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Clinical Trials/NCT01941862
NCT01941862
Completed
Not Applicable

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

Florida State University1 site in 1 country300 target enrollmentNovember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
Florida State University
Enrollment
300
Locations
1
Primary Endpoint
Interpersonal Needs Questionnaire (INQ)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
September 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Norman Schmidt

Professor

Florida State University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Anxiety Sensitivity Index-3 (ASI-3)(Month 6 follow-up)

Study Sites (1)

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