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Completed

NCT Number: NCT01941862

Depression and Anxiety Reduction Treatment for Suicide

The purpose of this study is to test the effectiveness and usability of multiple computer-based treatments for mood and anxiety relevant risk factors. The target of the treatment is related to cognitive stress, which has been shown to be associated with a variety of negative mental health outcomes such as Post-Traumatic Stress Disorder, suicidal ideation, and substance use disorders.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Self-Injurious Behavior Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Suicide Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University

Tallahassee, Florida, 32304, United States

About this study

DARTS is a newly developed computerized treatment targeting specific risk factors associated with suicide, mood, and anxiety symptoms. Eligible individuals will be randomized to one of several conditions. In all conditions, participants will complete various self-report questionnaires and a neurophysiology assessment that involves an EEG. Some participants will also be asked to complete four additional EEG assessments. In addition, all participants will be asked to complete a 1, 3, and 6-month follow-up appointment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At or above community sample mean on ASI-3
  • At or above community sample mean on INQ-R
  • English speakers
  • 18 years of age or older

Exclusion criteria

  • Significant medical illness
  • Current substance dependence
  • Current or past psychotic-spectrum disorders
  • Uncontrolled bipolar disorder
  • Serious suicidal intent that warranted immediate treatment

Treatment and study plan

Psychoeducation and Cognitive Bias Modification

Behavioral

Primary outcomes

  1. Interpersonal Needs Questionnaire (INQ)

    Time frame: Month 6 follow-up

    The INQ is a 15-item self-report measure of the constructs of thwarted belongingness and perceived burdensomeness as defined by the Interpersonal Theory of Suicide. Van Orden et al. report high internal consistency coefficients for the thwarted belongingness (α=.85) and perceived burdensomeness subscales (α=.89). In support of construct validity, both subscales were found to prospectively predict suicidal ideation.

Secondary outcomes

  1. Anxiety Sensitivity Index-3 (ASI-3)

    Time frame: Month 6 follow-up

    The ASI-3 is an 18-item self-report measure of anxiety sensitivity (AS). This scale was developed to provide a more stable measure of the three most widely recognized AS subfactors (cognitive, social and physical concerns) than the original ASI provides. Each subfactor is represented by six items. The measure has shown good psychometric properties.

Other outcomes

  1. Beck Suicide Scale (BSS)

    Time frame: Month 6 follow-up

    The BSS is a 21-item widely used self-report measure assessing a broad spectrum of behaviors and attitudes related to suicide risk, including suicidal ideation and past suicide attempts. It has demonstrated strong reliability and validity.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

Development and Evaluation of a Brief, Suicide Prevention Intervention Targeting Anxiety and Mood Vulnerabilities

Acronym: DARTS

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 13, 2013
Registry last updated
Jun 19, 2018

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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