Assessment of Emotion Regulation Strategies Used When Suicidal

Sponsor
Ohio State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05722197
Collaborator
Medical University of South Carolina (Other)
334
1
1
60
5.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Crisis Response Planning and Lethal Means Safety Counseling
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
334 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Real-Time Assessment of Emotion Regulation Strategies Used by Suicidal Military Personnel
Actual Study Start Date :
Jan 23, 2022
Anticipated Primary Completion Date :
Jan 23, 2027
Anticipated Study Completion Date :
Jan 23, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Suicidal Ideation - Ecological Momentary Assessment [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 Outcome Measures

  1. Scale for Suicide Ideation [baseline, 1,2,3,6,9, and 12 months after baseline]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Ohio State University Wexner Medical Center Columbus Ohio United States 43214

Sponsors and Collaborators

  • Ohio State University
  • Medical University of South Carolina

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lauren Khazem, Research Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier:
NCT05722197
Other Study ID Numbers:
  • 2022H0155
First Posted:
Feb 10, 2023
Last Update Posted:
Feb 13, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 13, 2023