search
Back to results

Depression and Anxiety Reduction Treatment for Suicide (DARTS)

Primary Purpose

Anxiety, Depression, Suicide

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychoeducation and Cognitive Bias Modification
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring computerized intervention, cognitive bias modification, anxiety, mood, perceived burdensomeness, thwarted belongingness, suicide, post-traumatic stress disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Florida State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Anxiety Risk Reduction

Mood Risk Reduction

Combined Risk Reduction

Repeated Contact Control

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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 (α=.85) and perceived burdensomeness subscales (α=.89). In support of construct validity, both subscales were found to prospectively predict suicidal ideation.

Secondary Outcome Measures

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.

Full Information

First Posted
July 20, 2013
Last Updated
June 18, 2018
Sponsor
Florida State University
Collaborators
United States Department of Defense
search

1. Study Identification

Unique Protocol Identification Number
NCT01941862
Brief Title
Depression and Anxiety Reduction Treatment for Suicide
Acronym
DARTS
Official Title
Development and Evaluation of a Brief, Suicide Prevention Intervention Targeting Anxiety and Mood Vulnerabilities
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
Collaborators
United States Department of Defense

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Suicide
Keywords
computerized intervention, cognitive bias modification, anxiety, mood, perceived burdensomeness, thwarted belongingness, suicide, post-traumatic stress disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anxiety Risk Reduction
Arm Type
Experimental
Arm Description
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.
Arm Title
Mood Risk Reduction
Arm Type
Experimental
Arm Description
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.
Arm Title
Combined Risk Reduction
Arm Type
Experimental
Arm Description
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.
Arm Title
Repeated Contact Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation and Cognitive Bias Modification
Primary Outcome Measure Information:
Title
Interpersonal Needs Questionnaire (INQ)
Description
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.
Time Frame
Month 6 follow-up
Secondary Outcome Measure Information:
Title
Anxiety Sensitivity Index-3 (ASI-3)
Description
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.
Time Frame
Month 6 follow-up
Other Pre-specified Outcome Measures:
Title
Beck Suicide Scale (BSS)
Description
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.
Time Frame
Month 6 follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norman B Schmidt, Ph.D.
Organizational Affiliation
Florida State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida State University
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32304
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33839487
Citation
Capron DW, Allan NP, Schmidt NB. The Depression Sensitivity Index: Initial Development and Tests of Convergent and Construct Validity. J Affect Disord. 2021 May 15;287:417-426. doi: 10.1016/j.jad.2021.03.051. Epub 2021 Mar 31.
Results Reference
derived
PubMed Identifier
31422845
Citation
Short NA, Stentz L, Raines AM, Boffa JW, Schmidt NB. Intervening on Thwarted Belongingness and Perceived Burdensomeness to Reduce Suicidality Among Veterans: Subanalyses From a Randomized Controlled Trial. Behav Ther. 2019 Sep;50(5):886-897. doi: 10.1016/j.beth.2019.01.004. Epub 2019 Jan 24.
Results Reference
derived
PubMed Identifier
29369665
Citation
Macatee RJ, Albanese BJ, Clancy K, Allan NP, Bernat EM, Cougle JR, Schmidt NB. Distress intolerance modulation of neurophysiological markers of cognitive control during a complex go/no-go task. J Abnorm Psychol. 2018 Jan;127(1):12-29. doi: 10.1037/abn0000323.
Results Reference
derived
PubMed Identifier
28585746
Citation
Short NA, Boffa JW, Norr AM, Albanese BJ, Allan NP, Schmidt NB. Randomized Clinical Trial Investigating the Effects of an Anxiety Sensitivity Intervention on Posttraumatic Stress Symptoms: A Replication and Extension. J Trauma Stress. 2017 Jun;30(3):296-303. doi: 10.1002/jts.22194. Epub 2017 Jun 6.
Results Reference
derived

Learn more about this trial

Depression and Anxiety Reduction Treatment for Suicide

We'll reach out to this number within 24 hrs