Assessing the Effectiveness of Self- and Clinician-administered Crisis Response Planning for Suicide Risk
Primary Purpose
Suicide, Attempted, Suicidal Ideation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Crisis Response Planning for Suicide Risk
Sponsored by
About this trial
This is an interventional treatment trial for Suicide, Attempted
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- US military veteran
- death or suicidal ideation/suicide attempt within the past month
Exclusion Criteria:
- non-Veteran status
- acute intoxication or active psychosis precluding provision of informed consent
- inability to communicate and comprehend English
- residence outside the United States
- lack of past-month death/suicide ideation or attempt
- lack of device connected to webcam or internet
Sites / Locations
- The Ohio State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Clinician-administered Crisis Response Plan
Self-administered Crisis Response Plan
Arm Description
Clinicians will administer the Crisis Response Plan to 75 military veterans.
Participants will complete a self-guided version of the Crisis Response plan online.
Outcomes
Primary Outcome Measures
Change in Suicide Visual Analog Scale scores from the previous daily assessment
The Suicide Visual Analog Scale The S-VAS assesses "urge to kill myself" using a horizontal line with anchors on the left reflecting "none" (score: 0) and on the right reflecting "extreme" (score: 100). The S-VAS is initially presented with the indicator on the "none" position, and non-movement of the indicator is followed by a prompt to remind the participant to move the indicator, if relevant, to ensure response accuracy. Higher scores are indicative of greater severity
Secondary Outcome Measures
Change in Patient Health Questionnaire - 2 scores from the previous daily assessment
The PHQ-2 is a 2-item measure of depression symptom severity adapted from the 9-item version of the PHQ (Kroenke & Spitzer, 2002). Item responses are scores on a Likert scale ranging from 0 to 3. Total scores range from 0 to 6, with higher scores indicating greater symptom severity.
Change in Positive and Negative Affect Schedule - Short Form scores from the previous daily assessment
The Positive and Negative Affect Schedule - Short Form a 20-item validated self-report measure of state positive and negative affect. The measure contains two, 10-item subscales measuring positive and negative affect, respectively. Possible total scores for each subscale range from 10 to 50, with higher scores indicating greater state affect.
Change in Crisis Response Plan Use from the previous daily assessment
- In order to assess whether CRP use after completion impacts suicide urges and affect, participants will be instructed to "Please list all dates and times that you used part or all of the Crisis Response Plan that you completed since you last completed this survey. (or since you completed your Crisis Response Plan if this is the first survey you will complete)" You may provide us with your best estimates of dates and times."
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04903431
Brief Title
Assessing the Effectiveness of Self- and Clinician-administered Crisis Response Planning for Suicide Risk
Official Title
Assessing the Effectiveness of Self- and Clinician-administered Crisis Response Planning for Suicide Risk
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
February 21, 2023 (Actual)
Study Completion Date
February 21, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
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
The aim of the current project is to compare the use and preliminary effectiveness of a self-administered version of the Crisis Response Plan (CRP) in decreasing suicidal/death ideation and distress and increasing positive affect when compared to a clinician-administered version of the protocol in a sample of 150 military Veterans experiencing current death or suicidal ideation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted, Suicidal Ideation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clinician-administered Crisis Response Plan
Arm Type
Active Comparator
Arm Description
Clinicians will administer the Crisis Response Plan to 75 military veterans.
Arm Title
Self-administered Crisis Response Plan
Arm Type
Experimental
Arm Description
Participants will complete a self-guided version of the Crisis Response plan online.
Intervention Type
Behavioral
Intervention Name(s)
Crisis Response Planning for Suicide Risk
Intervention Description
Crisis Response Planning is focused on creating personalized set of steps for individuals to follow in case of a crisis and includes individuals' personal warning signs of distress, behavioral coping strategies, reasons for living, social supports to contact, and contact information for professional services, including emergency services. Personalization of the Crisis Response Plan is encouraged, and individuals are instructed to handwrite each step of the Crisis Response Plan on an index card to review.
Primary Outcome Measure Information:
Title
Change in Suicide Visual Analog Scale scores from the previous daily assessment
Description
The Suicide Visual Analog Scale The S-VAS assesses "urge to kill myself" using a horizontal line with anchors on the left reflecting "none" (score: 0) and on the right reflecting "extreme" (score: 100). The S-VAS is initially presented with the indicator on the "none" position, and non-movement of the indicator is followed by a prompt to remind the participant to move the indicator, if relevant, to ensure response accuracy. Higher scores are indicative of greater severity
Time Frame
Administered daily for eight consecutive days
Secondary Outcome Measure Information:
Title
Change in Patient Health Questionnaire - 2 scores from the previous daily assessment
Description
The PHQ-2 is a 2-item measure of depression symptom severity adapted from the 9-item version of the PHQ (Kroenke & Spitzer, 2002). Item responses are scores on a Likert scale ranging from 0 to 3. Total scores range from 0 to 6, with higher scores indicating greater symptom severity.
Time Frame
Administered daily for eight consecutive days
Title
Change in Positive and Negative Affect Schedule - Short Form scores from the previous daily assessment
Description
The Positive and Negative Affect Schedule - Short Form a 20-item validated self-report measure of state positive and negative affect. The measure contains two, 10-item subscales measuring positive and negative affect, respectively. Possible total scores for each subscale range from 10 to 50, with higher scores indicating greater state affect.
Time Frame
Administered daily for eight consecutive days
Title
Change in Crisis Response Plan Use from the previous daily assessment
Description
- In order to assess whether CRP use after completion impacts suicide urges and affect, participants will be instructed to "Please list all dates and times that you used part or all of the Crisis Response Plan that you completed since you last completed this survey. (or since you completed your Crisis Response Plan if this is the first survey you will complete)" You may provide us with your best estimates of dates and times."
Time Frame
Administered daily for eight consecutive days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
US military veteran
death or suicidal ideation/suicide attempt within the past month
Exclusion Criteria:
non-Veteran status
acute intoxication or active psychosis precluding provision of informed consent
inability to communicate and comprehend English
residence outside the United States
lack of past-month death/suicide ideation or attempt
lack of device connected to webcam or internet
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessing the Effectiveness of Self- and Clinician-administered Crisis Response Planning for Suicide Risk
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