Depression and Anxiety Reduction Treatment for Suicide (DARTS)

June 18, 2018 updated by: Norman Schmidt, Florida State University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tallahassee, Florida, United States, 32304
        • Florida State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anxiety Risk Reduction
The anxiety risk reduction condition will be a combination of psychoeducation plus Cognitive Bias Modification (CBM-I) for anxiety sensitivity (AS). The psychoeducational component will focus on the nature of stress and its effect on the body. Interoceptive exposure (IE) exercises, designed to correct the conditioned fear to these bodily sensations, will be explained and practiced.
Behavioral: Psychoeducation and Cognitive Bias Modification
Experimental: Mood Risk Reduction
The mood risk reduction condition will be a combination of psychoeducation plus Cognitive Bias Modification (CBM-I) for perceived burdensomeness and thwarted belongingness. The psychoeducational component will focus on dispelling myths related to burdensomeness and belongingness and describe their role in the development of mood symptoms.
Behavioral: Psychoeducation and Cognitive Bias Modification
Experimental: Combined Risk Reduction
The combined intervention will involve all of the interventions in the anxiety and mood risk reduction conditions and thus will not be matched for length.
Behavioral: Psychoeducation and Cognitive Bias Modification
No Intervention: Repeated Contact Control
Participants assigned to the repeated contact group will be assigned a "personal" study coordinator. The coordinator will contact them at specific intervals during the study. The rationale for these contacts will be provided (e.g., checking in on their status and helping to administer some brief measures). During the three weeks (corresponding to treatment session intervals for those in one of the active treatment conditions), the study coordinator will contact the participant once per week for a brief phone check in where suicide risk will be evaluated. Participants in the control group will also meet with their study coordinator during each of the scheduled follow-up visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Month 6 follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Month 6 follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Month 6 follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida State University

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Norman B Schmidt, Ph.D., Florida State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

July 20, 2013

First Submitted That Met QC Criteria

September 10, 2013

First Posted (Estimate)

September 13, 2013

Study Record Updates

Last Update Posted (Actual)

June 19, 2018

Last Update Submitted That Met QC Criteria

June 18, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W81XWH-10-2-0181 (Department of Defense)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Psychoeducation and Cognitive Bias Modification

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe