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Assessment of Emotion Regulation Strategies Used When Suicidal

Primary Purpose

Suicidal Ideation, Treatment Refusal, Emotion Regulation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Crisis Response Planning and Lethal Means Safety Counseling
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicidal Ideation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Ohio State University Wexner Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Crisis Response Plan and Lethal Means Counseling

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 30, 2023
Last Updated
February 9, 2023
Sponsor
Ohio State University
Collaborators
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT05722197
Brief Title
Assessment of Emotion Regulation Strategies Used When Suicidal
Official Title
Real-Time Assessment of Emotion Regulation Strategies Used by Suicidal Military Personnel
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 23, 2022 (Actual)
Primary Completion Date
January 23, 2027 (Anticipated)
Study Completion Date
January 23, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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: 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. 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. Affect intensity and social context will significantly moderate the time-lagged effects of Crisis Response Planning and emotion regulation strategy use on suicidal ideation. 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. (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Treatment Refusal, Emotion Regulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
334 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Crisis Response Plan and Lethal Means Counseling
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Crisis Response Planning and Lethal Means Safety Counseling
Intervention Description
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
Primary Outcome Measure Information:
Title
Suicidal Ideation - Ecological Momentary Assessment
Description
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.
Time Frame
Change over 28 consecutive days
Secondary Outcome Measure Information:
Title
Scale for Suicide Ideation
Description
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.
Time Frame
baseline, 1,2,3,6,9, and 12 months after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Khazem, PhD
Phone
614-366-2294
Email
lauren.khazem@osumc.edu
Facility Information:
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Khazem, PhD
Phone
614-366-2294
Email
lauren.khazem@osumc.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Assessment of Emotion Regulation Strategies Used When Suicidal

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