Assessing the Effectiveness of Self- and Clinician-administered Crisis Response Planning for Suicide Risk

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.

Study Overview

• Status: Completed
• Conditions: Suicidal Ideation; Suicide, Attempted
• Intervention / Treatment: Behavioral: Crisis Response Planning for Suicide Risk

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43214
      • The Ohio State University

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Clinician-administered Crisis Response Plan; Clinicians will administer the Crisis Response Plan to 75 military veterans.	Behavioral: Crisis Response Planning for Suicide Risk; 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.
Experimental: Self-administered Crisis Response Plan; Participants will complete a self-guided version of the Crisis Response plan online.	Behavioral: Crisis Response Planning for Suicide Risk; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Administered daily for eight consecutive days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Administered daily for eight consecutive days
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.	Administered daily for eight consecutive days
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."	Administered daily for eight consecutive days

Collaborators and Investigators

• Sponsor: Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Actual): February 21, 2023
• Study Completion (Actual): February 21, 2023

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 24, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation; Suicide, Attempted
• Other Study ID Numbers: 2020B0414-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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