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Completed

NCT Number: NCT04903431

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.

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Key information

Conditions

Suicide, Attempted Behavior Behavioral Symptoms Self-Injurious Behavior Suicidal Ideation Suicide

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University

Columbus, Ohio, 43214, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Suicide Visual Analog Scale scores from the previous daily assessment

    Time frame: Administered daily for eight consecutive days

    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 outcomes

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

    Time frame: Administered daily for eight consecutive days

    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.

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

    Time frame: Administered daily for eight consecutive days

    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.

  3. Change in Crisis Response Plan Use from the previous daily assessment

    Time frame: Administered daily for eight consecutive days

    • 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."

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 26, 2021
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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