Assessment of Emotion Regulation Strategies Used When Suicidal

Suicidal Ideation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05722197
• Other study ID #: 2022H0155
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2022
• Est. completion date: January 23, 2027

Study information

• Verified date: March 2024
• Source: Ohio State University
• Contact: Lauren Khazem, PhD
• Phone: 614-366-2294
• Email: lauren.khazem[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 334
• Est. completion date: January 23, 2027
• Est. primary completion date: January 23, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emotion Regulation
• Suicidal Ideation
• Treatment Refusal

Intervention

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

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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