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

NCT04903431 | Completed

• 1 other identifier: 2020B0414-B
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide, Attempted; Suicidal Ideation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Patient Health Questionnaire - 2 scores from the previous daily assessment

  Administered daily for eight consecutive days

• Change in Positive and Negative Affect Schedule - Short Form scores from the previous daily assessment

  Administered daily for eight consecutive days

• Change in Crisis Response Plan Use from the previous daily assessment

  Administered daily for eight consecutive days

Study Arms (2)

Clinician-administered Crisis Response Plan

ACTIVE COMPARATOR

Clinicians will administer the Crisis Response Plan to 75 military veterans.

Behavioral: Crisis Response Planning for Suicide Risk

Self-administered Crisis Response Plan

EXPERIMENTAL

Participants will complete a self-guided version of the Crisis Response plan online.

Behavioral: Crisis Response Planning for Suicide Risk

Interventions

Crisis Response Planning for Suicide Risk BEHAVIORAL

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.

Clinician-administered Crisis Response Plan; Self-administered Crisis Response Plan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• US military veteran
• death or suicidal ideation/suicide attempt within the past month

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43214, United States

Location

MeSH Terms

Conditions

Suicide, Attempted; Suicidal Ideation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 26, 2021
• Study Start: December 15, 2021
• Primary Completion: February 21, 2023
• Study Completion: February 21, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)