Overview

This trial is active, not recruiting.

Conditions anxiety, depression, suicide
Treatment psychoeducation and cognitive bias modification
Sponsor Florida State University
Collaborator United States Department of Defense
Start date November 2013
End date September 2017
Trial size 300 participants
Trial identifier NCT01941862, W81XWH-10-2-0181

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
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.
psychoeducation and cognitive bias modification
(Experimental)
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.
psychoeducation and cognitive bias modification
(Experimental)
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.
psychoeducation and cognitive bias modification
(No Intervention)
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.

Primary Outcomes

Measure
Interpersonal Needs Questionnaire (INQ)
time frame: Month 6 follow-up

Secondary Outcomes

Measure
Anxiety Sensitivity Index-3 (ASI-3)
time frame: Month 6 follow-up

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Development and Evaluation of a Brief, Suicide Prevention Intervention Targeting Anxiety and Mood Vulnerabilities
Principal investigator Norman B Schmidt, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Florida State University.