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

Suicidal Ideation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04903431
• Other study ID #: 2020B0414-B
• Status: Completed
• Phase: N/A
• Start date: December 15, 2021
• Est. completion date: February 21, 2023

Study information

• Verified date: October 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: February 21, 2023
• Est. primary completion date: February 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide
• Suicide, Attempted

Intervention

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.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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