Depression and Anxiety Reduction Treatment for Suicide

Depression Clinical Trial

— DARTS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01941862
• Other study ID #: W81XWH-10-2-0181
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: September 2017

Study information

• Verified date: June 2018
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder
• Suicide

Intervention

Behavioral:
• Psychoeducation and Cognitive Bias Modification

Locations

Country	Name	City	State
United States	Florida State University	Tallahassee	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida State University	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Beck Suicide Scale (BSS)	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.	Month 6 follow-up
Primary	Interpersonal Needs Questionnaire (INQ)	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 (a=.85) and perceived burdensomeness subscales (a=.89). In support of construct validity, both subscales were found to prospectively predict suicidal ideation.	Month 6 follow-up
Secondary	Anxiety Sensitivity Index-3 (ASI-3)	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.	Month 6 follow-up