone Number: 614-366-2294; Email: lauren.khazem@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43214
      • Recruiting
      • The Ohio State University Wexner Medical Center
      • Contact: Lauren Khazem, PhD; Phone Number: 614-366-2294; Email: lauren.khazem@osumc.edu

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: Crisis Response Planning and Lethal Means Safety Counseling; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scale for Suicide Ideation	The Scale for Suicide Ideation is a 21-item self-report measure of past-week or worse-points suicidal ideation. The minimum score is 0, and the maximum score is 42. Higher scores are indicative of more severe suicidal ideation.	baseline, 1,2,3,6,9, and 12 months after baseline

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2022
• Primary Completion (Estimated): January 23, 2027
• Study Completion (Estimated): January 23, 2027

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 10, 2023

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation
• Other Study ID Numbers: 2022H0155

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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